Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Short term relief of constipation.
Adults and children over 10 years: 1 to 2 coated tablets (5-10 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.
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.
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.
After ingestion of oral forms of DULCOLAX, 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.
3 years.
Do not store above 25°C.
Keep container in the outer carton.
Blister packs consisting of opaque white PVC/PVDC blister foil and aluminium foil (covering foil).
Blister packs consisting of colourless PVC blister foil and aluminium foil (covering foil).
Packs of 6, 8, 10, 20, 30, 40 and 60.
Not all pack sizes may be marketed.
None stated.
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