Insulin glargine: package leaflet

For patients

Package leaflet, verbatim

Lantus

Package leaflet: Lantus 100 units/ml solution for injection in a vial / Insulin glargine

1. What Lantus is and what it is used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.

Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

2. What you need to know before you use Lantus

Do not use Lantus

If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Lantus.
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Lantus). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Travel

Before travelling consult your doctor. You may need to talk about
- the availability of your insulin in the country you are visiting,
- supplies of insulin, syringes etc.,
- correct storage of your insulin while travelling,
- timing of meals and insulin administration while travelling,
- the possible effects of changing to different time zones,
- possible new health risks in the countries to be visited,
- what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):
- If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
- If you are not eating enough your blood sugar level may become too low (hypoglycaemia).
In most cases you will need a doctor. Make sure that you contact a doctor early.

If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Children

There is no experience with the use of Lantus in children below the age of 2 years.

Other medicines and Lantus

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.

Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
- all other medicines to treat diabetes,
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),
- disopyramide (used to treat certain heart conditions),
- fluoxetine (used to treat depression),
- fibrates (used to lower high levels of blood lipids),
- monoamine oxidase (MAO) inhibitors (used to treat depression),
- pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever),
- sulfonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
- corticosteroids (such as "cortisone" used to treat inflammation),
- danazol (medicine acting on ovulation),
- diazoxide (used to treat high blood pressure),
- diuretics (used to treat high blood pressure or excessive fluid retention),
- glucagon (pancreas hormone used to treat severe hypoglycaemia),
- isoniazid (used to treat tuberculosis),
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),
- phenothiazine derivatives (used to treat psychiatric disorders),
- somatropin (growth hormone),
- sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),
- thyroid hormones (used to treat thyroid gland disorders),
- atypical antipsychotic medicines (such as clozapine, olanzapine),
- protease inhibitors (used to treat HIV).

Your blood sugar level may either rise or fall if you take:
- beta-blockers (used to treat high blood pressure),
- clonidine (used to treat high blood pressure),
- lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

Lantus with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:
- you have hypoglycaemia (low blood sugar levels),
- you have hyperglycaemia (high blood sugar levels),
- you have problems with your sight.

Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines). You should contact your doctor for advice on driving if:
- you have frequent episodes of hypoglycaemia,
- the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Important information about some of the ingredients of Lantus

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Lantus

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Please, consult your doctor for further information.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will:
- determine how much Lantus per day you will need and at what time,
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- tell you when you may need to inject a higher or lower dose of Lantus.

Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents

Lantus can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need one injection of Lantus every day, at the same time of the day.

Method of administration

Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject Lantus. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle the vials

Look at the vial before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. Do not shake or mix it before use. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. Do not mix Lantus with any other insulins or medicines. Do not dilute it. Mixing or diluting may change the action of Lantus.

Always use a new vial if you notice that your blood sugar control is unexpectedly getting worse. This is because the insulin may have lost some of its effectiveness. If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist

Insulin mix-ups

You must always check the insulin label before each injection to avoid mix-ups between Lantus and other insulins.

If you use more Lantus than you should

−
If you have injected too much Lantus, your blood sugar level may become too low
(hypoglycaemia).
Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use Lantus

−
If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently.
For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
−
Do not take a double dose to make up for a forgotten dose.

If you stop using Lantus

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice signs of your blood sugar being too low (hypoglycaemia), take the action to increase you blood sugar straight away (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level falls too low, you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.

Severe allergic reactions (rare, may affect up to 1 in 1,000 people) – the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reactions.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

- Skin changes at the injection site:
If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) (may affect up to 1 in 100 people) or thicken (lipohypertrophy) (may affect up to 1 in 10 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

Common reported side effects (may affect up to 1 in 10 people)
- Skin and allergic reactions at the injection site
The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.

Rare reported side effect (may affect up to 1 in 1,000 people)
- Eye reactions
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
- General disorders
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.

Very rare reported side effects (may affect up to 1 in 10,000 people)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Use in children and adolescents

In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
There is no experience in children under 2 years.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lantus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after “EXP”. The expiry date refers to the last day of that month.

Unopened vials
Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer or a freezer pack. Keep the vial in the outer carton in order to protect from light.

Opened vials
Once in use, the 5 ml vial may be stored for a maximum of 4 weeks in the outer carton not above 25°C and away from direct heat or direct light.
Once in use, the 10 ml vial may be stored for a maximum of 4 weeks in the outer carton not above 30°C and away from direct heat or direct light.
Do not use it after this time period. It is recommended that the date of the first use be noted on the label.

Do not use Lantus if you notice particles in it. Only use Lantus if the solution is clear, colourless and waterlike.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lantus contains

The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of Lantus”) and hydrochloric acid (for pH adjustment), polysorbate 20 (10 ml vial only) and water for injections.

What Lantus looks like and contents of the pack

Lantus 100 units/ml solution for injection in a vial is a clear, colourless and waterlike solution.
Each vial contains 5 ml of solution for injection (equivalent to 500 units) or 10 ml of solution for injection (equivalent to 1000 units).
Pack sizes of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131
Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A
Tel: +34 93 485 94 00

Polska sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: +39 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?
Examples include:
- you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
- you are taking or have taken certain other medicines (see section 2, "Other medicines and Lantus").

Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

What should you do if you experience hyperglycaemia?
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?
Examples include:
- you inject too much insulin,
- you miss meals or delay them,
- you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
- you lose carbohydrates due to vomiting or diarrhoea,
- you drink alcohol, particularly if you are not eating much,
- you are doing more exercise than usual or a different type of physical activity,
- you are recovering from an injury or operation or other stress,
- you are recovering from an illness or from fever,
- you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Lantus").

Hypoglycaemia is also more likely to occur if
- you have just begun insulin treatment or changed to another insulin preparation, (when changing from your previous basal insulin to Lantus hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night)
- your blood sugar levels are almost normal or are unstable,
- you change the area of skin where you inject insulin (for example from the thigh to the upper arm),
- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

-In your body
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast:
sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

-In your brain
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
- you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
- you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
- you have almost normal or, at least, greatly improved blood sugar levels,
- you have recently changed from an animal insulin to a human insulin such as Lantus,
- you are taking or have taken certain other medicines (see section 2, "Other medicines and Lantus").

