Brand name Epivir

Form solution, oral

Active substance / Dosage

LAMIVUDINE

Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription

ATC code

J05AF05

Registration number 031984

Manufacturer VIIV HEALTHCARE BV

Table of Contents

Package Leaflet: Information for the User
Epivir 150 mg film-coated tablets
1. What Epivir is and what it is used for
2. What you need to know before taking Epivir
3. How to take Epivir
4. Possible side effects
5. How to store Epivir
6. Package contents and other information
Package Leaflet: Information for the User
Epivir 10 mg/ml oral solution
1. What Epivir is and what it is used for
2. What you need to know before taking Epivir
3. How to take Epivir
4. Possible side effects
5. How to store Epivir
6. Package contents and other information
Package Leaflet: Information for the User
Epivir 300 mg film-coated tablets
1. What Epivir is and what it is used for
2. What you should know before taking Epivir
3. How to take Epivir
4. Possible side effects
5. How to store Epivir
6. Package contents and other information

Package Leaflet: Information for the User

Epivir 150 mg film-coated tablets

lamivudine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Epivir is and what it is used for
What you need to know before taking Epivir
How to take Epivir
Possible side effects
How to store Epivir
Contents of the pack and other information

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 substance in Epivir is lamivudine. Epivir is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Epivir does not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at low levels. In addition, it increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Epivir in the same way. Your doctor will monitor how well the treatment is working.

2. What you need to know before taking Epivir

Do not take Epivir:

if you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in Section 6). Consult your doctor if you think this applies to you.

Take special care with Epivir
Some people taking Epivir or other combination therapies for the treatment of HIV are at increased risk of serious side effects. You should be aware of these additional risks:

if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Epivir without consulting your doctor, as hepatitis may worsen)
if you are severely overweight (particularly if you are a woman)
if you or your child have kidney problems, the dose may need to be adjusted. Inform your doctor if any of these situations apply to you. You may require additional monitoring, including blood tests, while taking this medicine. See Section 4 for further information.

Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions which may be serious. You should be aware of important signs and symptoms so that you can remain vigilant while taking Epivir.
Please read the information on '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 have recently taken any, including herbal remedies or other medicines purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while on treatment with Epivir.
The following medicines must not be taken with Epivir:

medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection)
emtricitabine (used to treat HIV infection)
high doses of co-trimoxazole, an antibiotic
cladribine (used to treat hairy cell leukaemia). Inform your doctor if you are taking any of these medicines.

Pregnancy
If you are pregnant, become pregnant, or are planning a pregnancy, discuss with your doctor the risks and benefits of taking Epivir for you and your baby.
Epivir and similar medicines may cause side effects in unborn children. If you have taken Epivir during pregnancy, your doctor may regularly perform blood tests and other diagnostic examinations to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

Breast-feeding
Breast-feeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
A small amount of the components of Epivir may also pass into breast milk.
If you are breast-feeding or considering breast-feeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
It is unlikely that Epivir will affect your ability to drive or use machines.

Epivir contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. 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 water. Epivir may be taken with or without food.
If you are unable to swallow the tablets whole, you may crush them and mix with a small amount of food or drink, then take the entire dose immediately.
Stay in regular contact with your doctor.
Epivir helps control your condition. You must take it every day to prevent your disease from worsening. You may still develop other infections and illnesses related to HIV infection.
Keep in contact with your doctor and do not stop taking Epivir without consulting your doctor.

Dosage
Adults, adolescents and children weighing at least 25 kg
The recommended dose of Epivir is 300 mg daily. This may be taken either as one 150 mg tablet twice daily (with approximately 12 hours between doses) or as two 150 mg tablets once daily, according to your doctor's advice.

Children weighing at least 20 kg but less than 25 kg
The recommended dose of Epivir is 225 mg daily. This may be taken either as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or as 225 mg (one and a half 150 mg tablets) once daily, according to your doctor's advice.

Children weighing at least 14 kg but less than 20 kg
The recommended dose of Epivir is 150 mg daily. This may be taken either as 75 mg (half a 150 mg tablet) twice daily (with approximately 12 hours between doses) or as 150 mg (one 150 mg tablet) once daily, according to your doctor's advice.

