DIVIDOL Coated tablet Ref.[28246] Active ingredients: Butylscopolamine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Dividol 10 mg coated tablets are indicated for the relief of spasm of the gastro-intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome (IBS).

4.2. Posology and method of administration

Posology

Relief of spasm of gastrointestinal tract

Adults and children over 12 years: Two tablets (20 mg) four times daily.

For the symptomatic relief of Irritable Bowel Syndrome

Adults and children over 12 years: The recommended starting dose is 1 tablet up to three times daily; this can be increased up to 2 tablets four times daily if necessary.

If symptoms do not improve or if they worsen after 2 weeks of treatment, a doctor should be consulted.

Dividol 10 mg coated tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

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.

Paediatric population

Dividol 10 mg coated tablets are not recommended for use in children under 12 years of age.

Method of administration

Oral administration.

Dividol 10 mg coated tablets should be swallowed whole with adequate water.

4.9. Overdose

Symptoms

Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.

Therapy

In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulphate (15%). Symptoms of Dividol overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally.

Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration should be considered. Catheterisation may be required for urinary retention.

In addition, appropriate supportive measures should be used as required.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protected from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 20 and 100 coated tablets.

PP containers with PE closure. Pack size of 1000 coated tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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