In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What should you do if you experience hypoglycaemia?

1.
Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2.
Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
The recovery of hypoglycaemia may be delayed because Lantus has a long action.
3.
If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4.
Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.

Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will require glucagon (a medicine which increases blood sugar) or an injection of glucose. These treatments are justified even if it is not certain that you have hypoglycaemia.

It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.

Package leaflet: Lantus 100 units/ml solution for injection in a cartridge / Insulin glargine

1. What Lantus is and what it is used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.

2. What you need to know before you use Lantus

Do not use Lantus

If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Lantus in cartridges is only suitable for injecting just under the skin using a reusable pen (see also section 3). Speak to your doctor if you need to inject your insulin by another method.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

Skin changes at the injection site

may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Travel

Before travelling consult your doctor. You may need to talk about
- the availability of your insulin in the country you are visiting,
- supplies of insulin, needles etc.,
- correct storage of your insulin while travelling,
- timing of meals and insulin administration while travelling,
- the possible effects of changing to different time zones,
- possible new health risks in the countries to be visited,
- what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In most cases you will need a doctor. Make sure that you contact a doctor early.

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.

Children

There is no experience with the use of Lantus in children below the age of 2 years.

Other medicines and Lantus

monoamine oxidase (MAO) inhibitors (used to treat depression),
pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever),
sulfonamide antibiotics.

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

Lantus with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:
- you have hypoglycaemia (low blood sugar levels),
- you have hyperglycaemia (high blood sugar levels),
- you have problems with your sight.

Important information about some of the ingredients of Lantus

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Lantus

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

Use in children and adolescents

Lantus can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need one injection of Lantus every day, at the same time of the day.

Method of administration

Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject Lantus. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle the cartridges

Lantus in cartridges is only suitable for injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.
To ensure you get the accurate dose, the Lantus cartridges are to be used only with the following pens:
- JuniorSTAR which delivers doses in steps of 0.5 units
- ClikSTAR, Tactipen, Autopen 24, AllStar or AllStar PRO which deliver doses in steps of 1 unit.
Not all of these pens may be marketed in your country.

The pen should be used as recommended in the information provided by the device manufacturer.
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.

Keep the cartridge at room temperature for 1 or 2 hours before inserting it in the pen.

Look at the cartridge before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. Do not shake or mix it before use.

After inserting a new cartridge:
You must check that your insulin pen is working properly before you inject the first dose. (see instructions for using the pen).

Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse.
This is because the insulin may have lost some of its effectiveness. If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.

Special care before injection

Before injection remove any air bubbles (see instructions for using the pen).

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not re-fill and re-use empty cartridges. Do not add any other insulin to the cartridge. Do not mix Lantus with any other insulins or medicines. Do not dilute it. Mixing or diluting may change the action of Lantus.

Problems with the insulin pen?

Refer to the manufacturer’s instructions for using the pen.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

Insulin mix-ups

You must always check the insulin label before each injection to avoid mix-ups between Lantus and other insulins.

If you use more Lantus than you should

If you have injected too much Lantus, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use Lantus

If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Do not take a double dose to make up for a forgotten dose.

If you stop using Lantus

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase you blood sugar level straight away (see the box at the end if this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood If your blood sugar level falls too low you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common reported side effects (may affect up to 1 in 10 people)
• Skin and allergic reactions at the injection site
The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.

Rare reported side effect (may affect up to 1 in 1,000 people)
• Eye reactions
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.

• General disorders
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.

Very rare reported side-effects (may affect up to1 in10,000 people)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Use in children and adolescents

Reporting of side effects

5. How to store Lantus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the cartridge after “EXP”. The expiry date refers to the last day of that month.

Unopened cartridges
Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer or a freezer pack. Keep the cartridge in the outer carton in order to protect from light.

In-use cartridges
Cartridges in use (in the insulin pen) or carried as a spare may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light. The cartridge in use must not be stored in a refrigerator. Do not use it after this time period.

Do not use Lantus if you notice particles in it. Only use Lantus if the solution is clear, colourless and waterlike.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lantus contains

The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of Lantus”) and hydrochloric acid (for pH adjustment) and water for injections.

What Lantus looks like and contents of the pack

Lantus 100 units/ml solution for injection in a cartridge is a clear and colourless solution.

Lantus comes in a special cartridge to be used only in conjunction with the pens ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO or JuniorSTAR. Each cartridge contains 3 ml of solution for injection (equivalent to 300 units).
Pack sizes of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40
България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A
Tel: +34 93 485 94 00

Polska sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos,Lda.
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: +39 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?
Examples include:
- you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
- your insulin pen does not work properly,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
- you are taking or have taken certain other medicines (see section 2, "Other medicines and Lantus").

HYPOGLYCAEMIA (low blood sugar levels)

Hypoglycaemia is also more likely to occur if
- you have just begun insulin treatment or changed to another insulin preparation (when changing from your previous basal insulin to Lantus hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),
- your blood sugar levels are almost normal or are unstable,
- you change the area of skin where you inject insulin (for example from the thigh to the upper arm),
- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

- In your body
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast:
sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

- In your brain
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

What should you do if you experience hypoglycaemia?

It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.

Package leaflet: Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen / Insulin glargine

1. What Lantus is and what it is used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.

2. What you need to know before you use Lantus

Do not use Lantus

If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Lantus in pre-filled pen is only suitable for injecting just under the skin (see also section 3). Speak to your doctor if you need to inject your insulin by another method.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

Skin changes at the injection site

may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Travel

Illnesses and injuries

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.

Children

There is no experience with the use of Lantus in children below the age of 2 years.

Other medicines and Lantus

pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever),
sulfonamide antibiotics.

Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.

Lantus with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.

