ZEFFIX 100 mg Фильм-Coated Таблетка

Содержание инструкции

1. Zeffix 100 mg film-coated tablets
   1. What is Zeffix 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
2. Zeffix 5 mg/ml oral solution
   1. What is Zeffix 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. Package Contents and Other Information

Zeffix 100 mg film-coated tablets

lamivudine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Zeffix and what it is used for

The active substance contained in Zeffix is lamivudine.

Zeffix is used for the treatment of chronic (long-lasting) 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 reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes a chronic (long-lasting) infection and
can damage the liver. Zeffix can be used in people in whom the liver is damaged but
still functions normally (compensated liver disease) and in association with other medicines
in people in whom the liver is damaged and does not function normally (decompensated liver
disease).
Treatment with Zeffix may reduce the amount of hepatitis B virus in the body. This should
lead to a reduction in liver damage and an improvement in liver function. Not
all people respond to treatment with Zeffix in the same way. The doctor will monitor
the effectiveness of treatment with regular blood tests.

2. What you need to know before taking Zeffix

The doctor must offer advice and testing for HIV infection before starting treatment with
lamivudine for hepatitis B infection and during treatment. If you have or may contract HIV infection, see paragraph 3.

Do not take Zeffix

• if you are allergicto lamivudine or to any of the other ingredients of this medicine ( listed in paragraph 6). ➔ See your doctorif you think this applies to you.

Warnings and precautions
Some people taking Zeffix or other similar medicines are at greater risk of serious side
effects. You need to be aware of these additional risks:

• if you have had other types of liver diseasesuch as hepatitis C
• if you are severely overweight(especially if you are a woman). ➔ Tell your doctor if any of these situations apply to you. You may need further checks, including blood tests, while taking the medicine. Seeparagraph 4for more information about the risks. Do not stoptaking Zeffixwithout your doctor's 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 taking blood samples to check for any increase in liver enzyme levels, which may indicate liver damage. See paragraph 3 for more information on how to take Zeffix.

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

• use a condomfor oral or penetrative sex.
• avoid contact with 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 you bought without a prescription.
Remember to tell your doctor or pharmacist if you start taking any new medicine during
treatment with Zeffix.

These 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)
• emtricitabine used to treat HIV infectionor hepatitis B virus infection
• cladribine used to treat hairy cell leukemia➔ Tell your doctorif you are being treated with any of these medicines.

Pregnancy
If you are pregnant, or suspect you may be pregnant, or are planning to become pregnant:
➔ discuss this with your doctorabout the risks and benefits of taking Zeffix during pregnancy.
Do not stop treatment with Zeffix without your doctor's advice.

Breastfeeding
Zeffix can pass into breast milk. If you are breastfeeding or planning to breastfeed:
➔ talk to your doctorbefore taking Zeffix.

Driving and using machines
Zeffix may make you feel tired, which could affect your ability to drive and use
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, which is essentially
‘sodium-free’.

3. How to take Zeffix

Always take this medicine exactly as your doctor has told you.If you have any doubts
ask your doctor or pharmacist.

Stay in constant contact with your doctor
Zeffix helps to control hepatitis B infection. It is necessary to take it every day to
control the infection and prevent the disease from worsening.
➔ Stay in contact with your doctor,anddo not stop taking Zeffixwithout your doctor's advice.

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

Patients who have or may contract HIV infection
If you have or contract HIV infection, which is not treated with medicines during the intake of
lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to
some medicines for HIV and become more difficult 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 a
different medicine containing a higher dose of lamivudine, usually 150 mg twice a day,
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 doctorif 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 Emergency
Room of the nearest hospital for further advice. If possible, show them the packaging of
Zeffix.

If you forget to take Zeffix
If you forget to take a dose, take it as soon as you remember. Then continue treatment as
before. Do not take a double dose to make up for a missed dose.

