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VANCOMYCIN 125MG CAPSULES HARD

Active substance(s): VANCOMYCIN HYDROCHLORIDE

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170 x 310 mm

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9 pt

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1 of 1

Version No.

2

Date

22-11-13

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Illustrator 11

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Vancomycin 125mg Capsules, Hard
Vancomycin
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 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. 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
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 suffer from 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. H O W T O
CAPSULES

TA K E

VA N C O M Y C I N

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

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
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).

!
!
!

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.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. H O W T O S T O R E VA N C O M Y C I N
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.
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
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough
LE11 5GW
UK
This leaflet was last revised in November
2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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