Driving and using machines

Your ability to concentrate or react may be reduced if:
- you have hypoglycaemia (low blood sugar levels),
- you have hyperglycaemia (high blood sugar levels),
- you have problems with your sight.

Important information about some of the ingredients of Lantus

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Lantus

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
- determine how much Lantus per day you will need and at what time.
- tell you when to check your blood sugar level, and whether you need to carry out urine tests,
- tell you when you may need to inject a higher or lower dose of Lantus.

Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.

Use in children and adolescents

Lantus can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Frequency of administration

You need one injection of Lantus every day, at the same time of the day.

Method of administration

Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor will show you in which area of the skin you should inject Lantus. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle SoloStar

SoloStar is a pre-filled disposable pen containing insulin glargine. Lantus in pre-filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

Read carefully the "SoloStar Instructions for Use" included in this package leaflet. You must use the pen as described in these Instructions for Use.

A new needle must be attached before each use. Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for Use”).
A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use SoloStar if you notice particles in it. Only use SoloStar if the solution is clear, colourless and waterlike. Do not shake or mix it before use.

To prevent the possible transmission of disease, never share your pen with anyone else. This pen is only for your use.

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse.

Empty pens must not be re-filled and must be properly discarded.

Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.

Insulin mix-ups

You must always check the insulin label before each injection to avoid mix-ups between Lantus and other insulins.

If you use more Lantus than you should

−
If you have injected too much Lantus, your blood sugar level may become too low
(hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use Lantus

−
If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
−
Do not take a double dose to make up for a forgotten dose.

If you stop using Lantus

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice signs of you blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level falls too low, you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very rare reported side-effects (may affect up to 1 in 10,000 people)
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.

Use in children and adolescents

In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
There is no experience in children under 2 years.

Reporting of side effects

5. How to store Lantus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.

Not in-use pens
Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.

In use pens
Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light. The pen in use must not be stored in the refrigerator Do not use it after this time period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lantus contains

The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of Lantus) and hydrochloric acid (for pH adjustment) and water for injections.

What Lantus looks like and contents of the pack

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen is a clear and colourless solution. Each pen contains 3 ml of solution for injection (equivalent to 300 units).
Pack sizes of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A
Tel: +34 93 485 94 00

Polska sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00
Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600
Italia
Sanofi S.r.l.
Tel: +39 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?
Examples include:
- you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
- your insulin pen does not work properly,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
- you are taking or have taken certain other medicines (see section 2, "Other medicines and Lantus").

Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine . Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

HYPOGLYCAEMIA (low blood sugar levels)

Warning symptoms of hypoglycaemia

- In your body
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast:
sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

- In your brain
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

What should you do if you experience hypoglycaemia?

It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.

Lantus SoloStar solution for injection in a pre-filled pen. INSTRUCTION FOR USE

SoloStar is a pre-filled pen for the injection of insulin. Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.

Read these instructions carefully before using your SoloStar. If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.

You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Keep this leaflet for future reference.
If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local representative number on the front of this leaflet.

Schematic diagram of the pen

Important information for use of SoloStar:

Always attach a new needle before each use. Only use needles that are compatible for use with SoloStar.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the safety test before each injection (see Step 3).
This pen is only for your use. Do not share it with anyone else.
If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Always have a spare SoloStar in case your SoloStar is lost or damaged.

Step 1. Check the insulin

A.
Check the label on your SoloStar to make sure you have the correct insulin. The Lantus Solostar is grey with a purple injection button.

B.
Take off the pen cap.

C.
Check the appearance of your insulin. Lantus is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

A.
Remove the protective seal from a new needle.

B.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

Step 3. Perform a Safety test

Always perform the safety test before each injection. This ensures that you get an accurate dose by:
- ensuring that pen and needle work properly
- removing air bubbles

A.
Select a dose of 2 units by turning the dosage selector.

B.
Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.

C.
Hold the pen with the needle pointing upwards.

D.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.

E.
Press the injection button all the way in. Check if insulin comes out of the needle tip.

You may have to perform the safety test several times before insulin is seen.

If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
If still no insulin comes out, the needle may be blocked. Change the needle and try again.
If no insulin comes out after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

A.
Check that the dose window shows “0” following the safety test.

B.
Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

Do not push the injection button while turning, as insulin will come out.

You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.

Step 5. Inject the dose

A.
Use the injection method as instructed by your doctor, pharmacist or nurse.

B.
Insert the needle into the skin.

C.
Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to “0” as you inject.

D.
Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar without a needle attached.
This helps prevent:
- Contamination and/or infection,
- Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A.
Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
- If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle. Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B.
Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.

C.
Always put the pen cap back on the pen, then store the pen until your next injection.

Storage instructions

See the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.

If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up.
Cold insulin is more painful to inject.

Discard your used SoloStar as required by your local authorities.

Maintenance

Protect your SoloStar from dust and dirt.

You can clean the outside of your SoloStar by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.

Toujeo (previously Optisulin)

Package leaflet: Toujeo 300 units/ml SoloStar solution for injection in a pre-filled pen / Insulin glargine

1. What Toujeo is and what it is used for

Toujeo is a type of long-acting insulin called ‘insulin glargine’.
- It is very similar to human insulin.
- It contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.
- It lowers your blood sugar steadily over a long period of time.
- It is injected once a day.
- You can change the time of your injection if you need to (for more information see section 3).

Toujeo is used to treat diabetes mellitus (diabetes) in adults, adolescents and children from the age of 6 years. This is an illness where your body does not make enough insulin to control your blood sugar.

2. What you need to know before you use Toujeo

Do not use Toujeo
- if you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Toujeo. Closely follow your doctors instructions for how much Toujeo to use, how to monitor your blood and urine, your diet and physical activity levels and injection technique.

Important:
- If your blood sugar is too low (hypoglycaemia) – see ‘what to do if you have low blood sugar’ at the end of this leaflet.
- Switching insulin - If you switch from another type, brand or manufacturer of insulin your dose may need to be changed.
- Pioglitazone used together with insulin can cause serious problems – see ‘Pioglitazone’ below.

