GIFRER PARAFFIN OIL Oral solution Bottle/250ml

Liquid paraffin oil........................................................................q.s. the content of the marketed pack

• Symptomatic treatment of constipation.

Dosage

• in adults: oral route 15 to 45 ml, i.e. 1 to 3 tablespoons per day.
• in children over 6 years: oral route: 10 to 15 ml (i.e. 2 to 3 teaspoons) per day.

It may be taken either in the morning on an empty stomach, or preferably away from meals. If taken in the evening, the patient should be advised not to lie down within 2 hours after taking it (see section Warnings and precautions) and to take into account the time to onset of action (6-8 hours).

Method of administration

Oral use.

• Hypersensitivity to paraffin oil
• Obstructive colopathy, given the laxative effect of the medicine
• Abdominal painful syndrome of undetermined and inflammatory cause (ulcerative rectocolitis, Crohn's disease...)
• Do not use in people with swallowing difficulties because of the risk of bronchial inhalation and lipid pneumonia.

Special warnings

Prolonged use of a laxative is not recommended.

1) Drug treatment of constipation is only an adjunct to dietary and hygiene treatment:

• enrichment of the diet with vegetable fibres and fluids,
• Advice on physical activity and rehabilitation of evacuation.

2) In children, the prescription of laxatives should be exceptional: it must take into account the risk of interfering with the normal functioning of the defecation reflex.

Precautions for use

• Prolonged use of paraffin oil may reduce the absorption of fat-soluble vitamins (A, D, E, K)
• Administration of paraffin oil to young children, debilitated or bedridden people, or in cases of gastro-oesophageal reflux must be cautious because of the risk of bronchial inhalation and lipoid pneumonia (see section Adverse effects).
• This oil must not be heated.

The data available to date do not suggest the existence of clinically significant interactions.

Given the available data, use in pregnant or breast-feeding women is possible occasionally.

The following table describes the adverse effects reported with liquid paraffin. The frequency of adverse effects is defined using the following convention: very common (≥ 1/10), common (≥1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from the available data).

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

No cases of overdose have been reported. However, use of liquid paraffin at high doses exposes to a risk of:

• steatorrhoea,
• anal seepage,
• and perianal irritation.

In case of overdose, stop the treatment (or possibly reduce the doses) and apply local symptomatic treatment.

Pharmacotherapeutic class: LAXATIVE, lubricant, ATC code: A06A A 01

Liquid paraffin is a mechanical-action laxative that acts by lubricating the colonic contents and softening the stools.

Its action occurs in 6 to 8 hours by oral route.

As liquid paraffin is not metabolised, its caloric intake is nil.

At the usual dose, liquid paraffin is not absorbed.

3 years

This medicinal product must be stored protected from light.

No special requirements.