Patient Information Leaflet

Zeffix 5 mg/ml Oral Solution

lamivudina

Read this 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 (NtIs).

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, see section 3.

Do not take Zeffix

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

?Consult your doctorif you think this affects you.

Warnings and precautions

Some people taking Zeffix or similar medications have a higher risk of 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 significantoverweight(especially if you are a woman)

?Consult your doctor if you have 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 are any problems. 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 others

HBV is transmitted by having sexual contact with someone who has 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 having oral or penetrative sex.
• Avoid blood transfer risk— for example, do not share needles.

Other medications and Zeffix

Inform your doctor or pharmacist if you are taking, have taken recentlyor 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 ofhair cell leukemia

?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 planning to breastfeed:

?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 will not affect you.

Zeffix contains sugar, preservatives, propylene glycol, and sodium

If you are diabetic, note that each dose of Zeffix (100 mg – 20 ml) contains4 gof sugar.

Zeffix contains sucrose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking Zeffix. Sucrose may be detrimental to your teeth.

Zeffix contains preservatives (parahydroxybenzoates) that may cause allergic reactions (possibly delayed).

This medication contains 400 mg of propylene glycol in each 20 ml.

This medication contains 58.8 mg of sodium (main component of table salt/for cooking) in each 20 ml. This is equivalent to 2.9% of the recommended maximum daily sodium intake for an adult.

Follow exactly the administration instructions of this medication as 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 20ml(100mg of lamivudine)once a day.

Your doctor may prescribe a lower dose if you have kidney problems.

?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, since 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.

See the diagram and instructions to measure and take a dose of medication after section 6 of this leaflet.

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 service 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 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 if there are 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, abdominal discomfort and 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 common side effect(may affect more than1 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 common side effect(may affectup to 1 in 10people) is:

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

A common side effectthat 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 cells involved in blood clotting (thrombocytopenia).

If you have side effects

?Consult your doctor or pharmacisteven 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 nurse, even if it's about possible side effects that don't appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. 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 bottle.

Do not store at a temperature above 25°C.

Dispose of after one month since it was first opened.

Medicines should not be thrown down the drain 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 milliliter of oral solution contains 5 mg of lamivudine.

The other components are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol (E1520), sodium citrate, artificial strawberry flavor, artificial banana flavor, purified water.

Appearance of the product and contents of the package

Zeffix oral solution is presented in packaging that contains a white polyethylene bottle with a child-resistant closure. The solution is clear, colorless or pale yellow with a strawberry/banana flavor. The bottle contains 240 ml of lamivudine solution (5 mg/ml). The package includes an oral graduated syringe and an adapter for the syringe that must be inserted into the bottle before use.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this prospectus:

The detailed information about this medication is available on the European Medicines Agency websitehttp://www.ema.europa.eu

How to measure the dose and take the medicine

To measure your dose accurately, use the oral syringe provided in the package (see also Section 3).

When full, the syringe contains10 ml of solution.

1Remove the plastic wrapperfrom the syringe/adapter.

2.Remove the adapterfrom the syringe.

3.Removethe child-resistant cap (A) from the bottle.Save the cap.

4.Hold the bottle.Insert the plastic adapter (B) into the neck of the bottle, as far as possible.

5.Insert the syringe (C)firmly into the adapter.

6.Place the bottle upside down.

7.Pull the plunger of the syringe (D)until the first portion of your full dose has been removed.

8.Return the bottle to its correct position.Remove the syringe from the adapter.

9.Place the syringe in your mouth, placing the end of the syringe towards the inside of your cheek.Press the plunger slowly, allowing time to swallow.Do not press too hardand spill the liquid towards the back of your throat or you may choke.

10.Repeat steps 5 to 9in the same way until the full dose has been taken. For example, if your dose is 20 ml, you need to take 2 full syringes of medicine.

11.Remove the syringe from the bottleandclean itwell with clean water. Leave them to dry completely before using them again. Leave the adapter in the bottle.

12.Close the bottle firmlywith the cap.

Dispose of the oral solution after one month of opening.