Država: Velika Britanija
Jezik: angleščina
Source: 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: 5024091747304 5024091747977
ZIRTEK ® ALLERGY 10MG TABLETS (cetirizine dihydrochloride) PATIENT INFORMATION LEAFLET 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 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. Your medicine will be referred to as Zirtek throughout the following leaflet. WHAT IS IN THIS LEAFLET: 1. What Zirtek is and what it is used for 2. What you need to know before you take Zirtek 3. How to take Zirtek 4. Possible side effects 5. How to store Zirtek 6. Content of the pack and further information. 1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an antiallergic medication In adults and children aged 6 years and above, Zirtek 10 mg film-coated tablets are indicated - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the relief of urticaria. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK DO NOT TAKE ZIRTEK - if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); - if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in Section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zirtek. 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 will be determined by your doctor. If you have problems passing urine (like spinal cord problems or prostate or bladder Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Excipients with known effect: 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 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 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 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 Contraindicated _Hepatic impairment_ No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impair Preberite celoten dokument