Vancocin Powder for Solution

• 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.

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

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

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

Talk to your doctor or hospital pharmacist or nurse before using Vancocin 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 Clostridium difficile infection instead of orally.

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

• You are receiving Vancocin 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 Vancocin. Consult your doctor immediately. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

Vancocin 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, nonsteroidal 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.

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 your Vancocin:

• anaesthetics – these may cause redness, flushing, fainting, collapse or even heart attacks. You should, therefore, tell your doctor that you are taking Vancocin 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 Vancocin and your doctor will be able to decide what is suitable for you.

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.

Vancocin should not affect your ability to drive or use machines.

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.

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 daily 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.

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.

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 Vancocin into your blood and not in the muscle.

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

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

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.

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

• 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).

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 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

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 diarrhea, 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.

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.

Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin, or 1 g vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin.

There are no other ingredients.

500 mg presentation: Rubber stoppered 10 ml vials each containing 500mg of vancomycin hydrochloride as an off-white powder.

One 10 ml vial packaged in a cardboard carton.

1000 mg presentation: Rubber stoppered 20 ml vials containing 1000 mg vancomycin hydrochloride as an off-white powder.

One 20 ml vial packaged in a cardboard carton.