Страна: Мальта
мова: англійська
Джерело: Medicines Authority
CETIRIZINE HYDROCHLORIDE
Galpharm Healthcare Limited
R06AE07
CETIRIZINE HYDROCHLORIDE
FILM-COATED TABLET
CETIRIZINE HYDROCHLORIDE 10 milligram(s)
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2012-05-03
CETIRIZINE DIHYDROCHLORIDE 10MG TABLETS / MAY 2016 PACKAGE LEAFLET: INFORMATION FOR THE USER CETERIZINE GALPHARM 10MG FILM-COATED TABLETS (CETIRIZINE DIHYDROCHLORIDE) READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without a prescription, however you still need to use Ceterizine Galpharm 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. _(Non-Prescription Products _ _Only)_ • If you have any further questions, ask your doctor or pharmacist. _(Prescription products _ _only)_ • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as ours. _(Prescription products only)_ • You must contact a doctor if your symptoms worsen or do not improve after 3 days. _(Non _ _Prescription Products Only)_ • If any of the side effects gets serious, or if notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT CETERIZINE GALPHARM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETERIZINE GALPHARM 3. HOW TO TAKE CETERIZINE GALPHARM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CETERIZINE GALPHARM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CETERIZINE GALPHARM IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Ceterizine Galpharm. Ceterizine Galpharm is an anti-allergic medication. In adults and the children aged 6 years and above, Ceterizine Galpharm is indicated • For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. • For the relief of chronic nettle rash (chronic idiopathic urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETERIZINE GALPHARM 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 CETERIZINE G Прочитайте повний документ
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MT: Cetirizine Galpharm, 10 mg, film-coated tablets PL: Cetirizine Galpharm DE: Cetirizindihydrochlorid Galpharm, 10 mg filmtabletten CZ: Cetirizine Galpharm IT: Cetirizine Galpharm NL: Cetirizine dihydrochloride Galpharm HU: Cetirizine Galpharm 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 10 mg cetirizine dihydrochloride Excipients: one film-coated tablet contains 53.50 mg lactose-monohydrate For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets Cetirizine Dihydrochloride 10 mg Tablets are white to off white, film coated, capsule shaped tablets, with one face of the tablet plain and a break-line on the other. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and paediatric patients 6 year and above: Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria. Page 2 of 10 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Children below 6 years of age: not recommended Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily). Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet). The tablets need to be swallowed with a glass of liquid. Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. Patients with moderate to severe renal impairment: there are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine cleara Прочитайте повний документ