ZIRTEC 10 mg x 10 tablets.

ZIRTEC / ZYRTEC 10 MG X 10 tablets.
 
Zyrtec contains the active substance cetirizine dihydrochloride. Zyrtec is an antiallergic medicine. Zyrtec is indicated in adults and children over 6 years of age:
for the relief of nasal and ocular symptoms in seasonal and perennial allergic rhinitis;
for relief of chronic hives (chronic idiopathic urticaria).
 
Dosage and administration:
Adults and adolescents over 12 years of age:
10 mg once daily as 1 tablet.
Children from 6 to 12 years old:
5 mg twice daily as half a tablet twice daily.
 
Ingredients:
One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are: microcrystalline cellulose, lactose, macrogol 400, magnesium stearate, hypromellose, colloidal anhydrous silica, titanium dioxide (E171).
 
Leaflet: information for the user Zyrtec 10 mg film-coated tablets Cetirizine dihydrochloride (Cetirizine dihydrochloride) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not listed in this leaflet. If you do not feel better after 3 days or your condition worsens, you should seek medical advice. What this leaflet contains 1. What Zyrtec is and what it is used for 2. What you need to know before you take Zyrtec 3. How to take Zyrtec 4. Possible side effects 5. How to store Zyrtec 6. Contents of the pack and other information 1. What Zyrtec is and what it is used for: Zyrtec contains the active substance cetirizine dihydrochloride. Zyrtec is an antiallergic medicine. Zyrtec is indicated in adults and children over 6 years of age: for the relief of nasal and eye symptoms of seasonal and perennial allergic rhinitis. for the relief of urticaria. 2. What you need to know before you take Zyrtec Do not take Zyrtec If you have severe kidney impairment (severe renal failure and creatinine clearance below 10 ml/min); If you are allergic to cetirizine dihydrochloride, any of the other ingredients (listed in section 6) to hydroxyzine or other piperazine derivatives (similar active ingredients of other medicines). Warnings and precautions If you have kidney failure, please ask your doctor for advice; if necessary, you will take a lower dose. Your doctor will determine the new dose. If you have problems urinating (such as problems with the spinal cord or bladder), please ask your doctor for advice. If you have epilepsy or a risk of convulsions, you should ask your doctor for advice. No clinically significant interactions have been observed between alcohol (at a blood alcohol concentration of 0.5 ppm (g/l), corresponding to a glass of wine) and cetirizine used in recommended doses. There is no safety data available on the simultaneous intake of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol. If you are scheduled for an allergy test, ask your doctor about the need to stop taking Zyrtec for a few days before the test. This medicine may affect your allergy test results. Other medicines and Zyrtec Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zyrtec with horseradish and drinks Food does not affect the absorption of Zyrtec. Pregnancy ¦ breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor before taking this medicine. The use of Zyrtec during pregnancy should be avoided. Accidental use by pregnant women should not cause harm to the foetus, but the medicine should nevertheless be used only if clearly needed and after consulting a doctor. Cetirizine passes into breast milk. Do not take Zyrtec during breast-feeding unless you have consulted a doctor. Driving and using machines Clinical studies have not shown any impairment of attention, alertness and ability to drive after taking Zyrtec at the recommended dose. If you intend to drive, perform potentially hazardous activities or operate machinery, you should carefully monitor the effects of the drug after taking Zyrtec. Do not exceed the recommended dose. Zyrtec film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicinal product. 