EPIVIR 10 mg /Ml Oral Solution

Зміст інструкції

1. Epivir 150 mg film-coated tablets
   1. What is Epivir 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. Contents of the pack and other information
2. Epivir 10 mg/ml oral solution
   1. What is Epivir and what is it 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
3. Epivir 300 mg film-coated tablets
   1. What is Epivir 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. Contents of the pack and other information

Epivir 150 mg film-coated tablets

lamivudine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Epivir is and what it is used for
• 2. What you need to know before you take Epivir
• 3. How to take Epivir
• 4. Possible side effects
• 5. How to store Epivir
• 6. Contents of the pack and other information

1. What is Epivir and what it is used for

Epivir is used to treat HIV (Human Immunodeficiency Virus) infection in adults and children.
The active substance contained in Epivir is lamivudine. Epivir is a type of medicine known as
antiretroviral. It belongs to a group of drugs 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. It also increases the number of CD4 cells in the blood. CD4 cells are
a type of white blood cells that are important in helping the body fight infection.
Not all people respond to treatment with Epivir in the same way. The doctor will monitor
the effectiveness of the treatment.

2. What you need to know before taking Epivir

Do not take Epivir:

• if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in Section 6). Talk to your doctorif 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
more at risk of serious side effects. You need to be aware of these
additional risks:

• if you have had a liver diseaseincluding hepatitis B or C (if you have hepatitis B infection, do not stop taking Epivir without consulting your doctor, as hepatitis may recur)
• if you are severely overweight(especially if you are a woman)
• if you or your child have kidney problems,the dose may be changed. Tell your doctor if any of these situations apply to you. You may need further checks, including blood tests, while taking the medicine. See Section 4 for more information.

Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that
can be serious. You need to be informed about important signs and symptoms, so that
you can pay attention while taking Epivir.

Read the information in ‘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 bought
without a prescription.
Remember to tell your doctor or pharmacist if you are starting any new medicine while you are
being treated with Epivir.

These 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 infectionor hepatitis B virus infection)
• emtricitabine (used to treat HIV infection)
• high doses of co-trimoxazole,an antibiotic
• cladribine (used to treat hairy cell leukemia). Tell your doctorif you are being treated with any of these medicines.

Pregnancy
If you are pregnant, are planning to become pregnant, or are trying to become pregnant, talk to your doctor about the
risks and benefits of taking Epivir for you and your baby.
Epivir and similar medicines can cause unwanted effects in unborn babies. If you have already
taken Epivir during pregnancy, your doctor may require regular blood tests and other
diagnostic tests to monitor the development of the baby. In children whose mothers have taken
NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side
effects.

Breastfeeding
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can
be transmitted to the baby through breast milk.
A small amount of the ingredients of Epivir can also pass into breast milk.
If you are breastfeeding or are thinking about breastfeeding you should talk to your doctor as soon as possible.

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

Epivir contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e.
it is 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 can be taken with or without food.
If you are unable to swallow the tablets whole, you can break them and add them to a small
amount of food or drink and take the entire dose immediately.

Remain in constant contact with your doctor
Epivir helps to control your condition. You need to take it every day to prevent the
disease from worsening. You may still develop other infections and diseases related to HIV infection.

Stay in contact with your doctor,anddo not stop taking Epivirwithout your doctor's advice.

Amount to take
Adults, adolescents and children weighing at least 25 kg
The recommended dose of Epivir is 300 mg per day.This can be taken either as one 150 mg
tablet twice a day (leaving approximately 12 hours between doses), or as two 150 mg
tablets once a day, as directed by your doctor.

Children weighing at least 20 kg and less than 25 kg
The recommended dose of Epivir is 225 mg per day.This can 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 a day, as directed by your
doctor.

Children weighing at least 14 kg and less than 20 kg
The recommended dose of Epivir is 150 mg per day.This can be taken either as 75 mg
(half a 150 mg tablet) twice a day (leaving approximately 12 hours between doses), or
as 150 mg (one 150 mg tablet) once a day, as directed by your doctor.
An oral solution is also available for the treatment of children over 3 months of age or for
patients who need to take a lower dose than usual, or are unable to
swallow the tablets.

If you or your child have kidney problems,the dose may be adjusted.

Talk to your doctorif this applies to you or your child.

