Summary of Product Characteristics (SmPC) - Liquid Paraffin and Magnesium Hydroxide emulsion BP
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTLiquid Paraffin and Magnesium Hydroxide Emulsion BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin BP 25% v/v
Magnesium Hydroxide 6%w/w
3. PHARMACEUTICAL FORM
A white emulsion
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For oral use for the temporary relief of constipation
4.2 Posology and method of administration
For adults over 12 years (including the elderly) 5 to 20ml orally as required (maximum daily dose 20ml)
For Children 3–12 years of age 5 to 15ml orally as required
(maximum daily dose 15ml)
4.3 Contraindications
Not recommended for children under 3 years of age.
Do not use when intestinal obstruction is suspected
4.4 Special warnings and special precautions for use
Avoid prolonged use.
Caution should be exercised in administering this product to the elderly with possible renal impairment.
Keep out of the sight and reach of children.
Store below 25°C
Do not freeze.
4.5 Interactions with other medicinal products and other forms of interaction
There may be interference with the absorption of fat soluble vitamins.
4.6 Pregnancy and lactation
Avoid in early pregnancy or lactation
4.7 Effects on ability to drive and use machines
Does not affect ability to drive and operate machinery.
4.8 Undesirable effects
Anal seepage of paraffin and consequent anal irritation can occur after prolonged use.
Granulomatous reactions caused by absorption of small quantities of liquid paraffin.
Lipoid pneumonia (by accidental inhalation) may occur and therefore caution is required in patients with swallowing difficulties.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
If large quantities are ingested, withdraw medication. Supportive treatment may be required.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Liquid Paraffin, taken internally, acts as a lubricant and is widely used to alleviate constipation.
Magnesium Hydroxide has antacid properties and also acts as a mild saline laxative.
5.2 Pharmacokinetic properties
There is some evidence that Magnesium salts may cause decreased absorption of the active ingredients of other medications. e.g. Digoxin.
Excessive use of Liquid Paraffin may lead to anal seepage and irritation and may, if emulsified, give rise to granulatomous reactions.
5.3 Preclinical safety data
6.1 List of excipients
Levomenthol
0.02%w/w
0.08%w/w
0.01%w/w to 100%
Sodium Saccharin
Benzalkonium Chloride
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
Unopened container 3 years
After opening 1 month
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
Amber glass baffles containing 150ml
High density polyethylene opaque bottles containing 500ml and 2000ml
6.6 Instructions for use/handling
7 MARKETING AUTHORISATION HOLDER
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0173
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6 November 1987 / 25 April 1994