Cetirizine Dihydrochloride Tablets 10mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER ZIRTEK TABLETS 10mg/
CETIRIZINE DIHYDROCHLORIDE TABLETS 10mg (cetirizine dihydrochloride)
Your medicine is known by either of the above name but will be referred to as Zirtek throughout the remainder of the leaflet.
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.
Read all of this leaflet carefully because it contains important
information 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.
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.
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.
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 10 ml/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 10 mg tablets:
• 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 0.5 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.
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:
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
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.
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 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.
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
5. HOW TO STORE ZIRTEK
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 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.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Zirtek should be stored below 30°C.
• Do not use after the expiry date printed on the carton, label or blister strip.
• 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 the doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.
• 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 tablet contains 10mg of the active ingredient cetirizine dihydrochloride
• The other ingredients are: colloidal silica, magnesium stearate, microcrystalline cellulose, lactose, titanium dioxide (E171), hypromellose, polyethylene glycol 400.
What Zirtek looks like and contents of the pack
Zirtek is available as a white oblong film-coated tablet coded ‘Y' either side of a score line on one face and plain on the reverse.
Zirtek is available as packs of 10, 20 or 30 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Zirtek is manufactured by
• Farchim SA, 1630 Bulle, Switzerland.
• UCB Farchim SA, 1630 Bulle, Switzerland.
| POM| PL No. 08747/0273
Leaflet revision date: 04 December 2012
273 Zirtek Tablets 10mg 20121204