Make sure you use the right type of insulin – always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins.
Never use a syringe to remove Toujeo from your pen. This is to avoid dosing errors and potential overdose which may lead to low blood sugar.
If you are blind or have poor eyesight, do not use the pre-filled pen without help. This is because you will not be able to read the dose window on the pen. Get help from a person with good eyesight who is trained in using the pen.

Skin changes where the injection is given
Change where you inject regularly. This is to prevent skin changes such as thickening, shrinking or lumps. The insulin may not work well if you inject into a lumpy area.
- Tell your doctor, pharmacist or nurse if you are currently injecting into a lumpy area before you start injecting in a different area.
Your doctor may tell you to check your blood sugar more closely, and to adjust the dose of your insulin or other anti-diabetic medications.

Illnesses and injuries
You may need to check your blood and urine more carefully to manage your diabetes if:
- you are ill or have a major injury. Your blood sugar level may increase - hyperglycaemia.
- you are not eating enough. Your blood sugar level may get too low - hypoglycaemia.
Tell a doctor as soon as you feel ill or get an injury.

If you have Type 1 diabetes and you have an illness or injury:
- do not stop your insulin
- keep eating enough carbohydrates.
Always tell people who are caring or treating you, that you have diabetes.

Insulin antibodies
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.

Travel and Toujeo
If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections. Talk to your doctor before travelling. You may need to talk about:
- If your type of insulin is available in the country you are visiting.
- How to arrange the supply of insulin, needles and other items.
- How to correctly store your insulin while travelling.
- The time you eat meals and use your insulin.
- The possible effects of changing to different time zones.
- Any health risks in the countries you will visit.
- What you should do in an emergency situation if you feel unwell or become ill.

Children and adolescents
Do not give this medicine to children under 6 years of age. This is because there is no experience with Toujeo in children of this age.

Other medicines and Toujeo
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines can change your blood sugar level. Your doctor will tell you if your insulin dose has to change. You also need to be careful when you stop taking a medicine.

Listed below are the most common medicines which may affect your insulin treatment:
Your blood sugar level may fall (hypoglycaemia) if you take:
- any other medicine for diabetes
- disopyramide – for some heart problems

fluoxetine – for depression
pentamidine – for some parasitic infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar
sulfonamide antibiotics – for infection
fibrates – for lowering high levels of fat in the blood
monoamine oxidase inhibitors (MAOIs) – for depression
pentoxifylline, propoxyphene and salicylates (such as aspirin) – for pain and mild fever
angiotensin converting enzyme (ACE) inhibitors – for heart problems or high blood pressure.

Your blood sugar level may rise (hyperglycaemia) if you take:
- danazol – for endometriosis
- diazoxide – for high blood pressure
- glucagon – for very low blood sugar
- isoniazid – for tuberculosis
- somatropin – a growth hormone
- thyroid hormones – for thyroid gland problems
- oestrogens and progestogens – such as in the contraceptive pill, for birth control
- corticosteroids such as cortisone – for inflammation
- protease inhibitors – for HIV
- diuretics – for high blood pressure or fluid retention
- clozapine, olanzapine and phenothiazine derivatives – for mental health problems
- sympathomimetics such as epinephrine (adrenaline), salbutamol and terbutaline – for asthma.

Your blood sugar level may either rise or fall if you take:
- beta-blockers or clonidine – for high blood pressure.
- lithium salts – for mental health problems.

Beta-blockers
- Beta-blockers like other “Sympatholytic medicines” (such as clonidine, guanethidine , reserpine– for high blood pressure) can hide or stop the signs of your blood sugar being too low (hypoglycaemia) or may make it harder to recognise warning signs.

Pioglitazone
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke treated with pioglitazone and insulin developed heart failure.
- Tell your doctor straight away if you have signs of heart failure – such as feeling unusually short of breath, rapid weight gain or localised swelling.

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using Toujeo.

Toujeo with alcohol
Your blood sugar level may rise or fall if you drink alcohol – you will need to check your blood sugar level more often than usual.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine:
- you may need to change your insulin dose during pregnancy and after giving birth, or both insulin dose and diet during breast-feeding
- to protect your baby it is very important to control your diabetes and prevent low blood sugar.

Driving and using machines
Having too low or too high blood sugar or sight problems can affect your ability to drive, use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others. Ask your doctor, pharmacist or nurse whether you can drive, use tools or machines if:
- you often get low blood sugar
- you find it hard to recognise your low blood sugar.

Toujeo contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium- free’.

3. How to use Toujeo

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Toujeo and insulin glargine 100 units/ml are not interchangeable, even though they contain same active substance. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Talk to your doctor for further information.

How much to use
The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 1 unit. The dose window of the SoloStar pen shows the number of units of Toujeo to be injected and no dose re-calculation is required.

Your doctor will decide:
- how much Toujeo you need each day and at what time
- when to check your blood sugar level and if you need to carry out urine tests
- when you may need a higher or lower dose.
These are based on your life-style, your blood sugar (glucose) tests and your insulin use in the past.

Talk to your doctor as you may need a lower dose if:
- you are 65 years or older
- you have kidney or liver problems.

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar.

Make sure you use the right type of insulin.
- Always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins .
- The strength “300” is highlighted in honey gold on the label of your Toujeo SoloStar pre-filled pen. Ask your doctor or pharmacist if you are not sure.

Many factors may affect your blood sugar level – learn what these are and what to do if your blood sugar level changes. This will help stop it becoming too high or too low. See ‘hyperglycaemia and hypoglycaemia’ at the end of this leaflet for more information.

When to use Toujeo
- Use Toujeo once a day, preferably at the same time every day.
- You can inject it up to 3 hours before or after the usual time that you use it.

Before injecting Toujeo
- Read the instructions for use that come with this package leaflet.
- If you do not follow all the instructions, you may get too much or too little insulin.

