DULCOLAX Gastro-resistant tablets (2017)
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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 tablet.
Therapeutic indications
Short term relief of constipation.
Posology and method of administration
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 ...
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 (≥1/10); ...
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
ATC code: A06AB02 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 ...
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
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). Blister packs consisting of colourless PVC blister foil and aluminium foil (covering foil). Packs of 6, ...
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Marketing authorization number(s)
PL 04425/0718
Date of first authorization / renewal of the authorization
01 June 1992 / 25 February 2005
Date of revision of the text
December 2017
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