Epivir
lamivudine
lamivudine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Epivir is and what it is used for
What you need to know before you take Epivir
How to take Epivir
Possible side effects
How to store Epivir
Contents of the pack and other information
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.
if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in Section 6).
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)
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.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Discuss with your doctor the precautions needed to avoid infecting other people.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 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).
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.
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:
Epivir is unlikely to affect your ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
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.
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.
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 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 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.
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.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.
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).
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.
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
inflammation of the pancreas (pancreatitis)
breakdown of muscle tissue
inflammation (hepatitis).
A rare side effect that may show up in blood tests is:
an increase in an enzyme called amylase.
These may affect up to 1 in 10,000 people:
Lactic acidosis (excess lactic acid in the blood)
tingling or numbness of the arms, legs, hands or feet.
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).
Combination therapy including Epivir may cause other conditions to develop during HIV treatment.
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:
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.
stiffness in the joints
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms:
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.
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.
The active substance is lamivudine.
The tablets also contain the following other ingredients:
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate
Film-coat: hypromellose, titanium dioxide, macrogol, polysorbate 80
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 ‘GXCJ7’ on both sides.
GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189
60-322 Poznan Poland
ViiV Healthcare BV
Van Asch van Wijckstraat 55H 3811 LP Amersfoort
Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ViiV Healthcare BV Tel: + 370 80000334
ViiV Healthcare BV Teл.: + 359 80018205
Tél/Tel: + 32 (0)10 85 65 00
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10
iiv.med.info@viivhealthcare.com
ViiV Healthcare BV Tel: + 356 80065004
ViiV Healthcare BV Tel: + 31 (0)33 2081199
ViiV Healthcare BV Tel: + 372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Τηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: +385 800787089
ViiV Healthcare BV Tel: + 40 800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
ViiV Healthcare BV Tel: + 386 80688869
Vistor hf.
Sími: +354 535 7000
ViiV Healthcare BV Tel: + 421 800500589
ViiV Healthcare S.r.l. Tel: + 39 (0)45 7741600
ViiV Healthcare BV Τηλ: + 357 80070017
ViiV Healthcare BV Tel: + 371 80205045
ViiV Healthcare BV Tel: + 44 (0)800 221441
https://www.ema.europa.eu.