If you take more Epivir than you should
If you take more Epivir, inform your doctor or pharmacist or contact the nearest hospital
Emergency Room 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 a missed dose.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose may occur
in the blood. This is partly related to the restoration of health and lifestyle, and, in the case of
blood lipids, sometimes to the HIV medications themselves. The doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
During HIV treatment, it may be difficult 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. 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 part of this leaflet under the heading ‘Other
possible side effects of combination HIV therapy’.

Common side effects
These can affect up to 1patient out of 10:

• headache
• feeling unwell (nausea)
• vomiting
• diarrhea
• stomach pain
• fatigue, lack of energy
• fever (high temperature)
• general feeling of discomfort
• muscle discomfort and pain
• joint pain
• difficulty sleeping (insomnia)
• cough
• irritation of the nose or runny nose
• skin rash
• hair loss (alopecia)

Uncommon side effects
These can affect up to 1patient out of 100:
Uncommon side effects that can be detected by blood tests are:

• reduction in the number of cells involved in blood clotting (thrombocytopenia)
• low number of red blood cells (anemia) or low number of white blood cells (neutropenia)
• increased liver enzymes.

Rare side effects
These can affect up to 1patient out of 1000:

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

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

• an increase in an enzyme called amylase.

Very rare side effects
These can affect up to 1patient out of 10,000:

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

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

• bone marrow failure to produce new red blood cells (pure red cell aplasia).

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

Other possible side effects of combination HIV therapy
Combination therapy including Epivir can cause the development of other illnesses during
treatment for HIV.

Old infections can reactivate
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, old infections, that were hidden, may reactivate, causing signs and symptoms of inflammation. These symptoms are
likely due to the reconstitution of the immune system, so that the body begins to
fight these infections.
In addition to opportunistic infections, autoimmune diseases (a condition that occurs when the
immune system attacks healthy tissue in the body) can also occur after you have started
taking medicines to treat HIV infection. Autoimmune diseases can
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, tell your doctor immediately to get
the necessary treatment.

If you notice any symptoms of infection while taking Epivir:

tell your doctor immediately. Do not take other medicines for the infection without advice
from your doctor.

You may have bone problems
Some people undergoing 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 flow to the bone. People may be more likely to develop this
condition:

• if they have been taking combination therapy for a long period
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness
• pain (especially in the knee, hip or shoulder)
• difficulty moving. If you notice any of these symptoms: tell your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 which is 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. Contents of the pack and other information

What Epivir contains
The active ingredient 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 Epivir and contents of the pack
Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or in packs
containing blister packs of 60 tablets. The film-coated tablets are white, diamond-shaped, divisible, with “GXCJ7” imprinted on both sides.

Marketing Authorisation Holder and Manufacturer
ManufacturerMarketing Authorisation Holder
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
For further information on this medicine, 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
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: + 356 80065004

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

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
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]

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

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 6969
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA.
Tel: + 351 21 094 08 01
[email protected]

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

ÍslandSlovenská republika
Vistor hf.
Sími: +354 535 7000
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
[email protected]

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

United Kingdom (Northern Ireland)
ViiV Healthcare BV
Tel: + 44 (0)800 221441
[email protected]
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Epivir 10 mg/ml oral solution

lamivudine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Epivir is and what it is used for
• 2. What you need to know before you take Epivir
• 3. How to take Epivir
• 4. Possible side effects
• 5. How to store Epivir
• 6. Contents of the pack and other information

1. What is Epivir and what is it used for

Epivir is used to treat HIV (Human Immunodeficiency Virus) infection in adults and children.
The active ingredient contained in Epivir is lamivudine. Epivir is a type of medicine known as
antiretroviral. It belongs to a group of drugs 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. It also increases the number of CD4 cells in the blood. CD4 cells are
a type of white blood cell that is important in helping the body fight infection.
Not all people respond to treatment with Epivir in the same way. The doctor will monitor
the effectiveness of the treatment.

2. What you need to know before taking Epivir

Do not take Epivir:

• if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in Section 6). Talk to your doctorif 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 a higher risk of serious side effects. You need to be aware of these
additional risks:

• if you have had a liver diseaseincluding hepatitis B or C (if you have hepatitis B infection do not stop taking Epivir without consulting your doctor as the hepatitis may return)
• if you are severely overweight(especially if you are a woman)
• if you or your child have kidney problems, the dose may be changed. Tell your doctor if any of these situations apply to you. You may need further checks, including blood tests, while taking the medicine. See Section 4 for more information.

Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that
can be serious. You need to be informed about important signs and symptoms, so that
you can pay attention while taking Epivir.