Do not stop taking Zeffix
You must not stop taking Zeffix without consulting your doctor. There is a risk that hepatitis
will worsen ( see paragraph 2). 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 any increase 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 that have been reported commonly in clinical studies of Zeffix were
fatigue, respiratory tract infections, sore throat, headache, discomfort and stomach pain,
nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles ( see

below).

Allergic reaction
These are 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 your doctor immediatelyif you experience these symptoms. Stop taking Zeffix.

Side effects that are thought to be caused by Zeffix
A very common side effect (these can affect more than 1person in 10)that may
be detected by blood tests is:

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

A common side effect(these can affect up to1person in 10)is:

• muscle cramps and pain
• rash or hives in any part of the body

A common side effectthat 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 (these can affect up to1person in 10,000)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
• a worsening of liver disease after stopping Zeffix or during treatment if the hepatitis B virus becomes resistant to Zeffix. This can be fatal in some people.

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

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

If you get 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, 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 which is stated on the pack and on the blister.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of Zeffix and contents of the pack
Zeffix film-coated tablets is supplied in packs with a tamper-evident seal containing blisters of
aluminium of 28 or 84 tablets. The tablets are caramel-coloured, film-coated, capsule-shaped,
biconvex, with “GX CG5” imprinted on one side.
Not all pack sizes may be marketed.

ManufacturerMarketing Authorisation Holder
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland
GlaxoSmithKline Trading Services
Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11
For further information on this medicine, 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
[email protected]

Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

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

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 800650042

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 802050456
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/

Zeffix 5 mg/ml oral solution

lamivudine

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Zeffix and what it is used for

The active substance contained in Zeffix is lamivudine.

Zeffix is used for the treatment of chronic (long-lasting) 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 reverse transcriptase inhibitors (NRTIs).
Hepatitis B is caused by a virus that infects the liver, causes a chronic (long-lasting) infection and
can damage the liver. Zeffix can be used in people in whom the liver is damaged but
functions normally still (compensated liver disease) and in association with other medicines
in people in whom the 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 a reduction in liver damage and an improvement in liver function. Not
all people respond to treatment with Zeffix in the same way. The doctor will monitor
the effectiveness of treatment with regular blood tests.

2. What you need to know before taking Zeffix

The doctor must offer advice and testing for HIV infection before starting treatment with
lamivudine for hepatitis B infection and during treatment. If you have or may contract HIV infection, see paragraph 3.

Do not take Zeffix

• if you are allergicto lamivudine or any of the other ingredients of this medicine ( listed in paragraph 6). ➔ See your doctorif you think this applies to you.

Warnings and precautions
Some people taking Zeffix or other similar medicines are at greater risk of serious side
effects. You need to be aware of these additional risks:

• if you have had other types of liver diseasesuch as hepatitis C
• if you are severely overweight(especially if you are a woman). ➔ Tell your doctor if any of these situations apply to you. You may need further checks, including blood tests, while taking the medicine. Seeparagraph 4for more information about the risks.

Do not stop taking Zeffixwithout your doctor's 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 taking blood samples to
check for any increase in liver enzyme levels, which may indicate liver damage.
See paragraph 3 for more information on how to take Zeffix.

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

• use a condomfor oral or penetrative sex.
• avoid contact with 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 you bought without a prescription.
Remember to tell your doctor or pharmacist if you start taking any new medicine during
treatment with Zeffix.

These 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 lamivudine, used to treat HIV infection(sometimes called AIDS)
• emtricitabine used to treat HIV infectionor hepatitis B virus infection
• cladribine used to treat hairy cell leukemia➔ Tell your doctorif you are being treated with any of these medicines.

Pregnancy
If you are pregnant, or suspect you might be pregnant or are planning a pregnancy:
➔ discuss with your doctorabout the risks and benefits of taking Zeffix during pregnancy.
Do not stop treatment with Zeffix without your doctor's advice.

Breastfeeding
Zeffix can pass into breast milk. If you are breastfeeding or planning to breastfeed:
➔ talk to your doctorbefore taking Zeffix.

