Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
KRKA, d.d., Novo mesto
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Marketed
2011-07-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVOCETIRIZINE KRKA 5 MG 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 Levocetirizine Krka is and what it is used for 2. What you need to know before you take Levocetirizine Krka 3. How to take Levocetirizine Krka 4. Possible side effects 5. How to store Levocetirizine Krka 6. Contents of the pack and other information 1. WHAT LEVOCETIRIZINE KRKA IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Levocetirizine Krka. Levocetirizine Krka is an antiallergic medicinal product. 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 LEVOCETIRIZINE KRKA DO NOT TAKE LEVOCETIRIZINE KRKA: - if you are allergic to levocetirizine dihydrochloride or to any other antihistamine or to any of the other ingredients of this medicine (listed in section 6), - if you have 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 Levocetirizine Krka. The use of Levocetirizne Krka is not recommended for children under 6 years since the film-coated tablets do not allow dose adaptation. 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 adv Lees het volledige document
Health Products Regulatory Authority 11 September 2019 CRN0099LV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine Krka 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipient(s) with known effect: 88.63 mg lactose/tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet The tablets are white, round, biconvex film-coated tablets with bevelled edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 of age and above:_ The recommended daily dose is 5 mg (1 film-coated tablet). _ _ _Elderly_ Adjustment of the daily 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. 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: Dosage adjustments in patients with impaired renal function: _Group_ _Creatinine clearance (ml/min)_ _Dosage and frequency_ Normal renal function ≥80 1 tablet once daily Mild renal impairment 50-79 1 tablet once daily Moderate renal impairment 30-49 1 tablet once every 2 days Severe renal impairment <30 1 tablet once every 3 days End-stage renal disease. – patients undergoing dialysis <10- Contraindicated 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 wit Lees het volledige document