Read the information in ‘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 bought
without a prescription.
Remember to tell your doctor or pharmacist if you are taking a new medicine while you are in
treatment with Epivir.

These medicines must not be taken with Epivir:

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

Pregnancy
If you are pregnant, if you become pregnant, or if you are planning a pregnancy, talk to your doctor about the
risks and benefits of taking Epivir for you and your baby.
Epivir and similar medicines can cause unwanted effects in unborn babies. If you have already
taken Epivir during pregnancy, your doctor may request regular blood tests and other
diagnostic tests to monitor the development of the baby. In children whose mothers took
NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of side
effects.

Breastfeeding
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can
be transmitted to the baby through breast milk.
A small amount of the components of Epivir can also pass into breast milk.
If you are breastfeeding or thinking about breastfeeding, you must talk to your doctor as soon as possible.
Driving and using machines
It is unlikely that Epivir will affect your ability to drive and use machines.

Important information about some of the excipients of Epivir
If you have diabetes, be aware that each dose (150 mg = 15 ml) contains 3 g of sugar.
Epivir contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact
your doctor before taking Epivir. Sucrose can be harmful to your teeth.
Epivir also contains preservatives (parahydroxybenzoates) which can cause allergic reactions (which
can also occur with a delay).

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

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.
Epivir can be taken with or without food.

Remain in constant contact with your doctor.
Epivir helps to control your condition. It is necessary to 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,anddo not stop taking Epivirwithout your doctor's advice.

Amount to take
Adults, adolescents and children weighing at least 25 kg
The recommended dose of Epivir is 30 ml (300 mg) per day.This can be taken either as
15 ml (150 mg) twice a day (leaving approximately 12 hours between doses) or as 30 ml
(300 mg) once a day.

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 a day (leaving approximately 12 hours between doses), or 1 ml/kg (10 mg/kg)
once a day.
Use the oral dosing syringe provided with the package to measure the dose accurately.

• 1. Remove the plastic wrapper from the syringe/adapter.
• 2. Remove the adapter from the syringe.
• 3. Remove the bottle capand keep it safely.
• 4. Hold the bottle firmly. Insert the plastic adapter at the top ofthe bottle itself.
• 5. Insertthe syringefirmly into the adapter.
• 6. Turn the bottle upside down.
• 7. Pull the syringe plungeruntil the syringe contains the first part of your full dose.
• 8. Return the bottle to an upright position. Remove the syringe from the adapter.
• 9. Insert the syringe into your mouth, positioning the upper end of the syringe towards the inside of your cheek. Press the plunger slowly, allowing time for swallowing.

Donot press too hard and donot inject the liquid into the back of the throat otherwise
this may cause choking.

• 10. Repeat steps 5 to 9in the same way until the entire dose has been taken. For example if your dose is 15 ml you must take a full syringe and half ofmedicine.
• 11. Remove the syringe from the bottleand washit thoroughly with clean water. Allow it to dry completely before using it again.
• 12. Closethe bottlecarefully with the cap, leaving the adapter in place.

Discard the oral solution one month after first opening.

If you or your child have kidney problems, the dose may be modified.

Talk to your doctorif this applies to you or your child.

If you take more Epivir than you should
If you take more Epivir, inform your doctor or pharmacist or contact the emergency room of the nearest
hospital 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 possible when you remember. Then continue
treatment as before. Do not take a double dose to make up for a missed dose.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
During HIV treatment, it may be difficult 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. 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 Epivirand other conditions may occur.
It is important to read the information in another part of this leaflet under the heading ‘Other
possible side effects of combination therapy for HIV’.

Common side effects
These can affect up to 1patient out of 10:

• headache
• feeling unwell (nausea)
• vomiting
• diarrhea
• stomach pain
• fatigue, lack of energy
• fever (high temperature)
• general feeling of discomfort
• muscle discomfort and pain
• joint pain
• difficulty sleeping (insomnia)
• cough
• irritation of the nose or runny nose
• skin rash
• hair loss (alopecia)

Uncommon side effects
These can affect up to 1patient out of 100:
Uncommon side effects that can be detected by blood tests are:

• reduction in the number of cells involved in blood clotting (thrombocytopenia)
• low number of red blood cells (anemia) or low number of white blood cells (neutropenia)
• increased liver enzymes.

Rare side effects
These can affect up to 1patient out of 1000:

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

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

• an increase in an enzyme called amylase.

