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1. Xyzal 5mg Film-Coated Tablets
2. Xyzal 5mg Film-Coated Tablets

USER

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 any further questions, ask your doctor or pharmacist.

■    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

■    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Xyzal 5mg film-coated tablets are and what they are used for

2.    Before you take Xyzal 5mg film-coated tablets

3.    How to take Xyzal 5mg film-coated tablets

4.    Possible side effects

5.    How to store Xyzal 5mg film-coated tablets

6.    Further information

1.    What Xyzal 5mg film-coated tablets are and what they are used for

Antihistamine for systemic use.

For the treatment of signs of illness (symptoms) associated with:

■    allergic rhinitis (including persistent allergic rhinitis);

■    chronic nettle rash of unknown origin (chronic idiopathic urticaria).

2.    Before you take Xyzal 5mg film-coated tablets

Do not take Xyzal 5mg film-coated tablets

■    if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine or any of the other ingredients of Xyzal 5mg film-coated tablets (see 'What Xyzal 5mg film-coated tablets contains')

■    if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min).

Take special care with Xyzal 5mg film-coated tablets

The use of Xyzal 5mg film-coated tablets is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Xyzal 5mg film-coated tablets with food and drink

Caution is advised if Xyzal 5mg film-coated tablets is taken at the same time as alcohol.

In sensitive patients, the simultaneous use of cetirizine or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has been shown not to increase the effect of alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor if you are pregnant, trying to get pregnant or breast-feeding.

Driving and using machines

Some patients being treated with Xyzal 5mg film-coated tablets may experience somnolence / drowsiness, tiredness and exhaustion. If you are intending to drive, engage in potentially hazardous activities or use machines you are therefore advised first to wait and observe your response to the medication. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.

Important information about some of the ingredients of Xyzal 5mg film-coated tablets

These tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.

3. How to take Xyzal 5mg film-coated tablets

Always take Xyzal 5mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and children aged 6 years and over is one tablet daily. Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease.

Patients who only have impaired liver function should take the usual prescribed dose.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.

Xyzal 5mg film-coated tablets is not recommended for children under 6 years of age.

How and when should you take Xyzal 5mg film-coated tablets?

The tablets should be swallowed whole with water and may be taken with or without food.

If you take more Xyzal 5mg film-coated tablets than you should

A substantial overdose may cause somnolence in adults. Children may initially show excitation and restlessness followed by somnolence.

If you think you have taken an overdose of Xyzal 5mg film-coated tablets, please tell your doctor who will then decide what action should be taken.

If you forget to take Xyzal 5mg film-coated tablets

If you forget to take Xyzal 5mg film-coated tablets, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to compensate; just wait for the foreseen time for intake of the next dose, and take a normal dose as prescribed by your doctor.

If you stop taking Xyzal 5mg film-coated tablets

Stopping the treatment with Xyzal 5mg film-coated tablets earlier than foreseen should have no detrimental effects, in the sense that the symptoms of the disease should just progressively reappear with a severity not higher than the one experienced prior to treatment with Xyzal 5mg film-coated tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xyzal 5mg film-coated tablets can cause side effects, although not everybody gets them. Commonly (1% to 10%), mainly mild to moderate side effects such as dry mouth, headache, tiredness and somnolence/drowsiness have been reported. Uncommon (0.1% to 1%), side effects such as exhaustion and abdominal pain have been observed. Other side effects such as palpitations, convulsions, visual disturbances, oedema, pruritis (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), shortness of breath, weight increase, muscular pain, aggressive or agitated behaviour, hepatitis, abnormal liver function and nausea, have also been reported.

At the first signs of a hypersensitivity reaction, stop taking Xyzal 5mg film-coated tablets and see your doctor immediately. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties together with hives (angiodema), sudden fall in blood pressure leading to collapse or shock, which may be fatal.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Xyzal 5mg film-coated tablets

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

Expiry Date:

Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Important:

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.

6.    Further information

What Xyzal 5mg film-coated tablets contain

Each tablet contains 5mg of levocetirizine dihydrochloride together with microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

What Xyzal 5mg film-coated tablets look like and the contents of the pack

The tablets are small, white, oval and film-coated with a Y logo on one side. They are supplied in blister packs of 30 tablets. Your medicine belongs to the antihistamine group of drugs.

Manufacturer:

Manufactured by: UCB Pharma S.p.A., Italy.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX

PL No: 21828/0112

XYZAL® is a registered trademark of UCB FARCHIM S.A. Z.I. Planchy Chemin de Croix-Blanche, 10 C. P. 411, Bulle, Switzerland, 1630

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 any further questions, ask your doctor or pharmacist.

