ZIRTEK ALLERGY 10MG FILM-COATED TABLETS
Active substance: CETIRIZINE DIHYDROCHLORIDE
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PATIENT INFORMATION LEAFLET Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need 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 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. after 3 days. to take it carefully to get the best results from it.
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). lactase deficiency or glucose-galactose malabsorption.
clearance below 10 ml/min);
You should not take Zirtek 10 mg tablets: if you have rare hereditary problems of galactose intolerance, the Lapp
If any of the above applies to you talk to your pharmacist. 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 0.5 g/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.
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.
Take special care with Zirtek If you are a patient with renal insufficiency, please ask your doctor for
3. HOW TO TAKE ZIRTEK ALLERGY
Zirtek Allergy
10 mg film-coated tablets
Cetirizine dihydrochloride 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.
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:
10 mg once daily as 1 tablet.
Children aged 6 to 12 years:
5 mg twice daily as half a tablet twice daily.
Patients with moderate to severe kidney impairment
Taking other medicines
Patients with moderate kidney impairment are recommended to take 5 mg once daily. If you feel that the effect of Zirtek is too weak or too strong, please consult your doctor.
1. WHAT ZIRTEK ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an antiallergic medicine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Duration of treatment
Taking Zirtek Allergy with food and drink Pregnancy
The duration of the treatment depends on the type, duration and course of your complaints. Please ask your pharmacist for advice.
In adults and children aged 6 years and above, Zirtek is used for the relief of nasal and ocular symptoms of seasonal and perennial
Food does not affect absorption of Zirtek. Avoid alcoholic drink while you are taking this medicine. 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.
If you take more Zirtek Allergy than you should
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
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 below 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.
Do not take Zirtek: if you have a severe kidney disease (severe renal failure with creatinine
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness
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. Like all medicines Zirtek Allergy 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 Urticaria (hives).
things), sleeplessness Very rare side effects (affects less than 1 in 10,000 people) Blurred vision, difficulty focussing 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 Memory loss and forgetfulness. 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.
What Zirtek Allergy looks like
4. POSSIBLE SIDE EFFECTS
The tablets are small white oblong film-coated tablets, each scored and bearing the logo Y/Y. Your medicine is supplied in blister packs of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets. Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom This leaflet was last updated July 2011 If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd, UK
5. HOW TO STORE ZIRTEK ALLERGY
Keep out of the reach and sight of children. Do not use Zirtek after the expiry date which is stated on the box and blister. This medicine does not require any special storage conditions.
6. FURTHER INFORMATION
What Zirtek Allergy contains
The active substance of Zirtek is cetirizine dihydrochloride One film-coated tablet contains 10 mg certirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, macrogol 400, and magnesium stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E171).
CIA71115A
listed in this leaflet, please tell your doctor or pharmacist. after 3 days. to take it carefully to get the best results from it.
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). lactase deficiency or glucose-galactose malabsorption.
clearance below 10 ml/min);
You should not take Zirtek 10 mg tablets: if you have rare hereditary problems of galactose intolerance, the Lapp
If any of the above applies to you talk to your pharmacist. 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 0.5 g/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.
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.
Take special care with Zirtek If you are a patient with renal insufficiency, please ask your doctor for
3. HOW TO TAKE ZIRTEK ALLERGY
Zirtek Allergy
10 mg film-coated tablets
Cetirizine dihydrochloride 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.
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:
10 mg once daily as 1 tablet.
Children aged 6 to 12 years:
5 mg twice daily as half a tablet twice daily.
Patients with moderate to severe kidney impairment
Taking other medicines
Patients with moderate kidney impairment are recommended to take 5 mg once daily. If you feel that the effect of Zirtek is too weak or too strong, please consult your doctor.
1. WHAT ZIRTEK ALLERGY IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an antiallergic medicine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Duration of treatment
Taking Zirtek Allergy with food and drink Pregnancy
The duration of the treatment depends on the type, duration and course of your complaints. Please ask your pharmacist for advice.
In adults and children aged 6 years and above, Zirtek is used for the relief of nasal and ocular symptoms of seasonal and perennial
Food does not affect absorption of Zirtek. Avoid alcoholic drink while you are taking this medicine. 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.
If you take more Zirtek Allergy than you should
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
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 below 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.
Do not take Zirtek: if you have a severe kidney disease (severe renal failure with creatinine
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness
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. Like all medicines Zirtek Allergy 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 Urticaria (hives).
things), sleeplessness Very rare side effects (affects less than 1 in 10,000 people) Blurred vision, difficulty focussing 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 Memory loss and forgetfulness. 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.
What Zirtek Allergy looks like
4. POSSIBLE SIDE EFFECTS
The tablets are small white oblong film-coated tablets, each scored and bearing the logo Y/Y. Your medicine is supplied in blister packs of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10x10) tablets. Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom This leaflet was last updated July 2011 If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd, UK
5. HOW TO STORE ZIRTEK ALLERGY
Keep out of the reach and sight of children. Do not use Zirtek after the expiry date which is stated on the box and blister. This medicine does not require any special storage conditions.
6. FURTHER INFORMATION
What Zirtek Allergy contains
The active substance of Zirtek is cetirizine dihydrochloride One film-coated tablet contains 10 mg certirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, macrogol 400, and magnesium stearate, hypromellose, colloidal silicon dioxide, titanium dioxide (E171).
CIA71115A
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
