lamivudine: package leaflet

For patients

Package leaflet, verbatim

Epivir

Package leaflet: Epivir 150 mg film-coated tablets

1. What Epivir is and what it is used for

Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children.
The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral.
It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Epivir

Do not take Epivir:
- if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in Section 6).

Check with your doctor if you think this applies to you.

Take special care with Epivir
Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:
- if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Epivir without your doctor’s advice, as your hepatitis may come back)
- if you are seriously overweight (especially if you are a woman)
- if you or your child has a kidney problem, your dose may be altered.

Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.

Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Epivir.
Read the information ‘Other possible side effects of combination therapy for HIV’ in Section 4 of this leaflet.

Other medicines and Epivir
Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Epivir.

These medicines should not be used with Epivir:
- medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
- other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
- emtricitabine (used to treat HIV infection)
- high doses of co-trimoxazole, an antibiotic
- cladribine (used to treat hairy cell leukaemia).
Tell your doctor if you are being treated with any of these.

Pregnancy
If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Epivir.

Epivir and similar medicines may cause side effects in unborn babies. If you have taken Epivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Breast-feeding
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
A small amount of the ingredients in Epivir can also pass into your breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines
Epivir may make you feel tired and have other side effects that could affect your ability to drive or use machines.
Don’t drive or use machines unless you are sure you’re not affected.

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

3. How to take Epivir

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

Swallow the tablets, with some water. Epivir can be taken with or without food.

If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.

Stay in regular contact with your doctor
Epivir helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
Keep in touch with your doctor, and do not stop taking Epivir without your doctor’s advice.

How much to take
Adults, adolescents and children who weigh at least 25 kg:
The usual dose of Epivir is 300 mg a day. This can be taken as either one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by your doctor.

Children weighing at least 20 kg and less than 25 kg:
The usual dose of Epivir is 225 mg a day. This can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor.

Children weighing at least 14 kg and less than 20 kg:
The usual dose of Epivir is 150 mg a day. This can be given as 75 mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as advised by your doctor.

An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.

If you or your child has a kidney problem, your dose may be altered.
Talk to your doctor if this applies to you or your child.

If you take more Epivir than you should
If you take too much Epivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. If possible, show them the Epivir pack.

If you forget to take Epivir
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, but not everyone gets them.

When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.

As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.

Common side effects
These may affect up to 1 in 10 people:
- headache
- feeling sick (nausea)
- being sick (vomiting)
- diarrhoea
- stomach pains
- tiredness, lack of energy
- fever (high temperature)
- general feeling of being unwell
- muscle pain and discomfort
- joint pain
- difficulty in sleeping (insomnia)
- cough
- irritated or runny nose
- rash
- hair loss (alopecia).

Uncommon side effects
These may affect up to 1 in 100 people:

Uncommon side effects that may show up in blood tests are:
- a decrease in the number of cells involved in blood clotting (thrombocytopenia)
- a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
- an increase in the level of liver enzymes.

Rare side effects
These may affect up to 1 in 1000 people:
- serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
- inflammation of the pancreas (pancreatitis)
- breakdown of muscle tissue (rhabdomyolysis)
- inflammation of the liver (hepatitis).

A rare side effect that may show up in blood tests is:
- an increase in an enzyme called amylase.

Very rare side effects
These may affect up to 1 in 10,000 people:
- excess lactic acid in the blood (lactic acidosis)
- tingling or numbness of the arms, legs, hands or feet (peripheral neuropathy [or paraesthesia]).

A very rare side effect that may show up in blood tests is:
- a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy including Epivir may cause other conditions to develop during HIV treatment.

Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

If you get any symptoms of infection while you are taking Epivir:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

You may have problems with your bones
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
- if they have been taking combination therapy for a long time
- if they are also taking anti-inflammatory medicines called corticosteroids
- if they drink alcohol
- if their immune systems are very weak
- if they are overweight.
Signs of osteonecrosis include:
- stiffness in the joints
- aches and pains (especially in the hip, knee or shoulder)
- difficulty moving.
If you notice any of these symptoms:
Tell your doctor.

