Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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TENSOLVE TENSION HEADACHE TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): TENSOLVE TENSION HEADACHE TABLETS COMPOSITION: Each tablet contains: Paracetamol 400 mg Codeine Phosphate 10 mg Diphenhydramine Hydrochloride 5 mg Caffeine Anhydrous 50 mg Preservative: Nipastat 0,02% m/m PHARMACOLOGICAL CLASSIFICATION: A 2.9 special analgesic combinations. PHARMACOLOGICAL ACTION: Tensolve Tension Headache Tablets have analgesic, antipyretic and antihistaminic properties. INDICATIONS: For mild to moderate pain. CONTRA-INDICATIONS: Patients with severe liver or kidney complications. Hypersensitivity to any of the ingredients. The use of monoamine oxidase inhibitors or within 10 days of stopping such treatment. WARNINGS: Do not use continuously for more than 10 days without consulting your doctor. Also consult your doctor if no relief is obtained with the recommended dosage. Due to the paracetamol content dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Care should be taken when administering this preparation during the first trimester of pregnancy. The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol and other central nervous system depressant agents. Patients should not operate hazardous machinery or drive motor vehicles when under medication. Must not be taken with sedatives or tranquillizers. DOSAGE AND DIRECTIONS FOR USE: Adults and children over 12 years: One to two tablets every 3 or 4 hours, with a maximum of 8 tablets daily. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Side-effects of Paracetamol: Haema Read the complete document