Vancocin Matrigel 125mg Hard Capsules

Vancomycin (as hydrochloride)

The name of your medicine is Vancocin Matrigel 125mg Hard Capsules, which will be referred to as Vancocin capsules throughout this document.

Vancocin 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.

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.

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).

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)
• 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

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.