Leaflet PROCTOLOG 120mg / 10mg suppositories

Indicated for: hemorrhoids; anorectal spasm and pain

Route of administration: rectal

Substance: trimebutine + ruscogenin (antispasmodic and topical venotonic)

ATC: C05AX03 (Cardiovascular system | Agents for treatment of hemorrhoids and anal fissures for topical use | Other agents for treatment of hemorrhoids and anal fissures for topical use)

Precautions:
Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Trimebutine + ruscogenins is a local combination used for symptoms of haemorrhoids and anal irritation, in forms such as cream or suppositories. Ruscogenins have anti-inflammatory and anti-swelling effects, while trimebutine may help reduce local pain and spasm. The aim of treatment is symptom relief rather than permanent correction of the underlying cause.

It is used according to the leaflet, usually after gentle local hygiene and, for suppositories, preferably after a bowel movement. It should not be applied to infected areas, significant wounds or heavy bleeding without medical assessment. Basic measures remain important: preventing constipation, using fibre and fluids, moving regularly and avoiding long straining on the toilet.

Side effects may include burning sensation, itching, irritation, local dryness, rash or allergic reactions. If symptoms worsen after application, treatment should be stopped. Repeated use without diagnosis can delay recognition of other problems, such as anal fissures, abscesses, inflammatory bowel disease or more serious rectal conditions.

Consult a doctor if rectal bleeding, severe pain, fever, pus-like discharge, a painful lump, anaemia, weight loss or persistent bowel habit changes occur. During pregnancy, breastfeeding and childhood, use only with medical advice. Treatment is intended for limited episodes and should be reassessed if there is no improvement.

General data about PROCTOLOG 120mg / 10mg

  • Substance: trimebutine + ruscogenin
  • Date of latest medicines list: 01-12-2018
  • Product code: W65042001
  • Concentration: 120mg / 10mg
  • Pharmaceutical form: suppositories
  • Quantity: 10
  • Product type: Original
  • Prescription status: OTC - Over the Counter = medicine that does not require a medical prescription.

Marketing authorisation

  • Manufacturer: FARMEA - FRANTA
  • Holder: PFIZER EUROPE MA EEIG - BELGIA
  • Number: 1946/2009/01
  • Shelf life: 3 years