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 Epivir

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.

Do not store Epivir above 30oC.

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

6. Contents of the pack and other information

What Epivir contains
The active substance is lamivudine.
The tablets also contain the following other ingredients:
Tablet core: microcrystalline cellulose (E 460), sodium starch glycollate, magnesium stearate Film-coat: hypromellose (E 464), titanium dioxide (E 171), macrogol, polysorbate 80

What Epivir looks like and the contents of the pack
Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets. They are white, diamond shaped, scored, film-coated tablets, marked with the code “GX CJ7” on both sides.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation
Holder

Manufacturer
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands

Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189
60-322 Poznan
Poland

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

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0)10 85 65 00
Lietuva
ViiV Healthcare BV
Tel: + 370 80000334

България
ViiV Healthcare BV
Teл.: + 359 80018205

Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0)10 85 65 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com

Magyarország
ViiV Healthcare BV
Tel.: +36 80088309
Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
ViiV Healthcare BV
Tel: + 356 80065004

Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501 es-ci@viivhealthcare.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
Infomed@viivhealthcare.com

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA.
Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com

Hrvatska
ViiV Healthcare BV
Tel: +385 800787089

România
ViiV Healthcare BV
Tel: + 40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
ViiV Healthcare BV
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
ViiV Healthcare BV
Tel: + 421 800500589

Italia
ViiV Healthcare S.r.l.
Tel: + 39 (0)45 7741600
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
ViiV Healthcare BV
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

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.

Package leaflet: Epivir 10 mg/mL oral solution

1. Remove the plastic wrap from the syringe/adapter.

2. Remove the adapter from the syringe.

3. Remove the bottle cap and keep it safe.

4. Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.

5. Insert the syringe firmly into the adapter.

6. Turn the bottle upside down.

7.
Pull out syringe plunger until the syringe contains the first part of your full dose.
8.
Turn the bottle the correct way up. Remove the syringe from the adapter.
9.
Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Do not push too hard and squirt the liquid into the back of your throat or you may choke.
10.
Thoroughly clean the syringe each time it has been emptied.
11.
Repeat steps 5 to 10 in the same way until you have taken your whole dose. For example, if your dose is 15 mL, you need to take one and a half syringe-fulls of medicine.
12.
After you have taken your complete dose wash the syringe thoroughly in clean water. Let it dry completely before you use it again.
13.
Close the bottle tightly with the cap, leaving the adapter in place.

Discard oral solution one month after first opening.

If you or your child has a kidney problem, the dose may be altered.
Talk to your doctor if this applies to you or your child.

If you forget to take Epivir
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.
Do not take a double dose to make up for a forgotten dose.

4.
Possible side effects
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, but not everyone gets them.

Uncommon side effects
These may affect up to 1 in 100 people:

Uncommon side effects that may show up in blood tests are:

a decrease in the number of cells involved in blood clotting (thrombocytopenia)
a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
an increase in the level of liver enzymes

A rare side effect that may show up in blood tests is:
- increase in an enzyme called amylase.

A very rare side effect that may show up in blood tests is:
- a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy such as Epivir may cause other conditions to develop during HIV treatment.

If you get any symptoms of infection while you are taking Epivir:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

- if their immune systems are very weak
- if they are overweight.
Signs of osteonecrosis include:
- stiffness in the joints
- aches and pains (especially in the hip, knee or shoulder)
- difficulty moving.
If you notice any of these symptoms:
Tell your doctor.

5.
How to store Epivir

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 container.

Discard one month after first opening.

Do not store above 25oC.

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

6.
Contents of the pack and other information

What Epivir contains
The active substance is lamivudine.
The oral solution also contains the following other ingredients: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), anhydrous citric acid, sodium citrate, propylene glycol (E1520), purified water, artificial strawberry and banana flavourings, sodium hydroxide and/or hydrochloric acid for pH adjustment.

