Medicinal Products

DULCOLAX 10 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Bisacodyl
laboratory: Boehringer Ingelheim

Suppository
Box of 6
All forms

Indication

- Symptomatic treatment of constipation by rectal dyschesia.
- Preparation for endoscopic examinations of the rectum.

Dosage DULCOLAX 10 mg suppository Box of 6

Reserved for adults: 1 suppository per day, half an hour before the time chosen for intestinal evacuation.

Suppositories usually work between 10 and 30 minutes.

They must be taken out of their packaging and placed in the rectum the flat bottom first (to avoid its rejection) tip tapered down.

Because of the risk of rectal irritation, administration of suppository should be as short as possible.

Against indications

· Known hypersensitivity to bisacodyl or any of the excipients.

· Severe dehydration state with electrolytic depletion.

· Inflammatory diseases of the colon, ulcerative colitis, Crohn's disease,

· Abdominal pain syndromes of undetermined cause, including severe abdominal pain associated with nausea and vomiting that may indicate a serious condition.

· Occlusive or subocclusive syndromes.

· Children

Dulcolax side effects

As with all laxative suppositories, prolonged use may give rise to sensations of anal burning and exceptionally congestive proctitis.

Adverse reactions are classified by organ-system and frequency according to the following convention:

Very common (³ 1/10)

Frequent (³ 1/100 to <1/10)

Uncommon (1/1000 to <1/100)

Rare (1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data).

The most commonly reported side effects during treatment are abdominal pain and diarrhea.

Immune system disorders

- Rare: Anaphylactic reactions, Quincke's edema.

Affection of skin and subcutaneous tissue

- Rare: Pruritus generalized.

Metabolism and nutrition disorders

- Rare: Dehydration.

- Not known: Hypokalemia.

Nervous system disorders

- Uncommon: Dizziness.

- Rare: Syncope.

Cases of dizziness or syncope after taking Bisacodyl appear to be a vasovagal response (eg, abdominal spasm, defecation).

Gastrointestinal disorders

- Common: abdominal pain, diarrhea

- Uncommon: rectorrhagia, anorectal discomfort (burning sensation and anorectal pain).

- Rare: Colitis.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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