Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
Chefaro Ireland DAC
R06AE; R06AE07
Cetirizine dihydrochloride
10 milligram(s)
Film-coated tablet
Oral use
7, 14 or 30 film-coated tablets
Product not subject to medical prescription
Chanelle Medical
Piperazine derivatives
Piperazine derivatives; cetirizine
In adults and paediatric patients 6 year and above: it is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of symptoms of chronic idiopathic urticaria.
Not marketed
2006-05-26
CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS (cetirizine dihydrochloride) READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This medicine is available without a prescription, however you still need to use Cetirizine Dihydrochloride 10mg Film-coated Tablets carefully to get the best results from them. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact your doctor if your symptoms change, worsen or do not improve. IN THIS LEAFLET: 1. What this medicine is for 2. Before you take the medicine 3. How to take the medicine 4. Possible side effects 5. Storing the medicine 6. Further information 1. WHAT THIS MEDICINE IS FOR Cetirizine Dihydrochloride 10mg Film-coated Tablets contain cetirizine dihydrochloride, which belongs to a group of drugs called antihistamines. These medicines help to relieve the symptoms of some allergies. This medicine is used to relieve: • symptoms of hayfever and other allergies such as sneezing, runny nose and burning, itchy eyes • symptoms of skin allergies such as rash, itching or urticaria (hives). 2. BEFORE YOU TAKE THE MEDICINE This medicine can be taken by adults, and children aged 6 years and over. Some people should not take this medicine or should talk to their pharmacist or doctor first. DO NOT TAKE IF YOU: • Are allergic (hypersensitive) to cetirizine dihydrochloride or any of the other ingredients in the medicine, listed in section 6. • Have serious kidney problems TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU: • Have epilepsy or are at risk of convulsions. • Have problems passing urine (like spinal cord problems, prostate or bladder problems) TAKING THIS MEDICINE WITH FOOD AND DRINK • Avoid alcoholic drink while you are taking this medicine. PREGNANCY AND BREAST-FEEDING • DO NOT TAKE if you are pregnant or breast-feeding. DRIVING AND USING MACHINES • Tests have shown that this medicine does not cause drowsiness in the vast major Les hele dokumentet
HealthProductsRegulatoryAuthority 08June2021 CRN00CDDH Page1of7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetirizinedihydrochloride10mgFilm-coatedTablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EachtabletcontainsCetirizinedihydrochloride10mg. Alsocontainslactose Forafulllistofexcipientssee6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. Whitecircularbiconvexfilm-coatedtablets,embossed`A`ononesideandadeepscoreontheother. Thetabletcanbedividedintoequalhalves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inadultsandpaediatricpatients6yearandabove: -Cetirizineisindicatedforthereliefofnasalandocularsymptomsofseasonalandperennial allergicrhinitis. -Cetirizineisindicatedforthereliefofsymptomsofchronicidiopathicurticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Childrenaged from6 to 12 years:_ 5mgtwicedaily(ahalftablettwicedaily). _Adults and adolescentsover 12 years of age:_ 10mgoncedaily(1tablet). _Elderly patients:_ Datadonotsuggestthatthedoseneedstobereducedinelderlysubjectsprovidedthattherenalfunctionisnormal. _Patients with moderate to severe renal impairment:_ Therearenodatatodocumenttheefficacy/safetyratioinpatientswithrenalimpairment.Sincecetirizineismainlyexcretedvia renalroute(seesection5.2),incasesnoalternativetreatmentcanbeused,thedosingintervalsmustbeindividualized accordingtorenalfunction.Refertothefollowingtableandadjustthedoseasindicated.Tousethisdosingtable,anestimate ofthepatient'screatinineclearance(CLcr)inml/mi Les hele dokumentet