Lamivudine Teva 100 mg film-coated tablets

Lamivudine Teva belongs to a group of medicines called antivirals. It is used for the treatment of hepatitis B infection.

Lamivudine Teva is used to treat adults with long term (chronic) hepatitis B.

Hepatitis B is a virus that infects the liver and can lead to liver damage. Treatment with Lamivudine Teva can reduce the amount of hepatitis B virus in your body. This should lead to a reduction in liver damage and an improvement in your liver function.

Do not take Lamivudine Teva

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

If you are not sure please consult your doctor.

Take special care with Lamivudine Teva

Lamivudine Teva reduces the amount of hepatitis B virus in your body, and keeps the liver disease under control, therefore reducing health problems relating to your liver in the future. For effective treatment you will need to take Lamivudine Teva every day. Patients respond to the treatment differently, therefore it is not known for how long you will have to take this medicine.

Your doctor will be checking your response to treatment by taking regular blood samples. The results of these tests will help your doctor to decide when your treatment with Lamivudine Teva can be stopped.

Before treatment with Lamivudine Teva, you should have discussed any additional medical problems that you have with your doctor. If you have kidney disease then this medicine is not suitable for you, as it is your kidneys that are mainly responsible for getting rid of the medicine from your body.

Do not stop taking Lamivudine Teva without instruction from your doctor, as there is a small risk of your hepatitis getting worse. When you stop taking Lamivudine Teva your doctor will monitor you for al least the following four months to check for any problems. This will mean taking blood samples to check for any abnormalities in the liver enzymes, indicating liver damage.
The active ingredient in this product is lamivudine. If you are already taking this medicinal product for HIV infection, your doctor will continue to treat you with the higher dose, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is insufficient to treat infection.
Because your medicine helps to control your hepatitis B and it is not yet known whether it will cure it, you are still at risk of transmitting this virus to others through sexual contact or by blood transfer, and you should use appropriate precautions to prevent this. There is an effective vaccine available to protect those at risk from becoming infected with hepatitis B.

Taking other medicines

Lamivudine Teva should not be taken with zalcitabine (which is used to treat HIV).

Some medicines may affect the action of Lamivudine Teva. 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 with food and drink

Lamivudine Teva can be taken with food or on an empty stomach.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant, or are planning to become pregnant, or if you are breast-feeding. Your doctor will advise whether you should continue to take Lamivudine Teva while you are pregnant. Do not stop treatment with Lamivudine Teva without our doctor?s advice. Since Lamivudine and the virus pass into breast milk it is recommended that mothers taking Lamivudine Teva do not breast-feed their infants.

Driving and using machines
No studies on the effect of Lamivudine Teva on the ability to drive and use machines has been performed.

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

The usual dose is one tablet (100 mg) once a day, taken by mouth with or without food.

If you take more Lamivudine Teva than you should

Accidentally taking too much Lamivudine Teva is unlikely to cause any serious problems. However, you should tell your doctor or pharmacist, or consult your nearest hospital emergency department for further advice.

If you forget to take Lamivudine Teva

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 Lamivudine Teva

You must not stop taking Lamivudine Teva 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 can cause side effects, although not everybody gets them. In clinical trials, the number and type of side effects reported in patients taking lamivudine were generally similar to those reported in patients taking an inactive substance (placebo). The most commonly reported were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea. However, increases in liver enzymes and enzymes produced in the muscles were sometimes more commonly reported in patients taking lamivudine.

Side effects thought to be caused by lamivudine are listed below:

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
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)

Very common

• Increases in enzymes produced by the liver called transaminases

Common

• Increases in an enzyme called creatine phosphokinase produced in the muscles

Very rare

• Reduction in platelets, blood cells important for blood clotting. If you have a low platelet count you may notice you bruise more easily
• Cramps, muscle pains and breakdown of muscle
• Marked worsening of liver disease after lamivudine is stopped or during treatment if resistance develops. This can be fatal in some patients

Some people may be allergic to medicines. If you have any of the following symptoms soon after taking Lamivudine Teva STOP taking the medicine and tell your doctor immediately:

* Sudden wheeziness and chest pain or tightening.
* Swelling of eyelids, face or lips.
* Skin rash or ?hives? anywhere on the body.

There have been some reports of the condition becoming worse during treatment and after withdrawl if resistance develops. This can be fatal in some patients.

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 after the expiry date which is stated on the label and carton. 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 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 contains

• The active substance is lamivudine. Each film-coated tablet contains 100 mg of Lamivudine.
• 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 red (E172).

What Lamivudine Teva looks like and contents of the pack

Orange, capsule shaped, biconvex film-coated tablet ? engraved with ?L100? on one side and plain on the other

Lamivudine Teva is available in aluminium blisters containing 28, 30, 84 or 100 tablets or HDPE containers containing 60 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

TEVA Pharma BV
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

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

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. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 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}.