InfoCons Consumer Protection informs you – Zeffix – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have 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.

ℹ️ 1. What Zeffix is and what it is used for

The active ingredient in Zeffix is lamivudine.

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

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

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

Treatment with Zeffix 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. Not everyone responds to treatment with Zeffix 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 Zeffix

Your healthcare provider should offer you counselling and testing for HIV infection before you start treatment with lamivudine for hepatitis B infection and during treatment. If you have or get HIV infection, see section 3.

Do not take Zeffix

• if you’re allergic to lamivudine or to any of the other ingredients of this medicine (listed in Section 6).

➔ Check with your doctor if you think this applies to you.

Warnings and precautions

Some people taking Zeffix or other similar medicines are more at risk of serious side effects. You need to be aware of the extra risks:

• if you have ever had other types of liver disease, such as hepatitis C
• if you’re seriously overweight (especially if you’re a woman).

➔ Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medication. See Section 4 for more information about the risks.

Don’t stop taking Zeffix without your doctor’s advice, as there is a risk of your hepatitis getting worse. When you stop taking Zeffix your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage. See section 3 for more information about how to take Zeffix.

Protect other people Hepatitis B infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Zeffix will not stop you passing hepatitis B infection on to other people. To protect other people from becoming infected with hepatitis B:  Use a condom when you have oral or penetrative sex.  Don’t risk blood transfer — for example, don’t share needles.

Other medicines and Zeffix

Tell your doctor or pharmacist if you’re taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking Zeffix.

These medicines should not be used with Zeffix:

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

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby: ➔ Talk to your doctor about the risks and benefits of taking Zeffix during your pregnancy.

Do not stop treatment with Zeffix without your doctor’s advice.

Breast-feeding

Zeffix can pass into breast-milk. If you are breast-feeding, or thinking about breast-feeding: ➔ Talk to your doctor before you take Zeffix.

Driving and using machines

Zeffix may make you feel tired, which could affect your ability to drive or use machines. ➔ Don’t drive or use machines unless you are sure you’re not affected.

Zeffix contains sugar, preservatives, propylene glycol and sodium

If you are diabetic, please note that each dose of Zeffix (100 mg = 20 ml) contains 4 g of sucrose.

Zeffix contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Zeffix. Sucrose may be harmful to the teeth.

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

This medicine contains 400 mg propylene glycol in each 20 ml.

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

💊 3. How to take Zeffix

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re not sure.

Stay in regular contact with your doctor Zeffix helps to control your hepatitis B infection. You need to keep taking it every day to control your infection and stop your illness getting worse. ➔ Keep in touch with your doctor, and don’t stop taking Zeffix without your doctor’s advice.

How much to take The usual dose of Zeffix is 20 ml (100 mg lamivudine) once a day.

Your doctor may prescribe a lower dose if you have problems with your kidneys. ➔ Talk to your doctor if this applies to you.

Patients who also have or may get HIV infection If you have or get HIV that is not being treated with medicines while taking lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. Lamivudine can also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine that contains a higher dose of lamivudine, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor first. ➔ Talk to your doctor if this applies to you.

Zeffix can be taken with or without food.

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

If you take more Zeffix than you should

If you accidentally take too much Zeffix, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. If possible, show them the Zeffix pack.

If you forget to take Zeffix

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.

Don’t take a double dose to make up for a missed dose.

Don’t stop taking Zeffix You must not stop taking Zeffix without consulting your doctor. There is a risk of your hepatitis getting worse (see section 2). When you stop taking Zeffix your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage.

❗ 4. Possible side effects

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

Side effects that were commonly reported in Zeffix clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).

Allergic reaction These arerare (may affect up to 1 in 1,000 people). Signs include:

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

Side effects thought to be caused by Zeffix A very common side effect (these may affect more than 1 in 10 people) which may show up in blood tests is:

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

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

• cramps and muscle pains
• skin rash or ‘hives’ anywhere on the body A common side effect which may show up in blood tests is:
• an increase in the level of an enzyme produced in the muscles (creatine phosphokinase) which may be a sign that body tissue is damaged.

