Dioctyl

Dioctyl 100 mg Capsules.

Sodium docusate 100 mg.

Capsules

Two-color (opaque white and opaque yellow) soft oval gelatin capsule with a transparent colorless liquid filler.

a) For the prevention and treatment of chronic constipation.

(i) soften hard, dry stools to facilitate defecation and reduce stool tension, and

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

b) As an auxiliary tool for radiological procedures of the abdominal cavity.

Method of use: Oral

Adults and the elderly:

Up to 500 mg should be taken daily in divided doses. Treatment should begin with large doses, which should be reduced as the patient's condition improves.

For use with barium food:

400 mg should be taken with a meal.

Children under 12 years old:

Not recommended.

These capsules should not be administered for abdominal pain, nausea, vomiting, or intestinal obstruction.

This drug should not be prescribed to patients with known hypersensitivity to Dioctyl capsules or any of its components.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Organic disorders should be excluded before the administration of any laxative.

Treatment of constipation with any medication is only an auxiliary tool to a healthy lifestyle and diet, for example:

- Increased intake of fluids and dietary fiber.

- Recommendations for appropriate physical activity

If you need laxatives every day or if you have constant abdominal pain, consult your doctor.

Contains sorbitol: Do not use this medicine if you are intolerant to small amounts of sugar (sorbitol, fructose).

Contains E110 dye, which can cause allergic reactions.

Out of stock

Rarely, these capsules can cause diarrhea, nausea, abdominal cramps, or skin rashes.

Report of suspected adverse reactions

It is important to report suspicious adverse reactions after obtaining approval for the use of the drug. This allows you to continue monitoring the benefit/risk balance of the drug. Health professionals are asked to report any suspected adverse reactions through the national reporting system listed below.

Yellow Card Scheme

Web site: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information about the safety of this medication.

In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluids. Electrolyte losses should be replaced where necessary.

ATC Code: A06A02 laxatives, plasticizers, softeners

Sodium docusate is an anionic wetting agent that acts as a fecal softener, reducing surface tension and allowing the accumulated hard, dry feces to penetrate with water and salts.

Sodium docusate also has stimulating activity.

Sodium docusate has its clinical effect in the gastrointestinal tract. There is some evidence that sodium docusate is absorbed and excreted in the bile. There is also evidence that sodium docusate can enhance the absorption of certain compounds administered simultaneously.

Not specified

Macrogol 400

Propylene Glycol

Gelatin 175 blooming

Purified water

Special sorbitol

Glycerin

Titanium Dioxide E171

Quinoline Yellow E104

Sunset yellow E110

Lecithin

Isopropyl alcohol

Medium-chain triglycerides

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PVC/Pvdh blister with aluminum foil: 18 months

Plastic / polypropylene containers: 24 months

Do not store at temperatures above 25°C. Store in the original packaging to protect against moisture.

Blister packaging made of PVC/PVdC with aluminum foil, containing 10, 20, 30, 40 or 50 capsules.

Polyethylene / polypropylene containers, for example: securitainers / tampertainers containing 30, 100 and 250 capsules.

Not all package sizes can be sold.

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UCB Pharma Limited

208 Bath Road

Swamp

Berkshire

POSTAL CODE SL1 3MY

United Kingdom

PL 00039/0737

June 17, 2010

July 2016