Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levocetirizine dihydrochloride
DE Pharmaceuticals
R06AE09
Levocetirizine dihydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XYZAL 5 MG FILM-COATED TABLETS For adults and children aged 6 years and above Levocetirizine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xyzal is and what it is used for 2. What you need to know before you take Xyzal 3. How to take Xyzal 4. Possible side effects 5. How to store Xyzal 6. Contents of the pack and other information 1. WHAT XYZAL IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Xyzal. Xyzal is an antiallergic medication. For the treatment of signs of illness (symptoms) associated with: • allergic rhinitis (including persistent allergic rhinitis); • nettle rash (urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL DO NOT TAKE XYZAL - if you are allergic to levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6). - if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xyzal. If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice. If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Xyzal may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking Xyzal for several d Belgenin tamamını okuyun
OBJECT 1 XYZAL 5MG TABLETS Summary of Product Characteristics Updated 30-Jul-2019 | UCB Pharma Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 elde Belgenin tamamını okuyun