Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Vancomycin capsules contain the active ingredient vancomycin. Vancomycin is an antibiotic that belongs to a group of antibiotics called "glycopeptides". Vancomycin works by eliminating certain bacteria that cause infections.
Vancomycin is used in adults and adolescents from 12 years of age for the treatment of infections of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium.
Do not take Vancomycin capsules: • If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions Talk to your doctor or pharmacist before taking Vancomycin capsules
• If you have a kidney disorder (you will need to have your blood and kidneys tested during treatment)
• If you have an inflammatory disorder of the digestive tract (you may be at risk of side effects, especially if you also have a kidney disorder)
• If you are elderly (you may need your blood and hearing monitored)
• If you have a hearing disorder (you may need hearing tests during treatment)
• If you are receiving Vancomycin capsules for a long time (you may develop another type of infection)
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking vancomycin. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.
• Signs of an allergic reaction to this medicine, including breathing problems and chest pain, have been reported with Vancomycin capsules. Stop immediately Vancomycin capsules and contact immediately your doctor or medical emergencies if you notice any of these signs.
Vancomycin capsules are not appropriate for children under 12 years or for adolescents unable to swallow them. Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Other medicines and Vancomycin capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important for the following, as they may interact with your Vancomycin capsules:
• any drug that harms your kidneys e.g. antibiotics such as gentamicin, tobramycin.
• any drug that harms your hearing e.g. antibiotics such as gentamicin, tobramycin.
It may still be alright for you to be given Vancomycin capsules and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines Vancomycin capsules should not affect your ability to drive or use machines.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents (from 12 years and older) The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to give a higher daily dose of up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If you suffered other episodes (infection of the mucosa) before you may need different dose and different duration of the therapy.
Method of administration For oral use.
Swallow the capsules whole with water.
The usual duration of the therapy is 10 days but it may be different depending on the individual response to treatment for every patient.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, redness on the upper part of the body, rash or itching.
Stop using vancomycin and seek medical attention immediately if you notice any of the following symptoms: • reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
Uptake of vancomycin from the gastrointestinal tract is negligible. Therefore, adverse events following intake of capsules are unlikely.
However, if you have an inflammatory disorder of the digestive tract, especially if you also have a kidney disorder, similar side effects as those that occur when vancomycin is given by infusion may appear. Therefore, the side effects and frequencies which are reported for vancomycin given as infusion are included.
Common side effects (may affect up to 1 in 10 people):
• Fall in blood pressure
• Breathlessness, noisy breathing (a high-pitched sound resulting from obstructed air flow in the upper airway)
• Increase of liver enzymes
• Rash and inflammation of the lining of the mouth, itching, itching rash, hives
• Kidney problems which may be detected primarily by blood tests
• Redness of upper body and face, inflammation of a vein
Uncommon side effects (may affect up to 1 in 100 people):
• Temporary or permanent loss of hearing
Rare side effects (may affect up to 1 in 1,000 people):
• Decrease in white blood cells, red blood cells and platelets (blood cells responsible for blood clotting)
• Increase in some of the white blood cells in the blood
• Loss of balance, ringing in your ears, dizziness
• Blood vessel inflammation
• Nausea (feeling sick)
• Inflammation of the kidneys and kidney failure
• Pain in the chest and back muscles
• Fever, chills
Very rare side effects (may affect up to 1 in 10,000 people):
• Sudden onset of severe allergic skin reaction with skin flaking, blistering or peeling skin. This may be associated with a high fever and joint pains
• Cardiac arrest
• Inflammation of the bowel which causes abdominal pain and diarrhoea, which may contain blood.
Not known (frequency cannot be estimated from the available data):
• Being sick (throwing up), diarrhoea
• Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal blood and liver function tests
• Rash with blisters and fever
• Excessive breakdown of red blood cells causing tiredness and pale skin (haemolytic anaemia)
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original blister in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Vancomycin capsules contain The active substance is vancomycin hydrochloride 125mg.
The other ingredients are:
Macrogol 6000, gelatin, indigo carmine, red iron oxide, yellow iron oxide and titanium dioxide.
The printing ink contains:
Shellac, propylene glycol, iron oxide red (E172) and potassium hydroxide.
What Vancomycin capsules look like and contents of the pack Vancomycin capsules are contained in blister packs of 20 capsules (2 strips of 10 capsules) or 28 capsules (4 strips of 7 capsules).
The capsules are dark blue and brown coloured and printed with the number 3125.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Flynn Pharma Ltd
5th Floor
40 Mespil Road
Dublin 4
D04 C2N4
IRELAND
Manufacturer MW Encap Limited
Units 1-8
Oakbank Park Way
Oakbank Industrial Estate
Mid Calder
Livingston
EH53 0TH
United Kingdom
NextPharma Ploermel
Zone Industrielle De Camagnon
56800 Ploermel
France
This leaflet was last revised in
January 2026
Other sources of information
Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your current illness,
Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:
• Dosage
• Schedules
• Duration of treatment
Consequently, to preserve the efficacy of this drug:
1. Use antibiotics only when prescribed
2. Strictly follow the prescription
3. Do not re-use any antibiotic without medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
5. After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly.
Flynn Pharma Ltd
Address
Hertlands House, Primett Road, Stevenage, Hertfordshire, SG1 3EE, UK
Telephone
+44 (0)1438 727822
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[email protected]
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Vancomycin 125 mg Hard Capsules comes as capsule containing 125mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Vancomycin 125 mg Hard Capsules is vancomycin hydrochloride.
Medicines with the same active substance, strength and form include: Vancomycin 125 mg hard capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Vancomycin 125 mg Hard Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Vancomycin capsules are indicated in patients 12 years and older for the treatment of Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology: Adults and adolescents aged 12 to less than 18 years old The recommended vancomycin dose is 125 mg every 6 hours for 10 days for the first episode of non- severe CDI. This dose can be increased to 500 mg every 6 hours for 10 days in case of severe or complicated disease. The maximum daily dose should not exceed 2 g. In patients with multiple recurrences, consideration may be given to treat the current episode of CDI with vancomycin, 125 mg four times daily for 10 days followed by either tapering the dose, i.e., gradually decreasing it until 125 mg per day or a pulse regimen, i.e., 125–500 mg/day every 2–3 days for at least 3 weeks. Treatment duration with vancomycin may need to be tailored to the clinical course of individual patients. Whenever possible the antibacterial suspected to have caused CDI should be discontinued. Adequate replacement of fluid and electrolytes should be instituted. Monitoring vancomycin serum concentrations after oral administration in patients with inflammatory intestinal disorders should be performed (see section 4.4). Special populations Renal impairment Due to the very low systemic absorption, dose adjustment is unlikely, unless substantial oral absorption may occur in case of inflammatory intestinal disorders or Clostridium difficile -induced pseudomembranous colitis (see section 4.4). Paediatric population Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them. Below 12 years, age-appropriate formulation should be used. Method of administration For oral use. The capsule should not be open and should be taken with plenty of water. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Oral use only This preparation is for oral use only and is not systemically absorbed. Orally administered Vancomycin capsules are not effective for other types of infections. Potential for systemic absorption Absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or Clostridium difficile -induced pseudomembranous colitis. These patients may be at risk for the development of adverse reactions, especially if there is a concomitant renal impairment. The greater the renal impairment, the greater the risk of developing the adverse reactions associated with the parenteral administration of vancomycin. Monitoring of serum vancomycin concentrations of patients with inflammatory disorders of the intestinal mucosa should be performed. Nephrotoxicity Serial monitoring of renal function should be performed when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside or other nephrotoxic drugs. Ototoxicity Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity in patients with an underlying hearing loss, or who are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside. Cardiovascular and cerebrovascular effects Cases of Kounis syndrome have been reported in patients treated with vancomycin. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction. Drug interactions with anti-motility agents and proton pump inhibitors Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered. Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with vancomycin treatment (see section 4.8). Most of these reactions occurred within a few days and up to eight weeks after commencing treatment with vancomycin. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, vancomycin should be withdrawn immediately and an alternative treatment considered. If the patient has developed a SCAR with the use of vancomycin, treatment with vancomycin must not be restarted at any time. Development of Drug-Resistant Bacteria Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Concurrent and/or sequential systemic or topical use of other potentially ototoxic and/or nephrotoxic drugs requires careful monitoring. Consideration should be given to discontinuing proton pump inhibitors and anti-motility agents in line with local guidelines for treatment of Clostridium difficile infection. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy
Teratology studies have been performed at 5 times the human dose in rats and 3 times the human dose in rabbits, and have revealed no evidence of harm to the foetus due to vancomycin. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin hydrochloride was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant, whose mother received vancomycin in the third trimester, experienced conductive hearing loss that was not attributable to vancomycin. Because vancomycin was administered only in the second and third trimesters, it is not known whether it causes foetal harm. Therefore vancomycin should be given to a pregnant woman only if clearly needed.
Breast-feeding
Vancomycin hydrochloride is excreted in human milk. Caution should be exercised when vancomycin is administered to a nursing woman.
Not relevant.
Summary of the safety profile The absorption of vancomycin from the gastrointestinal tract is negligible. However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, side effects that occur when vancomycin is administered parenterally may appear. Therefore, the below mentioned adverse reactions and frequencies related to parenteral vancomycin administration are included. When vancomycin is administered parenterally, the most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment (see section 4.4). Tabulated List of Adverse reactions Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The adverse reactions listed below are defined using the following MedDRA convention and system organ class database: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). System organ class Frequency Adverse reaction Blood and the lymphatic system disorders: Rare Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia. Not known Haemolytic anaemia Immune system disorders: Rare Hypersensitivity reactions, anaphylactic reactions Ear and labyrinth disorders: Uncommon Transient or permanent loss of hearing Rare Vertigo, tinnitus, dizziness Cardiac disorders Very rare Cardiac arrest Not known Kounis syndrome Vascular disorders: Common Decrease in blood pressure Rare Vasculitis Respiratory, thoracic and mediastinal disorders: Common Dyspnoea, stridor Gastrointestinal disorders: Rare Nausea Very rare Pseudomembranous enterocolitis Not known Vomiting, diarrhoea Hepatobiliary disorders: Common Alanine aminotransferase increased, aspartate aminotransferase increased Skin and subcutaneous tissue disorders: Common Flushing of the upper body (“red man syndrome”), exanthema and mucosal inflammation, pruritus, urticaria Very rare Exfoliative dermatitis, Stevens-Johnson syndrome, Toxic epidermal necrolysis (TEN), Linear IgA bullous dermatosis Not known Eosinophilia and systemic symptoms (DRESS syndrome), AGEP (Acute Generalized Exanthematous Pustulosis) Renal and urinary disorders: Common Renal insufficiency manifested primarily by increased serum creatinine and serum urea Rare Interstitial nephritis, acute renal failure Not known Acute tubular necrosis General disorders and administration site conditions: Common Phlebitis, redness of the upper body and face Rare Drug fever, shivering, pain and muscle spasm of the chest and back muscles Description of selected adverse drug reactions Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g. Intravenous vancomycin should be infused slowly. During or shortly after rapid infusion anaphylactic/anaphylactoid reactions including wheezing may occur. The reactions abate when administration is stopped, generally between 20 minutes and 2 hours. Necrosis may occur after intramuscular injection. Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment. Ototoxicity has primarily been reported in patients given high doses, or in those on concomitant treatment with other ototoxic medicinal product like aminoglycoside, or in those who had a pre-existing reduction in kidney function or hearing. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Supportive care is advised, with maintenance of glomerular filtration.
Vancomycin is poorly removed by dialysis. Haemofiltration and haemoperfusion with Amberlite resin XAD-4 have been reported to be of limited benefit.
Ask anything about Vancomycin 125 mg Hard Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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