An oral solution is also available for the treatment of children over 3 months of age or for patients who require a lower than usual dose or who are unable to swallow tablets.

If you or your child have kidney problems, the dose may need to be adjusted.
Talk to your doctor if this applies to you or your child.

If you take more Epivir than you should
If you take more Epivir than prescribed, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, show them the Epivir packaging.

If you forget to take Epivir
If you forget to take a dose, take it as soon as you remember. Then continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

4. Possible side effects

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

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

During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of Epivir or of other medicines you are taking, or an effect of the HIV disease itself. For this reason, it is very important to inform your doctor about any change in your health status.

During combination therapy for HIV, both the side effects listed below for Epivir and other conditions may occur.

It is important to read the information in another section of this leaflet under the heading ‘Other possible side effects of combination therapy for HIV’.

Common side effects
These may affect up to 1 in 10 patients:

headache
feeling unwell (nausea)
vomiting
diarrhoea
stomach pain
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
muscle discomfort and pain
joint pain
difficulty sleeping (insomnia)
cough
nasal irritation or runny nose
rash
hair loss (alopecia)

Uncommon side effects
These may affect up to 1 in 100 patients:
Uncommon side effects that may be detected by blood tests include:

reduced number of cells involved in blood clotting (thrombocytopenia)
low number of red blood cells (anaemia) or low number of white blood cells (neutropenia)
increased levels of liver-produced enzymes

Rare side effects
These may affect up to 1 in 1,000 patients:

severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing
inflammation of the pancreas (pancreatitis)
breakdown of muscle tissue
inflammation (hepatitis)

A rare side effect that may be detected by blood tests is:

increase in an enzyme called amylase

Very rare side effects
These may affect up to 1 in 10,000 patients:

lactic acidosis (excess lactic acid in the blood)
tingling or numbness in arms, legs, hands or feet

A very rare side effect that may be detected by blood tests is:

failure of the bone marrow to produce new red blood cells (pure red cell aplasia)

If you experience side effects
Tell your doctor or pharmacist if any of the side effects becomes severe or bothersome, or if you notice any side effect not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy including Epivir may lead to the development of other conditions during HIV treatment.

Old infections may flare up again

People with advanced HIV infection (Acquired Immunodeficiency Syndrome - AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, previously hidden infections may flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the body begins to fight these infections.

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

If you notice any symptoms of infection while taking Epivir:
inform your doctor immediately. Do not take any other medicines for infection without medical advice.

You may have bone problems

Some people receiving combination antiretroviral therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone. People may be more likely to develop this condition:

if they have been on combination therapy for a long time
if they are also taking anti-inflammatory medicines called corticosteroids
if they consume alcoholic beverages
if their immune system is very weak
if they are overweight

Signs of osteonecrosis include:

stiffness of the joints
pain (especially in the knee, hip or shoulder)
difficulty in movement
If you notice any of these symptoms: inform your doctor.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 stated on the pack.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Epivir contains
The active substance is lamivudine.
The tablets also contain the following excipients:
Tablet core: microcrystalline cellulose, sodium starch glycolate (gluten-free), magnesium stearate
Coating: hypromellose, titanium dioxide, macrogol, polysorbate 80.

Description of the appearance of Epivir and pack contents
Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or in packaging containing 60-tablet blisters. The film-coated tablets are white, diamond-shaped, divisible, and marked “GXCJ7” on both sides.

Marketing Authorisation Holder and Manufacturer
Manufacturer Marketing Authorisation Holder
Delpharm Poznań Spółka Akcyjna ViiV Healthcare BV
ul. Grunwaldzka 189 Van Asch van Wijckstraat 55H
60-322 Poznan 3811 LP Amersfoort
Poland Netherlands

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

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

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

Česká republika Magyarország
GlaxoSmithKline s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0)33 2081199
[email protected]

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

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tél.: + 33 (0)1 39 17 6969 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: +385 800787089 Tel: + 40 800672524

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

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

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

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 371 80205045 Tel: + 44 (0)800 221441
[email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Package Leaflet: Information for the User

Epivir 10 mg/ml oral solution

lamivudine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Epivir is and what it is used for
What you need to know before taking Epivir
How to take Epivir
Possible side effects
How to store Epivir
Contents of the pack and other information

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 substance in Epivir is lamivudine. Epivir is a type of medicine known as an
antiretroviral. It belongs to a group of drugs called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Epivir does not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at low levels. In addition, it increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Epivir in the same way. Your doctor will monitor how well the treatment is working.