■    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

■    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Xyzal 5mg film-coated tablets are and what they are used for

2.    Before you take Xyzal 5mg film-coated tablets

3.    How to take Xyzal 5mg film-coated tablets

4.    Possible side effects

5.    How to store Xyzal 5mg film-coated tablets

6.    Further information

1.    What Xyzal 5mg film-coated tablets are and what they are used for

Antihistamine for systemic use.

For the treatment of signs of illness (symptoms) associated with:

■    allergic rhinitis (including persistent allergic rhinitis);

■    chronic nettle rash of unknown origin (chronic idiopathic urticaria).

2.    Before you take Xyzal 5mg film-coated tablets

Do not take Xyzal 5mg film-coated tablets

■    if you are allergic (hypersensitive) to levocetirizine dihydrochloride or to an antihistamine or any of the other ingredients of Xyzal 5mg film-coated tablets (see 'What Xyzal 5mg film-coated tablets contains')

■    if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min).

Take special care with Xyzal 5mg film-coated tablets

The use of Xyzal 5mg film-coated tablets is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.

Taking Xyzal 5mg film-coated tablets with food and drink

Caution is advised if Xyzal 5mg film-coated tablets is taken at the same time as alcohol.

In sensitive patients, the simultaneous use of cetirizine or levocetirizine and alcohol or other centrally acting agents may have effects on the central nervous system, although the racemate cetirizine has been shown not to increase the effect of alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor if you are pregnant, trying to get pregnant or breast-feeding.

Driving and using machines

Some patients being treated with Xyzal 5mg film-coated tablets may experience somnolence / drowsiness, tiredness and exhaustion. If you are intending to drive, engage in potentially hazardous activities or use machines you are therefore advised first to wait and observe your response to the medication. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.

Important information about some of the ingredients of Xyzal 5mg film-coated tablets

These tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.

3. How to take Xyzal 5mg film-coated tablets

Always take Xyzal 5mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and children aged 6 years and over is one tablet daily. Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease.

Patients who only have impaired liver function should take the usual prescribed dose.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.

Xyzal 5mg film-coated tablets is not recommended for children under 6 years of age.

How and when should you take Xyzal 5mg film-coated tablets?

The tablets should be swallowed whole with water and may be taken with or without food.

If you take more Xyzal 5mg film-coated tablets than you should

A substantial overdose may cause somnolence in adults. Children may initially show excitation and restlessness followed by somnolence.

If you think you have taken an overdose of Xyzal 5mg film-coated tablets, please tell your doctor who will then decide what action should be taken.

If you forget to take Xyzal 5mg film-coated tablets

If you forget to take Xyzal 5mg film-coated tablets, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to compensate; just wait for the foreseen time for intake of the next dose, and take a normal dose as prescribed by your doctor.

If you stop taking Xyzal 5mg film-coated tablets

Stopping the treatment with Xyzal 5mg film-coated tablets earlier than foreseen should have no detrimental effects, in the sense that the symptoms of the disease should just progressively reappear with a severity not higher than the one experienced prior to treatment with Xyzal 5mg film-coated tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xyzal 5mg film-coated tablets can cause side effects, although not everybody gets them. Commonly (1% to 10%), mainly mild to moderate side effects such as dry mouth, headache, tiredness and somnolence/drowsiness have been reported. Uncommon (0.1% to 1%), side effects such as exhaustion and abdominal pain have been observed. Other side effects such as palpitations, convulsions, visual disturbances, oedema, pruritis (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), shortness of breath, weight increase, muscular pain, aggressive or agitated behaviour, hepatitis, abnormal liver function and nausea, have also been reported.

At the first signs of a hypersensitivity reaction, stop taking Xyzal 5mg film-coated tablets and see your doctor immediately. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties together with hives (angiodema), sudden fall in blood pressure leading to collapse or shock, which may be fatal.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

5.    How to store Xyzal 5mg film-coated tablets

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

Expiry Date:

Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Important:

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.

6.    Further information

What Xyzal 5mg film-coated tablets contain

Each tablet contains 5mg of levocetirizine dihydrochloride together with microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

What Xyzal 5mg film-coated tablets look like and the contents of the pack

The tablets are small, white, oval and film-coated with a Y logo on one side. They are supplied in blister packs of 30 tablets. Your medicine belongs to the antihistamine group of drugs.

Manufacturer:

Manufactured by: UCB Pharma S.p.A., Italy.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX

PL No: 21828/0112

XYZAL® is a registered trademark of UCB FARCHIM S.A. Z.I. Planchy Chemin de Croix-Blanche, 10 C. P. 411, Bulle, Switzerland, 1630

Page 2 of 2