Země: Jihoafrická republika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
SYRUP
EACH 5,0 ml SYRUP CONTAINS DESLORATADINE 2,5 mg
Registered
2014-03-07
ADCOCK INGRAM LIMITED DESLOMED SYRUP 43/5.7.1/0079 PATIENT INFORMATION LEAFLET _____________________________________________________________________________________ Date: 6 May 2022 Page 1 of 7 Initials: A.G SCHEDULING STATUS S2 PROPRIETARY NAME AND PHARMACEUTICAL DOSAGE FORM DESLOMED SYRUP Actives substance per 5 ml is: Desloratadine 2,5 mg Preservatives: Sodium benzoate 0,1% m/v Sugar free Contains sweeteners: Blend ADI 450 (acesulfame potassium and sucralose) 1,50 mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. _DESLOMED SYRUP is available without a doctor’s prescription, for you to treat a mild illness. _ _Nevertheless, you still need to use DESLOMED SYRUP carefully to get the best results from it. _ • Keep this leaflet. You may need to read it again. • Do not share DESLOMED SYRUP_ _with any other person. • Ask your health care provider or pharmacist if you need more information or advice. 1. WHAT DESLOMED SYRUP_ _IS AND WHAT IT IS USED FOR DESLOMED SYRUP is an antihistamine that provides relief of seasonal hay fever. The active substance is: Desloratadine 2,5 mg The other ingredients are: Citric acid anhydrous, colour FD&C yellow No. 6, disodium edetate, liquid maltitol, orange flavour type sweet 96472-33, propylene glycol, sodium citrate, sorbitol solution ADCOCK INGRAM LIMITED DESLOMED SYRUP 43/5.7.1/0079 PATIENT INFORMATION LEAFLET _____________________________________________________________________________________ Date: 6 May 2022 Page 2 of 7 Initials: A.G 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLOMED SYRUP DO NOT USE DESLOMED SYRUP • If you are pregnant • if you are breastfeeding • if you are allergic to any of the syrup ingredients. • if you are allergic to any other antihistamines • if you have porphyria WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH DESLOMED SYRUP: • Tell your doctor if you suffer from liver or kidney disease. • Tell your doctor if you have ever had any unusual or allergic reaction to DESLOMED SYRUP • Efficacy and Přečtěte si celý dokument
ADCOCK INGRAM LIMITED DESLOMED SYRUP 43/5.7.1/0079 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE __________________________________________________________________________________ Date: 6 May 2022 Page 1 of 9 Initials: A.G SCHEDULING STATUS: S2 1.NAME OF MEDICINE: DESLOMED SYRUP STRENGTH Desloratadine 2,5 mg PHARMACEUTICAL FORM Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 5 ml of DESLOMED SYRUP contains: Desloratadine 2,5 mg Preservative: Sodium benzoate 0,1% _m/v_ Sugar free Contains sweeteners: Blend ADI 450 (acesulfame potassium and sucralose) 1,50 mg For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM A clear, orange coloured aqueous solution with a sweet orange odour. ADCOCK INGRAM LIMITED DESLOMED SYRUP 43/5.7.1/0079 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE __________________________________________________________________________________ Date: 6 May 2022 Page 2 of 9 Initials: A.G 4. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS DESLOMED SYRUP is indicated for symptomatic relief of seasonal types of allergy that present with symptoms such as rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Children 2 to 5 years of age_: 2,5 ml (1,25 mg) once a day, with or without food. _Children 6 to 11 years of age_: 5 ml (2,5 mg) once a day, with or without food. _Adults and adolescents (12 years of age and over)_: 10 ml (5 mg) once a day, with or without food._ _ Patients with hepatic or renal impairment should be given 5 mg DESLOMED SYRUP on alternate days initially. 4.3 CONTRAINDICATIONS: Hypersensitivity to active substance or to any of the excipients. Pregnancy and lactation (see section 4.6). Cross sensitivity to other antihistamines. Porphyria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with the rare hereditary condition of sorbitol or maltitol intolerance should not take DESLOMED SYRUP. ADCOCK INGRAM LIMITED DESLOMED SYRUP 43/5.7.1/0079 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE _________________________________________________________________ Přečtěte si celý dokument