Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
DRISTAN® COLD ND TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form) : DRISTAN ® COLD ND TABLETS COMPOSITION: Each tablet contains: Paracetamol 500 mg Pseudoephedrine HCl 30 mg PHARMACOLOGICAL CLASSIFICATION: A 5.8 Preparations for the common cold including nasal decongestants and antihistamines. PHARMACOLOGICAL ACTION: DRISTAN COLD ND has analgesic, antipyretic and decongestant properties. INDICATIONS: For the symptomatic relief of nasal, sinus and Eustachian tube mucal congestion and associated pain and fever due to colds and influenza. CONTRA-INDICATIONS: Sensitivity to any of the ingredients. Contra-indicated in persons receiving monoamine oxidase inhibitors, or within 14 days of termination of treatment. Contra-indicated in persons with benign prostatic hypertrophy, in the presence of other sympathomimetic agents, and alpha and beta-blocking drugs. Severe liver function impairment. Safety in pregnancy and lactation has not been established. Children under the age of 12 years. Do not use in patients hypersusceptable to the effects of pseudoephedrine, particular those with hyperthyroidism. Do not use in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms. Do not use in patients with diabetes or closed angle glaucoma. Avoid in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as they may induce ventricular fibrillation. WARNING: Dosages in excess of those recommended may cause severe liver damage. Persons with high blood pressure, heart disease diabetes, thyroid disease, difficulty in urination due to an enlarged prostate gland or taking an anti- depressan Read the complete document