Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
DOLOROL® TABLETS SCHEDULING STATUS: Not scheduled: Pack sizes of 25 tablets or less, containing 500 mg or less of paracetamol. Schedule: 1 Pack sizes of more than 25 tablets PROPRIETARY NAME: (and dosage form): DOLOROL ® TABLETS COMPOSITION: Each tablet contains: Paracetamol 500 mg Preservative: Nipastat 0,2% m/m PHARMACOLOGICAL CLASSIFICATION: A 2.7 Antipyretic or antipyretic and anti-inflammatory agents. PHARMACOLOGICAL ACTION: Paracetamol has analgesic and antipyretic properties. However, it has no anti-inflammatory effect and does not share the antirheumatic properties of the salicylates. It is rapidly and practically completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is about 2 hours after therapeutic doses. It is distributed into most body tissues. It crosses the placenta and is present in breast milk. INDICATIONS: For the relief of mild to moderate pain and fever. CONTRA-INDICATIONS: Hypersensitivity to paracetamol. Severe liver function impairment. WARNING: Dosages in excess of those recommended can cause severe liver damage. Prolonged excessive use may cause irreversible kidney damage. Patients suffering from liver or kidney disease should only take Paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting your doctor. DOSAGE AND DIRECTIONS FOR USE: Adults: 1 to 2 tablets every 4 hours when necessary (maximum 8 tablets in 24 hours). Children: 6-12 years: ½ to 1 tablet when necessary (maximum 4 tablets in 24 hours). Children under 6 years: Dolorol tablets are not recommended. SIDE-EFFECTS A Read the complete document