Zeffix

Patient Information Leaflet

Zeffix 100 mg film-coated tablets

lamivudine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 contained in Zeffix is lamivudine.
Zeffix is used to treat chronic (long-term) hepatitis B infection in adults.
Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of
medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes chronic (long-term) infection, and
can damage the liver. 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 properly (decompensated liver disease).
Treatment with Zeffix can reduce the amount of hepatitis B virus in the body. This should lead to less liver damage and improvement in liver function. Not all people respond to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of treatment with regular blood tests.

2. What you need to know before taking Zeffix

The doctor should provide counselling and perform an HIV test before starting treatment with
lamivudine for hepatitis B infection, and during treatment. If you have or may acquire 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 similar medicines are at higher risk of serious side effects. You should be aware of these additional risks:

• if you have had other types of liver disease, such as hepatitis C
• if you are severely overweight (especially if you are a woman). ➔ Inform your doctor if any of these situations apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information on risks. Do not stop taking Zeffix without medical advice, as there is a risk of worsening hepatitis. If you discontinue Zeffix, your doctor will monitor you for at least four months to check for any problems. This will include blood sampling to monitor for any increase in liver enzyme levels, which may indicate liver damage. See section 3 for further information on how to take Zeffix.

Protecting other people
Hepatitis B infection spreads through sexual contact with infected individuals or through transfer of infected blood (e.g. by sharing injecting needles). Zeffix will not prevent transmission of hepatitis B infection to others. To protect others from hepatitis B infection:

• use a condom during oral or penetrative sex.
• avoid exposure to blood – for example, do not share needles.

Other medicines and Zeffix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies or other medicines purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine during treatment with Zeffix.
The following medicines must not be taken with Zeffix:

• medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• other medicines containing lamivudine, used to treat HIV infection (sometimes called AIDS virus)
• emtricitabine used to treat HIV infection or hepatitis B virus infection
• 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 may be pregnant, or are planning to become pregnant:
➔ Discuss with your doctor the risks and benefits of taking Zeffix during pregnancy.
Do not stop treatment with Zeffix without consulting your doctor.
Breast-feeding
Zeffix may pass into breast milk. If you are breast-feeding or are 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 if you feel tired.
Zeffix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Zeffix

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Stay in regular contact with your doctor.
Zeffix helps control hepatitis B infection. You must take it every day to keep the infection under control and to prevent the disease from worsening.
➔ Stay in contact with your doctor and do not stop taking Zeffix without your doctor's advice.

Dosage
The usual dose of Zeffix is one tablet (100 mg lamivudine) once daily.
Your doctor may prescribe a lower dose if you have kidney problems. An oral solution of Zeffix is available for people who require a lower than recommended dose or who cannot take tablets.
➔ Talk to your doctor if this applies to you.

Patients who have or may acquire HIV infection
If you have or acquire HIV infection that is not treated with antiviral medicines while taking lamivudine for hepatitis B infection, the HIV virus may develop resistance to certain HIV medicines, making it harder to treat. Lamivudine may also be used to treat HIV infection. Talk to 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, because the lower dose of 100 mg lamivudine is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, talk to your doctor first about this change.
➔ Talk to your doctor if this applies to you.

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 contact the nearest hospital emergency department for further 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 your treatment as before. Do not take a double dose to make up for the missed dose.

Do not stop taking Zeffix
You must not stop taking Zeffix without consulting your doctor. There is a risk that hepatitis may worsen (see section 2). After stopping Zeffix, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to monitor any increases in 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.
The side effects commonly reported in clinical studies with Zeffix include fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting, diarrhoea, increases in liver enzymes and in enzymes produced in muscles (see below).

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

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

Side effects believed to be caused by Zeffix
A very common side effect (may affect more than 1 in 10 people), which can be detected by blood tests, is:

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

A common side 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 side effect that can be detected by blood tests is:

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

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 occurred in a very small number of people, but their exact frequency is unknown:

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

A side effect that may be detected by blood tests is:

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

If you experience side effects
➔ Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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.
Do not use this medicine after the expiry date stated on the carton and blister.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zeffix contains
The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
The other components are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate,
hypromellose, titanium dioxide, macrogol 400, polysorbate 80, yellow and red synthetic iron oxides.

