Ország: Dél-afrikai Köztársaság
Nyelv: angol
Forrás: South African Health Products Regulatory Authority (SAHPRA)
Roussel
ALTACITE TABLETS ALTACITE SUSPENSION SCHEDULING STATUS : Unscheduled PROPRIETARY NAME : (and dosage form) ALTACITE TABLETS ALTACITE SUSPENSION COMPOSITION : Tablets : Each tablet contains 500 mg hydrotalcite . Suspension : Each 5 mL of suspension contains 500 mg hydrotalcite (preservative: bronopol 0,02% m/v). PHARMACOLOGICAL CLASSIFICATION : A.11.4 antacid/antipepsin. PHARMACOLOGICAL ACTION : Hydrotalcite adjusts stomach acidity to within the optimum range of pH 3,0 - 5,0 whilst at the same time inhibiting pepsin activity. INDICATIONS: Acid-pepsin disorders, peptic ulceration, gastritis, dyspepsia, hyper-acidity, 'heartburn' associated with reflux oesophagitis and hiatus hernia. CONTRA-INDICATIONS : Renal insufficiency. DOSAGE AND DIRECTIONS FOR USE: Adults: 1 to 2 tablets to be chewed slowly and swallowed, or 1 to 2 medicine measuresful to be taken between meals. Children : (Age 6 - 12 years) ½-1½ tablets or ½ -1½ medicine measuresful. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Occasional nausea and/or diarrhoea. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: No acute or lasting effects of overdosage are to be expected. IDENTIFICATION: Tablets : White 15 mm cylindrical, flat bevelled edge tablet flavoured with buttermint, marked ‘altacite’on one side and ‘roussel’on the reverse. Suspension : An aqueous suspension, slightly off-white, viscous and flavoured with buttermint. PRESENTATION: White buttermint flavoured tablets marked 'altacite’in packs of 30’s and 100’s, and a 200 mL bottle of white buttermint flavoured suspension. STORAGE INSTRUCTIONS: Store in a cool dry place, below 25°C. Store in a cool dry place, below 25°C. Keep out of reach of children. REGISTRATION NUMBER Olvassa el a teljes dokumentumot