Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetirizine hydrochloride
Sandoz Ltd
R06AE07
Cetirizine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
Cetirizine hydrochloride WHAT IS IN THIS LEAFLET: 1. What Cetirizine is and what it is used for 2. What you need to know before you take Cetirizine 3. How to take Cetirizine 4. Possible side effects 5. How to store Cetirizine 6. Contents of the pack and other information Cetirizine dihydrochloride is the active ingredient of Cetirizine. Cetirizine is an antiallergic medication. In adults and children aged 6 years and above, Cetirizine is indicated • for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. • for the relief of chronic nettle rash (chronic idiopathic urticaria). DO NOT TAKE CETIRIZINE: • if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min); • if you are allergic to cetirizine to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines). WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Cetirizine Hydrochloride. If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice. 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 are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice. If you plan having an allergy skin test made. The use of Cetirizin Sandoz should be interrupted at least 3 days prior to skin tests. No interactions susceptible to have a noticeable impact have been observed between alcohol (at PACKAGE LEAFLET: INFORMATION FOR THE USER the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol. OTHER MEDICINES AND CETIRIZINE Tell your doctor or pharmacist if you are taking, hav Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetirizine Hydrochloride 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg of Cetirizine Hydrochloride. Excipient: 81,80 mg lactose /film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. White, oblong, scored on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and paediatric patients 6 years 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 Posology 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) 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 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 (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: CL cr = _ [140 - age(years)] x weight (kg) _ _ _ _72 x serum creatinine (mg/dl) _ Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dosage and frequency Normal Mild Moderate Severe End-stage renal disease- Patients undergoing dialysis ≥ 80 50-79 30-49 <30 <10 10 mg once daily 10 mg once daily 5 mg once daily 5 mg once every 2 days Contra-indicated Lesen Sie das vollständige Dokument