Laxbene® ratiopharm Filmtabletten

Composition
1 film-coated tablet contains 5 mg Bisacodyl, 10 mg Dimethylpolysiloxane.
Other ingredient: 1 film-coated tablet contains 157.5 mg Lactose monohydrate.

Indications

• For short-term use in constipation;
• for preparation for surgery and diagnostic procedures;
• for conditions requiring easier bowel movements.

Dosage, method and duration of use
In children up to 10 years of age with chronic constipation, Laxbene ratiopharm may only be used under medical supervision. Laxbene ratiopharm should not be used in children under 2 years of age.
Short-term use in constipation
Adults, adolescents and children over 10 years: 1-2 film-coated tablets (5-10 mg)
Children from 2 to 10 years: 1 film-coated tablet (5 mg) Laxbene ratiopharm is taken once a day before bedtime as needed. When taken in the evening, 1-2 soft bowel movements occur after about 6-12 hours.
For preparation for surgery and diagnostic procedures
Complete bowel emptying must always be carried out under medical supervision. The attending physician will determine the necessary laxatives on a case-by-case basis, taking into account the specific circumstances. To ensure complete bowel emptying, the following dosage is recommended: Adults, adolescents and children over 10 years: On the day before the examination, 2 Laxbene ratiopharm film-coated tablets (10 mg) each in the morning and evening, and 1 Laxbene ratiopharm suppository (10 mg) on the morning of the examination.
Use in conditions requiring easier bowel movements
For conditions requiring easier bowel movements, the dosage is initially the same as for short-term use in the treatment of constipation (1-2 Laxbene ratiopharm film-coated tablets). The dosage should be continuously adjusted to the specific requirements of the underlying disease.

Side effects
The frequency of side effects was determined from pooled data from a total of 16 clinical studies in which 3,056 patients were treated with bisacodyl. The most common side effects during treatment were abdominal discomfort and diarrhea. The following classification was used for describing the frequency of side effects:
Very common: >1/10, Common: >1/100 and <1/10, Uncommon: >1/1,000 and <1/100, Rare: >1/10,000 and <1/1,000, Very rare: <1/10,000, Not known: Frequency cannot be estimated from the available data.
Immune system disorders
Rare: Hypersensitivity reactions, anaphylactic reactions*, angioedema* Metabolic and nutritional disorders, dehydration*
Nervous system disorders
Uncommon: Dizziness; Rare: Syncope. The occurrence of dizziness and syncope after taking bisacodyl appears to be consistent with a vasovagal reaction (e.g. to abdominal cramps and
defecation).
Gastrointestinal disorders
Common: abdominal cramps and pain, diarrhea, nausea; Uncommon: abdominal discomfort, vomiting, hematochezia (blood in stool), anorectal discomfort; Rare: Colitis* Diarrhea-like, watery stools can lead to fluid, electrolyte and especially potassium loss, and subsequently cause fatigue and muscle weakness.

* These side effects were not observed in clinical studies with bisacodyl, but are spontaneously reported events after global market introduction. The frequency estimation is made according to the EU SmPC Guideline.