LAX-TAB Gastro-resistant tablet Ref.[50289] Active ingredients: Bisacodyl

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

For evacuation of the colon in constipation and in preparation for radiological investigation.

4.2. Posology and method of administration

Short-term treatment for constipation

Adults and children over 10 years: 1 to 2 coated tablets (5–10 mg) daily before bedtime.

Children 4–10 years: 1 coated tablet (5 mg) daily before bedtime.

It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum daily dose should not be exceeded.

In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.

Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children aged 4 years or younger.

For preparation of diagnostic procedures and preoperatively

For preparation of diagnostic procedures, in pre- and postoperative treatment when defaecation needs to be facilitated, Lax-Tab should be used under medical supervision.

Adults and children over 10 years: 2 coated tablets (10 mg) in the morning and 2 coated tablets (10 mg) in the evening.

Children aged 4-10 years of age: 1 coated tablet (5 mg) in the evening.

Instructions for use

It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should be swallowed whole with an adequate amount of fluid.

The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.9. Overdose

Symptoms

If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.

Laxatives when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi.

Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy

After ingestion of oral forms of Lax-Tab, absorption can be minimised or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.

Administration of antispasmodics may be of value.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C.

Protect from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack-sizes of 30, 50, 100 and 1000 gastro-resistant tablets.

PP containers with PE closure. Pack-sizes of 50 and 1000 gastro-resistant tablets.

Not all pack-sizes may be marketed.

6.6. Special precautions for disposal and other handling

None stated.

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