Leaflet IBUTIN 300mg prolonged-release film-coated tablets

Indicated for: gastrointestinal spasms; functional abdominal pain

Route of administration: oral

Substance: trimebutin (analgesic and antipyretic)

ATC: A03AA05 (Alimentary tract and metabolism | Drugs for functional gastrointestinal disorders | Synthetic anticholinergics, esters with tertiary amino group)

Trimebutine is a medication used to treat functional disorders of the gastrointestinal tract, such as irritable bowel syndrome (IBS), functional dyspepsia, or other conditions associated with spasms and abdominal discomfort. It is a regulator of intestinal motility, capable of normalizing the activity of smooth muscles in the digestive tract.

Trimebutine works by modulating opioid receptors in the intestinal wall, providing a dual effect: it stimulates intestinal motility when it is reduced and inhibits it when it is excessive. This helps alleviate symptoms such as abdominal pain, bloating, constipation, or diarrhea.

The medication is available in the form of tablets, capsules, or oral suspensions and is usually taken 2-3 times a day before meals. The exact dosage and duration of treatment are determined by the doctor, depending on the severity of symptoms and the patient’s response to therapy.

Trimebutine is generally well-tolerated, but mild side effects such as nausea, dry mouth, dizziness, or allergic reactions may occur. In rare cases, more severe adverse effects may develop, requiring discontinuation of the treatment and medical consultation.

This medication is not recommended for young children, pregnant women, or breastfeeding mothers unless strictly necessary and under medical supervision. It is important for patients to follow their doctor’s instructions and avoid long-term use without medical advice.

General data about IBUTIN 300mg

  • Substance: trimebutin
  • Date of latest medicines list: 01-07-2013
  • Product code: W42800001
  • Concentration: 300mg
  • Pharmaceutical form: prolonged-release film-coated tablets
  • Quantity: 10
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: GALENICA PHARMACEUTICAL INDUSTRY S.A. - GRECIA
  • Holder: ZENTIVA S.A. - ROMANIA
  • Number: 12413/2019/01
  • Shelf life: 2 years

Concentrations available for trimebutin

  • 100mg
  • 200mg
  • 24mg/5ml
  • 300mg

Combinations with other substances