Package leaflet: Tamiflu 30 mg hard capsules

1. What Tamiflu is and what it is used for

Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
Tamiflu may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community.
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

2. What you need to know before you take Tamiflu

Do not take Tamiflu:
- if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu listed in section 6.
Talk to your doctor if this applies to you. Do not take Tamiflu.

Warnings and precautions:
Before you take Tamiflu, make sure the prescribing doctor knows
- if you are allergic to other medicines
- if you have problems with your kidneys. If so, your dose may need adjustment
- if you have a severe medical condition, which may require immediate hospitalisation
- if your immune system is not working
- if you have chronic heart disease or respiratory disease.

During treatment with Tamiflu, tell a doctor immediately:
- if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents). These may be signs of rare but serious side effects.

Tamiflu is not a flu vaccine
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Other medicines and Tamiflu
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This includes medicines obtained without a prescription. The following medicines are particularly important:
- chlorpropamide (used to treat diabetes)
- methotrexate (used to treat e.g. rheumatoid arthritis)
- phenylbutazone (used to treat pain and inflammation)
- probenecid (used to treat gout)

Pregnancy and breast-feeding
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Tamiflu is right for you.

The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.

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

Driving and using machines
Tamiflu has no effect on your ability to drive or use machines.

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

3. How to take Tamiflu

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

Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting.

The recommended doses

For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly.

For patients with a weak immune system, treatment will continue for 10 days.

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient’s body weight.You must use the amount of oral capsules or suspension prescribed by the doctor.

Adults, and adolescents 13 years and over

Body weight
Treating flu:
dose for 5 days
Treating flu
(Immunocompromised
Patients):
dose for 10 days*
Preventing flu:
dose for 10 days
More than 40 kg
75 mg** twice daily
75 mg** twice daily
75 mg** once daily
* For patients with a weak immune system, treatment is for 10 days
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Children 1 to 12 years

Body weight
Treating flu:
dose for 5 days
Treating flu
(Immunocompromised
Patients):
dose for 10 days*
Preventing flu:
dose for 10 days
10 to 15 kg
30 mg twice daily
30 mg twice daily
30 mg once daily
More than 15 kg and up to 23 kg
45 mg twice daily
45 mg twice daily
45 mg once daily
More than 23 kg and up to 40 kg
60 mg twice daily
60 mg twice daily
60 mg once daily
More than 40 kg
75 mg** twice daily
75 mg** twice daily
75 mg** once daily
* For children with a weak immune system, treatment is for 10 days**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Infants less than 1 year (0 to 12 months)
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

Body weight
Treating flu:
dose for 5 days
Treating flu
(Immunocompromised
Patients):
dose for 10 days*
Preventing flu:
dose for 10 days
3 kg to 10+ kg,

3 mg per kg body weight**, twice daily
3 mg per kg body weight**, twice daily
3 mg per kg**, once daily
* For infants with a weak immune system, treatment is for 10 days.
** mg per kg = mg for each kilogram of the infant’s body weight. For example:
If a 6-month-old weighs 8 kg, the dose is
8 kg x 3mg per kg = 24 mg

Method of administration
Swallow the capsules whole with water. Do not break or chew the capsules.

Tamiflu can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension. If you need Tamiflu oral suspension, but it’s not available from your pharmacy, you can make a liquid form of Tamiflu from these capsules. See Making liquid Tamiflu at home, over the page.

If you take more Tamiflu than you should
Stop taking Tamiflu and contact a doctor or pharmacist immediately.
In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Overdose has been reported to have occurred more frequently when Tamiflu was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for children and when administering Tamiflu capsules or liquid Tamiflu to children.

If you forget to take Tamiflu
Do not take a double dose to make up for a forgotten capsule.

If you stop taking Tamiflu
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.

The following serious side effects have been rarely reported since oseltamivir has been marketed:
- Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
- Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
- Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
- Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
- Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
- Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, get medical help immediately.

The most frequently (very common and common) reported side effects of Tamiflu are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.

Rare but serious effects: get medical help at once
(These may affect up to 1 in 1,000 people)
During Tamiflu treatment, rare events have been reported that include
- Convulsions and delirium, including altered level of consciousness

- Confusion, abnormal behaviour
- Delusions, hallucinations, agitation, anxiety, nightmares
These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
- Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.
If you notice any of these symptoms, especially in younger people, get medical help immediately.