Description of the appearance of Zeffix and contents of the pack
Zeffix film-coated tablets are supplied in cartons with a tamper-evident seal containing aluminum blisters of 28 or 84 tablets. The tablets are caramel-colored, film-coated, capsule-shaped, biconvex, with "GX CG5" engraved on one side.

Not all pack sizes may be marketed.

Manufacturer Marketing Authorization Holder
Delpharm Poznań Spółka Akcyjna GlaxoSmithKline Trading Services
ul. Grunwaldzka 189 Limited
60-322 Poznan 12 Riverwalk
Poland Citywest Business Campus
Dublin 24
Ireland
D24 YK11

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0)10 85 52 00 Tel: + 370 80000334

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

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 800650042
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0) 33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline Glaxo Wellcome Farmacêutica, Lda.
Tél.: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089 Tel: + 40 800672524

Ireland Slovenija
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Trading Services Limited
Sími: + 354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 802050456

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Patient information leaflet: information for the patient

Zeffix 5 mg/ml oral solution

lamivudine
Please read this leaflet carefully before starting to take this medicine, as
it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 (long-term) hepatitis B infection in adults.
Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of
medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes chronic (long-term) infection, and
can damage the liver. Zeffix may 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 the body. This should lead to reduced liver damage and improvement in liver function. Not all people respond to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of treatment with regular blood tests.

2. What you need to know before taking Zeffix

Your doctor should provide counselling and perform an HIV test before starting treatment with lamivudina for hepatitis B infection, and during treatment. If you have or may have 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 taking Zeffix or similar medicines are at higher risk of serious side effects. You should be aware of these additional risks:

• if you have had other types of liver disease, such as hepatitis C
• if you are severely overweight (especially if you are a woman). ➔ Inform your doctor if any of these situations apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information on risks.

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

Protecting other people

Hepatitis B infection spreads through sexual contact with infected individuals or through transfer of infected blood (for example, by sharing injection needles). Zeffix will not prevent transmission of hepatitis B to other people. To protect others from hepatitis B infection:

• use a condom during oral or penetrative sex.
• avoid exposure to blood – for example, do not share needles.

Other medicines and Zeffix

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other non-prescription medicines.

Remember to inform your doctor or pharmacist if you start taking a new medicine during treatment with Zeffix.

The following medicines must not be taken with Zeffix:

• medicines (usually liquid) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• other medicines containing lamivudina, used to treat HIV infection (sometimes called AIDS virus)
• emtricitabine used to treat HIV infection or hepatitis B virus infection
• 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, suspect you may be pregnant, or are planning to become pregnant:
➔ Discuss with your doctor the risks and benefits of taking Zeffix during pregnancy.
Do not stop treatment with Zeffix without consulting your doctor.

Breast-feeding

Zeffix may pass into breast milk. If you are breast-feeding or plan to breast-feed:
➔ Talk to your doctor before taking Zeffix.

Driving and use of machines

Zeffix may make you feel tired, which could affect your ability to drive or operate machinery.
➔ Do not drive or operate machinery if you feel tired.

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 your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking Zeffix. Sucrose may be harmful to teeth.

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

This medicine contains 400 mg of propylene glycol per 20 ml.

This medicine contains 58.8 mg of sodium (a main component of table salt) per 20 ml. This corresponds to 2.9% of the maximum daily dietary sodium intake recommended for an adult.

3. How to take Zeffix

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Stay in regular contact with your doctor.
Zeffix helps control hepatitis B infection. You must take it every day to control the infection and prevent the disease from getting worse.
➔ Stay in contact with your doctor and do not stop taking Zeffix without consulting your doctor.

Dosage
The usual dose of Zeffix is 20 ml (100 mg of lamivudine) once daily.
Your doctor may prescribe a lower dose if you have kidney problems.
➔ Talk to your doctor if this applies to you.

Patients who 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 treatment, the HIV virus may develop resistance to certain HIV medicines, making the infection harder to treat. Lamivudine may also be used to treat HIV infection. Talk to 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, because the lower dose of 100 mg of lamivudine is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, talk to your doctor about this change first.
➔ Talk to your doctor if this applies to you.

Zeffix can be taken with or without food.
See the instructions on how to measure and take the dose of the medicine 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 contact the Emergency Department of your nearest hospital for further 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 with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

Do not stop taking Zeffix
You must not stop taking Zeffix without consulting your doctor. There is a risk that hepatitis may worsen (see section 2). After stopping Zeffix, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to monitor any increases in 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.
The side effects commonly reported in clinical studies with Zeffix include fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and in enzymes produced in the muscles (see below).

