Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Vancomycin 125 mg hard capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Vancomycin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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.
What you need to know before you take it
e Vancomycin capsules
Do not take Vancomycin capsules:
- if you are allergic to vancomycin hydrochloride 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: x if you have kidney problems, especially if you are currently taking other medicines that can affect the kidneys (see "Other medicines and Vancomycin capsules", below) because vancomycin can cause kidney damage; x 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); x if you suffer from deafness or ear problems; x 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. x 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. Children and adolescents 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. In particular, tell your doctor if you are taking any of the following: x other antibiotics such as streptomycin, neomycin, gentamycin, cephaloridine, polymixin B, colistin, tobramycine or amykacine. These medicines may affect your kidneys and/or hearing if you take them at the same time with vancomycin.
Vancomycin capsules with food, drink and alcohol
There is no data on the interaction of vancomycin with food, drink or alcohol.
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. Talk to your doctor before starting treatment with this medicine if you are breast-feeding. This is because Vancomycin passes into breast milk.
Driving and using machines
This medicine is not known to affect your ability to drive and use machines.
How to take it
Vancomycin capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual recommended dose is: 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. If you take more Vancomycin capsules than you should If you take more capsules than prescribed, seek medical attention immediately. If you forget to take Vancomycin capsules Do not take a double dose to make up for a forgotten dose. Simply continue taking the capsules as before. If you stop taking Vancomycin capsules You must continue the course of treatment with vancomycin as prescribed by your doctor or pharmacist. If you stop taking vancomycin without finishing the course of treatment, there may be a risk that you will feel worse again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
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. 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.
Dimension – 180 x 300 mm
Front Side MFG. LOCATION: KRSG
NON PRINTING COLOUR
Vancomycin hard capsules 125 & 250 mg Strides Pharma UK Ltd.
Pack Insert
180 x 300 mm 1053371
-1048787
BLACK
1
PC-ODF/2025/958 – Record Number: 480865
7.0
Front & Back Printing. To be supplied in the unfolded size 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
Stop using vancomycin and seek medical attention immediately if you notice any of the following symptoms: x 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). x Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). x A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). x Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome. 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)
- 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
- Increase of liver enzymes 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
How to store it
Vancomycin capsules
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the package, after "EXP". The expiry date refers to the last day of that month. Do not store above 25oC. Do not throw away any medicines via wastewater or
Dimension – 180 x 300 mm
Back Side
MFG. LOCATION: KRSG
NON PRINTING COLOUR
Vancomycin hard capsules 125 & 250 mg Strides Pharma UK Ltd.
Pack Insert
180 x 300 mm 1053371
-1048787
BLACK
1
PC-ODF/2025/958 – Record Number: 480865
7.0
Front & Back Printing. To be supplied in the unfolded size 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
Contents of the pack and other information
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:
- Use antibiotics only when prescribed.
- Strictly follow the prescription.
- Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
- Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
- After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly. What Vancomycin capsules contains
- The active ingredient is vancomycin hydrochloride. Each hard capsule contains 125mg vancomycin hydrochloride (equivalent to 125,000 IU vancomycin) or 250 mg vancomycin hydrochloride (equivalent to 250,000 IU vancomycin).
- The other ingredient is polyethylene glycol (Macrogol) 6000.
- The capsule coating is made of gelatin and colorants.
- The capsules contain the following colorants: x Iron oxide Yellow (E172) x Iron oxide Red (E172) x Titanium dioxide (E171) x Iron Oxide Black (E172)
What Vancomycin capsules look like and contents of the pack The 125 mg capsules are grey/pink hard gelatin capsules containing white to off white liquid mixture as solid mass. The 250 mg capsules are brown hard gelatin capsules containing white to off white liquid mixture as solid mass. Original packs containing 4, 12, 20, 28 or 30 hard capsules. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre, Dwight Road, Watford, WD18 9SS United Kingdom
This leaflet was last revised in 12/2025.
1053371
Frequently asked questions about Vancomycin 125 mg hard capsules
How do I take Vancomycin 125 mg hard capsules?
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.
What is the active substance in Vancomycin 125 mg hard capsules?
The active substance in Vancomycin 125 mg hard capsules is vancomycin hydrochloride.
Are there equivalent medicines to Vancomycin 125 mg hard capsules?
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.
Where does this information come from?
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.
Can I get Vancomycin 125 mg hard capsules without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: vancomycin hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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.
4.2. Posology and method of administration
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.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
4.4. Special warnings and precautions for use
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.
Drug interactions with anti-motility agents and proton pump inhibitors
Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
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.
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.
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.
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent and/or sequential systemic or topical use of other potentially ototoxic and/or nephrotoxic drugs requires careful monitoring.
4.6. Fertility, pregnancy and lactation
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. Vancomycin was administered only in the second and third trimesters; hence it is not known whether it causes foetal harm.
Consequently, vancomycin should only be given in pregnancy if clearly needed and after a careful benefit-risk assessment.
Breast-feeding
Vancomycin is secreted in breast milk and should therefore only be used during breast-feeding if other antibiotics have failed. In breast-fed infants, disorders of the intestinal flora with diarrhoea, fungus infection and possibly sensitisation may occur. It is recommended to stop breast-feeding during vancomycin treatment. Risks of systemic effects in premature and young neonates exposed to vancomycin in breast milk cannot be excluded due to relatively high intestinal permeability and immature elimination functions of these infants.
Fertility
Animal studies regarding effects on fertility are not available.
4.7. Effects on ability to drive and use machines
Vancomycin has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the Safety profile
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).
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.
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 lymphatic system disorders:
Rare
Reversible neutropenia1, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.
Not known
Haemolytic anaemia
Immune system disorders:
Rare
Hypersensitivity reactions, anaphylactic reactions2
Ear and labyrinth disorders:
Uncommon
Transient or permanent loss of hearing4
Rare
Vertigo, dizziness, tinnitus3
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
1 Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.
2 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.
3 Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment.
4 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 national reporting system, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Treatment of overdose
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 about this leaflet
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.
Medicines containing Vancomycin hydrochloride
- Vancomycin 1000 mg powder for concentrate for solution for infusion
- Vancomycin 1000mg powder for concentrate for solution for infusion vials
- Vancomycin 250 mg hard capsules
- Vancomycin 500 mg powder for concentrate for solution for infusion
- Vancomycin 500mg powder for concentrate for solution for infusion vials