2. What you need to know before taking Epivir

Do not take Epivir:

if you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in Section 6). Consult your doctor if you think this applies to you.

Take special care with Epivir
Some people who take Epivir or other combination therapies for the treatment of HIV are at increased risk of serious side effects. You should be aware of these additional risks:

if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Epivir without consulting your doctor, as hepatitis may reappear)
if you are severely overweight (especially if you are a woman)
if you or your child have kidney problems, the dose may need to be adjusted. Inform your doctor if any of these situations apply to you. You may require additional monitoring, including blood tests, while taking this medicine. See Section 4 for further information.

Be aware of important symptoms
Some people who take medicines for HIV infection develop other conditions that may be serious. You should be informed about important signs and symptoms so that you can remain vigilant while taking Epivir.
Read the information on ‘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 have recently taken any, including herbal remedies or other medicines purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while on treatment with Epivir.

The following medicines must not be taken with Epivir:

medicines (usually liquid formulations) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection)
emtricitabine (used to treat HIV infection)
high doses of co-trimoxazole, an antibiotic
cladribine (used to treat hairy cell leukaemia). Inform your doctor if you are being treated with any of these medicines.

Pregnancy
If you are pregnant, become pregnant, or are planning a pregnancy, discuss with your doctor the risks and benefits of taking Epivir for you and your baby.
Epivir and similar medicines may cause side effects in unborn children. If you have taken Epivir during pregnancy, your doctor may carry out regular blood tests and other diagnostic examinations to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

Breast-feeding
Breast-feeding is not recommended for women who are HIV-positive, as HIV infection can be transmitted to the baby through breast milk.
A small amount of the components of Epivir may also pass into breast milk.
If you are breast-feeding or considering breast-feeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
It is unlikely that Epivir will affect your ability to drive or operate machinery.

Important information about some of the excipients in Epivir
If you are diabetic, please note that each dose (150 mg = 15 ml) contains 3 g of sugar.
Epivir contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking Epivir. Sucrose may be harmful to teeth.

Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (which may occur with delay).

Epivir contains sodium
This medicine contains 39 mg of sodium in each 15 ml. This is equivalent to 1.95% of the maximum daily recommended intake of sodium for an adult.

3. How to take Epivir

Always take this medicine exactly as indicated by your doctor or pharmacist.
Check with your doctor or pharmacist if you are unsure.
Epivir may be taken with or without food.
Stay in regular contact with your doctor.
Epivir helps control your condition. You must take it every day to prevent the disease from worsening. You may still develop other infections and illnesses related to HIV infection.
Stay in contact with your doctor and do not stop taking Epivir without consulting your doctor.

Dosage
Adults, adolescents and children weighing at least 25 kg
The recommended dose of Epivir is 30 ml (300 mg) daily. This may be taken either as
15 ml (150 mg) twice daily (approximately 12 hours apart) or as 30 ml (300 mg) once daily.

Children from 3 months of age weighing less than 25 kg
The dose depends on the child's body weight. The recommended dose of Epivir is 0.5 ml/kg (5 mg/kg) twice daily (approximately 12 hours apart), or 1 ml/kg (10 mg/kg) once daily.
Use the oral dosing syringe provided with the package to measure the dose accurately.

Remove the plastic cover from the syringe/adapter.
Remove the adapter from the syringe.
Remove the cap from the bottle and keep it safely.
Hold the bottle firmly. Insert the plastic adapter into the top of the bottle.
Insert the syringe firmly into the adapter.
Turn the bottle upside down.
Pull back the plunger of the syringe until the syringe contains the first portion of the full dose.
Return the bottle to an upright position. Remove the syringe from the adapter.
Place the syringe in the mouth, positioning the tip against the inside of the cheek. Slowly push the plunger, allowing time for swallowing.

