Zirtek Allergy
PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully because it contains important
i nformation for you.
• This medicine is available without prescription. However, you still need to take it carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Zirtek® Allergy 10mg film-coated tablets
(cetirizine dihydrochloride)
The name of your medicine is Zirtek Allergy 10mg film-coated tablets but it will be referred to as Zirtek throughout this leaflet.
In this leaflet:
1. What Zirtek is and what it is used for
2. Before you take Zirtek
3. How to take Zirtek
4. Possible side effects
5. How to store Zirtek
6. Further information.
1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an antiallergic medicine.
In adults and children aged 6 years and above, Zirtek is used
• for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hayfever and year-round allergies affecting the nose and eyes).
• for the relief of chronic nettle rash (chronic idiopathic urticaria).
2. BEFORE YOU TAKE ZIRTEK Do not take Zirtek:
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10ml/min)
• if you are known to be hypersensitive to the active substance of Zirtek, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
You should not take Zirtek:
• if you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
If any of the above applies to you talk to your pharmacist.
Take special care with Zirtek
• If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at the blood level of 0.5g/l corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Zirtek with alcohol. If you are scheduled for allergy testing, ask your doctor if you should stop taking Zirtek for several days before testing. This medicine may affect your allergy test results.
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 Zirtek with food and drink
Food does not affect absorption of Zirtek.
Avoid alcoholic drink while you are taking this medicine.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. As with other drugs, use of Zirtek should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be administered if necessary and after medical advice.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zirtek at the recommended dose. You should closely observe your response to the drug after you have taken Zirtek if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
This medicine contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
3. HOW TO TAKE ZIRTEK
These guidelines apply unless your doctor has given you different instructions on how to use Zirtek. Please follow these instructions, otherwise Zirtek may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Adults and adolescents aged 12 years and over:
10mg once daily as 1 tablet.
Children aged 6 to 12 years:
5mg twice daily as half a tablet twice daily.
Patients with moderate to severe kidney impairment
Patients with moderate kidney impairment are recommended to take 5mg once daily.
If you feel that the effect of Zirtek is too weak or too strong, please consult your doctor.
Duration of treatment
The duration of the treatment depends on the type, duration and course of your complaints. Please ask your pharmacist for advice.
If you take more Zirtek than you should
If you think you have taken an overdose of Zirtek please inform your doctor. Your doctor will then decide what measures, if any, should be taken. After an overdose, the side effects described overleaf may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take a tablet
Do not take a double dose to make up for forgotten dose.
If you stop taking Zirtek
If you have any other questions about taking this medicine, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Zirtek can cause side effects, although not everybody gets them.
The following side effect is very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice them
• Allergic reactions, including severe reactions and angioedema (serious allergic reaction which cause swelling of the face and throat). These reactions may start soon after you first take the medicine, or it might start later.
The frequency of possible side effects listed below is defined using the following convention:
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from available data)
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea
• Dizziness
• Sore throat
• Cold-like symptoms of the nose (children only).
Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Asthenia (extreme fatigue) or generally unwell
• Tingling in the hands and feet
• Feeling agitated
• Pain in the abdomen.
Rare side effects (affects less than 1 in 1000 people)
• Tachycardia (heart beating too fast)
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what to do)
• Convulsions
• Weight increased
• Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
• Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difficulty focusing
• Oculogyration (eyes having uncontrolled circular movements)
• Low level of blood platelets causing unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics (habit spasm)
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face or throat
• Fainting
• A recurring rash
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).
Not known frequency of side effects Zirtek® Allergy 10mg film-coated tablets,
PL No: 18799/2450
• Memory loss and forgetfulness.
Leaflet date: 29.06.2015
If you develop one of the side effects described above, please inform your doctor or pharmacist. At the first signs of a hypersensitivity reaction, stop taking Zirtek. Your doctor will then assess the severity and decide on any further measures that may be necessary. If you think you have any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZIRTEK
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
This product does not require any special storage conditions.
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. FURTHER INFORMATION What Zirtek contains
Each film-coated tablet contains 10mg cetirizine dihydrochloride.
The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 containing hypromellose E 464, titanium dioxide E 171 and macrogol 400.
What Zirtek looks like and contents of the pack
Zirtek is white, oblong, film-coated tablet, with breakline and Y-Y logo on one side and plain on the reverse.
Zirtek is supplied in blister packs containing 30 tablets.
Manufactured by: UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Read all of this leaflet carefully because it contains important
i nformation for you.