How to inject
- Inject Toujeo under the skin. This is called ‘subcutaneous use’ or ‘SC’.
- Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).
- Change the place within the area where you inject each day – to reduce the risk of skin shrinking or thickening (see section 4).
- Always use a new sterile needle for each injection – to reduce the risk of infection and blocked needles which can lead to you getting too much or too little insulin.
- Throw away the used needle in a puncture resistant container, or as instructed by your pharmacist.
- Do not share your insulin pen with anyone else, even when the needle is changed – to prevent spreading disease.
- Do not use a syringe to remove Toujeo from your pen – to avoid potential overdose.

Do not use Toujeo:
- in a vein – this changes the way it works and may cause your blood sugar to become too low.
- in an insulin infusion pump.
- if there are particles in the insulin – the liquid should be clear, colourless and water-like

Throw the pen away and use a new one if:
- you notice that your blood sugar control is unexpectedly getting worse
- the pen is damaged or has not been stored correctly.
Talk to your doctor, pharmacist or nurse if you are not sure your pen is working properly.

If you use more Toujeo than you should
If you use too much of this medicine, your blood sugar level may get too low – see ‘low blood sugar’ at the end of this leaflet for advice.

If you forget to use Toujeo
- If you forget a dose, inject the missed dose within 3 hours of the time you usually inject it.
- If you remember when more than 3 hours have passed, do not inject the missed dose – check your blood sugar and then inject your next dose at the usual time the next day.
- Do not inject a double dose to make up for a forgotten dose.
- If you miss a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may get too high – see ‘high blood sugar (hyperglycaemia)’ at the end of this leaflet for advice.

If you stop using Toujeo
Do not stop using this medicine without talking to your doctor. If you stop using this medicine, this could lead to very high blood sugar and a build-up of acid in the blood called ‘ketoacidosis’, see ‘high blood sugar’ at the end of this leaflet for advice.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

If you have signs of low blood sugar, try to increase your blood sugar level straight away. See advice in ‘low blood sugar’ at the end of this leaflet.

The signs of severe allergic reactions (rare: may affect up to 1 in 1,000 people) may include:
- feeling short of breath
- swelling of the skin or mouth
- rash and itching all over the body
- feeling faint with fast heartbeat and sweating.
Tell your doctor, pharmacist or nurse straight away as severe allergic reactions may become life-threatening.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Skin changes where the injection is given
If you inject insulin too often at the same place, the skin may change which include:
- skin shrinking (lipoatrophy) (may affect up to 1 in 100 people)
- skin thickening (lipohypertrophy) (may affect up to 1 in 10 people)
- lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area.
Change the area where the injection is given regularly to prevent skin changes.

Common: may affect up to 1 in 10 people
- skin and allergic reactions where the injection is given, The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear within a few days to a few weeks.

Rare: may affect up to 1 in 1,000 people
- eye problems – a large change in your blood sugar control, getting better or worse, can disturb your vision. If you have a diabetic eye disorder called “proliferative retinopathy”, very low blood sugar attack may cause temporary loss of vision.
- swelling in the calves and ankles – due to your body keeping more water than it should.

Very rare: may affect up to 1 in 10,000 people
- changes in taste (dysgeusia).
- muscular pain (myalgia).

Tell your doctor, pharmacist or nurse if you notice any of the side effects above.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Toujeo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month.

Before first use
- Store in a refrigerator, 2°C - 8°C.
- Do not freeze or place next to the freezer compartment or a freezer pack.
- Keep the pen in the outer carton in order to protect from light.

After first use or if carried as a spare
- Do not store the pen in a refrigerator.
- The pen may be stored for up to 6 weeks at room temperature - below 30°C and away from direct heat or direct light. Discard the pen after this time period.
- Do not leave your insulin in a car on a very warm or cold day.
- Always keep the cap on the pen when you are not using it in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

6. Contents of the pack and other information

What Toujeo contains
- The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.
- The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 ‘Toujeo contains sodium’) and hydrochloric acid (for pH adjustment).

What Toujeo looks like and contents of the pack
- Toujeo is a clear and colourless solution.
- Each pen contains 1.5 ml of solution for injection (equivalent to 450 units).
- Packs of 1, 3, 5 and 10 pre-filled pens.
- Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország sanofi-aventis zrt., Magyarország
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52010
Tel : aus dem Ausland +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: +39 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Hyperglycaemia and hypoglycaemia

If you take insulin, you should always carry the following things with you:
- Sugar (at least 20 grams).
- Information so that others know you have diabetes.

High blood sugar (hyperglycaemia)

Warning signs of high blood sugar:
- feeling thirsty, needing to urinate more often
- feeling tired or dry skin, reddening of the face, loss of appetite
- low blood pressure, fast heartbeat
- glucose and ketone bodies in urine
- stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

What to do if you have high blood sugar
- Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs.
- Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital.

High blood sugar can happen if:
- you have not injected your insulin or not injected enough.
- your insulin is not working properly – this could be because it was not stored properly.
- your insulin pen does not work properly.
- you do less exercise than usual.
- you are under stress – such as emotional distress or excitement.
- you have an injury, infection or fever or have had an operation.
- you take or have taken some other medicines, see section 2 – ‘Other medicines and Toujeo’.

Low blood sugar (hypoglycaemia)
Very low blood sugar may make you pass out (unconscious), cause a heart attack or brain damage and be life-threatening. Learn to recognise the signs when your blood sugar is falling – and what to do to stop it getting worse.

Warning signs of low blood sugar
The first signs may be in your body generally:
- feeling sweaty
- having clammy skin
- feeling anxious
- fast or irregular heartbeat, high blood pressure, palpitations

Other signs in your brain may come slightly later:
- headache, trembling, feeling dizzy
- changes in your sight
- feeling very hungry, feeling sick (nausea) or vomiting
- changes in behaviour, aggression, depression
- feeling tired or sleepy, sleeping problems, feeling restless
- difficulty concentrating, confusion, slowed reactions or difficulty speaking (sometimes total loss of speech)
- not being able to move (paralysis), tingling in hands or arms, feeling numb and tingling often around the mouth
- loss of self-control, being unable to look after yourself, fits or passing out.

