LAMIVUDINE TEVA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lamivudine Teva 100 mg Film-Coated Tablets EFG

lamivudine

Read all of 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 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Lamivudine Teva and what is it used for

The active substance of Lamivudine Teva is lamivudine.

Lamivudine Teva is used to treat long-term (chronic) hepatitis B infection in adults.

Lamivudine Teva is an antiviral medicine that stops the hepatitis B virus from multiplying and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

The hepatitis B virus infects the liver and can cause long-term infection and liver damage. Lamivudine Teva can be used in patients whose liver is damaged but still works normally (compensated liver disease) and in combination with other medicines in patients whose liver is damaged and does not work normally (decompensated liver disease).

Treatment with Lamivudine Teva may reduce the amount of hepatitis B virus in your body. This can lead to a reduction in liver damage and an improvement in the function of your liver. Not everyone responds to treatment with Lamivudine Teva in the same way. Your doctor will monitor the effectiveness of your treatment with regular blood tests.

2. What you need to know before you take Lamivudine Teva

Do not take Lamivudine Teva

• if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in section 6).

Consult your doctorif you think this applies to you.

Warnings and precautions

Some people taking Lamivudine Teva or similar medicines have a higher risk of serious side effects. You need to know that there is a higher risk:

• if you have ever had other types of liver disease, such as hepatitis C
• if you are significantly overweight (especially if you are a woman)

Consult your doctorif you have any of these conditions. You may need extra checks, such as blood tests, while you are taking this medicine. For more information about the risks, see section 4.

Do not stop taking Lamivudine Tevawithout your doctor's advice, as there is a risk that your hepatitis may get worse. When you stop taking Lamivudine Teva, your doctor will monitor you for at least four months to check for any problems. This will involve taking blood samples to check for any increase in liver enzyme levels that may indicate liver damage. See section 3 for more information on how to take Lamivudine Teva.

Protect others

Hepatitis B is spread by having sexual contact with someone who has the disease or by the transfer of infected blood (for example, by sharing needles for injection). Lamivudine Teva does not prevent the risk of passing on hepatitis B infection to others. To prevent others from becoming infected with hepatitis B:

• Use a condomwhen you have oral or penetrative sex.
• Avoid the risk of blood transfer— for example, do not share needles.

Other medicines and Lamivudine Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, and herbal medicines.

Remember to tell your doctor or pharmacist if you start taking any other medicines while you are taking Lamivudine Teva.

These medicines must not be taken with Lamivudine Teva:

• medicines that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol) if taken regularly (usually liquids)
• other medicines that contain lamivudine, used to treat HIV infection (sometimes called AIDS)
• emtricitabine, used to treat HIV or hepatitis B infection
• cladribine, used to treat hairy cell leukaemia

Tell your doctorif you are being treated with any of these medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby:

Talk to your doctorabout the risks and benefits of taking Lamivudine Teva during pregnancy.

Do not stop taking Lamivudine Teva without your doctor's advice.

Lamivudine Teva can pass into breast milk. If you are breastfeeding or think you may want to breastfeed:

Talk to your doctorbefore taking Lamivudine Teva.

Driving and using machines

Lamivudine Teva may make you feel tired, which could affect your ability to drive or use machines.

Do not drive or use machines unless you are sure that this will not affect you.

Lamivudine Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Lamivudine Teva

Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

Keep in regular contact with your doctor

Lamivudine Teva helps to control your hepatitis B infection. You need to keep taking it every day to control the infection and prevent it from getting worse.

Stay in touch with your doctor and do not stop taking Lamivudine Tevawithout your doctor's advice.

How much to take

The usual dose of Lamivudine Teva is one 100 mg tablet once a day.

Your doctor may prescribe a lower dose if you have kidney problems. A lower strength oral solution of Lamivudine Teva is available for people who need a lower dose than usual or who cannot take tablets.

Talk to your doctorif you are in this situation.

If you are already taking another medicine that contains lamivudine for HIV infection, your doctor will continue to treat you with the higher dose (usually 150 mg twice a day), because the dose of lamivudine in Lamivudine Teva (100 mg) is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor before.

Swallow the tablet whole with water. Lamivudine Teva can be taken with or without food.

If you take more Lamivudine Teva than you should

If you accidentally take too much Lamivudine Teva, tell your doctor or pharmacist, or go to the nearest hospital casualty department. If possible, show them the Lamivudine Teva pack.

If you forget to take Lamivudine Teva

If you miss a dose, take it as soon as you remember. Then continue taking it as before. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Lamivudine Teva

Do not stop taking Lamivudine Teva without talking to your doctor first. There is a risk that your hepatitis may get worse (see section 2). When you stop taking Lamivudine Teva, your doctor will monitor you for at least four months to check for any problems. This will involve taking blood samples to check for any increase in liver enzyme levels that may indicate liver damage.

4. Possible side effects

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

The most common side effects reported with Lamivudine Teva in clinical trials were fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting, and diarrhoea, increased liver enzymes, and increased muscle enzymes (see below).

Allergic reaction

This is rare (may affect up to 1 in 1,000 people). The signs include:

• swelling of the eyelids, face, or lips.
• difficulty swallowing or breathing.

See a doctor immediatelyif you get these symptoms. Stop taking Lamivudine Teva.

Side effects that are thought to be caused by Lamivudine Teva:

A very common side effect(may affect more than 1 in 10people) that may appear in blood tests is:

• an increase in the levels of some liver enzymes (transaminases), which may be a sign of liver inflammation or damage.

A common side effect(may affect more than 1 in 10people)

• muscle cramps and pains
• skin rash or “hives” anywhere on the body.

A common side effectthat may appear in blood tests is:

• an increase in the level of a muscle enzyme (creatine phosphokinase) that may be a sign of muscle damage.

A very rare side effect(may affect up to 1 in 10,000people) is:

• lactic acidosis (excess of lactic acid in the blood).

Other side effects

Other side effects have been reported in a small number of people, but their exact frequency is unknown:

• muscle breakdown.
• worsening of liver disease if the hepatitis B virus becomes resistant to Lamivudine Teva or if treatment is stopped. This can be fatal in some people.

A side effect that may appear in blood tests is:

• a decrease in the number of blood cells involved in blood clotting (thrombocytopenia).

If you get side effects

Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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.

5. Storage of Lamivudine Teva

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton or blister and on the bottle after EXP. The expiry date refers to the last day of the month.

This medicine 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 protect the environment.

6. Contents of the pack and other information

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 coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172)

Appearance and packaging

Orange, capsule-shaped, biconvex, film-coated tablet, engraved with “L 100” on one side and plain on the other.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Teva Operations Poland Sp.z o. o.

Mogilska 80 Str.

31-546 Kraków

Poland

You can get more information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet: {MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.