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SPC, UK: DULCOLAX 5 mg Gastro-resistant Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Boehringer Ingelheim Limited Consumer Healthcare
Διεύθυνση :
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
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Δωρεάν εγγραφή

Name of the medicinal product

DULCOLAX 5 mg Gastro-resistant Tablets.

Qualitative and quantitative composition

Each tablet contains Bisacodyl 5mg. For excipients, see 6.1

Pharmaceutical form

Gastro-resistant tablets for oral administration. Circular, biconvex, yellow, sugar-coated and enteric-coated tablet.

Therapeutic indications

Short term relief of constipation. Constipation, either chronic or of recent onset, whenever a stimulant laxative is required. Bowel clearance before surgery or radiological investigation. Replacement ...

Posology and method of administration

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. Short-term ...

Contraindications

DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with ...

Special warnings and precautions for use

As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation. Prolonged excessive use may lead to fluid and electrolyte ...

Interaction with other medicinal products and other forms of interaction

The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation. The concomitant use of diuretics or adreno-corticosteroids ...

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy. Clinical data show that neither the active ...

Effects on ability to drive and use machines

No studies on the effects of DULCOLAX on the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may ...

Undesirable effects

The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea. Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ ...

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 ...

Pharmacodynamic properties

Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl ...

Pharmacokinetic properties

Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa. Administration ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Tablet core: Lactose Maize starch Soluble maize starch Glycerol Magnesium stearate Tablet coating: Magnesium stearate Sucrose Talc Acacia Titanium dioxide (E171) Methacrylic acid-methylmethacrylate copolymer ...

Incompatibilities

None stated.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C. Keep container in the outer carton.

Nature and contents of container

Blister packs consisting of opaque white PVC/PVDC blister foil and aluminium foil (covering foil). Pack sizes 20, 40, 60, 80, 100, and 200. Blister packs consisting of colourless PVC blister foil and aluminium ...

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Boehringer Ingelheim Limited Ellesfield Avenue Bracknell Berkshire RG12 8YS United Kingdom Trading as Boehringer Ingelheim Consumer Healthcare.

Marketing authorization number(s)

PL 00015/0241

Date of first authorization / renewal of the authorization

1st April 1999

Date of revision of the text

September 2012