Package Insert: Information for the Patient

Zeffix 100 mg Film-Coated Tablets

lamivudina

Read this package insert carefully before starting to take this medication.

• Keep this package insert, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert..See section 4.

The active ingredient of Zeffix is lamivudine.

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

Zeffix is an antiviral medication that inhibits the hepatitis B virus and belongs to a group of medications calledinhibitors of reverse transcriptase analogs of nucleosides(INTIs).

The hepatitis B virus infects the liver, causes a long-term (chronic) infection, and can cause liver damage. Zeffix may be used in patients whose liver is damaged but still functions normally (compensated liver disease) and in combination with other medications 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 would lead to a reduction in liver damage and an improvement in liver function. Not everyone responds to Zeffix treatment in the same way. Your doctor will monitor the effectiveness of treatment with periodic blood tests.

Your doctor should provide you with advice and testing to detect HIV infection before starting treatment with lamivudine for hepatitis B infection and during treatment. If you have or contract HIV infection, consult section 3.

Do not take Zeffix

• if you areallergicto lamivudine or to any of the other components ofthis medication (including in section 6).

?Consult your doctorif you think this affects you.

Warnings and precautions

Some people taking Zeffix or other similar medications have a higher risk of suffering severe side effects.You need to know that there is a higher risk:

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

?Consult your doctor ifyou suffer from any of these circumstances.You may need additional tests, such as blood tests, while taking this medication.For more information on the riskssee Section 4.

Do not stop taking Zeffixwithout consulting your doctor, as there is a risk that your hepatitis will worsen. When you stop taking Zeffix, your doctor will monitor you for at least four months to check if there is any problem. This will involve taking blood samples to check if there are elevations in liver enzyme levels that may indicate liver damage. See section 3 for more information on how to take Zeffix.

Protect other people

HBV is transmitted by maintaining sexual contact with someone who suffers from the disease or by blood transfer (for example, by sharing needles). Zeffix does not prevent the risk of HBV infection transmission to others. To prevent others from becoming infected with HBV:

• Use a condomwhen engaging in oral or penetrative sex.
• Avoid the risk of blood transfers— for example, do not share needles.

Other medications and Zeffix

Inform your doctor or pharmacist if you are taking, have recently takenor may have totake any other medication, including those with herbal plants or over-the-counter medications.

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

These medications should not be taken with Zeffix:

• medications, if taken regularly, (usually liquids) that contain sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol)
• other medications that contain lamivudine, used to treatHIV infection(sometimes also called HIV virus)
• emtricitabine, used to treatHIV infectionorhepatitis B
• cladribine, used for the treatment offollicular lymphoma

?Inform your doctorif you are being treated with any of these medications.

Pregnancy

If you are pregnant,think you may be pregnant or intend to become pregnant:

?Talk to your doctorabout the risks and benefits of taking Zeffix during pregnancy.

Do not interrupt Zeffix treatment without consulting your doctor.

Breastfeeding

Zeffix may pass into breast milk.If you are breastfeeding, or thinking of breastfeeding:

?Talk to your doctorbefore taking Zeffix.

Driving and operating machinery

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 sure this does not affect you.

Zeffix contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Maintain regular contact with your doctor

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

?Maintain contact with your doctor and do not stop taking Zeffixwithout consulting your doctor.

How much to take

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

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

?Talk to your doctorif you are in this situation.

Patients who also have or may contract HIV infection

If you have or contract HIV infection, which is not being treated with medication, while taking lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to certain HIV medications and become difficult to treat. Lamivudine can also be used to treat HIV infection. Consult with your doctor if you have HIV infection. Your doctor may treat you with another medication that contains a higher dose of lamivudine, usually 150 mg twice a day, as the lower dose of 100 mg 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 doctorif 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 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 compensate for the missed doses.

Do not interrupt Zeffix treatment

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 that they will perform blood tests to check if there is an increase in liver enzyme levels, which may indicate liver damage.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Allergic reaction

It 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.

?Contact a doctor immediatelyif you have these symptoms. Stop taking Zeffix.

Side effects believed to be caused by Zeffix:

A very frequent side effect(may affectmore 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 inflammation or liver damage.

A frequent side effect(may affectup to 1 in 10people) is:

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

A frequent side effect that may appear in blood tests is:

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

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

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

Other side effects

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

• muscle rupture
• worsening of liver diseaseif the hepatitis B virus becomes resistant to Zeffix or treatment is interrupted. 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 have side effects

?Consult your doctor orpharmacisteven if it's about possible side effects that don't appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, evenif it's aboutpossibleside effects that don't appear in this prospectus. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not take this medication after the expiration date that appears on the packaging and blister.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.This will help protect the environment.

Composition of Zeffix

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

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

Appearance of the product and contents of the pack

Zeffix film-coated tablets are presented in unbreakable blisters containing 28 or 84 tablets. The tablets are caramel-colored, capsule-shaped, biconvex, and marked "GX CG5" on one side.

Only some pack sizes may be marketed.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of thisleaflet:

The detailed information about this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu