Dioctyl

Dioctyl 100 mg capsules

Docusate sodium 100 mg.

Excipients with known effect: sorbitol and sunset yellow (E110)

For the full list of excipients, see section 6.1.

Capsule, soft.

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

a) To prevent and treat chronic constipation.

(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and

(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.

b) As an adjunct in abdominal radiological procedures.

Posology

Adults:

Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For use with barium meals:

400 mg to be taken with the meal.

Elderly:

As for adults.

Paediatric population:

The safety and efficacy of Dioctyl in children aged 0 to 11 years have not yet been established. No data are available.

Method of administration

For oral use.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Dioctyl should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.

Organic disorders should be excluded prior to the administration of any laxative.

The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:

• increased intake of fluids and dietary fibre.

• advice on appropriate physical activity

If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.

Excipients

Fructose intolerance:

This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Excipients which may cause allergic reactions:

This product contains sunset yellow (E110) which may cause allergic reactions.

Dioctyl should not be taken concurrently with mineral oil.

Pregnancy

There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.

Use in pregnancy only if the benefits outweigh the risks.

Breast-feeding

Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.

None known.

Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Gastrointestinal disorders:

Rare: diarrhoea, nausea, abdominal cramps

Skin and subcutaneous tissue disorders:

Not known: skin rash and pruritus.

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 reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.

Pharmacotherapeutic group: softeners, emollients, ATC code: A06AA02

Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.

Docusate Sodium also possesses stimulant activity.

Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.

None stated.

Macrogol 400

Propylene glycol

Gelatin 175 bloom

Purified water

Sorbitol special

Glycerol

Titanium dioxide (E171)

Quinoline yellow (E104)

Sunset yellow (E110)

Lecithin

Isopropyl alcohol

Medium-chain triglycerides

None.

PVC/PVdC blister packs with aluminium foil: 18 months

Polyethylene / polypropylene containers: 2 years

Do not store above 25°C. Store in the original package in order to protect from moisture.

PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.

Polyethylene / polypropylene containers, holding 30 or 100 capsules.

Not all pack sizes may be marketed.

No special requirements for disposal.

Teofarma S.r.l.

Via Fratelli Cervi 8

Valle Salimbene

PV

27010

Italy

PL 16250/0014

17 June 2010

August 2023