What to do if you have low blood sugar
1.
Do not inject insulin.
2.
Take about 10 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary-drink.
Do not drink or eat foods that contain artificial sweeteners (such as diet drinks). They do not help treat low blood sugar.
3.
Then eat something such as bread or pasta that will raise your blood sugar over a longer time.
Ask your doctor or nurse if you are not sure which foods you should eat. With Toujeo, it may take longer to recover from low blood sugar because it is long-acting.
4.
If the low blood sugar comes back again, take another 10 to 20 grams of sugar.
5.
Speak to a doctor straight away if you are not able to control the low blood sugar - or if it comes back.

What other people should do if you have low blood sugar
- Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
- You will require glucagon (a medicine which increases blood sugar) or an injection of glucose.
These treatments should be given even if it is not certain that you have hypoglycaemia.
- You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.

Low blood sugar can happen if:
- you inject too much insulin.
- you miss meals or eat late.
- you do not eat enough, or eat food containing less sugar than normal – artificial sweeteners are not sugars.
- you drink alcohol – especially when you have not eaten much.
- you are sick (vomit) or have diarrhoea.
- you do more exercise than usual or a different type of physical activity.
- you are recovering from an injury, operation or other stress.
- you are recovering from an illness or from fever.
- you take or have taken some other medicines, see section 2 – ‘Other medicines and Toujeo’.

Low blood sugar is more likely to happen if:
- you have just started insulin treatment or changed to another insulin – if low blood sugar occurs, it may be more likely to happen in the morning.
- your blood sugar levels are almost normal or are unstable.
- you change the area of body where you inject insulin, for example from the thigh to the upper arm.
- you have severe kidney or liver disease, or some other disease such as hypothyroidism.

Signs of low blood sugar may be different, less clear or missing if:
- you are elderly
- you have had diabetes for a long time.
- you have a nervous disease called “diabetic autonomic neuropathy”.
- you have recently had too low blood sugar, for example the day before.
- your low blood sugar comes on slowly.
- your low blood sugar is always around “normal” or your blood sugar has got much better.
- you have recently changed from an animal insulin to a human insulin, like Toujeo.
- you take or have taken some other medicines, see section 2, ‘Other medicines and Toujeo’.

In such cases, you may get very low blood sugar and even pass out before you know what is happening. Know your warning signs. You may need to test your blood sugar more often - to help you spot low blood sugar. If you find it difficult to spot your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by low blood sugar.

Toujeo 300 units/ml solution for injection in a pre-filled pen (SoloStar)
INSTRUCTIONS FOR USE

Read this first

Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen
- Never re-use needles. If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.
- Never use a syringe to remove insulin from your pen. If you do you will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.

Important information

Never share your pen – it is only for you.
Never use your pen if it is damaged or if you are not sure that it is working properly.
Always perform a safety test
Always carry a spare pen and spare needles in case they got lost or stop working.

Learn to inject

Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call Sanofi number on the front of this leaflet.

Extra items you will need:

a new sterile needle (see STEP 2).
a puncture resistant container for used needles and pens.

Places to inject

Stomach
Upper arms
Thighs

Get to know your pen

* You will not see the plunger until you have injected a few doses.

STEP 1: Check your pen

Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful to inject.

A Check the name and expiration date on the label of your pen.
- Make sure you have the correct insulin. This is especially important if you have other injector pens.
- Never use your pen after the expiration date.

B Pull off the pen cap.

C Check that the insulin is clear.
- Do not use the pen if the insulin looks cloudy, coloured or contains particles.

Pen cap
Rubber seal
Insulin scale
Insulin name
Injection button
Dose selector
Cartridge holder
Plunger*
Dose window Dose pointer

STEP 2: Attach a new needle

Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
Only use needles that are compatible for use with Toujeo (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).

A Take a new needle and peel off the protective seal.

B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.

C
Pull off the outer needle cap. Keep this for later.

D
Pull off the inner needle cap and throw away.

Handling needles
- Take care when handling needles – this is to prevent needle injury and cross-infection.

STEP 3: Do a safety test

Always do a safety test before each injection – this is to:
- check your pen and the needle are working properly.
- make sure that you get the correct insulin dose.

A Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4.

B Press the injection button all the way in.
- When insulin comes out of the needle tip, your pen is working correctly.

If no insulin appears:
- You may need to repeat this step up to 3 times before seeing insulin.
- If no insulin comes out after the third time, the needle may be blocked. If this happens:
- change the needle (see STEP 6 and STEP 2),
- then repeat the safety test (STEP 3).
- Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
- Never use a syringe to remove insulin from your pen.

If you see air bubbles
- You may see air bubbles in the insulin. This is normal, they will not harm you.

STEP 4: Select the dose

Never select a dose or press the injection button without a needle attached. This may damage your pen.

A Make sure a needle is attached and the dose is set to ‘0’.

B Turn the dose selector until the dose pointer lines up with your dose.
- If you turn past your dose, you can turn back down.
- If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
- If you cannot select your full prescribed dose, split the dose into two injections or use a new pen.

How to read the dose window

Even numbers are shown in line with the dose pointer:

Odd numbers are shown as a line between even numbers:

Units of insulin in your pen
- Your pen contains a total of 450 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
- You can see roughly how many units of insulin are left by looking at where the plunger is on the 30 units selected 29 units selected

insulin scale.
STEP 5: Inject your dose

If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

A Choose a place to inject as shown in the picture

B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
- Do not touch the injection button yet.

C Place your thumb on the injection button. Then press all the way in and hold.
- Do not press at an angle – your thumb could block the dose selector from turning.

D Keep the injection button held in and when you see "0" in the dose window, slowly count to 5.
- This will make sure you get your full dose.

E After holding and slowly counting to 5, release the injection button. Then remove the needle from your skin.

If you find it hard to press the button in:
- Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).

If you still find it hard to press in, get a new pen.
Never use a syringe to remove insulin from your pen.

STEP 6: Remove the needle

Take care when handling needles – this is to prevent needle injury and cross-infection.
Never put the inner needle cap back on.

