SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Mil-Par

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml spoonful contains 3.75ml Magnesium Hydroxide BP and 1.25ml Liquid Paraffin Ph Eur.

3.    PHARMACEUTICAL FORM

Oral Suspension

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Mil-Par is recommended for the temporary relief of constipation

4.2. 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.

4.3    Contraindications

Use is contraindicated in children under three years of age.

Hypersensitivity to the active substances or to any of the excipients

4.4    Special warnings and precautions for use

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.

Caution is required with patients whose conditions bear a risk of aspiration

Use with caution in patients with renal impairment and renal insufficiency as hypermagnesaemia may occur due to decreased renal clearance of absorbed magnesium.

Hypermagnesemia can produce a central nervous system depression

If you are taking medication, suffer from kidney disease or are under a doctor's care, then you should consult your doctor before taking this.

This product should not be given to patients with symptoms of appendicitis, intestinal obstruction, inflammatory bowel disease or abdominal pain of unknown origin.

Prolonged use of laxatives can lead to fluid and electrolyte imbalance.

4.5 Interaction with other medicinal products and other forms of interaction

Laxatives can interfere with proper absorption of other compounds/drugs due to increased motility of the alimentary tract.

Interference with the absorption of fat-soluble vitamins may occur with liquid paraffin.

4.6. 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.

4.7. Effects on Ability to Drive and Use Machines

None Known

4.8    Undesirable effects

The following side effects might be possible 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 are unlikely to occur with Mil-Par due to the low content of liquid paraffin in the product

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Tel:    Freephone 0808 100 3352

Website:    www.mhra.gov.uk/yellowcard

4.9    Overdose

If large doses are ingested withdraw medication, supportive treatment may be required.

Do not induce vomiting due to the risk of aspiration.

5.    PHARMACOLOGICAL PROPERTIES

5.1. 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.

5.2. Pharmacokinetic Properties

Mil-Par exerts its therapeutic effect within the gastrointestinal tract and does not therefore, depend upon pharmacokinetic properties.

5.3. 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.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Sodium Bicarbonate Ph.Eur and Purified Water Ph. Eur.

6.2. Incompatibilities

None known.

6.3. Shelf-Life

Five Years.

6.4. Special Precautions for Storage

Keep from freezing.

Do not use after the expiry date shown.

6.5. 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).

6.6. Instructions for Use, Handling and Disposal

None.

7. MARKETING AUTHORISATION HOLDER

Seven Seas Limited

T/A Merck Consumer Health

Hedon Road

Marfleet

Kingston Upon Hull HU9 5NJ United Kingdom

8.    MARKETING AUTHORISATION NUMBER(S)

PL 01932/0032

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

30 April 1988

10 DATE OF REVISION OF THE TEXT

24/03/2014