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Vancomycin 250mg Capsules Hard

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PACKAGE LEAFLET: INFORMATION FOR THE USER


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 is and what it is used for

2.    Before you take Vancomycin

3.    How to take Vancomycin

4.    Possible side effects

5.    How to store Vancomycin

6.    Further information

1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR

Vancomycin is an antibiotic with bactericidal activity against a bacteria in the intestine called Clostridium difficile. Vancomycin capsules act solely in the intestinal system.

Vancomycin capsules are used to treat inflammation of the intestines and colon caused by the bacterium Clostridium difficile.

2. BEFORE YOU TAKE VANCOMYCIN

Do not take Vancomycin

•    if you are allergic (hypersensitive) to vancomycin or any of the other ingredients of Vancomycin.

Take special care with Vancomycin

•    if you have kidney problems. Inform your doctor before you start taking Vancomycin.

•    if you have ever had inflammation of the large bowel called collitis or any other severe disease affecting your gut.

Taking other medicines

Please tell your doctor or pharmacist if you are taking

or have recently taken any other medicines, including

medicines obtained without a prescription, especially:

•    medicines that can affect your kidneys

•    medicines that can affect your ears

•    contraceptive pill, concomitant use of antibiotics has in rare cases reduced the effect of the contraceptive pill.

Pregnancy and breast-feeding

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

Vancomycin should only be used during pregnancy if clearly needed.

Vancomycin passes into the breastmilk. If you are breastfeeding, discuss with your doctor before you start treatment with Vancomycin.

Driving and using machines

Rarely vancomycin causes vertigo and dizziness, if affected you should not drive or operate machinery.

3. HOW TO TAKE VANCOMYCIN

Always take Vancomycin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For adults and adolescents

The usual dose is 1 capsule of 125mg 4 times a day for 7 to 10 days.

For more severe infections and recurrences the dose can be increased up to 500mg four times a day for 10-14 days.

For children aged 12 years or less

The usual dose is 30-40mg/kg/day taken in 3 to 4 divided doses a day for 7 to 10 days. The daily dose should not exceed 2g. The dose is determined by your childs doctor, who adjusts it individually to your child.

If you take more Vancomycin than you should

If you have taken too many Vancomycin capsules please contact your doctor or the nearest hospital for advice as soon as possible.

If you forget to take Vancomycin

Take the capsule as soon as you remember it.

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

If you stop taking Vancomycin

Do not stop treatment with Vancomycin without discussing it first with your doctor.

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

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE VANCOMYCIN


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

If you notice any of the following serious side effects, stop taking Vancomycin and contact a doctor immediately:

•    Reddening of the skin with blisters or peeling and may be associated with a high fever and joint pains. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. This effect is rare, affecting 1 to 10 users in 10,000.

•    Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction. This effect is rare, affecting 1 to 10 users in 10,000.

•    Chest pain or abnormal heartbeat. This could possibly lead to cardiac arrest (sudden cessation of heartbeat). This effect is very rare, affecting less than 1 user in 10,000.

•    skin rash with fever and swollen glands and increase of some white blood cells (eosinophilia) (DRESS syndrome). This effects frequency is not known and cannot be estimated from the available data.

•    Vancomycin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Other side effects:

Uncommon (affects 1 to 10 users in 1,000)

•    hearing loss

•    feeling sick (nausea)

•    rash, itching

•    fever

Rare (affects 1 to 10 users in 10,000)

•    reduction of white blood cells (leukopenia, agranulocytosis), reduction of platelets in the blood (thrombocytopenia), increase in white blood cells (eosinophilia)

•    ringing or buzzing in the ears

•    feeling dizzy, especially when you stand up suddenly (this is caused by a drop in blood pressure), blood vessel inflammation (vasculitis)

•    shortness of breath, high pitched wheezing sound when breathing (stridor)

•    redness on the upper body, itchy skin rash

•    muscle cramps and pains in the chest and back

•    kidney failure, increase of creatinine in the blood, inflammation of tubes in the kidney

•    chills, dizziness

Very rare (affects less than 1 user in 10,000)

•    infection of the colon (pseudomembranous enterocolitis), cardiac arrest (sudden cessation of heartbeat)

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.

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Vancomycin after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater 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 What Vancomycin contains

•    The active substance is vancomycin (as hydrochloride). Each 125mg hard capsule contains 125mg vancomycin (as hydrochloride). Each 250 mg hard capsule contains 250mg vancomycin (as hydrochloride)

•    The other ingredients are: Capsule content: Macrogol 6000; Capsule cap and body: Titanium Dioxide (E 171), Iron oxide Black (E 172), Iron oxide Yellow (E 172), Iron oxide Red (E 172), Gelatin.

What Vancomycin looks like and contents of the pack

125mg capsule: Grey/pink 18.1 mm hard capsule containing white to off white congealed liquid mixture as solid mass.

250mg capsule: Brown 21.6 mm hard capsule containing white to off white congealed liquid mixture as solid mass.

Blister packs of 28

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Balkanpharma - Dupnitsa AD 3 Samokovsko Shosse str.

Dupnitsa 2600 Bulgaria

This leaflet was last approved in November 2012

If you would like a leaflet with larger text, please contact 01271 311257.

^actavis

Actavis, Barnstaple, EX32 8NS, UK

AAAE5982