Very rare side effects
These can affect up to 1patient out of 10,000:

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

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

• bone marrow failure to produce new red blood cells (pure red cell aplasia).

If you experience side effects
Tell your doctor or pharmacistif any of the side effects becomes 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 can cause the development of other illnesses during
treatment for HIV.

Old infections can reactivate
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, old infections,
that were hidden, may reactivate, causing signs and symptoms of inflammation. These symptoms are
likely due to the reconstitution of the immune system, so that the body begins to
fight these infections.
In addition to opportunistic infections, autoimmune diseases (a condition that occurs when the
immune system attacks healthy tissue of the body) can also occur after you have started
taking medicines to treat HIV infection. Autoimmune diseases can
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, tell your doctor immediately to get
the necessary treatment.
If you notice any symptoms of infection while taking Epivir:

tell your doctor immediately. Do not take other medicines for the infection without advice
from your doctor.

You may have bone problems
Some people undergoing 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 flow to the bone. People may be more likely to develop this
condition:

• if they have been taking combination therapy for a long period
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness
• pain (especially in the knee, hip or shoulder)
• difficulty moving. If you notice any of these symptoms: tell your doctor.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell 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 which is stated on the packaging.
Discard the package one month after first opening.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in 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 ingredient 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 flavourings.
This medicine contains 300 mg of propylene glycol per 15 ml.

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

Marketing Authorisation Holder and Manufacturer
Manufacturer
ViiV Healthcare Trading Services UK
Limited
12 Riverwalk,
Citywest Business Campus
Dublin 24,
Ireland

Marketing Authorisation Holder

ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
For further information on this medicine, 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
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: + 356 80065004

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

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
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]

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

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 6969
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA.
Tel: + 351 21 094 08 01
[email protected]

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 hf.

Slovenská republika
ViiV Healthcare BV
Sími: +354 535 7000 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
[email protected]

Latvija
ViiV Healthcare BV.
Tel: + 371 80205045

United Kingdom (Northern Ireland)
ViiV Healthcare BV
Tel: + 44 (0)800 221441
[email protected]
Further details on this medicine are available on the European Medicines Agency website: http://www.ema.europa.eu

Epivir 300 mg film-coated tablets

lamivudine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Epivir is and what it is used for
• 2. What you need to know before you take Epivir
• 3. How to take Epivir
• 4. Possible side effects
• 5. How to store Epivir
• 6. Contents of the pack and other information

1. What is Epivir and what it is used for

Epivir is used to treat HIV (Human Immunodeficiency Virus) infection in adults and children.
The active ingredient contained in Epivir is lamivudine. Epivir is a type of medicine known as
antiretroviral. It belongs to a group of drugs 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. It also increases the number of CD4 cells in the blood. CD4 cells are
a type of white blood cells important in helping the body fight infection.
Not all people respond to treatment with Epivir in the same way. The doctor will monitor
the effectiveness of the treatment.

2. What you need to know before taking Epivir

Do not take Epivir:

• if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in Section 6). Talk to your doctorif 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
more at risk of serious side effects. You need to be aware of these
additional risks:

• if you have had a liver diseaseincluding hepatitis B or C (if you have hepatitis B infection do not stop taking Epivir without consulting your doctor as the hepatitis may return)
• if you are severely overweight(especially if you are a woman)
• if you have kidney problems,the dose may be changed. Tell your doctor if any of these situations apply to you. You may need further checks, including blood tests, while taking the medicine. SeeSection 4 for more information.

Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that
can be serious. You need to be informed about important signs and symptoms, so that
you can pay attention while taking Epivir.

Read the information in ‘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 start taking a new medicine while you are
being treated with Epivir.

These 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 infectionor hepatitis B virus infection)
• emtricitabine (used to treat HIV infection)
• high doses of co-trimoxazole,an antibiotic
• cladribine (used to treat hairy cell leukemia). Tell your doctorif you are being treated with any of these medicines.

Pregnancy
If you are pregnant, if you become pregnant, or if you are planning to become pregnant, talk to your doctor about the
risks and benefits of taking Epivir for you and your baby.
Epivir and similar medicines can cause unwanted effects in unborn babies. If you have already
taken Epivir during pregnancy, your doctor may request regular blood tests and other
diagnostic tests to monitor the development of the baby. In children whose mothers have taken
NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side
effects.

