VANCOMYCIN CAPSULES 250 MG - patient leaflet, side effects, dosage

Vancomycin Capsules 125 mg and 250 mg

Vancomycin hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• 1. What Vancomycin capsules are and what they are used for

• 2. What you need to know before you take Vancomycin capsules

• 3. How to take Vancomycin capsules

• 4. Possible side effects

• 5. How to store Vancomycin capsules

• 6. Contents of the pack and other information

• 1. WHAT VANCOMYCIN CAPSULES ARE AND WHAT THEY ARE USED FOR

How does the medicine work?

Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections.

What is the medicine used for?

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.

2. what you need to know before you take vancomycin capsules

Do not take Vancomycin capsules if:

• If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).
• You have kidney problems
• You are hard of hearing
• You have inflammatory disorders in the intestines
• You are elderly.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

• You should tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should take Vancomycin capsules.

Warnings and precautions

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).

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.

Talk to your doctor or 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.

3. how to take vancomycin capsules

Always take Vancomycin capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often. 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.

Children:

The required dose will depend on their weight. The usual dose is 40 mg/kg body weight daily divided into 3 or 4 doses for 7 to 10 days.

For example: a child weighing 20 kg should have 800 mg daily.

The total daily dose should not exceed 2 g.

If you take more Vancomycin capsules than you should

If you accidentally take too many capsules, you should contact your doctor. Always take the labelled medicine package with you, whether there are any capsules left or not.

If you forget to take a dose:

Do not take a double dose to make up for a forgotten dose.

If you forget to take your capsules on time, take one as soon as you can. If you have missed several doses, tell your doctor.

Driving and using machines

Ringing in your ears and dizziness have been reported and this may effect your ability to drive and use machines.

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.

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.

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.

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).

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 diarrhea, which may contain blood

Not known (frequency cannot be estimated from the available data):

• Being sick (throwing up), diarrhea
• 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.

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 via the national reporting system Yellow Card Scheme at: yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store vancomycin capsules

Keep out of the reach and sight of children. Store the Vancomycin capsules at room temperature (15°C to 25°C), protected from moisture.

Do not take any of the capsules after the expiry date which is printed on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

Vancomycin capsules are available in two strengths containing 125 mg and 250 mg of the active ingredient, vancomycin hydrochloride.

The other ingredients are polyethylene glycol 6000, gelatin, black and yellow iron oxide (E172), and titanium dioxide (E171).

The 250 mg capsules also contain indigo carmine (E132).

The printing ink for the 125 mg capsules contains: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).

The printing ink for the 250 mg capsules contains: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).

What Vancomycin capsules look like and contents of the pack:

The 125 mg capsules are half light grey and half grey. “Vanco 125 mg” is printed on the capsules. They are available in packs containing 28 capsules.

The 250 mg capsules are half turquoise and half green. “Vanco 250 mg” is printed on the capsules. They are available in packs containing 28 capsules.

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.

• 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.

Marketing Authorisation Holder and Manufacturer

Xellia Pharmaceuticals ApS Dalslandsgade 11

2300 Copenhagen S

Denmark

This leaflet was last revised in January 2021.

• 19 1 2021 105×297 mm Vancomycin Capsules 125 mg and 250 mg UK Die line