A very rare side effect (these 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 occurred in a very small number of people but their exact frequency is unknown

• breakdown of muscle tissue
• a worsening of liver disease after Zeffix is stopped or during treatment if the hepatitis B virus becomes resistant to Zeffix. This can be fatal in some people.

A side effect which may show up in blood tests is:

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

If you get any 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 or pharmacist. 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. How to store Zeffix

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

Don’t take this medicine after the expiry date shown on the bottle and the carton.

Don’t store above 25 °C.

Discard one month after first opening.

Do not throw away any medicines in your wastewater or household rubbish. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Zeffix contains

The active substance is lamivudine. Each ml of oral solution contains 5 mg of lamivudine.

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

What Zeffix looks like and contents of the pack

Zeffix oral solution is supplied in cartons containing a white polyethylene bottle, with a child resistant cap. The solution is clear, colourless to pale yellow in colour with strawberry/banana flavouring. The bottle contains 240 ml of lamivudine solution (5 mg/ml). The pack includes an oral applicator with ml graduations and an applicator-adapter, which should be fitted to the bottle before use.

Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland D24 YK11 GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin 24 Ireland D24 YK11 For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder

België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00 Lietuva GlaxoSmithKline Trading Services Limited Tel: + 370 80000334 България GlaxoSmithKline Trading Services Limited Teл.: + 359 80018205 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgique/Belgien Tél/Tel: + 32 (0)10 85 52 00 Česká republika GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111 Magyarország GlaxoSmithKline Trading Services Limited Tel.: + 36 80088309 [email protected] Danmark GlaxoSmithKline Pharma A/S Tlf.: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Trading Services Limited Tel: + 356 80065004 Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 [email protected] Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 Eesti GlaxoSmithKline Trading Services Limited Tel: + 372 8002640 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 Ελλάδα GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Τηλ: + 30 210 68 82 100 Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 [email protected] España GlaxoSmithKline, S.A.

Tel: + 34 900 202 700 [email protected] Polska GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000 France Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 [email protected] Portugal Glaxo Wellcome Farmacêutica, Lda.

Tel: + 351 21 412 95 00 [email protected] Hrvatska GlaxoSmithKline Trading Services Limited Tel: + 385 800787089 România GlaxoSmithKline Trading Services Limited Tel: + 40 800672524 Ireland GlaxoSmithKline Trading Services Limited Tel: + 353 (0)1 4955000 Slovenija GlaxoSmithKline Trading Services Limited Tel: + 386 80688869 Ísland Vistor hf.

Sími: + 354 535 7000 Slovenská republika GlaxoSmithKline Trading Services Limited Tel: + 421 800500589 Italia GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Κύπρος GlaxoSmithKline Trading Services Limited Τηλ: + 357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija GlaxoSmithKline Trading Services Limited Tel: + 371 80205045

This leaflet was last revised in

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

How to measure the dose and take the medicine Use the oral applicator supplied with the pack to measure your dose accurately (see also Section 3).

When full, the applicator contains 10 ml of solution.

1. Remove the plastic wrap from the applicator/adapter.

2. Remove the adapter from the applicator.

3. Remove the child-proof bottle cap (A) and keep it safely.

4. Hold the bottle. Push the adapter (B) firmly into the neck of the bottle, as far as it will go.

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

6. Turn the bottle upside down.

7. Pull out the applicator plunger (D) until the applicator contains the first part of your full dose.

8. Turn the bottle the right way up. Remove the applicator from the adapter.

9. Put the applicator into your mouth, placing the tip of the applicator against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don’t push too hard and squirt the liquid into the back of your throat, or you may choke.

10. Repeat steps 5 to 9 in the same way until you have taken your whole dose. For example, if your dose is 20 ml, you need to take 2 applicator-fulls of medicine.

11. Take the applicator out of the bottle and wash it thoroughly in clean water. Let it dry completely before you use it again. Leave the adapter in the bottle.

12. Close the bottle tightly with the cap.

Discard oral solution one month after first opening.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Zeffix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/99/114).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.