Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS LORATADINE 10,0 mg
Registered
2004-06-02
APPLICANT: ADCOCK INGRAM LIMITED PROPRIETARY NAME: ALLERGEX TABLETS DOSAGE FORM: TABLET STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG 8 March 2024 Page 1 of 10 PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS: ALLERGEX® TABLETS (4 MG) Chlorphenamine maleate 4 mg Contains sugar: Lactose 119,80 mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALLERGEX TABLETS is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use ALLERGEX TABLETS carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share ALLERGEX TABLETS with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET 1. What ALLERGEX TABLETS is and what it is used for 2. What you need to know before you take ALLERGEX TABLETS 3. How to take ALLERGEX TABLETS. 4. Possible side effects. 5. How to store ALLERGEX TABLETS. 6. Contents of the pack and other information S2 APPLICANT: ADCOCK INGRAM LIMITED PROPRIETARY NAME: ALLERGEX TABLETS DOSAGE FORM: TABLET STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG 8 March 2024 Page 2 of 10 1. WHAT ALLERGEX TABLETS IS AND WHAT IT IS USED FOR ALLERGEX TABLETS is used for the treatment of allergic and anaphylactic conditions such as hay fever, vasomotor rhinitis (allergy in the nose when the small blood vessels in the nose dilate causing nasal congestion), urticaria (itchy rash that appears on the skin), angioedema (swelling under the skin), drug reactions, contact dermatitis, atopic dermatitis, insect bites, pruritus and pruritus vulvae. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLERGEX TABLETS DO NOT TAKE ALLERGEX TABLETS • If you are hypersensitive (allergic) to chlorphenamine maleate or any of the other ingredients of ALLERGEX TABLETS (listed in section 6) • If you suffer from recur Baca dokumen lengkapnya
APPLICANT: ADCOCK INGRAM LIMITED PROPRIETARY NAME: ALLERGEX TABLETS DOSAGE FORM: TABLET STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG 8 March 2024 Page 1 of 8 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS: 1. NAME OF MEDICINE ALLERGEX® TABLETS (4 MG) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: Chlorpheniramine maleate 4 mg Contains sugar: Lactose 119,80 mg For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Yellow, round, normal convex tablet, scored on one side and embossed with A on the reverse side. S2 APPLICANT: ADCOCK INGRAM LIMITED PROPRIETARY NAME: ALLERGEX TABLETS DOSAGE FORM: TABLET STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG 8 March 2024 Page 2 of 8 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS: Allergic and anaphylactic conditions such as hay fever, vasomotor rhinitis, urticaria, angioedema, drug reactions, contact dermatitis, atopic dermatitis, insect bites, pruritus and pruritus vulvae. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and children 12 years or older: One 4 mg ALLERGEX TABLET every 4 to 6 hours, up to a maximum of 24 mg in 24 hours._ _ Children 6 to 12 years: 2 mg (Half a ALLERGEX TABLET) every 4 to 6 hours, up to a maximum of 12 mg in 24 hours. Children up to 6 years: Use is not recommended. METHOD OF ADMINISTRATION Oral administration 4.3 CONTRAINDICATIONS: Hypersensitivity to Chlorpheniramine or to any of the excipients of ALLERGEX TABLETS listed in section 6.1. Epilepsy, Acute attacks of asthma. Premature infants and new-born babies. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chlorphenamine maleate may produce epileptiform seizures in patients with focal lesions of the cerebral cortex. Allergic reactions and cross-sensitivity to related drugs may be produced. Because of its antimuscarinic properties chlorpheniramine maleate should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic APPLICANT: ADCOCK INGRAM LIMITED PROPRIETARY Baca dokumen lengkapnya