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Vancomycin 125mg Capsules Hard

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin 125mg Capsules, Hard

Vancomycin

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information foryou.

•    Keep this leaflet. You may need to read it again.

•    If you have 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 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.

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

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

3.    Howto take Vancomycin Capsules

4.    Possible side effects

5.    Howtostore Vancomycin Capsules

6.    Contents of the pack and other information

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

The name of your medicine is Vancomycin Capsules. It contains the active ingredient called vancomycin hydrochloride. Vancomycin belongs to a group of antibiotics called tricyclic glycopeptide antibiotics. These antibiotics work by killing or stopping the growth of the bacteria causing your infection. Vancomycin Capsules are used to treat certain bacterial infections of the large bowel.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN CAPSULES

Do not use Vancomycin Capsules if:

•    You are allergic (hypersensitive) to vancomycin or to any of the other ingredients (listed in section 6).

Warnings and precautions:

Talk to your doctor or pharmacist before using Vancomycin Capsules if:

•    You are pregnant, trying for a baby or breast feeding

•    You have a kidney disease, especially if you take other certain medicines that can affect the kidneys (see “Other medicines and Vancomycin Capsules” below)

•    You have ulcerative colitis

•    You sufferfrom deafness or ear problems

•    You have a fungal infection e.g. thrush (white furring in the mouth) since long term treatment may result in fungal infections.

If you suffer or have suffered from deafness or kidney disease, the dose may need to be adjusted and therefore your doctor may test your kidney function and/or your hearing before giving you the medicine. Vancomycin Capsules may cause deafness, especially if you are elderly and your hearing may be tested during treatment.

Other medicines and Vancomycin Capsules

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription; In particular, if you taking any of the following:

•    Other antibiotics that can affect your kidneys or ears e.g. gentamicin, tobramycin, amikacin netilmicin, polymyxin B, colistin or bacitracin.

•    Anaesthetics given by injection as this may cause a rash and severe allergic reaction.

•    Oral contraceptives as Vancomycin Capsules may affect the action of these.

Vancomycin Capsules with food and drink

Vancomycin Capsules do not have known interactions with any food or drink and can be taken with or without food.

Fertility, 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.

Experience is limited from the use of Vancomycin Capsules in pregnant women. Vancomycin is excreted in human milk. If you are pregnant or breast feeding, your doctor will advise if Vancomycin Capsules are appropriate for you.

Driving and using machines

Rarely (1 in 10,000 users) Vancomycin Capsules causes vertigo and dizziness, if affected you should not drive or operate machinery.

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. The recomended dose is:

Adults

The usual dose of Vancomycin Capsules for adults is one (125mg) capsule every 6-8 hours for 7 to 10 days.

Use in children

The usual dose of Vancomycin Capsules for children under 12 years of age is 40mg/kg per day, divided in 3-4 doses for 7 to 10 days. Vancomycin Capsules may not be suitable for children below the age of 6 years. Other formulations (e.g. solution) of Vancomycin are available and should be used instead.

In more severe infection the dose may be increased.

The capsules should be swallowed whole with a glass of water.

If you take more Vancomycin Capsules than you should

Never take more than the recommended dose each day. If you or someone else swallows several of these capsules all together, contact your doctor, pharmacist or hospital emergency

Colours Used

Balck

Keyline (not to print)


department immediately. Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules.

If you forget to take Vancomycin Capsules

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Vancomycin Capsules

Continue taking Vancomycin Capsules until you finish the pack or for as long as your doctor recommends.

Keep taking Vancomycin Capsules for the full time of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

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

4. POSSIBLE SIDE EFFECTS

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 Yellow Card Scheme, Website: www.mhra.aov.uk/vellowcard 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 carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Keep blisters in the outer carton to protect from moisture.

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

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

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

•    irregular or fast heartbeat, wheezing, breathlessness or rash.

•    redness of the upper body or pain and muscle spasm of the chest and back.

•    difficulty hearing, dizziness or ringing in the ears.

Other side effects include:

Common (more than one in 100 but less than one in 10 patients):

•    Feeling faint (low blood pressure), breathlessness, a high pitched sound

•    Redness on the face and upper body

•    Pain and muscle spasm of the chest and back

•    Reduction in kidney function

•    Skin reactions, such as rash and hives, blisters, itch, mucus membranes inflammation.

Rare (more than one in 10,000 but less than one in 1,000 patients):

•    Allergic reaction, with symptoms such as fever, swelling and sometimes a sudden fall in blood pressure (suddenly feeling dizzy, fainting).

•    Shivering

•    Nausea (feeling sick)

•    Ringing in your ears, dizziness

•    Kidney inflammation

•    Abnormal increase or decrease in some types of cells with your blood

•    Large blisters of the skin

•    Inflammation of the blood vessels

Very rare (less than one in 10,000 patients):

•    Loss of hearing

•    Severe disturbances of the heart

•    Severe skin reactions, e.g. blisters, skin infections with flaky skin, mucus membranes disorders (sometimes severe).

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vancomycin Capsules contain

The active substance is Vancomycin Hydrochloride. Each capsule contains 128.15mg of vancomycin hydrochloride equivalent to 125mg vancomycin base.

The other ingredient is polyethylene glycol.

The capsule shell contains:

Gelatin, FD & C blue no.2 lake (E132), iron oxide red (E172), iron oxide yellow (E172), purified water, sodium lauryl sulphate, titanium dioxide (E171)

What Vancomycin Capsules look like & contents of pack

The capsules are opaque, blue and brown coloured hard capsules.

The capsules are available in blister packs of 10, 14, 15, 20, 28, 30, 56, 60, 84, 90 and 112 capsules. Not all pack sizes may be marketed

MarketingAuthorisation Holder

Morningside Healthcare Ltd

115 Narborough Road

Leicester

LE3OPA

UK

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way

Loughborough

LE11 5GW

UK

This leaflet was last revised in November 2013