देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetirizine hydrochloride
UCB Pharma Ltd
R06AE07
Cetirizine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5024091747021 05413787220885
Font size body text: 8pt Pharma code: TBC Colours: Tech Colours: Product name: CIA70971I_MU1 GB Creation date: 27/09/2019 DCMF No: N/A Operator: TC Commodity: UCB10100 Ref no: CIA70971I_MU1 CMO Code: N/A Core spec size: TI006PIL-024-06 305x148 Revision: 2019_SEP_0031_1 Page no: 1 of 2 Amended by: N/A Modification date: N/A Proof no: 01 BLACK DIE-CUT TECHNICAL (do not print) NOTE: Artwork studio checks pre-press suitability of this artwork on ly. Ensure the artwork has been thoroughly checked for textual accuracy and has been approved as such. Aesica Queenborough Ltd. North Road, Queenborough, Kent ME11 5EL UK Zirtek ® ALLERGY RELIEF 10 MG FILM COATED TABLETS Cetirizine dihydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER 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 have 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 3 days. WHAT IS IN THIS LEAFLET: 1. What Zirtek Allergy Relief is and what it is used for 2. What you need to know before you take Zirtek Allergy Relief 3. How to take Zirtek Allergy Relief 4. Possible side effects 5. How to store Zirtek Allergy Relief 6. Content of the pack and other information. 1. WHAT ZIRTEK ALLERGY RELIEF IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride, the active ingredient of the tablets is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions. In adults and children aged 6 years and above, Zirtek Allergy Relief is used to treat people who have hay fever (seasonal allergic rhinitis), yea पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek allergy relief 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablets contains 10 mg cetirizine dihydrochloride Excipients with known effects: one film-coated tablet contains 66.40 mg lactose-monohydrate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablets White, oblong, film-coated tablet, with breakline and Y-Y logo The tablet can be divided into 2 equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine dihydrochloride 10 mg film-coated tablets are 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 urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 10 mg once daily (1 tablet). Special population _Elderly _ Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. _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 clearance (CL cr ) in mL/min is needed. The CL cr (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 10 mg once daily Mild 50 – 79 10 mg once daily Moderate 30 – 49 5 mg once daily Severe <30 5 mg once every 2 days End-stage renal disease - Patients undergoing dialysis <10 Contra-indicated _Hepatic impairment _ No dose adjustment is needed in patients with solely hepatic पूरा दस्तावेज़ पढ़ें