TOILAX MICRO ENEMA Rectal suspension Ref.[50433] Active ingredients: Bisacodyl

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

4.1. Therapeutic indications

Toilax is indicated in adults and children over 10 years for evacuation of the colon in constipation for short term use only. Prior to surgical and diagnostic procedures and in obstetrics prior to delivery. Use for other purposes must be under medical supervision.

4.2. Posology and method of administration

Children aged 10 years or younger with chronic constipation should only be treated under the guidance of a physician.

Bisacodyl should not be used in children below 2 years of age.

Short-term treatment for constipation

Adults and children over 10 years: One micro enema (10 mg) applied to the rectum for immediate effect.

Children 2-10 years: Half a micro enema (5 mg) applied to the rectum for immediate effect.

For preparation of diagnostic procedures and preoperatively

Should only be used under medical supervision

Adults and children over 10 years: The recommended dose is one micro enema (10 mg) rectally on the morning of the examination, (preceded the previous day by two 5 mg bisacodyl oral tablets in the morning and two 5 mg bisacodyl oral tablets again in the evening).

Children 4-10 years of age: The recommended dose is half a micro enema (5 mg) rectally on the morning of the examination, (preceded the previous evening by one 5 mg bisacodyl oral tablet).

Older people

Dose as in adults for both indications. In some cases no more than 5 mg should be administered.

The dosage refers to one administration per day. Long term use cannot be recommended.

Make sure the enema is at room temperature before instillation.

Micro enema should be administered in the morning.

When used in children, the product nozzle should be inserted half its length only

4.9. Overdose

Overdose of bisacodyl is possible if excessive quantities are taken or if the recommended doses are administered for prolonged periods.

Symptoms of overdose include abdominal pain and diarrhoea. Electrolyte imbalances such as hypokalaemia with muscular weakness and ECG alterations may develop.

Absorption can be minimised or prevented, if an overdose has been taken and/or the product ingested orally, by inducing vomiting within a short time of ingestion. Otherwise gastric lavage should be performed. Activated charcoal should be administered.

If high doses are taken watery stools (diarrhoea), a clinically significant loss of potassium and other electrolytes can occur and treatment consists of adequate replacement of fluids and correction of any electrolyte disturbances. This is especially important in the older people and the young.

Administration of antispasmodics may be of some value.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Keep the applicators in the outer carton.

6.5. Nature and contents of container

Disposable enema applicator tube with elongated tube nozzle containing 5 ml suspension packed as 5 or 50 single-use 5ml plastic enemas in a cardboard outer container.

6.6. Special precautions for disposal and other handling

For single use only.

Any unused medicinal product or waste material should immediately be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.