Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Clonmel Healthcare Ltd
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Marketed
2009-10-09
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER RINOZAL 5MG FILM-COATED TABLETS 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 Rinozal 5 mg is and what it is used for 2. What you need to know before you take Rinozal 5 mg 3. How to take Rinozal 5 mg 4. Possible side effects 5. How to store Rinozal 5 mg 6. Contents of the pack and other information 1. WHAT RINOZAL 5 MG IS AND WHAT IT IS USED FOR The active substance of Rinozal 5 mg is levocetirizine dihydrochloride, which is an anti allergic agent. It is used to treat symptoms associated with allergic conditions, such as: chronic nettle rash 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RINOZAL 5 MG DO NOT TAKE RINOZAL 5 MG If you are allergic to levocetirizine, any other related substance, or any of the other ingredients of this medicine (listed in section 6). If you suffer from severe kidney failure (less than 10 ml/min creatinine clearance). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Rinozal 5 mg. 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 Levocetirizine dihydrochloride 5 mg may cause seizure aggravation. If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine dihydrochloride 5 mg for several days b Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rinozal 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride (equivalent to 4.2 mg of levocetirizine). Excipient with known effect Each film-coated tablet contains 64.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, oval, biconvex film-coated tablets, debossed with ‘L9CZ’ on one side and ‘5’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine is indicated for: the relief of symptoms of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents 12 years and above_ The daily recommended dose is 5 mg (one film-coated tablet) once daily. _Elderly_ For the time being, there is no data to suggest that the dose needs to be reduced in elderly patients provided that the renal function is normal. _Renal impairment_ There are no data to document the efficacy/safety ratio in patients with renal impairment. Since levocetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualised 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: Dosing adjustments for adult patients with impaired renal function: Group Creatinine clearance (ml/min) Dosage and frequency Normal 80 One tablet daily H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Belgenin tamamını okuyun