What Epivir looks like and the contents of the pack
Epivir oral solution is supplied in a white polyethylene bottle containing 240 mL of solution. An oral dosing syringe and a plastic adapter for the bottle is included in the pack.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands

ViiV Healthcare Trading Services
UK Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland

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

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0)10 85 65 00
Lietuva
ViiV Healthcare BV
Tel: + 370 80000334

България
ViiV Healthcare BV
Teл.: + 359 80018205

Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0)10 85 65 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com

Magyarország
ViiV Healthcare BV
Tel.: +36 80088309
Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
ViiV Healthcare BV
Tel: + 356 80065004

Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501 es-ci@viivhealthcare.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
Infomed@viivhealthcare.com

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA.
Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com

Hrvatska
ViiV Healthcare BV
Tel: +385 800787089

România
ViiV Healthcare BV
Tel: + 40800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
ViiV Healthcare BV
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
ViiV Healthcare BV
Tel: + 421 800500589

Italia
ViiV Healthcare S.r.l.
Tel: + 39 (0)45 7741600
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
ViiV Healthcare BV
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

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.

Package leaflet: Epivir 300 mg film-coated tablets

1. What Epivir is and what it is used for

Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Epivir

Do not take Epivir:
- if you are allergic to lamivudine or any of the other ingredients in this medicine (listed in Section 6).
Check with your doctor if you think this applies to you.

Take special care with Epivir
Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:
- if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Epivir without your doctor’s advice, as your hepatitis may come back)
- if you are seriously overweight (especially if you are a woman)
- if you have a kidney problem, your dose may be altered.
Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.

These medicines should not be used with Epivir:
- medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
- other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
- emtricitabine (used to treat HIV infection)
- high doses of co-trimoxazole, an antibiotic.
- cladribine (used to treat hairy cell leukaemia).
Tell your doctor if you are being treated with any of these.

Pregnancy
If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Epivir.

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

3. How to take Epivir

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

Swallow the tablet with some water. Epivir can be taken with or without food.

If you cannot swallow the tablet whole, you may crush and combine it with a small amount of food or drink, and take all the dose immediately.

How much to take
Adults, adolescents and children who weigh at least 25 kg:
The usual dose is one 300 mg tablet once a day.

A 150 mg strength Epivir tablet is also available for the treatment of children from 3 months of age who weigh less than 25 kg:

An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.

If you have a kidney problem, your dose may be altered.
Talk to your doctor if this applies to you.

If you forget to take Epivir
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, but not everyone gets them.

Uncommon side effects
These may affect up to 1 in 100 people:

A rare side effect that may show up in blood tests is:
- increase in an enzyme called amylase.

A very rare side effect that may show up in blood tests is:
- a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy including Epivir may cause other conditions to develop during HIV treatment.

Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

If you get any symptoms of infection while you are taking Epivir:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

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 Epivir

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.
Do not store Epivir above 30oC.

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

6. Contents of the pack and other information

What Epivir looks like and the contents of the pack
Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 30 tablets. They are grey, diamond shaped film-coated tablets, marked with the code "GX EJ7” on one side.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation
Holder

Manufacturer

ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands

Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189
60-322 Poznan
Poland

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

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0)10 85 65 00
Lietuva
ViiV Healthcare BV
Tel: + 370 80000334

България
ViiV Healthcare BV
Teл.: + 359 80018205
Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0)10 85 65 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com

Magyarország
ViiV Healthcare BV
Tel.: +36 80088309
Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
ViiV Healthcare BV
Tel: + 356 80065004
Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10 viiv.med.info@viivhealthcare.com

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: + 372 8002640
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501 es-ci@viivhealthcare.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
Infomed@viivhealthcare.com

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com

Hrvatska
ViiV Healthcare BV
Tel: +385 800787089

România
ViiV Healthcare BV
Tel: + 40 800672524
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
ViiV Healthcare BV
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
ViiV Healthcare BV
Tel: + 421 800500589

Italia
ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741600
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
ViiV Healthcare BV
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

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.

