Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
LORATADINE; PSEUDOEPHEDRINE SULFATE
BAYER ISRAEL LTD
R06AX13
TABLETS PROLONGED RELEASE
LORATADINE 5 MG; PSEUDOEPHEDRINE SULFATE 120 MG
PER OS
Required
BAYER CONSUMER CARE LTD, SWITZERLAND
LORATADINE
LORATADINE
Relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired.
2017-02-28
2 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor's prescription only Clarinase Repetabs Prolonged-release tablets Each tablet contains: Loratadine 5 mg Pseudoephedrine sulphate 120 mg Inactive ingredients and allergens: see section 2 ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information’. 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. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1) What is this medicine intended for? Clarinase Repetabs is intended for the relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired. Therapeutic group: Clarinase Repetabs contains a combination of two active substances (loratadine and pseudoephedrine sulphate). Loratadine is an antihistamine. Pseudoephedrine sulphate is a decongestant. Antihistamines help reduce allergy symptoms by stopping the effects of a substance called histamine, which is produced by the body when you are allergic to something. Decongestants help reduce nasal congestion. 2) Before using this medicine Do not use this medicine: • If you are sensitive (allergic) to loratadine, pseudoephedrine or to any of the other ingredients in this medicine. For a list of the inactive ingredients, see section 6 “Additional information”. Due to the presence of pseudoephedrine, do not take Clarinase Repetabs: • If you are taking medicine to lower blood pressure or for heart disease. • If you have glaucoma, difficulty in urinating, urinary tract blockage, high blood pressure, heart or blood vessel disease, a history of haemorrhagic stroke, you have other risk factors that increase the Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CLARINASE REPETABS Prolonged Release Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg loratadine and 120 mg pseudoephedrine sulphate. Excipients with known effect: The quantities of sucrose and lactose monohydrate in each prolonged-release tablet are 173.23 mg and 156.80 mg respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Round, biconvex, lustrous, white, coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CLARINASE REPETABS_ _is indicated for the relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: _ One CLARINASE REPETABS_ _tablet twice daily with a glass of water. The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared. It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish. After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with loratadine alone, if necessary. _PAEDIATRIC POPULATION _ The safety and efficacy of _Clarinase Repetabs _in children below the age of 12 years have not been established. No data are available. Clarinase Repetabs are not recommended for use in children below the age of 12 years. _ELDERLY PATIENTS _ The combination product should not be administered to patients above 60 years of age. Patients 60 years or older are more likely to experience adverse reactions to sympathomimetic medications (see section 4.4). PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT The combination product should not be used in patients with impaired renal function, renal tubular acidosis or impaired hepatic function (see section 4.4). METHOD OF ADMINISTRATION Oral use. The tablet must be swall Olvassa el a teljes dokumentumot