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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Boehringer Ingelheim Limited Consumer Healthcare
Διεύθυνση Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
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Περιεχόμενα

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 ...

Therapeutic indications

Short term relief of constipation. Constipation, either chronic or of recent onset, whenever a stimulant ...

Posology and method of administration

Children aged 10 years or younger with chronic or persistent constipation should only be treated under ...

Contraindications

DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions ...

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 ...

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 ...

Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence ...

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. ...

Undesirable effects

The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea. Adverse ...

Overdose

Symptoms If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant ...

Pharmacodynamic properties

Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. ...

Pharmacokinetic properties

Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle ...

Preclinical safety data

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

List of excipients

Tablet core: Lactose Maize starch Soluble maize starch Glycerol Magnesium stearate Tablet coating: Magnesium ...

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 ...

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 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.