A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
- To reduce the risk of accidental needle injury, never replace the inner needle cap.
- If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
- Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.

C Put the pen cap back on.
- Do not put the pen back in the fridge.

Use by

Only use your pen for up to 6 weeks after its first use.

How to store your pen

Before first use
- Keep new pens in a fridge, at 2°C to 8°C.
- Do not freeze.

After first use
- Keep your pen at room temperature, below 30°C.
- Never put your pen back in the fridge.
- Never store your pen with the needle attached.
- Store your pen with the pen cap on.

How to care for your pen

Handle your pen with care
- Do not drop your pen or knock it against hard surfaces.
- If you think that your pen may be damaged, do not try to repair it, use a new one.

Protect your pen from dust and dirt
- You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or lubricate your pen – this may damage it.

Throwing your pen away
- Remove the needle before throwing your pen away.
- Throw away your used pen as told by your pharmacist or local authority.

Package leaflet: Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen / Insulin glargine / Each DoubleStar pen delivers 2-160 units in steps of 2 units

1. What Toujeo is and what it is used for

2. What you need to know before you use Toujeo

Do not use Toujeo
- If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6).

Make sure you use the right type of insulin – always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins.
Never use a syringe to remove Toujeo from your pen. This is to avoid dosing errors and potential overdose which may lead to low blood sugar
To avoid an insulin underdose, perform safety tests before the first use of a new pen and also before every use of the pen (see Step 3 of the Instructions for use). Please, see also section 3.
If you are blind or have poor eyesight, do not use the pre-filled pen without help. This is because you will not be able to read the dose window on the pen. Get help from a person with good eyesight who is trained in using the pen.

Children and adolescents
Do not give this medicine to children under 6 years of age. This is because there is no experience with Toujeo in children of this age.

Listed below are the most common medicines which may affect your insulin treatment:

Your blood sugar level may fall (hypoglycaemia) if you take:
- any other medicine for diabetes
- disopyramide – for some heart problems
- fluoxetine – for depression
- pentamidine – for some parasitic infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar
- sulfonamide antibiotics – for infection
- fibrates – for lowering high levels of fat in the blood
- monoamine oxidase inhibitors (MAOIs) – for depression
- pentoxifylline, propoxyphene and salicylates (such as aspirin) – for pain and mild fever
- angiotensin converting enzyme (ACE) inhibitors – for heart problems or high blood pressure.

Your blood sugar level may either rise or fall if you take:
- beta-blockers or clonidine – for high blood pressure.
- lithium salts – for mental health problems.

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using Toujeo.

Toujeo with alcohol
Your blood sugar level may rise or fall if you drink alcohol – you will need to check your blood sugar level more often than usual.

you often get low blood sugar
you find it hard to recognise your low blood sugar.

Toujeo contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium- free’

3. How to use Toujeo

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use
The Toujeo DoubleStar pre-filled pen can provide a dose of 2 to 160 units per injection, in steps of 2 units. The pen is recommended for patient who need at least 20 units of insulin per day (see also section 2).dose window of the DoubleStar pen shows the number of units of Toujeo to be injected and no dose re-calculation is required.

Talk to your doctor as you may need a lower dose if:
- you are 65 years or older
- you have kidney or liver problems.

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar.

Make sure you use the right type of insulin.
- Always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins .
- The strength “300” is highlighted in honey gold on the label of your Toujeo DoubleStar pre-filled pen. Ask your doctor or pharmacist if you are not sure.

When to use Toujeo
- Use Toujeo once a day, preferably at the same time every day.
- You can inject it up to 3 hours before or after the usual time that you use it.

Before injecting Toujeo
- Read the instructions for use that come with this package leaflet.
- If you do not follow all the instructions, you may get too much or too little insulin.
- Perform a safety test as described in Step 3 of the Instructions for Use. If you don’t, your full dose will not be delivered. If this occurs, you should increase the frequency of checking your blood sugar level and might need to administer additional insulin. Please, also see section 2.

If you use more Toujeo than you should
If you use too much of this medicine, your blood sugar level may get too low – see ‘low blood sugar’ at the end of this leaflet for advice.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Low blood sugar (hypoglycaemia) – very common: may affect more than 1 in 10 people
- If your blood sugar falls too much, you may pass out.
- Serious low blood sugar may cause brain damage and may be life-threatening.
If you have signs of low blood sugar, try to increase your blood sugar level straight away. See advice in ‘low blood sugar’ at the end of this leaflet.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very rare: may affect up to 1 in 10,000 people
- changes in taste (dysgeusia).
- muscular pain (myalgia).

Tell your doctor, pharmacist or nurse if you notice any of the side effects above.

5. How to store Toujeo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month.

Before first use
- Store in a refrigerator, 2°C - 8°C.
- Do not freeze or place next to the freezer compartment or a freezer pack.
- Keep the pen in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

6. Contents of the pack and other information

What Toujeo contains
- The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each DoubleStar pen contains 3 ml of solution for injection, equivalent to 900 units.
- The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 ‘ Toujeo contains sodium’) and hydrochloric acid (for pH adjustment).

What Toujeo looks like and contents of the pack
- Toujeo is a clear and colourless solution.
- Each DoubleStar pen contains 3 ml of solution for injection (equivalent to 900 units).
- Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.
- Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország sanofi-aventis zrt., Magyarország
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel : 0800 52 52010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: +39 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Hyperglycaemia and hypoglycaemia

If you take insulin, you should always carry the following things with you:
- Sugar (at least 20 grams).
- Information so that others know you have diabetes.

High blood sugar (hyperglycaemia)

What to do if you have high blood sugar
- Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs
- Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital.

Low blood sugar (hypoglycaemia)
Very low blood sugar may make you pass out (unconscious), cause heart attack or brain damage and be life-threatening. Learn to recognise the signs when your blood sugar is falling – and what to do to stop it getting worse.