Breastfeeding
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can be
transmitted to the baby through breast milk.
A small amount of the ingredients of Epivir may also pass into breast milk.
If you are breastfeeding or are thinking about breastfeeding you should talk to your doctor as soon as possible.
Driving and using machines
It is unlikely that Epivir will affect your ability to drive and use machines.

Epivir contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is
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 can be taken with or without food.
If you are unable to swallow the tablets whole, you can break them and add them to a small
amount of food or drink and take the entire dose immediately.

Remain in constant contact with your doctor
Epivir helps to control your condition. You need to take it every day to prevent the
disease from worsening. You can still develop other infections and diseases related to HIV infection.

Stay in contact with your doctor,anddo not stop taking Epivirwithout your doctor's advice.

Amount to take
Adults, adolescents and children weighing at least 25 kg
The recommended dose is one 300 mg tablet once a day.
A 150 mg Epivir tablet is also available for the treatment of children from
3 months of age and weighing less than 25 kg.
An oral solution is also available for the treatment of children over 3 months of age or for
patients who need to take a lower dose than usual, or are unable to
swallow the tablets.

If you have kidney problemsthe dose may be adjusted.

Talk to your doctorif this applies to you.

If you take more Epivir than you should
If you take more Epivir, inform your doctor or pharmacist or contact the nearest hospital emergency room 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 possible when you remember. Then continue
treatment as before. Do not take a double dose to make up for a missed dose.

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
During HIV treatment, it may be difficult 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. For this
reason, it is very important to inform your doctor about any changes in your
health status.
During combinationtherapy for HIV, both the side effects
listed below for Epivirand other conditions may occur.
It is important to read the information in another part of this leaflet under the heading ‘Other
possible side effects of combination therapy for HIV’.

Common side effects
These can affect up to 1patient out of 10:

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

Uncommon side effects
These can affect up to 1patient out of 100:
Uncommon side effects that can be detected by blood tests are:

• reduced number of cells involved in blood clotting (thrombocytopenia)
• low number of red blood cells (anemia) or low number of white blood cells (neutropenia)
• increased liver enzymes.

Rare side effects
These can affect up to 1patient out of 1000:

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

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

• an increase in an enzyme called amylase.

Very rare side effects
These can affect up to 1patient out of 10,000:

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

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

• bone marrow failure to produce new red blood cells (red cell aplasia).

If you get side effects
Tell your doctor or pharmacistif any of the side effects becomes serious 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 can cause the development of other illnesses during
treatment for HIV.

Old infections can reactivate
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, old infections, which were
hidden, may reactivate causing signs and symptoms of inflammation. These symptoms are
likely due to the reconstitution of the immune system, so that the body begins to
fight these infections.
In addition to opportunistic infections, autoimmune diseases (a condition that occurs when the
immune system attacks healthy tissue in the body) can also occur after you have started
taking medicines to treat HIV infection. Autoimmune diseases can
occur many months after starting treatment. If you notice any symptoms of infection or other
symptoms such as muscle weakness, weakness that starts in the hands and feet and moves towards the
trunk, palpitations, tremor or hyperactivity, tell your doctor immediately to get
the necessary treatment.

If you notice any symptoms of infection while taking Epivir:

tell your doctor immediately. Do not take other medicines for the infection without advice
from your doctor.

You may have bone problems
Some people undergoing 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 flow to the bone. People may be more likely to develop this
condition:

• if they have been taking combination therapy for a long period
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness
• pain (especially in the knee, hip 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 side effects not listed in this leaflet. 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 which is 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. Contents of the pack and other information

What Epivir contains
The active ingredient is lamivudine.
The tablets also contain the following excipients:

Tablet core:microcrystalline cellulose, sodium starch glycolate (gluten-free), magnesium
stearate.

Coating:hypromellose, titanium dioxide, iron oxide black (E172), macrogol, polysorbate 80.

Description of Epivir and contents of the pack
Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or in packs
containing blisters of 30 tablets. The film-coated tablets are lozenge-shaped and grey in colour,
with “GXEJ7” imprinted on one side.

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

Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
For further information on this medicine, 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

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

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: + 356 80065004

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

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

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Eesti
ViiV Healthcare BV
Tel: + 372 8002640

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]

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

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 6969
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL,
LDA.
Tel: + 351 21 094 08 01
[email protected]

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 hf.
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

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

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

United Kingdom (Northern Ireland)
ViiV Healthcare BV
Tel: + 44 (0)800 221441
[email protected]
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu