Vancomycin Enterocaps 250 mg capsules – not marketed in Serbia: medicine information and alternatives

Vancomycin Enterocaps 250 mg is a glycopeptide antibiotic in the form of hard capsules for oral use. The active substance is vancomycin (as vancomycin hydrochloride). When taken by mouth, vancomycin is practically not absorbed from the gut into the bloodstream, so it acts locally – in the bowel, where it kills susceptible bacteria.

For this reason oral vancomycin is not effective for infections outside the gut. According to the official documents that were valid in Serbia (ALIMS, 2016) and the recommendation of the European Medicines Agency (EMA, 2017), oral vancomycin is used to treat infection with the gut bacterium Clostridioides (formerly Clostridium) difficile, which causes severe diarrhoea and inflammation of the large bowel, often after treatment with other antibiotics. All information on this page comes from the official documents listed in the sources.

What is Vancomycin Enterocaps, what is it used for and what is available in Serbia?

Key facts about the medicine

What is oral vancomycin used for?

• Clostridioides difficile infection – diarrhoea and enterocolitis (including pseudomembranous colitis) caused by the toxins of this bacterium.
• The earlier Summary of Product Characteristics (ALIMS, 2016) also listed staphylococcal enterocolitis. In 2017 the European Medicines Agency concluded that oral vancomycin should no longer be used for staphylococcal enterocolitis and gut decontamination, but only for C. difficile infection.
• Oral vancomycin is not effective for other infections, because it does not pass from the gut into the blood to any significant extent.

How is it used?

The capsules were swallowed whole with a little water, with or without food. According to the EMA recommendation, the capsules are used in patients aged 12 years and over, while age-appropriate forms are used for younger children; the maximum daily dose is 2 g. Treatment usually lasts 10 days, and in recurrent episodes the doctor may prescribe longer treatment according to a special schedule.

This information describes the official documents and is not an individual recommendation – the dose and duration of treatment are decided by the doctor according to the official instructions.

Important safety information from the official documents

• Contraindication: hypersensitivity to vancomycin or to any of the excipients.
• In inflammation of the intestinal lining, especially with impaired kidney function, vancomycin may reach the blood in significant amounts after repeated doses – blood levels of the medicine, kidney function and, if needed, hearing are then monitored.
• Closer monitoring is needed when medicines that can damage the kidneys or hearing are used at the same time.
• Longer use can lead to the growth of resistant microorganisms (for example vancomycin-resistant enterococci) and superinfection; the doctor watches for signs of a new infection.
• Pregnancy: the capsules are given to pregnant women only if clearly necessary; vancomycin passes into breast milk, so the doctor assesses whether breastfeeding should continue.
• The medicine has no or negligible influence on the ability to drive.
• Side effects after oral use are rare (for example nausea); when the medicine reaches the blood, side effects similar to those after infusion are possible – kidney damage, hearing loss and ringing in the ears, blood count changes and hypersensitivity reactions, including rash and, rarely, flushing of the upper body.

What is available in Serbia?

No vancomycin capsules are currently authorised in Serbia. Medicines containing vancomycin are authorised as powder for solution for infusion, used in healthcare institutions:

The choice of medicine and how it is given are always decided by the doctor. C. difficile infection requires a medical diagnosis (stool test) and monitoring, and whenever possible the antibiotic that probably caused the infection is stopped.

Composition, pack and manufacturer

• Active substance: 250 mg vancomycin hydrochloride in one hard capsule (at least 262,500 IU of vancomycin).
• Appearance: opaque gelatin capsule with a dark blue cap and a grey body, marked "250"; the contents are an almost white to pinkish-brown solid mass.
• Pack: blister with 10 hard capsules in a folding carton.
• Authorisation holder in Serbia (until 2021): Beohem-3 d.o.o., Belgrade; first authorised on 26 May 2011.

Storage

• Store below 30 °C in the original package to protect from moisture.
• Shelf life: 2 years (ALIMS, 2016).
• Keep out of the sight and reach of children.

Frequently asked questions

Can Vancomycin Enterocaps be bought in Serbia?

No. The authorisation for Vancomycin Enterocaps expired in 2021 and there is no renewal in the published ALIMS lists, so the medicine is not marketed in Serbia.

Why does vancomycin in capsules act only in the gut?

When taken orally, vancomycin is hardly absorbed and stays in the gut, where it reaches high concentrations. This is why it is effective for C. difficile gut infection, but not for infections of other organs.

How is C. difficile infection treated in Serbia?

Treatment is decided by the doctor, most often in hospital. According to the current Summary of Product Characteristics, the authorised Vankomicin MIP powder for solution for infusion may, after preparation, also be given orally for this indication. The choice of medicine depends on the severity of the disease and previous episodes.

Is oral vancomycin used for staphylococcal enterocolitis?

Not any more. In 2017 the European Medicines Agency recommended that oral vancomycin be used only for C. difficile infection, and not for staphylococcal enterocolitis or gut decontamination.

Sources

• ALIMS – Summary of Product Characteristics Vancomycin Enterocaps 250 mg (authorisation 515-01-00678-16-001, November 2016, Serbian)
• ALIMS – Package leaflet Vancomycin Enterocaps 250 mg (November 2016, Serbian)
• EMA – Recommendations for vancomycin-containing medicines (2017)
• ALIMS – Summary of Product Characteristics Vankomicin MIP® 500 mg and 1000 mg (May 2026, Serbian)
• ALIMS – New authorisations and renewals 1 April–31 May 2026 (Vankomicin MIP®, Serbian)
• ALIMS – National Register of Medicines 2021 (Serbian)

Sources checked on: 23 October 2026.