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

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

Side effects believed to be caused by Zeffix
A very common side effect (may affect more than 1 in 10 people), which may be detected by blood tests, is:

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

A common side 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 side effect which may be detected by blood tests is:

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

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 occurred in a very small number of people, but their exact frequency is unknown:

• muscle tissue breakdown
• worsening of liver disease after stopping Zeffix or during treatment if the hepatitis B virus becomes resistant to Zeffix. This may be fatal in some people. A side effect that may be detected by blood tests is:
• a reduction in the number of cells involved in blood clotting (thrombocytopenia).

If you experience side effects
➔ Tell 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, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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.
Do not use this medicine after the expiry date stated on the bottle and the outer carton.
Do not store above 25°C.
Do not use more than one month after first opening.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zeffix contains
The active substance is lamivudine. Each ml of oral solution contains 5 mg of lamivudine.
The other components are: sucrose, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), citric acid, propylene glycol (E1520), sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.

Description of the appearance of Zeffix and package contents
Zeffix oral solution is supplied in cartons containing a white polyethylene bottle with a child-resistant safety closure. The solution is clear, colourless to pale yellow, with a strawberry/banana flavour. The bottle contains 240 ml of lamivudine solution (5 mg/ml). The pack also includes an oral dosing dispenser with graduations in ml and an adapter for the dispenser, which must be attached to the bottle before use.

Manufacturer
Marketing Authorization Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00

България (Bulgaria)
GlaxoSmithKline Trading Services Limited
Tel: + 359 80018205

Česká republika (Czech Republic)
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Danmark (Denmark)
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00
[email protected]

Deutschland (Germany)
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
[email protected]

Eesti (Estonia)
GlaxoSmithKline Trading Services Limited
Tel: + 372 8002640

Ελλάδα (Greece)
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

España (Spain)
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

Hrvatska (Croatia)
GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089

Ireland
GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000

Ísland (Iceland)
Vistor hf.
Sími: + 354 535 7000

Italia (Italy)
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Κύπρος (Cyprus)
GlaxoSmithKline Trading Services Limited
Τηλ: + 357 80070017
[email protected]

Latvija (Latvia)
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045

Lietuva (Lithuania)
GlaxoSmithKline Trading Services Limited
Tel: + 370 80000334

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00

Magyarország (Hungary)
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 80065004

Nederland (Netherlands)
GlaxoSmithKline BV
Tel: + 31 (0) 33 2081100

Norge (Norway)
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Österreich (Austria)
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

Polska (Poland)
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

Portugal
Glaxo Wellcome Farmacêutica, Lda.
Tel: + 351 21 412 95 00
[email protected]

România (Romania)
GlaxoSmithKline Trading Services Limited
Tel: + 40 800672524

Slovenija (Slovenia)
GlaxoSmithKline Trading Services Limited
Tel: + 386 80688869

Slovenská republika (Slovakia)
GlaxoSmithKline Trading Services Limited
Tel: + 421 800500589

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Sverige (Sweden)
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

How to measure and take the medicine

Use the oral dosing dispenser provided with the pack to measure the dose accurately (see also section 3).
When completely filled, the dispenser holds 10 ml of solution.

1. Remove the plastic wrap from the dispenser/adapter.
2. Remove the adapter from the dispenser.
3. Remove the child-resistant cap (A) from the bottle and keep it safely.
4. Hold the bottle. Firmly insert the adapter (B) into the neck of the bottle until it clicks into place.
5. Firmly insert the dispenser (C) into the adapter.
6. Invert the bottle.
7. Pull the plunger of the dispenser (D) until the dispenser contains the first portion of the full dose.
8. Return the bottle to upright position. Remove the dispenser from the adapter.
9. Insert the dispenser into the mouth, placing the tip against the inside of the cheek. Slowly push the plunger, allowing time for swallowing. Do not push too hard and do not inject the liquid to the back of the throat, as this may cause choking.
10. Repeat steps 5 to 9 in the same way until the entire dose has been administered. For example, if your dose is 20 ml, you must take 2 full dispensers of medicine.
11. Remove the dispenser from the bottle and wash it thoroughly with water. Allow it to dry completely before reuse. Leave the adapter in the bottle.
12. Close the bottle tightly with the cap.

Discard the oral solution one month after first opening.