3. How to take Zyrtec Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The tablet should be swallowed with a glass of liquid. The tablet can be divided into 2 equal doses. Adults and adolescents over 12 years of age: 10 mg once a day as 1 tablet. Children from 6 to 12 years of age: 5 mg twice daily as half a tablet twice daily. Patients with renal impairment In patients with moderate renal impairment, a dose of 5 mg once daily is recommended. If you suffer from severe kidney disease, please contact your doctor or pharmacist, who can adjust the dose accordingly. If your child suffers from kidney disease, please contact your doctor or pharmacist, who can adjust the dose according to your child's needs. If you think that the effect of Zyrtec is too weak or too strong, please consult your doctor. Duration of treatment: The duration of treatment depends on the type, duration and response to your complaints and is determined by your doctor. If you have taken more Zyrtec than you should If you think you have overdosed Zyrtec, please inform your doctor. Your doctor will decide what measures to take, if any, are necessary. After an overdose, the side effects described below may occur with increased frequency. Side effects such as confusion, diarrhoea, dizziness, tiredness, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, abnormally fast heart rate, tremor and urinary retention have been reported. If you forget to take Zyrtec Do not take a double dose to make up for a forgotten dose. If you stop taking Zyrtec If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Zyrtec can cause side effects, although not everybody gets them. The following side effects are rare or very rare, and you should stop taking the medicine and tell your doctor as soon as you notice them: Allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat). These reactions may start immediately after you first take the medicine or later. Common side effects (may affect up to 1 in 10 people) Drowsiness Dizziness, headache Pharyngitis, rhinitis (in children) Diarrhoea, nausea, dry mouth Fatigue Abdominal pain Itching, rash Asthenia (total exhaustion), malaise Rare side effects (may affect up to 1 in 1,000 patients) Allergic reactions, some of which are severe (very rare) Depression, hallucinations, aggression, confusion, insomnia Convulsions Tachycardia (rapid heartbeat) Impaired liver function Urticaria Oedema (swelling) Weight gain Very rare side effects (may affect up to 1 in 10,000 patients) Thrombocytopenia (low levels of platelets in the blood) Tics (acquired spasm) Seizures, dyskinesia (involuntary movements), dystonia (unusually long muscle contractions), tremor, dysgeusia (altered taste) Blurred vision, accommodation disorder, oculogyration (uncontrolled circular movements of the eyes) Angioedema (severe allergic reaction that causes swelling of the face or throat), fixed drug rash. Pathological urine output (nighttime urination, pain and/or difficulty urinating) Side effects with unknown frequency (frequency cannot be estimated from the available data) Increased appetite Suicidal ideation (recurrent thoughts or ideas about suicide) Amnesia, memory impairment Vertigo (sensation of spinning or movement) Urinary retention (inability to empty the bladder completely) If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store Zyrtec Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 6. Contents of the pack and other information What Zyrtec contains The active substance is: cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride. The other ingredients are: microcrystalline cellulose, lactose monohydrate, silicon dioxide, magnesium stearate, Opadry Y-1-7000, celupromellose (E 464), titanium dioxide (E 171), macrogol 400). What Zyrtec looks like and contents of the pack White, oblong film-coated tablets with a score line and the marking YY Packs of 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100 or 100 (10 x 10) tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: UCB Pharma GmbH, Alrred-Nobel-Str. 10,40789 Monheim, Germany Manufacturer: Aesica Pharmaceuticals SrL, Via Praglia 15,1-10044 Pianezza (TO), Italy This medicinal product is authorised in the Member States of the EEA under the following names Austria: Zyrtec 10 mg – Filmtabletten Belgium: Zyrtec Bulgaria: Zyrtec Czech Republic: Zyrtec Cyprus: Zyrtec Denmark: Zyrtec Estonia: Zyrtec Finland: Zyrtec France: Zyrtec Germany: Zyrtec Greece: Ziptek Hungary: Zyrtec fibntabletta Ireland: Zirtek tablets Italy: Zirtec 10 mg compresse rivestite con film Latvia: Zyrtec Lithuania: Zyrtec Luxembourg: Zyrtec Malta: Zyrtec Netherlands: Zyrtec Norway: Zyrtec Poland: Zyrtec Portugal: Zyrtec Slovak Republic: Zyrtec tbl flm lOmg Slovenia: Zyrtec 10 mg filmsko oblozene tablete Spain: Zyrtec comprimidos recubiertos con pelicula Sweden: Zyrlex United Kingdom: Zirtek allergy tablets