PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancocin Matrigel 125mg

Hard Capsules

Vancomycin

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

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.

In this leaflet:

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

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

3.    How to take Vancocin capsules

4.    Possible side effects

5.    How to store Vancocin capsules

6.    Contents of the pack and other information

1    What Vancocin capsules are and what they are used for

Vancocin capsules contain the active ingredient vancomycin hydrochloride, which is an antibiotic.

Vancocin capsules are used to treat two specific bacterial gut infections, namely, staphylococcal enterocolitis and pseudomembranous colitis (caused by Clostridium difficile).

Vancocin capsules may also be given with an infusion of vancomycin for the same infections.

2    What you need to know before you take Vancocin capsules

Do not take Vancocin capsules:

■    If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vancocin capsules

■    If you have a kidney disorder (you will need to have your blood and kidneys tested during treatment)

■    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)

■    If you are elderly (you may need your blood and hearing monitored)

■    If you have a hearing disorder (you may need hearing tests during treatment)

■    If you are receiving Vancocin capsules for a long time (you may develop another type of infection)

Other medicines and Vancocin 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. This is especially important of the following, as they may interact with your Vancocin capsules:

■    any drug that harms your kidneys e.g. antibiotics such as gentamicin, tobramycin.

■    any drug that harms your hearing e.g. antibiotics such as gentamicin, tobramycin.

It may still be alright for you to be given Vancocin capsules and your doctor will be able to decide what is suitable for you.

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.

Driving and using machines

Vancocin capsules should not affect your ability to drive or use machines.

3 How to take Vancocin 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.

A solution made from Vancomycin powder should be used if you are unable to swallow the capsules.

The recommended dose is:

Adults and the elderly

The usual total daily dose is 500mg in divided doses (i.e. one 125mg capsule four times a day) for 7 to 10 days. In severe colitis up to 2g per day, in 3 or 4 divided doses may be used. The maximum daily dose is 2g.

Use in Children

The usual total daily dose is 40mg/kg (body weight) in 3 or 4 divided doses for 7 to 10 days.

The maximum daily dose is 2g

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. All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Because vancomycin is not usually absorbed (unless you have severe colitis) side effects to Vancocin capsules are not very common.

Serious side effects

The following side effects are serious. You should stop taking this medicine and tell your doctor immediately if you experience them:

■    serious peeling or blistering of the skin, mouth, eyes or genitals, possibly with a fever

■    severe allergic reactions including shortness of breath, wheezing, fainting, collapse, very slow pulse rate, swollen hands and face, and hearing loss

The following side effects have been reported

■    changes in blood counts, which will show up as bruising or a very tired feeling (a blood test carried out by a doctor will detect these)

■    chills

■    fever

■    decrease in blood pressure (hypotension)

■    redness of upper body and face (red-neck syndrome)

■    pain

■    spasm of the chest and back muscles

■    nausea

■    widespread, itchy scaling of the skin or a red-purple rash

■    you may stop urinating or notice that you are urinating much less than usual (kidney failure) or that your urine becomes cloudy

■    spinning sensation (vertigo)

■    dizziness

■    ringing in the ears (tinnitus)

■    hearing loss

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5 How to store Vancocin capsules

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.

6 Contents of the pack and other information

What Vancocin capsules contain

The active substance is vancomycin hydrochloride 125mg.

The other ingredients are:

Macrogol 6000, gelatin, indigo carmine, red iron oxide, yellow iron oxide and titanium dioxide.

The printing ink contains:

Shellac, propylene glycol, iron oxide red (E172) and potassium hydroxide.

What Vancocin capsules look like and contents of the pack

Vancocin capsules are contained in blister packs of 20 capsules (2 strips of 10 capsules) or 28 capsules (4 strips of 7 capsules).

The capsules are dark blue and peach coloured and printed with the number 3125.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Flynn Pharma Ltd Alton House 4 Herbert Street Dublin 2 Ireland

Manufacturer

Encap Drug Delivery Building 1

Oakbank Park Way Livingston West Lothian EH53 0TH United Kingdom.

This leaflet was last revised in

July 2015