Package leaflet: Information for the user Vancomycin 125 mg hard capsules Vancomycin 250 mg hard capsules

Vancomycin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    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.

What is in this leaflet

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

Vancomycin hard capsules (referred to as “Vancomycin capsules” throughout this leaflet) contain the active ingredient vancomycin hydrochloride, which is an antibiotic. Vancomycin capsules are used for the following conditions:

•    inflammation of the lining of the small and large intestine with damage to the mucosa (pseudomembranous colitis) caused by a certain type of bacteria (Clostridium difficile), as a result of treatment with antibiotics;

•    inflammation of the lining of the small and large intestine (enterocolitis) as a result of a certain type of bacteria (Staphylococci).

Vancomycin given orally is not effective for the treatment of other conditions than the indications listed above.

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

Do not take Vancomycin capsules:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Vancomycin capsules:

•    if you have kidney problems, especially if you are currently taking other medicines that can affect the kidneys (see “Other medicines and Vancomycin capsules”, below) because vancomycin can cause kidney damage;

•    if you suffer from deafness or ear problems;

•    if you are pregnant, trying to have a baby or breast feeding

If you are being treated for inflammation of the lining of the small and large intestine (pseudomembranous colitis) caused by a specific type of bacteria (Clostridium difficile), the concentration of vancomycin in your blood may be increased, causing other side effects.

Other medicines and Vancomycin capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    other antibiotics such as streptomycin, neomycin, gentamycin, cephaloridine, polymixin B, colistin, tobramycine or amykacine. These medicines may affect your kidneys and/or hearing if you take them at the same time with vancomycin.

Vancomycin capsules with food, drink and alcohol

There is no data on the interaction of vancomycin with food, drink or alcohol.

Pregnancy and breast-feeding

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.

Talk to your doctor before starting treatment with this medicine if you are breast-feeding. This is because Vancomycin passes into breast milk.

Driving and using machines

This medicine is not known to affect your ability to drive and use machines.

3. How to take Vancomycin capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Your doctor will determine your dose and adjust it if needed. Swallow the capsules whole with water.

The usual recommended dose is:

Adults, adolescents and older people: 500 mg of

vancomycin, three to four times daily, for 7-10 days. Children (under 12 years): this depends on the weight of the child. The usual dosing is 40 mg of vancomycin per kg of body weight per day, three to four times daily, for 7-10 days.

Vancomycin capsules may not be suitable for children below the age of 6 years. Other formulations of Vancomycin (for example solution) are available and should be used instead.

If you take more Vancomycin capsules than you should If you take more capsules than prescribed, seek medical attention immediately.

If you forget to take Vancomycin capsules

Do not take a double dose to make up for a forgotten dose. Simply continue taking the capsules as before.

If you stop taking Vancomycin capsules

You must continue the course of treatment with vancomycin as prescribed by your doctor or pharmacist. If you stop taking vancomycin without finishing the course of treatment, there may be a risk that you will feel worse again.

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

4. Possible side effects

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

Seek medical attention immediately if you experience any of the following:

•    signs of an allergic reaction such as shortness of breath, wheeziness, itching, rash, swelling (edema);

•    aching, headaches, feverishness, vomiting, diarrhoea followed by a red rash across the face and body with blisters in the nose, mouth, eyes and genital areas, as these may be symptoms of life threatening skin disease called Stevens-Johnson syndrome.

Other side effects include:

Uncommon (may affect up to 1 in 100 people)

•    nausea;

•    rash, itching (pruritus);

•    hearing loss (ototoxicity);

Rare (may affect up to 1 in 1,000 people)

•    severe allergic reaction (anaphylaxis)

•    low blood pressure (hypotension),

•    wheezing;

•    hives (urticaria),

•    serious illness with blistering of the skin (toxic epidermal necrolysis), skin infections with skin exfoliation (exfoliative dermatitis),

•    inflammation of blood vessels, often with skin rash (vasculitis);

•    ringing in the ear (tinnitus);

•    dizziness;

•    the sensation of spinning, associated with feeling or being sick (vertigo);

•    changes in kidney function;

•    decrease of numbers or lack of specific blood cells that fight infection (neutropenia), decrease of blood cells involved in blood clotting (thrombocytopenia)

•    increase in specific blood cells (eosinophilia)

•    muscle spasm or pain of the chest and back.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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: 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 this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package, after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25 °C.

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 protect the environment.

6.    Contents of the pack and other information

What Vancomycin capsules contains

-    The active ingredient is Vancomycin hydrochloride. Each hard capsule contains 125mg Vancomycin (equivalent to NLT 131,250 IU) or 250 mg Vancomycin (equivalent to NLT 262,500 IU) (as hydrochloride).

-    The other ingredient is polyethylene glycol (Macrogol) 6000.

-    The capsule coating is made of gelatin and colorants.

-    The capsules contain the following colorants: o Iron oxide Yellow (E172)

o Iron oxide Red (E172) o Titanium dioxide (E171) o Iron Oxide Black (E172)

What Vancomycin capsules look like and contents of the pack

The 125 mg capsules are grey/pink hard gelatin capsules containing white to off white liquid mixture as solid mass. The 250 mg capsules are brown hard gelatin capsules containing white to off white liquid mixture as solid mass.

Marketing Authorization Holder and Manufacturer

Co-Pharma Limited Unit 4, Metro Centre, Tolpits Lane Watford, Hertfordshire, WD 18 9SS United Kingdom

This leaflet was last approved in {11/2014}