Patient information leaflet    21198-08

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.

In this leaflet:

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

2.    Before you take Vancomycin capsules

3.    How to take Vancomycin capsules

4.    Possible side effects

5.    How to store Vancomycin capsules

6.    Further information

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

How does the medicine work?

Vancomycin is an antibiotic. Antibiotics help your body fight infections. Vancomycin works by destroying certain bacteria that cause infection. Vancomycin capsules work mainly in the intestines.

What is the medicine used for?

Vancomycin capsules are used for the treatment of serious infections caused by certain bacteria in the intestines.

2.    BEFORE YOU TAKE VANCOMYCIN CAPSULES Do not take Vancomycin capsules if

•    You have had an allergic reaction to Vancomycin or to any of the other ingredients of this medicine.

Talk to your doctor before taking this medicine if:

•    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 breastfeeding. Your doctor will then decide whether you should take Vancomycin capsules.

Ask your doctor or pharmacist for advice before taking any medicine.

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. Swallow the capsules whole with a glass of water.

Adults and elderly:

The usual dosage is 500 mg daily:

125 mg capsules: 1-4 capsules 4 times daily.

250 mg capsules: 1-2 capsules 2-4 times daily.

The total daily dose should not exceed 2 g.

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.

•    any kind of an allergic reactions such as difficulty in breathing, rash or itching, although serious allergic reactions e.g anaphylactic shock, flushing of the upper body ("red man syndrome") are common (may occur in more than 1 out of 100 patient and less than 1 out of 10)

•    any kind of serious rash, as this can be related to serious life-threatening skin diseases (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis), although these are very rare (may occur in less than 10,000 patients).

Common side effects (may occur in more than 1 out of 100 patients and less than 1 out of 10):

•    fall in blood pressure

•    kidney problems which may be detected primarily by blood tests

•    redness of upper body and face.

Rare side effects (may occur in more than 1 out of 10,000 and less than 1 out of 1000 patients):

•    increase or decrease in some of the white cells in the blood, decrease in platelets (blood cells responsible for blood clotting). The fall in the white blood cells is normalized when the treatment is stopped

•    ringing in the ears, dizziness

•    nausea (feeling sick)

•    inflammation of the kidneys and kidney failure

•    pain in the chest and back muscles

•    drug fever, chills.

•    stridor, shortness of breath.

Very rare side effects (may occur in less than 1 out of 10,000 patients):

•    blood vessel inflammation

•    temporary or permanent loss of hearing

•    inflammation of the bowel which causes abdominal pain and diarrhea, which may contain blood.

•    cardiac arrest.

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

•    skin condition with blistering.

•    drug rash with cosinophilia and systemic symptoms (DRESS syndrome).

Contact your doctor or nurse if it is ringing in your ears as this could be the onset of deafness.

If any of the side effects are troublesome or you experience side effects that are not mentioned above, tell your doctor.

You can also report side effects directly via the national reporting system Yellow Card Scheme at : www.mhra.gov.uk/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 sight and reach 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.    FURTHER INFORMATION

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

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Vancomycin capsules can cause side effects, although not everybody gets them.

Vancomycin capsules work mainly in the intestines and are not absorbed in the blood. Therefore they do not generally cause side effects. If you have inflammatory disorders in the intestines some absorption may occur and you will experience some side effects. Therefore please tell your doctor or nurse immediately if you experience any of following serious side effects:

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.

Marketing Authorisation Holder and

Manufacturer

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

This leaflet was last approved in October 2015.

AIPILUK V07 Version 01

xellia