Vancomycin 1000 mg powder for concentrate for solution for infusion

Patient Leaflet Updated 23-Mar-2026 | hameln pharma ltd

Vancomycin 500 mg & 1000 mg powder for concentrate for solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin 500 mg powder for concentrate for solution for infusion

Vancomycin 1000 mg powder for concentrate for solution for infusion

Vancomycin hydrochloride

The name of your medicine is Vancomycin 500 mg & 1000 mg powder for concentrate for solution for infusion, which will be referred to as Vancomycin throughout the rest of this document.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Vancomycin is and what it is used for
2. What you need to know before you are given Vancomycin
3. How you are given Vancomycin
4. Possible side effects
5. How to store Vancomycin
6. Contents of the pack and other information

1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR

Vancomycin contains 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 powder is made into a solution for infusion or oral solution.

Vancomycin is used in all age groups by infusion for the treatment of the following serious infections:

  • Infections of the skin and tissues below the skin,
  • Infections of bone and joints,
  • An infection of the lungs called “pneumonia”,
  • Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures.

Vancomycin can be given orally in adults and children for the treatment of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridioides difficile bacterium.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VANCOMYCIN

Do not use Vancomycin:

  • If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Serious side effects that may lead to loss of vision have been reported following the injection of vancomycin in the eyes.

Signs of an allergic reaction to this medicine, including breathing problems and chest pain, have been reported with Vancomycin. Stop immediately Vancomycin and contact immediately your doctor or medical emergencies if you notice any of these signs.

Talk to your doctor, hospital pharmacist or nurse before using Vancomycin 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.
  • you suffered a previous allergic reaction to teicoplanin, because this could mean you are also allergic to vancomycin,
  • you have a hearing disorder, especially if you are elderly (you may need hearing tests during treatment),
  • you have a kidney disorder (you will need to have your blood and kidneys tested during treatment),
  • you are receiving vancomycin by infusion for the treatment of the diarrhoea associated with Clostridioides difficile infection instead of orally.

Talk to your doctor or hospital pharmacist or nurse during treatment with Vancomycin if:

  • you are receiving vancomycin for a long time (you may need to have your blood, liver and kidneys tested during treatment),
  • you develop any skin reaction during the treatment,
  • you develop severe or prolonged diarrhoea during or after using vancomycin, consult your doctor immediately. This may be a sign of bowel inflammation (pseudomembranous colitis), which can occur following treatment with antibiotics.

Children

Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulate vancomycin in the blood. This age group may need blood tests for controlling vancomycin levels in blood.

Concomitant administration of vancomycin and anaesthetic agents has been associated with skin redness (erythema) and allergic reactions in children. Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory agents (NSAIDs, e.g. ibuprofen) or amphotericin B (medicine for fungal infection) can increase the risk of kidney damage, and therefore more frequent blood and renal tests may be necessary.

Other medicines and Vancomycin

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 of the following, as they may interact with vancomycin:

  • anaesthesics - these may cause redness, flushing, fainting, collapse or even heart attacks. You should therefore tell your doctor that you are taking Vancomycin if you are going to have an operation.
  • any drug that affects your nerves or kidneys such as amphotericin B (treats fungal infections), aminoglycosides, bacitracin, polymixin B, colistin, viomycin (antibiotics) or cisplatin (a chemotherapy drug), piperacillin/ tazobactam.
  • Potent diuretics (strong medicines which are given to encourage the production of urine) such as furosemide

It may still be all right for you to be given Vancomycin, 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 should not affect your ability to drive or use machines.

3. HOW YOU ARE GIVEN VANCOMYCIN

You will be given Vancomycin by medical staff while you are in hospital. Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.

Dosage

The dose given to you will depend on:

  • your age,
  • your weight,
  • the infection you have,
  • how well your kidneys are working,
  • your hearing ability,
  • any other medicines you may be taking.

Intravenous administration

Adults and adolescents (from 12 years and older)

The dosage will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg for each kg of body weight. It is usually given every 8 to 12 hours. In some cases, your doctor may decide to give an initial dose of up to 30 mg for each kg of body weight. The maximum dose should not exceed 2 g.

Use in children

Children aged from one month to less than 12 years of age

The dosage will be calculated according to your child’s body weight. The usual infusion dose is 10 to 15 mg for each kg of body weight. It is usually given every 6 hours.

Preterm and term newborn infants (from 0 to 27 days)

The dosage will be calculated according to post-menstrual age (time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age).

The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.

Oral administration

Adults and adolescents (from 12 to 18 years)

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.

Use in children

Neonates, infants and children less than 12 years old

The recommended dose is 10 mg for each kg of body weight. It is usually given every 6 hours. The maximum daily dose should not exceed 2 g.

Method of administration

Intravenous use

Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body. Your doctor or nurse will always give vancomycin into your blood and not in the muscle.

Vancomycin will be given into your vein for at least 60 minutes.

Oral use

If given for treatment of gastric disorders (so-called pseudomembranous colitis), the medicinal product must be administered as a solution for oral use (you will take the medicine by mouth).

Duration of treatment

The length of treatment depends on the infection you have and may last a number of weeks.

The duration of the therapy may be different depending on the individual response to treatment for every patient.

During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.

If you are given more Vancomycin than you should receive

As vancomycin will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. 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.

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.

The absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disorder of the digestive tract, especially if you also have a kidney disorder, side effects that occur when vancomycin is administered by infusion may appear.

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 airflow 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 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, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE VANCOMYCIN

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 carton and the label after "EXP". The expiry date refers to the last day of that month.

Unopened vials: No special storage conditions are required.

The stability of the reconstituted and the diluted solution is given at the end of the leaflet in the section intended for healthcare professionals.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vancomycin contains
  • The active substance is vancomycin (as hydrochloride).
    Each vial contains 500 mg of vancomycin hydrochloride equivalent to 500,000 IU vancomycin or 1000 mg of vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin.
  • There are no other ingredients.

What Vancomycin looks like and contents of the pack

Vancomycin 500 mg presentation:

An off white to light beige coloured cake.

Type I colourless glass vial with a bromobutyl stopper and aluminium closure with violet plastic flip off cap.

Vancomycin 1000 mg presentation:

An off white to light beige coloured cake.

Type I colourless glass vial with a bromobutyl stopper and aluminium closure with green plastic flip off cap.

Pack sizes: 1, 5, 10 vial(s)

Not all package sizes may be marketed.

Marketing Authorisation Holder
hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer
ANFARM HELLAS S.A.
61st km Nat. Rd. Athens-Lamia
Schimatari Viotias 32009
Greece

This leaflet was last revised in 01/2026

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 an antibiotic without medical prescription, even if you want to treat a similar illness.

3712/03/26

Company Contact Details
hameln pharma ltd
Address

Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK

Telephone

+44 (0)1452 621 661

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https://www.hameln-pharma.com

Fax

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