Land: Israël
Taal: Engels
Bron: Ministry of Health
DESLORATADINE
ORGANON PHARMA ISRAEL LTD., ISRAEL
R06AX27
TABLETS
DESLORATADINE 5 MG
PER OS
Required
ORGANON LLC, USA
DESLORATADINE
DESLORATADINE
Aerius tablet is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:- allergic rhinitis - urticaria
2017-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold under doctor's prescription only AERIUS ® TABLETS FILM-COATED TABLETS EACH FILM COATED TABLET CONTAINS: Desloratadine 5 mg For a list of inactive ingredients please refer to section 6 “WHAT AERIUS TABLETS CONTAINS?” See also section 2.8 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE". READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • This leaflet contains concise information about AERIUS TABLETS. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their ailment seems similar to yours. • This medicine is intended for adults and adolescents 12 years of age and older. 1. WHAT IS AERIUS TABLETS INTENDED FOR? AERIUS TABLETS is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. This medicine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. AERIUS TABLETS is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. THERAPEUTIC GROUP: H 1 receptor antagonists - antihistamines. 2. BEFORE YOU USE AERIUS TABLETS 2.1 DO NOT USE AERIUS TABLETS IF YOU: • are allergic (hypersensitive) to desloratadine, or any of the other ingredients of AERIUS TABLETS (for a list of inactive ingredients, see section 6.1) or to loratadine. 2.2 SPECIAL WARNINGS CONCERNING USE OF AERIUS TABLETS BEFORE STARTING TREATMENT WITH AERIUS TABLETS, TELL THE Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Aerius ® Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 5 mg desloratadine. Excipient(s) with known effect: This medicinal product contains lactose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Light blue, round and embossed film-coated tablets with elongated letters “S” and “P” on one side and plain on the other. The diameter of the film-coated tablet is 6.5 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Aerius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1) 4.2 Posology and method of administration Posology _Adults and adolescents (12 years of age and over)_ The recommended dose of Aerius is one tablet once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods. _Paediatric population _ There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1). The safety and efficacy of Aerius 5 mg film-coated tablets in children below the age of 12 years have not been established. Method of administration Oral use. The dose can be taken with or without food. 4.3 Contraindications Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine. 4.4 Special warnings and precautions for use Renal function impairment In the case of severe renal insufficiency, Aerius should be Lees het volledige document