Do not push too hard and do not inject the liquid into the back of the throat, as this may cause choking.

Repeat steps 5 to 9 in the same manner until the entire dose has been administered. For example, if your dose is 15 ml, you must take one full syringe and half a syringe of medicine.
Remove the syringe from the bottle and wash it thoroughly with clean water. Allow it to dry completely before using it again.
Close the bottle tightly with the cap, leaving the adapter in place.

Discard the oral solution one month after first opening.
If you or your child has kidney problems, the dose may need to be adjusted.
Talk to your doctor if this applies to you or your child.

If you take more Epivir than you should
If you take more Epivir than prescribed, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice. If possible, show them the Epivir packaging.

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 the missed dose.

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes also to the HIV medications themselves. Your doctor will monitor these changes.

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

During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of Epivir or of other medicines you are taking, or an effect of the HIV disease itself. For this reason, it is very important to inform your doctor about any changes in your health status.

During combination therapy for HIV, both the side effects listed below for Epivir and other conditions may occur.

It is important to read the information in another section of this leaflet under the heading ‘Other possible side effects of combination therapy for HIV’.

Common side effects
These may affect up to 1 in 10 patients:

headache
feeling unwell (nausea)
vomiting
diarrhoea
stomach pain
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
muscle discomfort and pain
joint pain
difficulty sleeping (insomnia)
cough
nasal irritation or runny nose
rash
hair loss (alopecia)

Uncommon side effects
These may affect up to 1 in 100 patients:
Uncommon side effects that may be detected by blood tests include:

reduced number of cells involved in blood clotting (thrombocytopenia)
low number of red blood cells (anaemia) or low number of white blood cells (neutropenia)
increased levels of liver enzymes

Rare side effects
These may affect up to 1 in 1,000 patients:

severe allergic reaction causing swelling of the face, tongue, or throat, which may lead to difficulty swallowing or breathing
inflammation of the pancreas (pancreatitis)
breakdown of muscle tissue
inflammation (hepatitis)

A rare side effect that may be detected by blood tests is:

increase in an enzyme called amylase

Very rare side effects
These may affect up to 1 in 10,000 patients:

lactic acidosis (excess lactic acid in the blood)
tingling or numbness in the arms, legs, hands, or feet

A very rare side effect that may be detected by blood tests is:

failure of the bone marrow to produce new red blood cells (pure red cell aplasia)

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

Other possible side effects of combination therapy for HIV
Combination therapy including Epivir may lead to the development of other conditions during HIV treatment.

Old infections may flare up again
People with advanced HIV infection (Acquired Immunodeficiency Syndrome - AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When such individuals start treatment, previously hidden infections may flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the body begins to fight these infections.

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

If you notice any symptoms of infection while taking Epivir:
inform your doctor immediately. Do not take any other medicines for infection without medical advice.

You may have bone problems
Some people receiving combination antiretroviral therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone. People may be more likely to develop this condition if:

they have been on combination therapy for a long time
they are also taking anti-inflammatory medicines called corticosteroids
they consume alcohol
their immune system is very weak
they are overweight

Signs of osteonecrosis include:

stiffness of the joints
pain (especially in the knee, hip, or shoulder)
difficulty in movement
If you notice any of these symptoms: inform your doctor.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects helps 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 stated on the pack.
Discard the container one month after first opening.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Epivir contains
The active substance is lamivudine.
The oral solution also contains the following excipients: sugar (sucrose 3 g/15 ml), methyl
parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene
glycol, water, artificial strawberry and banana flavours.
This medicine contains 300 mg of propylene glycol in each 15 ml.

Description of the appearance of Epivir and contents of the pack
Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution.
The pack includes an oral dosing syringe and a plastic bottle adapter.

Marketing Authorisation Holder and Manufacturer
Manufacturer Marketing Authorisation Holder
ViiV Healthcare Trading Services UK ViiV Healthcare BV
Limited Van Asch van Wijckstraat 55H
12 Riverwalk, 3811 LP Amersfoort
Citywest Business Campus Netherlands
Dublin 24,
Ireland

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder: