LIQUID PARAFFIN BP 100 %v/v Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARAFFIN, LIQUID

Available from:

Pinewood Laboratories Ltd,

INN (International Name):

PARAFFIN, LIQUID

Dosage:

100 %v/v

Pharmaceutical form:

Oral Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2010-07-21

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin BP 100%v/v Oral Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains Liquid Paraffin 100% v/v.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral liquid
A colourless, transparent, oily liquid, free from fluorescence in daylight.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Used for the temporary relief of constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dosage:
4.3 CONTRAINDICATIONS
Liquid paraffin should not be used in patients with appendicitis, undiagnosed rectal bleeding, congestive heart failure,
intestinal obstruction, dysphagia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid prolonged use.
If symptoms persist consult your doctor.
Habitual use must be avoided. Overuse or extended use may cause dependence for bowel function.
Adults:
10-30 ml as required.
Elderly:
Not recommended for bedridden elderly patients since they are more prone to aspiration of oil
droplets, which may produce lipid pneumonia.
Children:
Not recommended for children under 6 years of age, unless prescribed by a doctor.
Infants and
neonates:
Not recommended
Special groups:
Patients under medical care should not take liquid paraffin, unless recommended by their doctor.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/08/2006_
_CRN 2027068_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Potassium sparing diuretics or potassium supplements: Chronic use or overuse of laxative may reduce serum potassium
concentrations by promoting excessive potassium loss from the intestinal tract, thus interfering with potassium-
retaining effects of diuretics.
Anticoagulants, oral