国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate
Thornton & Ross Ltd
Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate
50mg/1ml ; 50mg/1ml ; 50mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010100; GTIN: 5011309033014
MAGNESIUM TRISILICATE MIXTURE 200ML PAGE 1 PAGE 2 PAGE 3 阅读完整的文件
OBJECT 1 MAGNESIUM TRISILICATE MIXTURE BP Summary of Product Characteristics Updated 08-Sep-2017 | Thornton & Ross Ltd 1. Name of the medicinal product Magnesium Trisilicate Mixture 2. Qualitative and quantitative composition Magnesium Carbonate Light 250mg/5ml Magnesium Trisilicate 250mg/5ml Sodium Hydrogen Carbonate 250mg/5ml For full list of excipients see section 6.1 3. Pharmaceutical form Mixture 4. Clinical particulars 4.1 Therapeutic indications For relief of the symptoms of indigestion, heartburn and dyspepsia. 4.2 Posology and method of administration Oral. RECOMMENDED DOSE Adults and children over 12 years: two to four 5ml spoonfuls. Children 5 to 12 years: one to two 5ml spoonfuls. Directions for use: shake the bottle. Take in a little water. DOSAGE SCHEDULE To be taken three times a day or as required. 4.3 Contraindications Contraindicated in severe renal failure_,_ hypophosphataemia and in patients who must control sodium intake e.g. congestive heart failure, hypertension, cirrhosis of the liver. Should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria. Hypersensitivity to any of the ingredients. 4.4 Special warnings and precautions for use The product should be used with caution in patients with fluid retention. In view of the sodium hydrogen carbonate content, the product should also be administered extremely cautiously to patients with renal impairment, to patients receiving corticosteroids or patients with respiratory acidosis, eclampsia, or aldosteronism. Magnesium trisilicate mixture has a sodium content of 6.4 mmol equivalent to 73.4 mg/5 ml or 147mg/10 ml dose. This must be taken into consideration for patients on a controlled sodium diet. This product contains sodium methyl and sodium propyl parahydroxybenzoates (E219 and E217 respectively) which may cause allergic reactions (possibly delayed). If renal function is impaired hypermagnesaemia may result giving the symptoms described under (4.9) overdose. The following warnings and precaut 阅读完整的文件