מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE; Cetirizine dihydrochloride
UCB (Pharma) Ireland Limited
R01BA; R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE; Cetirizine dihydrochloride
5mg/120 milligram(s)
Prolonged-release tablet
Product not subject to medical prescription
Sympathomimetics; pseudoephedrine, combinations
Marketed
2006-06-30
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENTS ZIRTEK PLUS DECONGESTANT 5 MG/120 MG PROLONGED-RELEASE TABLETS (5 mg cetirizine dihydrochloride - 120 mg pseudoephedrine hydrochloride) 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. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET : 1. What Zirtek Plus Decongestant is and what it is used for 2. What you need to know before you take Zirtek Plus Decongestant 3. How to take Zirtek Plus Decongestant 4. Possible side effects 5. How to store Zirtek Plus Decongestant 6. Contents of the pack and other information 1. WHAT ZIRTEK PLUS DECONGESTANT IS AND WHAT IT IS USED FOR Zirtek Plus Decongestant 5mg/120mg prolonged release tablets contains two active substances: cetirizine dihydrochloride which is an antihistamine and pseudoephedrine hydrochloride which is a decongestant. Zirtek Plus Decongestant is a medicine that is used to relieve allergic symptoms, especially when the anti-allergy properties of cetirizine are combined with the effects of pseudoephedrine in reducing swelling of the mucous membranes inside the nose. Zirtek Plus Decongestant is indicated for the treatment of symptoms such as blocked nose, sneezing, runny nose, itchy nose or itchy eyes, which occur in seasonal allergic rhinitis (hay fever) or perennial allergic rhinitis (house-dust allergy). Zirtek Plus Decongestant is indicated for adults and adolescents from 12 years of age and above. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK PLUS DECONGESTANT DO NOT TAKE ZIRTEK PLUS DECONGESTANT קרא את המסמך השלם
Health Products Regulatory Authority 29 November 2021 CRN00CPKY Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet provides 5 mg cetirizine dihydrochloride for immediate release, and 120 mg pseudoephedrine hydrochloride for prolonged release. Excipients with known effect: one tablet contains 43.23 mg lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. White to off-white, round, biconvex circle-embossed, film-coated tablet, having a circular logo on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine-pseudoephedrine is indicated for the treatment of symptoms such as nasal congestion, sneezing, rhinorrhoea, and nasal and ocular pruritus associated with seasonal or perennial allergic rhinitis. Cetirizine-pseudoephedrine should be administered when the anti-allergic properties of cetirizine dihydrochloride and the nasal decongestant activity of pseudoephedrine hydrochloride are desired. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ One tablet two times a day (morning and evening), corresponding to the maximum recommended dose of 10 mg of cetirizine dihydrochloride and 240 mg of pseudoephedrine hydrochloride daily. Special populations _Paediatric population_ Adolescents from 12 years of age and above: 1 tablet two times a day (morning and evening), with or without food. Children under 12 years of age: the use of the product is contraindicated (see sections 4.3 and 4.4). _ _ _Renal impairment_ The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. Dosing Adjustments for Adult Patients with Impaired Renal Function GROUP GFR (ML / MIN) DOSAGE AND FREQUENCY NORMAL RENAL FUNCTION ³ 90 1 TABLET* TWICE DAILY MILDLY DECREASED RENAL FUNCTION 60 – < 90 1 TABLET* TWICE DAILY MODERATELY DECREASED RENAL FUNCTIO קרא את המסמך השלם