Magnesium trisilicate oral suspension

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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下载 资料单张 (PIL)
07-06-2018
下载 产品特点 (SPC)
07-06-2018

有效成分:

Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate

可用日期:

Thornton & Ross Ltd

INN(国际名称):

Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate

剂量:

50mg/1ml ; 50mg/1ml ; 50mg/1ml

药物剂型:

Oral suspension

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 01010100; GTIN: 5011309033014

资料单张

                                MAGNESIUM TRISILICATE MIXTURE 200ML
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产品特点

                                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
                                
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