Zeffix 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zeffix 100mg film-coated tablets

lamivudine

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Zeffix is and what it is used for

The active substance in Zeffix is lamivudine.

Zeffix is used to treat chronic hepatitis B infection in adults.

Zeffix is an antiviral medicine that inhibits the hepatitis B virus and belongs to a group of medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).

The hepatitis B virus infects the liver, causes a long-term (chronic) infection, and may lead to liver damage. Zeffix can be used in patients whose liver is damaged but still functions normally (compensated liver disease) and in combination with other medicines in patients whose liver is damaged and does not function normally (decompensated liver disease).

Treatment with Zeffix may reduce the amount of hepatitis B virus in your body. This may result in reduced liver damage and improved liver function. Not everyone responds to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of treatment with periodic blood tests.

2. What you need to know before taking Zeffix

Your doctor should provide you with counselling and testing for HIV infection before starting lamivudine treatment for hepatitis B infection and during treatment. If you have or develop HIV infection, see section 3.

Do not take Zeffix

• if you are allergic to lamivudina or to any of the other ingredients of this medicine (listed in section 6).
• Consult your doctor if you think this applies to you.

Warnings and precautions

Some people who take Zeffix or other similar medicines are at increased risk of serious side effects. You should be aware that the risk is higher:

• if you have previously had other types of liver disease, such as hepatitis C
• if you are significantly overweight (especially if you are female)
• Consult your doctor if you have any of these conditions. You may need additional tests, such as blood tests, while taking this medicine. For more information about the risks, see Section 4.

Do not stop taking Zeffix without medical advice, as there is a risk that your hepatitis may worsen. When you stop taking Zeffix, your doctor will monitor you for at least four months to check for any problems. This will involve taking blood samples to check for increases in liver enzyme levels that could indicate liver damage. See section 3 for more information on how to take Zeffix.

Protect other people

Hepatitis B is spread through sexual contact with someone who has the disease or through transfer of infected blood (for example, by sharing needles). Zeffix does not prevent the risk of spreading hepatitis B infection to others. To prevent other people from becoming infected with hepatitis B:

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

Other medicines and Zeffix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or over-the-counter medicines.

Remember to tell your doctor or pharmacist if you start taking any other medicine while taking Zeffix.

These medicines must not be taken with Zeffix:

• medicines, if taken regularly (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol)
• other medicines containing lamivudine, used to treat HIV infection (sometimes also called AIDS virus)
• emtricitabine, used to treat HIV infection or hepatitis B
• cladribine, used to treat hairy cell leukaemia
• Inform your doctor if you are being treated with any of these medicines.

Pregnancy

If you are pregnant, think you might be pregnant, or are planning to become pregnant:

• Talk to your doctor about the risks and benefits of taking Zeffix during pregnancy.

Do not stop treatment with Zeffix without medical advice.

Breast-feeding

Zeffix may pass into breast milk. If you are breast-feeding or considering breast-feeding:

• Talk to your doctor before taking Zeffix.

Driving and using machines

Zeffix may make you feel tired, which could affect your ability to drive or operate machinery.

• Do not drive or operate machinery unless you are certain that it does not affect you.

Zeffix contains sodium

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

3. How to take Zeffix

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Keep in regular contact with your doctor

Zeffix helps 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 contact with your doctor and do not stop taking Zeffix without your doctor's advice.

How much to take

The usual dose of Zeffix is one tablet (100 mg of lamivudine) once daily.

Your doctor may prescribe a lower dose if you have kidney problems. Zeffix oral solution is available for patients who require a lower than usual dose or who cannot take tablets.

• Talk to your doctor if you are in this situation.

Patients who also have or may acquire HIV infection

If you have or acquire HIV infection that is not being treated with antiviral medicines while taking lamivudine for hepatitis B, the HIV virus may develop resistance to certain HIV medicines, making it harder to treat. Lamivudine can also be used to treat HIV infection. Consult your doctor if you have HIV infection. Your doctor may treat you with another medicine containing a higher dose of lamivudine, usually 150 mg twice daily, as the lower 100 mg dose is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor beforehand.

• Talk to your doctor if you are in this situation.

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

If you take more Zeffix than you should

If you accidentally take too much Zeffix, inform your doctor or pharmacist or go immediately to the nearest hospital emergency department for advice. If possible, show them the Zeffix packaging.

If you forget to take Zeffix

If you forget to take 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 missed dose.

Do not interrupt treatment with Zeffix

Do not stop taking Zeffix without consulting your doctor. There is a risk that your hepatitis may worsen (see section 2). When you stop taking Zeffix, your doctor will monitor you for at least four months to check for any problems. This means you will have blood tests to monitor liver enzyme levels, which may indicate liver damage.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most commonly reported adverse effects in clinical trials with Zeffix were fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, and increases in liver enzymes and in enzymes produced in the muscles (see below).

Allergic reaction

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

• swelling of the eyelids, face or lips
• difficulty swallowing or breathing.
• Contact a doctor immediately if you have these symptoms. Stop taking Zeffix.

Adverse effects believed to be caused by Zeffix:

A very common adverse effect (may affect more than 1 in 10 people), which may be detected in blood tests, is:

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

A common adverse effect (may affect up to 1 in 10 people) is:

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

A common adverse effect that may appear in blood tests is:

• an increase in the level of an enzyme produced in the muscles (creatine phosphokinase), which may be a sign of body tissue damage.

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

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

Other adverse effects

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

• muscle rupture
• worsening of liver disease if the hepatitis B virus becomes resistant to Zeffix or if treatment is stopped. This may be fatal in some people.

An adverse effect that may appear in blood tests is:

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

If you experience adverse effects

• Consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zeffix

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

Do not use this medicine after the expiry date stated on the packaging and blister.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zeffix

The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.

The other components are: microcrystalline cellulose, sodium carboxymethylstarch, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic red and yellow iron oxide.

Appearance of the product and contents of the pack

Zeffix film-coated tablets are presented in tamper-evident blisters containing 28 or 84 tablets. The tablets are caramel-coloured, capsule-shaped, biconvex, and marked “GX CG5” on one side.

Only certain pack sizes may be marketed.

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet: MM/YYYY

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