Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
Pinewood Laboratories Ltd
R06AE07
Cetirizine dihydrochloride
Film-coated tablet
cetirizine
Marketed
2022-06-03
PACKAGE LEAFLET: INFORMATION FOR THE USER CETIRIZINE DIHYDROCHLORIDE PINEWOOD 10 MG FILM-COATED TABLETS CETIRIZINE DIHYDROCHLORIDE 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 Cetirizine Tablets are and what they are used for 2. What you need to know before you take Cetirizine Tablets 3. How to take Cetirizine Tablets 4. Possible side effects 5. How to store Cetirizine Tablets 6. Contents of the pack and other information 1. WHAT CETIRIZINE TABLETS ARE AND WHAT THEY ARE USED FOR Cetirizine 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 Cetirizine 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 CETIRIZINE TABLETS DO NOT TAKE CETIRIZINE TABLETS IF: you have severe kidney problems (severe renal failure with creatinine clearance below 10 ml/min). you are allergic to cetirizine dihydrochloride, any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or piperazine derivatives (closely related active ingredients of other medicines). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Cetirizine Tablets: if you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose w Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 03 June 2022 CRN00C5VQ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetirizine dihydrochloride Pinewood 10 mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg cetirizine dihydrochloride. Excipient with known effect: One film-coated tablet contains 65mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White to off white capsule shaped film coated tablets with breakline on one side & '10' debossed on the other side. The tablet can be divided into 2 equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine 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 chronic idiopathic 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 where 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: CL cr = [140 −age (years)] x weight (kg) (x0.85 for women) 72 x serum creatinine (mg/dl) 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 Mo Կարդացեք ամբողջական փաստաթուղթը