MILK OF MAGNESIA Oral Suspension (2013)
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Περιεχόμενα
Name of the medicinal product
Phillips' Milk of Magnesia.
Qualitative and quantitative composition
Magnesium Hydroxide BP 415 mg per 5 ml suspension.
Pharmaceutical form
Oral Suspension.
Therapeutic indications
Milk of Magnesia is indicated as an antacid for the symptomatic relief of stomach discomfort, indigestion, hyperacidity, heartburn and flatulence; and as a laxative for constipation.
Posology and method of administration
Use a 5 ml spoon or the dosing cup provided. Doses may be taken with milk or water if desired. Do not exceed the stated dose. As an antacid Adults: 5-10 ml (one or two 5 ml spoonfuls or fill the dosing ...
Contraindications
Hypersensitivity to any of the ingredients.
Special warnings and precautions for use
Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately. In case of renal impairment a doctor should be consulted as ...
Interaction with other medicinal products and other forms of interaction
Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium ...
Pregnancy and lactation
For Magnesium hydroxide no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Magnesium hydroxide is unlikely to cause any effects on the ability to drive and use machines.
Undesirable effects
Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see section 4.9).
Overdose
Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, ...
Pharmacodynamic properties
Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is ...
Pharmacokinetic properties
Magnesium hydroxide exerts its antacid therapeutic effect rapidly within the gastro-intestinal tract following oral administration and this action is therefore independent of pharmacokinetic properties. ...
Preclinical safety data
Magnesium hydroxide has been used for many years and no further data are presented in this section.
List of excipients
Sodium Hydrogen Carbonate EP Oil of Peppermint EP Glycerol EP Sodium Saccharin EP Purified Water EP
Incompatibilities
None.
Shelf life
Shelf life: 36 months; after opening, 6 months.
Special precautions for storage
Store below 25°C. Do not freeze.
Nature and contents of container
Blue HDPE bottles with white HDPE screw turn tamper evident inner cap and external click on dosing cap. Pack size 100ml and 200ml.
Special precautions for disposal and other handling
Shake bottle well before use. Use within 6 months of opening.
Marketing authorization holder
Omega Pharma Ltd., 1<sup>st</sup> Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom
Marketing authorization number(s)
PL 02855/0072
Date of first authorization / renewal of the authorization
22<sup>nd</sup> March 1999
Date of revision of the text
9<sup>th</sup> July 2013
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