Magnesium trisilicate oral suspension

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate

MAH:

Thornton & Ross Ltd

INN:

Magnesium trisilicate; Magnesium carbonate light; Sodium bicarbonate

dosage:

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

pharmaceutical_form:

Oral suspension

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 01010100; GTIN: 5011309033014

PIL

MAGNESIUM TRISILICATE MIXTURE 200ML
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SPC

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