Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
Pinewood Laboratories Ltd,
R06AE; R06AE07
Cetirizine dihydrochloride
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; cetirizine
Not marketed
2002-03-08
PHARMACODE PHARMACODE PACKAGE LEAFLET: INFORMATION FOR THE USER ZIRPINE 10 mg TABLETS Cetirizine dihydrochloride 24LF01683PD Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. What is in this leaflet: 1. What Zirpine 10 mg Tablets are and what they are used for 2. What you need to know before you take Zirpine 10 mg Tablets 3. How to take Zirpine 10 mg Tablets 4. Possible side effects 5. How to store Zirpine 10 mg Tablets 6. Contents of the pack and other information 1. What Zirpine 10 mg Tablets are and what they are used for Zirpine 10 mg Tablets contain the active ingredient cetirizine dihydrochloride. This is an antihistamine used to treat seasonal allergic rhinitis (hay fever) and perennial rhinitis, and urticaria (hives) in adults and children over 6 years of age. Antihistamines like Zirpine relieve the symptoms and discomfort associated with these conditions, such as sneezing, an itchy, runny and blocked nose, itchy, red and watering eyes and itchy skin rashes. 2. What you need to know before you take Zirpine 10 mg Tablets Do NOT take Zirpine 10 mg Tablets: • if you have had an allergic reaction to cetirizine or hydroxyzine or any of the other ingredients listed in this medicine_ (see Section 6 and end of Section 2)._ • if you have severe kidney problems Zirpine is not recommended for use in children under 6 years. Warnings and Precautions Talk to your doctor before taking Zirpine 10 mg Tablets: • if you have kidney or liver problems which are not severe • if you have a hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption _(see end Pročitajte cijeli dokument
Health Products Regulatory Authority 13 November 2019 CRN009G62 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirpine 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg cetirizine dihydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets White, round, film-coated tablets embossed with AG on one side, breakline on the reverse. The tablets can be divided into equal doses. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 patients: Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. For patients with moderate to severe renal impairment: There are no data to document efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via the renal route (see section 5.2), in cases where 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 this 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: CLcr = [140-age (years)] x weight (kg) (x 0.85 for women) 72 x serum creatinine (mg/dl) Dosing adjustments for adult patients with impaired renal function GROUP CREATININE CLEARANCE (ML/MIN) POSOLOGY AND FREQUENCY Normal ≥80 10 mg once daily Mild 50 Pročitajte cijeli dokument