Active substance(s): MAGNESIUM HYDROXIDE / PARAFFIN LIQUID
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml spoonful contains 3.75ml Magnesium Hydroxide Mixture BP and 1.25ml Liquid Paraffin Ph Eur.
PHARMACEUTICAL FORM Oral Suspension
CLINICAL PARTICULARS Therapeutic Indications Mil-Par is recommended for the temporary relief of constipation
Posology and Method of Administration Adults including the elderly: One or two tablespoonfuls (15 to 30ml) before breakfast or at bedtime. Children aged 7 years and over: Half to one tablespoonful (7.5 to 15ml) at bedtime. Children aged 3 to 7 years: One or two teaspoonfuls (5 to 10ml) at bedtime. Not recommended for children under three years of age. Mil-Par is for oral administration only. If desired, the dose may be mixed with half a glass of milk or water.
Use is contraindicated in children under three years of age. Hypersensitivity to the active substances or to any of the excipients
Special warnings and precautions for use
Caution is required in patients with swallowing difficulties. Repeat use is not recommended. If laxatives are needed every day, if there is persistent abdominal pain, if you find swallowing difficult or if symptoms persist, contact your doctor. Do not use repeatedly. Use with caution in patients with renal impairment as hypermagnesaemia may occur due to decreased renal clearance of absorbed magnesium.
4.5. Interactions with other Medicinal Products and other Forms of Interaction Interference with the absorption of fat-soluble vitamins may occur with liquid paraffin. However, there is no evidence that this occurs with Mil-Par and due to the low content of liquid paraffin in the product, this is unlikely to occur.
Pregnancy and Lactation Mil-Par has been widely used during pregnancy without ill-effect, but, as with all medicines during pregnancy and lactation, advice from the doctor should be sought.
Effects on Ability to Drive and Use Machines None Known
Undesirable Effects The following side effects have been reported with liquid paraffin: anal seepage of paraffin and consequent anal irritation after prolonged use; granulomatous reactions caused by absorption of small quantities of liquid paraffin; lipoid pneumonia (by accidental inhalation) may occur and caution is therefore required in patients with swallowing difficulties.
These side effects have not been reported with Mil-Par and are unlikely to occur due to the low content of liquid paraffin.
Overdose If large doses are ingested withdraw medication, supportive treatment may be required.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Magnesium hydroxide has an indirect cathartic action, which results from water retention in the stomach lumen due to increased osmotic pressure. Liquid paraffin acts as a mild laxative by softening stools thus easing defaecation.
Pharmacokinetic Properties Mil-Par exerts its therapeutic effect within the gastrointestinal tract and does not therefore, depend upon pharmacokinetic properties.
Pre-clinical Safety Data There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
PHARMACEUTICAL PARTICULARS List of Excipients Sodium Bicarbonate Ph.Eur and Purified Water Ph. Eur.
Incompatibilities None known.
Shelf-Life Five Years.
Special Precautions for Storage Keep from freezing. Do not use after the expiry date shown.
Nature and Contents of Container 100, 200 and 500ml blue PVC bottles sealed with LDPE Snap-On hinged closures with removable, tamper proof tear strips (jaycap closures).
Instructions for Use, Handling and Disposal None.
MARKETING AUTHORISATION HOLDER Seven Seas Limited T/A Merck Consumer Health Hedon Road Marfleet Kingston Upon Hull HU9 5NJ United Kingdom
MARKETING AUTHORISATION NUMBER(S) PL 01932/0032
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION 30 April 1988
DATE OF REVISION OF THE TEXT