COOPER LIQUID PARAFFIN Oral solution in bottle Bottle/250ml

Liquid paraffin ..................................................................................................q.s. to the bottle capacity

Symptomatic treatment of constipation.

Oral use

Dosage

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

Method of administration

The dose 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 following intake (see section Warnings and precautions) and to take into account the onset of action (6-8 hours).

Hypersensitivity to paraffin oil,

Obstructive colopathy, given the laxative effect of the medicine,

Abdominal pain syndrome of undetermined and inflammatory cause (ulcerative colitis, Crohn's disease...),

Do not use in people with swallowing difficulties because of the risk of bronchial inhalation and lipoid pneumonia.

Warning

Prolonged use of a laxative is not recommended.

• Drug treatment of constipation is only an adjunct to hygienic-dietary treatment:
  • enrichment of the diet with vegetable fibres and fluids;
  • Advice on physical activity and rehabilitation of evacuation.
• In children, the prescription of laxatives should be exceptional: it must take into account the risk of hindering 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 liquid paraffin to young children, debilitated or bedridden persons, or in cases of gastro-oesophageal reflux should be done with caution because of the risk of bronchial inhalation and lipid 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 breastfeeding women is possible on an occasional basis.

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 treatment (or possibly reduce doses) and apply local symptomatic treatment.

Pharmacotherapeutic class: LAXATIVE, ATC code: A06AA01

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

Its action manifests in 6 to 8 hours orally.

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

At the usual dose, liquid paraffin is not absorbed.

3 years.

Protect from light.

No special requirements.