Country: Израел
Језик: Енглески
Извор: Ministry of Health
LORATADINE
BAYER ISRAEL LTD
R06AX
TABLETS
LORATADINE 10 MG
PER OS
Not required
BAYER BITTERFELD GMBH, GERMANY
OTHER ANTIHISTAMINES FOR SYSTEMIC USE
Seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria.
2016-06-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor’s prescription LORASTINE TABLETS, 10 MG Each tablet contains: Loratadine 10 mg See section 6 for a list of inactive ingredients. See also section 2 under ’Important information about some of this medicine’s ingredients’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Take this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Consult your doctor if your symptoms of illness get worse or do not get better. 1. WHAT IS THIS MEDICINE INTENDED FOR? Lorastine Tablets are used to treat allergic rhinitis and the symptoms associated with it, such as sneezing, runny or itchy nose, and burning or itchy eyes. They are also used to treat allergy of the skin - hives )urticaria(. HOW THIS MEDICINE WORKS Lorastine Tablets relieve your allergy symptoms by preventing the effects of a substance called histamine, which is produced by the body when you are allergic to something. THERAPEUTIC GROUP: This medicine contains the active ingredient loratadine which belongs to a class of medicines called “antihistamines”. 2. BEFORE USING THIS MEDICINE X DO NOT USE THIS MEDICINE IF: − You are allergic )sensitive( to loratadine or to any of the other ingredients of this medicine )see section 6 for a list of inactive ingredients(. SPECIAL WARNINGS ABOUT USING THIS MEDICINE ! TALK TO YOUR DOCTOR, PHARMACIST, OR NURSE BEFORE TAKING LORASTINE TABLETS IF: - You have liver disease. - You are about to have any skin tests for allergies. Do not take Lorastine Tablets for two days before having these tests. This is because the medicine may affect the test results. If any of the conditions described above apply to you )or if you are not sure(, consult your doctor, pha Прочитајте комплетан документ
Revised in April 2020 1. NAME OF THE MEDICINAL PRODUCT LORASTINE ® TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg loratadine. Excipients with known effect: The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white, oval tablet with flask and bowl, score and “10” on one side, plain on the other side. The score line of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorastine tablets are indicated for: Seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ One tablet once daily. _Paediatric population: _ Children 6 years of age and older with a body weight greater than 30 kg: One tablet once daily. For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are other formulations more suitable. Children under 2 years of age: The safety and efficacy of Lorastine Tablets have not been established. No data are available. _Patients with hepatic impairment_ Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg. _Patients with renal impairment_ No dosage adjustments are required in patients with renal insufficiency. _Elderly_ No dosage adjustments are required in the elderly. _Method of administration_ Oral use. The tablet may be taken without regard to meal time. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Lorastine Tablets should be administered with caution in patients with severe liver impairment (see section 4.2). This medicinal product c Прочитајте комплетан документ