Adults and adolescents 13 and over

Very common side effects
(may affect more than 1 in 10 people)
- Headache
- Nausea.

Common side effects
(may affect up to 1 in 10 people)
- Bronchitis
- Cold sore virus
- Cough
- Dizziness
- Fever
- Pain
- Pain in limb
- Runny nose
- Sleeping difficulties
- Sore throat
- Stomach ache
- Tiredness
- Upper abdominal fullness
- Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
- Upset stomach
- Vomiting.

Uncommon side effects
(may affect up to 1 in 100 people)
- Allergic reactions
- Altered level of consciousness
- Convulsion
- Heart rhythm abnormalities
- Mild to severe liver function disorders
- Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects
(may affect up to 1 in 1,000 people)
- Thrombocytopenia (low platelet count)
- Visual disturbances.

Children 1 to 12 years

Very common side effects
(may affect more than 1 in 10 people)
- Cough
- Nasal congestion

Vomiting.

Common side effects
(may affect up to 1 in 10 people)
- Conjunctivitis (red eyes and discharge or pain in the eye)
- Ear inflammation and other ear disorders
- Headache
- Nausea
- Runny nose
- Stomach ache
- Upper abdominal fullness
- Upset stomach.

Uncommon side effects
(may affect up to 1 in 100 people)
- Inflammation of the skin
- Tympanic membrane (eardrum) disorder.

Infants less than 1 year
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported..

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,
- if you or your child are repeatedly sick, or
- if the influenza symptoms get worse or the fever continues
Tell your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor. 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 Tamiflu

Keep out of the sight and reach of children.

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

Do not store above 25 °C.

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 to protect the environment.

6. Contents of the pack and other information

What Tamiflu contains

The active substance is:

Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir

- The other ingredients are:
capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate (see section 2 ‘Tamiflu contains sodium’) capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171) printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine E132).

What Tamiflu looks like and contents of the pack
The 30 mg hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue.

Tamiflu 30 mg hard capsules are available in blister packs of 10.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

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

België/Belgique/Belgien,
Luxembourg/Luxemburg
N.V. Roche S.A.
België/Belgique/Belgien
Tél/Tel: +32 (0) 2 525 82 11

Latvija
Roche Latvija SIA
Tel: +371 - 6 7039831
България
Рош България ЕООД
Тел: +359 2 474 5444

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111
Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 99

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

Ελλάδα, Kύπρος
Roche (Hellas) A.E.
Ελλάδα
Τηλ: +30 210 61 66 100

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

France
Roche
Tél: +33 (0) 1 47 61 40 00

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Hrvatska
Roche d.o.o
Tel: +385 1 4722 333

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ireland, Malta
Roche Products (Ireland) Ltd.
Ireland/L-Irlanda
Tel: +353 (0) 1 469 0700

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Ísland
Roche Pharmaceuticals A/S c/o Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Italia
Roche S.p.A.
Tel: +39 - 039 2471
Sverige
Roche AB
Tel: +46 (0) 8 726 1200

This leaflet was last revised in {MM/YYYY}.

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

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Information for the user

For people who find it hard to take capsules, including very young children, there’s a liquid medicine, Tamiflu oral suspension.

If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Tamiflu capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.

If the pharmacy preparation is not available either, you can make liquid Tamiflu from these capsules at home.

The dose is the same for treating or preventing flu. The difference is how often it is given.

Making liquid Tamiflu at home

- If you have the right capsule for the dose needed (a 30 mg or a 60 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product.
This is usually suitable for children over 1 year. See the upper set of instructions.

- If you need smaller doses, making liquid Tamiflu from capsules involves extra steps. This is suitable for younger children and babies: they usually need a Tamiflu dose of less than 30 mg.
See the lower set of instructions.

Children 1 to 12 years

To make a 30 mg or a 60 mg dose, you need:
- One or two 30 mg Tamiflu capsule(s)
- Sharp scissors
- One small bowl
- Teaspoon (5 ml spoon)
- Water
- Sweet food to hide the bitter taste of the powder.

Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.
Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

30 mg dose

60 mg dose

You should use only 30 mg capsules for 30 mg and 60 mg doses. Do not try to make a 45 mg or 75 mg dose by using the contents of 30 mg capsules. Use the appropriate size capsule instead.

Weight
Dose of Tamiflu
Number of 30 mg capsules
Up to 15 kg
30 mg
1 capsule
More than 15 kg up to 23 kg
45 mg
Do not use 30 mg capsules
More than 23 kg up to 40 kg
60 mg
2 capsules

Step 2: Pour all the powder into a bowl

Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Pour all of the powder into the bowl.
Open a second capsule for a 60 mg dose. Pour all of the powder into the bowl.
Be careful with the powder, because it may irritate your skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl.
This is to hide the bitter taste of the Tamiflu powder.
Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants less than 1 year

To make a smaller single dose, you need:
- One 30 mg Tamiflu capsule
- Sharp scissors
- Two small bowls (use separate pairs of bowls for each child)
- One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser
- One small oral dose dispenser showing measurements of 0.1 ml, to give the dose
- Teaspoon (5 ml spoon)
- Water

- Sweet food to hide the bitter taste of the Tamiflu.
Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl

Hold a 30 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.
Pour all of the powder into the bowl, whatever the dose you are making.
The amount is the same whether you are treating or preventing flu.

Step 2: Add water to dilute the medicine

Use the larger dispenser to draw up 5 ml water.

Add the water to the powder in the bowl.

Stir the mixture with the teaspoon for about 2 minutes.

Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.

Step 3: Choose the correct amount for your child’s weight
Look up the child’s weight on the left side of the table.
The column on the right of the table shows how much of the liquid mixture you will need to draw up.

Infants less than 1 year (including full-term newborn babies)

Child’s weight
(nearest)
How much mixture to draw up
3 kg
1.5 ml
3.5 kg
1.8 ml
4 kg
2.0 ml
4.5 kg
2.3 ml
5 kg
2.5 ml
5.5 kg
2.8 ml
6 kg
3.0 ml
6.5 kg
3.3 ml
7 kg
3.5 ml
7.5 kg
3.8 ml
8 kg
4.0 ml
8.5 kg
4.3 ml
9 kg
4.5 ml
9.5 kg
4.8 ml
10 kg or more
5.0 ml

Step 4: Draw up the liquid mixture

Make sure you have the right size dispenser.
Draw up the correct amount of liquid mixture from the first bowl.
Draw it up carefully so as not to include air bubbles.
Gently squirt the correct dose into the second bowl.

Step 5: Sweeten and give to the child

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl.
This is to hide the bitter taste of the Tamiflu.
Mix the sweet food and Tamiflu liquid well.

Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

Repeat this procedure every time you need to give the medicine.

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Information for healthcare professionals only

Patients who are unable to swallow capsules:
Commercially manufactured Tamiflu for oral suspension (6mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed. In the event thatTamiflu powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Tamiflu capsules. If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.

Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for administering the pharmacy compounded suspension, and for the procedures involved in the home preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Tamiflu-water mixture. For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.

The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are shown below.

Infants less than 1 year (including full term new born babies):

Dose of Tamiflu
Amount of Tamiflu suspension
Dispenser size to use
(grading 0.1 ml)
9 mg
1.5 ml
2.0 ml (or 3.0 ml)
10 mg
1.7 ml
2.0 ml (or 3.0 ml)
11.25 mg
1.9 ml
2.0 ml (or 3.0 ml)
12.5 mg
2.1 ml
3.0 ml
13.75 mg
2.3 ml
3.0 ml
15 mg
2.5 ml
3.0 ml
16.25 mg
2.7 ml
3.0 ml
18 mg
3.0 ml
3.0 ml (or 5.0 ml)
19.5 mg
3.3 ml
5.0 ml
21 mg
3.5 ml
5.0 ml
22.5 mg
3.8 ml
5.0 ml
24 mg
4.0 ml
5.0 ml
25.5 mg
4.3 ml
5.0 ml
27 mg
4.5 ml
5.0 ml
28.5 mg
4.8 ml
5.0 ml
30 mg
5.0 ml
5.0 ml

Package leaflet: Tamiflu 45 mg hard capsules

1. What Tamiflu is and what it is used for

Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.