Lamivudine Teva Pharma B.V. 300 mg film-coated tablets

Lamivudine Teva Pharma B.V. belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

Lamivudine Teva Pharma B.V. is used in antiretroviral combination therapy for the treatment of HIV infection in adults and children. Lamivudine Teva Pharma B.V. reduces the amount of HIV virus in your body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to fight infection. Response to treatment with Lamivudine Teva Pharma B.V. varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

Lamivudine Teva Pharma B.V. should not be used on its own.

If you are taking lamivudine to treat both HIV infection and hepatitis B, then you should also refer to the Product Information Leaflet for treatment of hepatitis B, for additional information on lamivudine.

Do not take Lamivudine Teva Pharma B.V.

• if you are allergic (hypersensitive) to lamivudine or any of the other ingredients of Lamivudine Teva Pharma B.V.

Take special care with Lamivudine Teva Pharma B.V.
Talk to your doctor before taking Lamivudine Teva Pharma B.V. if you:

• have kidney problems. Your kidneys are responsible for removing this medicine from your body.Therefore, if you have kidney disease, then the doctor may decide to reduce the dose.
• have a chronic hepatitis B or C infection, then you are at an increased risk ofsuffering severe and potentially fatal liver disease, and may receive blood tests to check the functioning of the liver.
• have a chronic hepatitis B infection, then your doctor may advise that you should not stop taking Lamivudine Teva Pharma B.V., as this may cause a recurrence of the disease. This recurrence will be more severe if you have severe liver disease.
• have liver problems
• Taking Lamivudine Teva Pharma B.V. does not reduce the risk of infecting someone else with HIV, either through the blood or by sexual intercourse. You should therefore continue to take appropriate precautions to prevent this.

Important information about your medicine

• Lactic acidosis Lamivudine Teva Pharma B.V. belongs to a group of medicines that can cause lactic acidosis ? which is a build up of lactic acid in the body, accompanied with an enlarged liver. If lactic acidosis occurs, then it will normally become apparent after a few months of treatment with lamivudine. Deep rapid breathing, drowsiness, and non specific symptoms such as nausea, stomach pain and vomiting, might indicate the presence of lactic acidosis. This rare, but serious side effect occurs more often in women, particularly if very overweight. If you have liver disease, then you may also be more at risk of getting lactic acidosis. Your doctor will therefore monitor you very closely when you are taking Lamivudine Teva Pharma B.V. for signs that you may be developing lactic acidosis.
• Changes in body fatRedistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
• Symptoms of inflammation from previous infections In some patients with advance HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
• Bone problems (Osteonecrosis)Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

Lamivudine should not be used in combination with zalcitabine (a medicine used to treat HIV), high doses of co-trimoxazole (used to treat bacterial infections), infusions of ganciclovir or foscarnet (antiviral medicines).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Lamivudine Teva Pharma B.V. with food and drink

Lamivudine Teva Pharma B.V. can be taken with or without food.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, or are planning to become pregnant, or if you are breast-feeding. Your doctor will discuss the potential adverse effects and benefits and risks of your antiretroviral therapy to you and your child. Lamivudine Teva Pharma B.V. is not recommended during the first three months of pegnancy.

If you have taken Lamivudine Teva Pharma B.V. during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleoside analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

Breast-feeding:
Both lamivudine and the HIV virus are contained in breast milk and can therefore be passed on to infants. It is therefore recommended that you should not breast-feed your children under any conditions.

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

Always take Lamivudine Teva Pharma B.V. exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You will need to take Lamivudine Teva Pharma B.V. every day. This medicine helps to control your condition, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor.

Lamivudine Teva Pharma B.V. tablets should be taken orally with a drink, with or without food.

Adults and adolescents over 12 years of age:

The usual dose is 300 mg each day. This can be taken either as 1 x 150 mg tablet twice a day, approximately 12 hours apart or 300 mg once a day (2 x 150 mg tablet or 1 x 300 mg tablet).

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

If you have kidney problems, then your doctor will perform tests on the functioning of the kidney, and determine what dose of Lamivudine Teva Pharma B.V. is appropriate.

If you take more Lamivudine Teva Pharma B.V. than you should

Accidentally taking too much Lamivudine Teva Pharma B.V. is unlikely to cause any serious problems.

However, you should tell your doctor or pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Lamivudine Teva Pharma B.V.

If you forget to take your medicine, take it as soon as you remember and then continue to take it as instructed.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lamivucine Teva Pharma B.V.

You must not stop taking Lamivudine Teva Pharma B.V. without consulting your doctor or pharmacist.

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

Like all medicines, Lamivudine Teva Pharma B.V. can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Lamivudine TEVA PHARMA, by other medicines you are taking at the same time or by the HIV disease. For this reason it is very important that you inform your doctor about any changes in your health.

The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

The common side effects are nausea, vomiting, stomach pain, diarrhoea, headache, joint pain, muscle disorders, cough, nasal symptoms (irritation, runny nose), fever, tiredness, general feeling of being unwell, skin rash, hair loss and difficulty in sleeping.

The following side effects are uncommon; anaemia (low red blood cell count), neutropenia (low white blood cell count), and reductions in platelets (blood cells important for blood clotting). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness. A reduction in your white blood cell count can make you more easily prone to infection. If you have a low platelet count you may notice that you bruise more easily. Increases in some liver enzymes have also been noted in blood samples from patients being treated with Lamivudine Teva Pharma.

There are rare reports of inflammation of the liver (hepatitis), inflammation of the pancreas (pancreatitis), breakdown of muscle tissue.

There are very rare reports of numbness, tingling sensation or sensation of weakness in the limbs, and severe anaemia and neutropenia.

Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see Take special care with Lamivudine Teva Pharma for more information).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term health effects of these conditions are not known at this time.

Combination antiretroviral therapy may also cause raised alctic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Lamivudine Teva Pharma B.V. after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

Do not use Lamivudine Teva Pharma B.V. if you notice any change in the appearance of the tablet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Lamivudine Teva Pharma B.V. contains

• The active substance is lamivudine. Each film-coated tablet contains 300 mg.
• The other ingredients are: Tablet core: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate. Tablet film coat: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, iron oxide yellow (E172), iron oxide black (E172)

What Lamivudine Teva Pharma B.V. looks like and contents of the pack

Grey, diamond shaped, biconvex film-coated tablet ? engraved with ?L 300? on one side and plain on the other

Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 90, 100 and 500 tablets or HDPE containers containing 30 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA Pharma B.V.
Computerweg 10, 3542DR Utrecht,
The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary

TEVA Pharmaceutical Works Private Limited Company
H-2100 Gödöllö
Táncsics Mihály út 82
Hungary

TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG UK

Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

TEVA Santé SA
Rue Bellocier
89107 Sens
France

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

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