• This medicine is available without prescription. However, you still need to take it carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Cetirizine dihydrochloride 10mg film-coated tablets
The name of your medicine is Cetirizine dihydrochloride 10mg film-coated tablets but it will be referred to as Cetirizine throughout this leaflet.
In this leaflet:
1. What Cetirizine is and what it is used for
2. Before you take Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Further information.
1. WHAT CETIRIZINE IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine. Cetirizine is an antiallergic medicine.
In adults and children aged 6 years and above, Cetirizine is used
• for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hayfever and year-round allergies affecting the nose and eyes).
• for the relief of chronic nettle rash (chronic idiopathic urticaria).
2. BEFORE YOU TAKE CETIRIZINE Do not take Cetirizine:
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10ml/min)
• if you are known to be hypersensitive to the active substance of Cetirizine, to any of its excipients (other constituents), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines).
You should not take Cetirizine:
• if you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
If any of the above applies to you talk to your pharmacist.
Take special care with Cetirizine
• If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
No clinically significant interactions have been observed between alcohol (at the blood level of 0.5g/l corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Cetirizine with alcohol. If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine for several days before testing. This medicine may affect your allergy test results.
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 Cetirizine with food and drink
Food does not affect absorption of Cetirizine.
Avoid alcoholic drink while you are taking this medicine.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
As with other drugs, use of Cetirizine should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be administered if necessary and after medical advice.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose. You should closely observe your response to the drug after you have taken Cetirizine if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
This medicine contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
3. HOW TO TAKE CETIRIZINE
These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine. Please follow these instructions, otherwise Cetirizine may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Adults and adolescents aged 12 years and over:
10mg once daily as 1 tablet.
Children aged 6 to 12 years:
5mg twice daily as half a tablet twice daily.
Patients with moderate to severe kidney impairment
Patients with moderate kidney impairment are recommended to take 5mg once daily.
If you feel that the effect of Cetirizine is too weak or too strong, please consult your doctor.
Duration of treatment
The duration of the treatment depends on the type, duration and course of your complaints. Please ask your pharmacist for advice.
If you take more Cetirizine than you should
If you think you have taken an overdose of Cetirizine please inform your doctor. Your doctor will then decide what measures, if any, should be taken. After an overdose, the side effects described overleaf may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take a tablet
Do not take a double dose to make up for forgotten dose.
If you stop taking Cetirizine
If you have any other questions about taking this medicine, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Cetirizine can cause side effects, although not everybody gets them.
The following side effect is very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice them
• Allergic reactions, including severe reactions and angioedema (serious allergic reaction which cause swelling of the face and throat). These reactions may start soon after you first take the medicine, or it might start later.
The frequency of possible side effects listed below is defined using the following convention:
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from available data)
The following side effects have also been reported.
Common side effects (affects less than 1 in 10 people)
• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea
• Dizziness
• Sore throat
• Cold-like symptoms of the nose (children only).
Uncommon side effects (affects less than 1 in 100 people)
• Itching and rash
• Asthenia (extreme fatigue) or generally unwell
• Tingling in the hands and feet
• Feeling agitated
• Pain in the abdomen.
Rare side effects (affects less than 1 in 1000 people)
• Tachycardia (heart beating too fast)
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what to do)
• Convulsions
• Weight increased
• Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
• Urticaria (hives).
Very rare side effects (affects less than 1 in 10,000 people)
• Blurred vision, difficulty focusing
• Oculogyration (eyes having uncontrolled circular movements)
• Low level of blood platelets causing unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics (habit spasm)
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face or throat
• Fainting
• A recurring rash
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).
Not known frequency of side effects Cetirizine® Allergy 10mg film-coated tablets,
PL No: 18799/2450
• Memory loss and forgetfulness.
Leaflet date: 29.06.2015
If you develop one of the side effects described above, please inform your doctor or pharmacist. At the first signs of a hypersensitivity reaction, stop taking Cetirizine. Your doctor will then assess the severity and decide on any further measures that may be necessary. If you think you have any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CETIRIZINE
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.
This product does not require any special storage conditions.
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. FURTHER INFORMATION What Cetirizine contains
Each film-coated tablet contains 10mg cetirizine dihydrochloride.
The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 containing hypromellose E 464, titanium dioxide E 171 and macrogol 400.
What Cetirizine looks like and contents of the pack
Cetirizine is white, oblong, film-coated tablet, with breakline and Y-Y logo on one side and plain on the reverse.
Cetirizine is supplied in blister packs containing 30 tablets.
Manufactured by: UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
