Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Cetirizine hydrochloride
Rowex Ltd
R06AE; R06AE07
Cetirizine hydrochloride
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; cetirizine
Marketed
2004-08-06
PACKAGE LEAFLET: INFORMATION FOR THE USER CETRINE 10 MG FILM-COATED TABLETS cetirizine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on the others. It may harm them even if their signs of illness are the same as yours. • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 3. H WHAT IS IN THIS LEAFLET: 1. What Cetrine is and what it is used for 2. What you need to know before you take Cetrine 3. How to take Cetrine 4. Possible side effects 5. How to store Cetrine 6. Contents of the pack and other information 1. WHAT CETRINE IS AND WHAT IT IS USED FOR . The active ingredient of Cetrine is cetirizine dihydrochloride. Cetrine is an anti-allergy medicine. It helps control your allergic reaction and its symptoms. In adults and children aged 6 years and above: Cetrine relieves symptoms associated with, for example, hay fever, allergy to dust mites (allergic rhinitis) such as: • sneezing, • runny or itchy nose, • itchy palate, • itchy, red or tearing eyes. Cetrine is also used to relieve symptoms such as itching and hives (associated with chronic urticaria of unknown cause). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETRINE DO NOT TAKE CETRINE: - if you are allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or piperazine derivatives (closely related active substances of other medicines) - if you have severe kidney problems. WARNINGS AND PRECAUTIONS - Talk to your doctor or pharmacist before taking Cetrine: - if you have KIDNEY PROBLEMS . Your treatment may need to be adjusted. - if you have predisposition factors of urinary retention (e.g. spinal cord lesions or prostatic hy Läs hela dokumentet
Health Products Regulatory Authority 04 April 2019 CRN008NYT Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetrine 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Excipients with known effect: Also contains 81.8mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets White, oblong film-coated tablet, scored on one side. The scoreline is to allow the tablet to be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetrine is indicated in adults and paediatric patients 6 years and above: - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the relief of symptoms of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Children aged from 6 to 12 years_: 5mg twice daily (a half a tablet twice daily) _ _ _Adults and adolescents over 12 years of age: _10 mg once daily (1 tablet). _ _ _Elderly patients_: 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 individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use the dosing table an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula; Dosing adjustments for adult patients with impaired renal function GROUP Creatinine Clearance (ml/min) Dosage and frequency Normal ≥80 10mg once daily Mild 50 – 79 10mg once daily Moderate 30 – 49 5mg once daily Severe <30 5 mg on Läs hela dokumentet