Driving and using machines
Zeffix can make you feel tired, which may affect your ability to drive and use
machinery.
➔ Do not drive or operate machinery if you feel tired.

Zeffix contains sugar, preservatives, propylene glycol and sodium.
If you have diabetes, be aware 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 some sugars, contact
your doctor before taking Zeffix. Sucrose can be harmful to your teeth.
Zeffix contains preservatives ( parahydroxybenzoates) which may cause allergic reactions (which
may occur even after a delay).
This medicine contains 400 mg of propylene glycol per 20 ml.
This medicine contains 58.8 mg of sodium (the main component of table salt) per
20 ml. This is equivalent to 2.9% of the recommended daily intake of sodium with the diet
for an adult.

3. How to take Zeffix

Always take this medicine exactly as your doctor has told you. If you have any doubts
ask your doctor or pharmacist.

Stay in constant contact with your doctor
Zeffix helps to control hepatitis B infection. You need to take it every day to
control the infection and prevent the disease from worsening.
➔ Stay in contact with your doctoranddo not stop taking Zeffixwithout your doctor's advice.

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

Patients who have or may contract HIV infection
If you have or contract HIV infection, which is not being treated with medicines while taking
lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to
some HIV medicines and become more difficult 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 a
different medicine containing a higher dose of lamivudine, usually 150 mg twice a day,
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 doctorif this applies to you.
Zeffix can be taken with or without food.

See the instructions on how to measure and take the medicine dose after paragraph 6 of
this leaflet.
If you take more Zeffix than you should
If you accidentally take too much Zeffix, tell your doctor or pharmacist, or contact the Emergency
Room of the nearest hospital for further advice. If possible, show them the pack of
Zeffix.

If you forget to take Zeffix
If you forget to take a dose, take it as soon as you remember. Then continue treatment as
before. Do not take a double dose to make up for a 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 paragraph 2). 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 any increase 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 that have been reported commonly in clinical studies of Zeffix have been
fatigue, respiratory tract infections, sore throat, headache, stomach discomfort and pain,
nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles ( see

below) .

Allergic reaction
These are 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 your doctor immediatelyif you experience these symptoms. Stop taking Zeffix.

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

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

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

• cramps and muscle pain
• rash or hives in any part of the body

A common side effectthat can 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(these may affect up to 1 in 10,000people) 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
• a worsening of liver disease after stopping Zeffix or during treatment if the hepatitis B virus becomes resistant to Zeffix. This can be fatal in some people. A side effect that can be detected by blood tests is:
• a reduction in the number of cells involved in blood clotting ( thrombocytopenia).

If you get 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, 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the packaging.
Do not store at a temperature above 25°C.
Do not use after one month from first opening.
Do not dispose of any medicine in waste water 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 ingredient 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.

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

ManufacturerMarketing 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 further information on 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
[email protected]

Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

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
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 the dose and take the medicine

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

• 1.Remove the plastic wrapperfrom the applicator/adapter.
• 2.Remove the adapterfrom the applicator.
• 3.Remove the child-resistant cap from the bottle (A)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.Insertthe applicator (C) firmly into the adapter.
• 6.Turn the bottle upside down.
• 7.Pull the applicator plunger (D)until the applicator contains the first part of the entire dose.
• 8.Return the bottle to the upright position. Remove the applicator from the adapter.
• 9.Insert the applicator into the mouth, positioning the upper end of the applicator towards the inside of the cheek. Press the plunger slowly, allowing time for swallowing. Do not press too hardand do not inject the liquid into the back of the throat as this may cause choking.
• 10.Repeat steps 5 to 9in the same way until the entire dose has been taken. For example, if your dose is 20 ml you must take 2 applicators full of medicine.
• 11.Remove the applicator from the bottleand wash itthoroughly with water. Allow it to dry completely before using it again. Leave the adapter in the bottle.
• 12.Close the bottle tightlywith the cap.

Discard the oral solution one month after first opening.