Zeffix

Package leaflet: Zeffix 100 mg film-coated tablets

1. What Zeffix is and what it is used for

The active ingredient in Zeffix is lamivudine.

Zeffix is used to treat long term (chronic) hepatitis B infection in adults.

Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Hepatitis B is a virus which infects the liver, causes long term (chronic) infection, and can lead to liver damage. Zeffix can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function normally (decompensated liver disease).

Treatment with Zeffix can reduce the amount of hepatitis B virus in your body. This should lead to a reduction in liver damage and an improvement in your liver function. Not everyone responds to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of your treatment with regular blood tests.

2. What you need to know before you take Zeffix

Your healthcare provider should offer you counselling and testing for HIV infection before you start treatment with lamivudine for hepatitis B infection and during treatment. If you have or get HIV infection, see section 3.

Do not take Zeffix
- if you’re allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6).
➔ Check with your doctor if you think this applies to you.

Warnings and precautions
Some people taking Zeffix or other similar medicines are more at risk of serious side effects. You need to be aware of the extra risks:
- if you have ever had other types of liver disease, such as hepatitis C
- if you’re seriously overweight (especially if you’re a woman).
➔ Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medication. See section 4 for more information about the risks.

Don’t stop taking Zeffix without your doctor’s advice, as there is a risk of your hepatitis getting worse. When you stop taking Zeffix your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage. See section 3 for more information about how to take Zeffix.

Protect other people
Hepatitis B infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Zeffix will not stop you passing hepatitis B infection on to other people. To protect other people from becoming infected with hepatitis B:
- Use a condom when you have oral or penetrative sex.
- Don’t risk blood transfer — for example, don’t share needles.

Other medicines and Zeffix
Tell your doctor or pharmacist if you’re taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking Zeffix.

These medicines should not be used with Zeffix:
- medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
- other medicines containing lamivudine, used to treat HIV infection (sometimes called the AIDS virus)
- emtricitabine used to treat HIV or hepatitis B infection
- cladribine, used to treat hairy cell leukaemia
➔
Tell your doctor if you’re being treated with any of these.

Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby:
➔
Talk to your doctor about the risks and benefits of taking Zeffix during your pregnancy.
Do not stop treatment with Zeffix without your doctor’s advice.

Breast-feeding
Zeffix can pass into breast-milk. If you are breast-feeding, or thinking about breast-feeding:
➔ Talk to your doctor before you take Zeffix.

Driving and using machines
Zeffix may make you feel tired, which could affect your ability to drive or use machines.
➔ Don’t drive or use machines unless you are sure you’re not affected.

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

3. How to take Zeffix

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re not sure.

Stay in regular contact with your doctor
Zeffix helps to control your hepatitis B infection. You need to keep taking it every day to control your infection and stop your illness getting worse.
➔ Keep in touch with your doctor, and don’t stop taking Zeffix without your doctor’s advice.

How much to take
The usual dose of Zeffix is one tablet (100 mg lamivudine) once a day.

Your doctor may prescribe a lower dose if you have problems with your kidneys. An oral solution of Zeffix is available for people who need a lower than usual dose, or who can’t take tablets.

➔ Talk to your doctor if this applies to you.

Patients who also have or may get HIV infection
If you have or get HIV that is not being treated with medicines while taking lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. Lamivudine can also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine that contains a higher dose of lamivudine, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor first.
➔ Talk to your doctor if this applies to you.

Swallow the tablet whole, with some water. Zeffix can be taken with or without food.

If you take more Zeffix than you should
If you accidentally take too much Zeffix, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. If possible, show them the Zeffix pack.

If you forget to take Zeffix
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.
Don’t take a double dose to make up for a missed dose.

Don’t stop taking Zeffix
You must not stop taking Zeffix without consulting your doctor. There is a risk of your hepatitis getting worse (see section 2). When you stop taking Zeffix your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage.

