Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levocetirizine dihydrochloride
UCB Pharma Ltd
R06AE09
Levocetirizine dihydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5024091001307
CHILDREN The use of Xyzal is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation. OTHER MEDICINES AND XYZAL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. XYZAL WITH FOOD, DRINK AND ALCOHOL Caution is advised if Xyzal is taken at the same time as alcohol or other agents acting on the brain. In sensitive patients, the concurrent administration of Xyzal and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance. Xyzal can be taken with or without food. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. DRIVING AND USING MACHINES Some patients being treated with Xyzal may experience somnolence / drowsiness, tired- ness and exhaustion. Use caution when driving or operating machinery untill you know how this medicine affects you. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage. XYZAL CONTAINS LACTOSE These tablets contain lactose, if you have been told by your doctor that you have an intoler- ance to some sugars you should contact your doctor before taking them. 3. HOW TO TAKE XYZAL Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and children aged 6 years and over is one tablet daily. Special dosage instructions for specific populations: Renal and hepatic impairment Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor. Patients who have severe impairme Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 5 mg film coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipient(s) with known effect 63.50 mg lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval, film-coated tablet with a Y logo on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xyzal 5 mg film-coated tablets are indicated in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet). _Elderly _ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below). _ _ _Renal impairment_ The dosing intervals must be individualised according to renal function (eGFR – estimated Glomerular Filtration Rate) . Refer to the following table and adjust the dose as indicated. Dosing adjustments for patients with impaired renal function: Group eGFR (ml/min) Dosage and frequency Normal renal function ≥ 90 1 tablet once daily Mildly decreased renal function 60 – < 90 1 tablet once daily Moderately decreased renal function 30 – < 60 1 tablet once every 2 days Severely decreased renal function 15 - < 30 (not requiring dialysis) 1 tablet once every 3 days End-stage renal disease (ESRD) < 15 (requiring dialysis treatment) Contra-indicated In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment. _Hepatic impairment_ No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment an Les hele dokumentet