Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Levocetirizine dihydrochloride
GLAXOSMITHKLINE PTE LTD
R06AE09
0.50 mg/ml
SOLUTION
Levocetirizine dihydrochloride 0.50 mg/ml
ORAL
Prescription Only
AESICA PHARMACEUTICALS S.R.L
ACTIVE
2008-05-20
Page 1 of 6 ZYR-NEX 5 MG FILM-COATED TABLET LEVOCETIRIZINE DIHYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Zyr-NEX carefully to get the best results from it. − Keep this leaflet. You may need to read it again. − Ask your pharmacist if you need more information or advice. − You must contact a doctor if your symptoms worsen or do not improve after 3 days. − If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. − Always read the label to make sure the product is appropriate for your child’s age. IN THIS LEAFLET 1. WHAT ZYR-NEX IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE ZYR-NEX 3. HOW TO TAKE ZYR-NEX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ZYR-NEX 6. FURTHER INFORMATION Page 2 of 6 1. WHAT ZYR-NEX IS AND WHAT IT IS USED FOR The active substance in Zyr-NEX is levocetirizine. Levocetirizine belongs to a group of antiallergic medicines called antihistamines. Zyr-NEX is used to treat symptoms such as sneezing, a runny nose and watery eyes associated with allergic rhinitis (including persistent allergic rhinitis). Zyr-NEX is also used to relieve the rashes and itching of chronic urticaria ( hives ). 2. BEFORE YOU TAKE ZYR-NEX DON’T TAKE ZYR-NEX • if you are ALLERGIC ( hypersensitive ) to levocetirizine, cetirizine, hydroxyzine, any piperazine derivatives (closely related active substances of other medicines) or any other ingredients of Zyr-NEX (listed in Section 6) • if you have SEVERE KIDNEY DISEASE (severe impairment of kidney function with creatinine clearance below 10 ml/min) • if you use other antiallergic medicines If you think any of these apply to you, DON’T TAKE Zyr-NEX until you have checked with your doctor. TAKE SPECIAL CARE WITH ZYR-NEX TALK TO YOUR DOCTOR OR PHARMACIST before using Zyr-NEX: • if you have DIFFICULTY PASSING URINE or you have conditions that ma Прочетете целия документ
[GSK logo] NAME OF THE MEDICINAL PRODUCT XYZAL ® PHARMACEUTICAL FORM AND STRENGTH Oral drops solution: clear and colourless liquid, each 1 ml (equivalent to 20 drops) containing 5 mg of levocetirizine dihydrochloride. Oral solution: clear and colourless liquid, each 1ml containing 0.5 mg of levocetirizine dihydrochloride. THERAPEUTIC INDICATIONS Levocetirizine is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. POSOLOGY AND METHOD OF ADMINISTRATION ORAL DROPS SOLUTION: it should be poured in a spoon or diluted in water, and taken orally. If dilution is used, it should be considered, especially for administration to children, that the volume of water to which the drops are added, needs to be adapted according to the quantity of water the patient is able to swallow. The diluted solution should be taken immediately. When counting the drops, the bottle should be held vertically (top down). In case of lack of flow of drops, if the right amount of drops has not been delivered, turn the bottle over in upright position, then hold it top down again and continue counting the drops. The drops can be taken with or without food. ORAL SOLUTION : A dosing syringe is included in the package. The appropriate volume of oral solution should be measured with the syringe, and poured in a spoon or in another liquid such as in a glass of water or fruit juice. The oral solution must be taken orally, and may be taken with or without food. Duration of use: Intermittent allergic rhinitis (symptoms <4days/week or for less than 4 weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms >4days/week or for more than 4 weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens. There is clinical experience with the use of levocetirizine for t Прочетете целия документ