Signs of low blood sugar may be different, less clear or missing if:
- you are elderly.
- you have had diabetes for a long time.
- you have a nervous disease called “diabetic autonomic neuropathy”.
- you have recently had too low blood sugar, for example the day before.
- your low blood sugar comes on slowly.
- your low blood sugar is always around “normal” or your blood sugar has got much better.
- you have recently changed from an animal insulin to a human insulin, like Toujeo.
- you take or have taken some other medicines, see section 2, ‘Other medicines and Toujeo’.

Toujeo 300 units/ml solution for injection in a pre-filled pen (DoubleStar)
INSTRUCTIONS FOR USE

Read this first

Toujeo DoubleStar contains 300 units/ml insulin glargine in a 3 ml disposable prefilled pen
- Never re-use needles. If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.
- Never use a syringe to remove insulin from your pen. If you do you will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.
- The dose selector of your Toujeo DoubleStar pen dials in steps of 2 units.

Important information

Never share your pen – it is only for you.
Never use your pen if it is damaged or if you are not sure that it is working properly.
Always perform a safety test before you use a new pen for the first time until you see insulin coming out of the needle tip (see STEP 3). If you see insulin coming out the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar To ensure the pen and needle are working, always perform the safety test until you see insulin coming out the needle tip before each injection (see STEP 3). If you do not perform the safety test before each injection, you may get too little insulin.
Always carry a spare pen and spare needles in case they get lost or stop working.

Learn to inject

Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
This pen is not recommended for use by people who are blind or have visual impairments without the assistance of a person trained in the proper use of the product.
Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call Sanofi number on the front of this leaflet.

Extra items you will need:

a new sterile needle (see STEP 2).
a puncture resistant container for used needles and pens.

Get to know your pen

* You will not see the plunger until you have injected a few doses.

STEP 1: Check your pen

Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful to inject.

B Pull off the pen cap.

C Check that the insulin is clear.
- Do not use the pen if the insulin looks cloudy, coloured or contains particles.

Cartridge holder
Plunger*
Pen cap
Rubber seal
Insulin scale
Insulin name
Dose selector
Injection button
Dose pointer
Dose window

STEP 2: Attach a new needle

Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
Only use needles that are compatible for use with Toujeo DoubleStar (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford) that are 8 mm long or shorter.

A Take a new needle and peel off the protective seal.

B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.

C
Pull off the outer needle cap. Keep this for later.

D
Pull off the inner needle cap and throw away.

Handling needles
- Take care when handling needles – this is to prevent needle injury and cross-infection.

STEP 3: Do a safety test

Always do a safety test before each injection – this is to:
- check your pen and the needle are working properly.
- make sure that you get the correct insulin dose.

If the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. If you see insulin coming out of the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar.

A Select 4 units by turning the dose selector until the dose pointer is at the 4 mark.

B Press the injection button all the way in.
- When insulin comes out of the needle tip, your pen is working correctly.

C
Repeat this step if no insulin appears:
- If you are using a new pen for the first time, you may have to repeat this step up to 6 times before seeing insulin.
- Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
- For all injections, if no insulin comes out, the needle may be blocked. If this happens:
- change the needle (see STEP 6 and STEP 2),
- then repeat the safety test (STEP 3A and STEP 3 B).
- Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
- Never use a syringe to remove insulin from your pen.

If you see air bubbles
- You may see air bubbles in the insulin. This is normal, they will not harm you.

STEP 4: Select the dose

Never select a dose or press the injection button without a needle attached. This may damage your pen.

Toujeo DoubleStar is made to deliver the number of insulin units that your doctor prescribed. Do not perform any dose re-calculation.

A Make sure a needle is attached and the dose is set to ‘0’.

B Turn the dose selector until the dose pointer lines up with your dose.
- Set the dose by turning the dose selector to a line in the dose window. Each line equals 2 units
- The dial clicks as you turn it
- Do not dial your dose by counting the clicks. You may dial the wrong dose. This may lead to you getting too much insulin or not enough insulin.
- Always check the number in the dose window to make sure you dialled the correct dose
- If you turn past your dose, you can turn back down.
- If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
- If you cannot select your full prescribed dose, split the dose into two injections or use a new pen. If you use a new pen, perform a safety test (see STEP 3).

How to read the dose window
The dose selector adjusts in steps of 2 units.
Each line in the dose window is an even number:

60 units selected

Units of insulin in your pen
- Your pen contains a total of 900 units of insulin. You can select doses from 2 to 160 units in steps of 2 units at a time. Each pen contains more than one dose.
- You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

STEP 5: Inject your dose

If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

A Choose a place to inject as shown in the picture labelled “Places to inject”

B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
- Do not touch the injection button yet.

C Place your thumb on the injection button. Then press all the way in and hold.
- Do not press at an angle – your thumb could block the dose selector from turning.

58 units selected

D
Keep the injection button held in and when you see "0" in the dose window, slowly count to 5.
- This will make sure you get your full dose.

E After holding and slowly counting to 5, release the injection button. Then remove the needle from your skin.

If you find it hard to press the button in:
- Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
- If you still find it hard to press in, get a new pen.
- Never use a syringe to remove insulin from your pen.

STEP 6: Remove the needle

Take care when handling needles – this is to prevent needle injury and cross-infection.
Never put the inner needle cap back on.

B Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.

C Put the pen cap back on.
- Do not put the pen back in the fridge.

Use by

Only use your pen for up to 6 weeks after its first use.

How to store your pen

Before first use
- Keep new pens in a fridge, at 2°C to 8°C.
- Do not freeze.

After first use
- Keep your pen at room temperature, below 30°C.
- Never put your pen back in the fridge.
- Never store your pen with the needle attached.
- Store your pen with the pen cap on.
- Keep your pen and needles out of the sight and reach of children

How to care for your pen

Handle your pen with care
- Do not drop your pen or knock it against hard surfaces.
- If you think that your pen may be damaged, do not try to repair it, use a new one.

Protect your pen from dust and dirt
- You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or lubricate your pen – this may damage it.

Throwing your pen away
- Remove the needle before throwing your pen away.
- Throw away your used pen as told by your pharmacist or local authority.

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.