Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
LTT Pharma Limited
R06AE; R06AE09
Levocetirizine dihydrochloride
0.5 milligram(s)/millilitre
Oral solution
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Authorised
2017-04-28
DRIVING AND USING MACHINES Some patients being treated with Xyzal may experience somnolence / drowsiness, tiredness and exhaustion. Use caution when driving or operating machinery until 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 MALTITOL LIQUID, METHYL PARAHYDROXYBENZOATE AND PROPYL PARAHYDROXYBENZOATE – This medicine contains maltitol liquid. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Xyzal. – Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed), such as headache, stomach upset, and diarrhoea. 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 is: – Adults and adolescents from the age of 12 years: 10 ml solution once 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 impairment of kidney function must not take Xyzal. Patients who only have impaired liver function should take the usual prescribed dose. Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the 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. _Elderly patients aged 65 years and above_ No adaptation of the dose is necessary in elderly patients, provided their renal function is normal. USE IN CHILDREN Children from the age of 6 to 12 years: 10 ml solution once dai Citiți documentul complet
Health Products Regulatory Authority 11 October 2018 CRN008N54 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 0.5 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride. Excipient(s) with known effect methyl parahydroxybenzoate propyl parahydroxybenzoate maltitol liquid For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution _Product imported from Czech Republic_ Clear and colourless solution. 4 CLINICAL PARTICULARS As per PA0891/003/003 5 PHARMACOLOGICAL PROPERTIES As per PA0891/003/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS sodium acetate trihydrate acetic acid methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) glycerol 85% maltitol (E965) saccharin sodium Fruit flavour contains triacetin (E1518) Health Products Regulatory Authority 11 October 2018 CRN008N54 Page 2 of 3 benzaldehyde orange oil vanillin ethyl butyrate orange oil concentrated isoamyl acetate allyl hexanoate gamma-undecalactone citral geraniol citronellol tocopherol (E307) purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the market in the country of origin. After first opening: 3 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Glass bottle closed with a white child-resistant closure in a cardboard box also containing a 10 ml oral syringe graduated at 0.25 ml. Pack size: 200 ml 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Health Products Regulatory Authority 11 October 2018 CRN008N54 Page 3 of 3 LTT Pharma Limited Unit 18 Oxleasow Ro Citiți documentul complet