Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LENADOL TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): LENADOL TABLETS COMPOSITION: Each tablet contains: Paracetamol 400 mg Diphenhydramine HCl 5 mg Caffeine Anhydrous 50 mg Codeine Phosphate 10 mg Preservative: Nipastat 0,02% m/m PHARMACOLOGICAL CLASSIFICATION: A 2.8 Analgesic combinations. PHARMACOLOGICAL ACTION: Lenadol has analgesic, antipyretic and antihistaminic properties. INDICATIONS: Lenadol relieves fever and pain-tension states. CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients. Patients with severe liver or kidney complications. The use of Lenadol during pregnancy should be avoided, as it crosses the placenta. It must be avoided in asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment and acute alcoholism. It must not be given to comatose patients. Do not administer to children under 12 years of age. WARNINGS: Lenadol contains codeine and exceeding the prescribed dose, together with prolonged and continuous use, may lead to dependence and addiction. The administration of codeine during labour may cause respiratory depression in the newborn infant. As this product contains paracetamol, doses in excess of those recommended may cause severe liver damage to occur. Patients suffering from kidney or liver disease should take paracetamol under strict medical supervision. Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for longer than 10 days without consulting your doctor. This m Read the complete document