Xyzal 5mg Film-Coated Tablets
Package leaflet: Information for the patients
Xyzal® 5mg film-coated tablets
(levocetirizine dihydrochloride)
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 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.
The name of your medicine is Xyzal 5mg film-coated tablets but will be referred to as Xyzal throughout this leaflet.
In this leaflet:
1. What Xyzal is and what it is used for
2. What you need to know before you take Xyzal
3. How to take Xyzal
4. Possible side effects
5. How to store Xyzal
6. Contents of the pack and other information
1. WHAT XYZAL IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Xyzal.
Xyzal is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
• allergic rhinitis (including persistent allergic rhinitis);
• nettle rash (urticaria).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL Do not take Xyzal
if you are allergic to levocetirizine dihydrochloride to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6) if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min)
Warnings and precautions
Talk to your doctor or pharmacist before taking Xyzal.
If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice.
Children
The use of Xyzal is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.
Other medicines and Xyzal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Xyzal with food, drink and alcohol
Caution is advised if Xyzal is taken at the same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Xyzal and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Xyzal can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients being treated with Xyzal may experience somnolence / drowsiness, tiredness and exhaustion. Use caution when driving or operating machinery until you know how this medicine affects you. 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.
Xyzal contains lactose
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and children aged 6 years and over is one tablet daily.
Special dosage instructions for specific populations:
Renal and hepatic impairment
Patients with impaired kidney function may be given a lower dose according to the severity of their 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.
Patients who have severe impairment of kidney function must not take Xyzal.
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.
Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.
Use in children
Xyzal is not recommended for children under 6 years of age.
How and when should you take Xyzal?
For oral use only.
Xyzal tablets should be swallowed whole with water and may be taken with or without food.
How long should you take Xyzal?
The duration of use depends on the type, duration and course of your complaints and is determined by your physician.
If you take more Xyzal than you should
If you take more Xyzal than you should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Xyzal, please tell your doctor who will then decide what action should be taken.
If you forget to take Xyzal
If you forget to take Xyzal, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to make up for a forgotten dose. Take your next dose at your normal time.
If you stop taking Xyzal
Stopping treatment should have no negative effects. Symptoms may return, but they should not be any worse than they were prior to the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/drowsiness
Uncommon: may affect up to 1 in 100 people Exhaustion and abdominal pain
Not known: frequency cannot be estimated from the available data Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Xyzal and tell your doctor. Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.
5. HOW TO STORE XYZAL
• Keep out of the sight and reach of children.
• Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• If the tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Xyzal contains
Each film-coated tablet contains 5mg of levocetirizine dihydrochloride as the active ingredient. It also contains microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.
What Xyzal looks like and contents of the pack
The tablets are white to off-white, oval and film-coated with a Y logo on one side. They are supplied in blister packs of 30 tablets.
Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.UK.
POM
Xyzal 5mg film-coated tablets; PL 18799/1824
Leaflet date: 21.09.2016
Xyzal is a registered trademark of UCB Pharma Limited.
Levocetirizine dihydrochloride 5mg film-coated tablets
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 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.
The name of your medicine is Levocetirizine dihydrochloride 5mg film-coated tablets but will be referred to as Levocetirizine throughout this leaflet.
In this leaflet:
1. What Levocetirizine is and what it is used for
2. What you need to know before you take Levocetirizine
3. How to take Levocetirizine
4. Possible side effects
5. Howto store Levocetirizine
6. Contents of the pack and other information
1. WHAT LEVOCETIRIZINE IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Levocetirizine.
Levocetirizine is an antiallergic medication.
For the treatment of signs of illness (symptoms) associated with:
• allergic rhinitis (including persistent allergic rhinitis);
• nettle rash (urticaria).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE Do not take Levocetirizine
if you are allergic to levocetirizine dihydrochloride to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6) if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min)
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine.
If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice.
Children
The use of Levocetirizine is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.
Other medicines and Levocetirizine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Levocetirizine with food, drink and alcohol
Caution is advised if Levocetirizine is taken at the same time as alcohol or other agents acting on the brain.
In sensitive patients, the concurrent administration of Levocetirizine and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Levocetirizine can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients being treated with Levocetirizine may experience somnolence / drowsiness, tiredness and exhaustion. Use caution when driving or operating machinary until you know how this medicine affects you. 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.
Levocetirizine contains lactose
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 LEVOCETIRIZINE
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and children aged 6 years and over is one tablet daily.
Special dosage instructions for specific populations:
Renal and hepatic impairment
Patients with impaired kidney function may be given a lower dose according to the severity of their 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.
Patients who have severe impairment of kidney function must not take Levocetirizine.
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.
Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.
Use in children
Levocetirizine is not recommended for children under 6 years of age.
How and when should you take Levocetirizine?
For oral use only.
Levocetirizine tablets should be swallowed whole with water and may be taken with or without food.
How long should you take Levocetirizine?
The duration of use depends on the type, duration and course of your complaints and is determined by your physician.
If you take more Levocetirizine than you should
If you take more Levocetirizine than you should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Levocetirizine, please tell your doctor who will then decide what action should be taken.
If you forget to take Levocetirizine
If you forget to take Levocetirizine, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to make up for a forgotten dose. Take your next dose at your normal time.
If you stop taking Levocetirizine
Stopping treatment should have no negative effects. Symptoms may return, but they should not be any worse than they were prior to the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, tiredness and somnolence/drowsiness
Uncommon: may affect up to 1 in 100 people Exhaustion and abdominal pain
Not known: frequency cannot be estimated from the available data Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, syncope, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, oedema, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, recurring thoughts of or preoccupation with suicide, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea have also been reported.
At the first signs of a hypersensitivity reaction, stop taking Levocetirizine and tell your doctor.
Hypersensitivity reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.
5. HOW TO STORE LEVOCETIRIZINE
• Keep out of the sight and reach of children.
• Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• If the tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Levocetirizine contains
Each film-coated tablet contains 5mg of levocetirizine dihydrochloride as the active ingredient. It also contains microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.
What Levocetirizine looks like and contents of the pack
The tablets are white to off-white, oval and film-coated with a Y logo on one side.
They are supplied in blister packs of 30 tablets.
Manufactured by: UCB Pharma S.A., Via Praglia 15, 10044 Pianezza (TO), Italy.
Procured from within the ELI and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Levocetirizine dihydrochloride 5mg film-coated tablets; PL 18799/1824
Leaflet date: 21.09.2016 |POM