LIQUID PARAFFIN BP 100 %v/v Oral Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
PARAFFIN, LIQUID
Available from:
Ricesteele Manufacturing Ltd
INN (International Name):
PARAFFIN, LIQUID
Dosage:
100 %v/v
Pharmaceutical form:
Oral Solution
Authorization status:
Withdrawn
Authorization date:
2008-11-09
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paraffin, liquid, 100% v/v.
3 PHARMACEUTICAL FORM
Oral liquid
Transparent, colourless, oily liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Liquid Paraffin is an intestinal lubricant. It is indicated for the treatment of occasional constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Recommended Dosage:
Adults:
1 - 4 tablespoonfuls daily.
Children:
Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to liquid paraffin.
Neurological conditions or disorders of swallowing that could predispose to aspiration of liquid paraffin (see 4.8
_Undesirable effects_).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist, or if undesirable effects occur, consult your doctor.
The product is for occasional use only. Prolonged use is not recommended.
Not for use in children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Inappropriate or prolonged use may decrease the absorption of nutrients, including the fat soluble vitamins A, K, E and
D.
4.6 PREGNANCY AND LACTATION
Safety in pregnancy has not been established.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/07/2006_
_CRN 2025349_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Leakage of oil past the anal sphincter can occur, resulting in anal seepage and irritation.
Liquid paraffin is absorbed to a slight extent. There have been reports suggesting an association between the occurrence
of foreign-body granulomata in the abdominal viscera and the prolonged intake of liquid paraffin from dietar
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