4. Possible side effects

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

Side effects that were commonly reported in Zeffix clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).

Allergic reaction
These are rare (may affect up to 1 in 1 000 people). Signs include:
- swelling of eyelids, face or lips

- difficulty swallowing or breathing
➔
Contact a doctor immediately if you get these symptoms. Stop taking Zeffix.

Side effects thought to be caused by Zeffix

A very common side effect (these may affect more than 1 in 10 people) which may show up in blood tests is:
- an increase in the level of some liver enzymes (transaminases), which may be a sign of inflammation or damage in the liver.

A common side effect (these may affect up to 1 in 10 people) is:
- cramps and muscle pains
- skin rash or ‘hives’ anywhere on the body

A common side effect which may show up in blood tests is:
- an increase in the level of an enzyme produced in the muscles (creatine phosphokinase) which may be a sign that body tissue is damaged.

A very rare side effect (these may affect up to 1 in 10 000 people) is:
- lactic acidosis (excess lactic acid in the blood).

Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown
- breakdown of muscle tissue
- a worsening of liver disease after Zeffix is stopped or during treatment if the hepatitis B virus becomes resistant to Zeffix. This can be fatal in some people.

A side effect which may show up in blood tests is:
- a decrease in the number of cells involved in blood clotting (thrombocytopenia).

If you get any side effects
➔
Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 Zeffix

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

Don’t take this medicine after the expiry date shown on the carton and blister.

Don’t store above 30 °C.

Do not throw away any medicines in your 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 Zeffix contains

The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.

The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.

What Zeffix looks like and contents of the pack

Zeffix film-coated tablets are supplied in tamper evident foil blisters containing 28 or 84 tablets. The tablets are butterscotch coloured, capsule shaped, biconvex and engraved “GX CG5” on one side.

Not all pack-sizes may be available in your country.

Manufacturer
Marketing Authorisation Holder
Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189
60-322 Poznan
Poland

GlaxoSmithKline Trading Services
Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00
Lietuva
GlaxoSmithKline Trading Services Limited
Tel: + 370 80000334

България
GlaxoSmithKline Trading Services Limited
Teл.: + 359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0)10 85 52 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111 cz.info@gsk.com

Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309
Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00 dk-info@gsk.com

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 80065004
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline Trading Services Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0 at.info@gsk.com

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700 es-ci@gsk.com

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0)1 39 17 84 44 diam@gsk.com

Portugal
Glaxo Wellcome Farmacêutica, Lda
Tel: + 351 21 412 95 00
FI.PT@gsk.com

Hrvatska
GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089

România
GlaxoSmithKline Trading Services Limited
Tel: + 40 800672524
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
GlaxoSmithKline Trading Services Limited
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: + 354 535 7000
Slovenská republika
GlaxoSmithKline Trading Services Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045

This leaflet was last revised in

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

Package leaflet: Zeffix 5 mg/ml oral solution

1. Remove the plastic wrap from the applicator/adapter.

2. Remove the adapter from the applicator.

3. Remove the child-proof bottle cap (A) and keep it safely.

4. Hold the bottle. Push the adapter (B) firmly into the neck of the bottle, as far as it will go.

5. Insert the applicator (C) firmly into the adapter.

6. Turn the bottle upside down.

7. Pull out the applicator plunger (D) until the applicator contains the first part of your full dose.
8. Turn the bottle the right way up. Remove the applicator from the adapter.
9. Put the applicator into your mouth, placing the tip of the applicator against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don’t push too hard and squirt the liquid into the back of your throat, or you may choke.
10. Repeat steps 5 to 9 in the same way until you have taken your whole dose. For example, if your dose is 20 ml, you need to take 2 applicator-fulls of medicine.
11. Take the applicator out of the bottle and wash it thoroughly in clean water. Let it dry completely before you use it again. Leave the adapter in the bottle.
12. Close the bottle tightly with the cap.

Discard oral solution one month after first opening.

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