Skip to Content

VANCOCIN MATRIGEL 125MG HARD CAPSULES

Active substance(s): VANCOMYCIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your
doctor or pharmacist.
n 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.
n 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:
n 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
n If you have a kidney disorder (you will need to
have your blood and kidneys tested during
treatment)
n 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)
n If you are elderly (you may need your blood and
hearing monitored)
n If you have a hearing disorder (you may need
hearing tests during treatment)
n 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:
n any drug that harms your kidneys e.g. antibiotics
such as gentamicin, tobramycin.
n 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:
n 
serious peeling or blistering of the skin, mouth,
eyes or genitals, possibly with a fever
n 
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
n 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)
n chills
n fever
n decrease in blood pressure (hypotension)
n redness of upper body and face (red-neck
syndrome)
n pain
n spasm of the chest and back muscles
n nausea
n widespread, itchy scaling of the skin or a
red-purple rash
n you may stop urinating or notice that you are
urinating much less than usual (kidney failure)
or that your urine becomes cloudy

n spinning sensation (vertigo)
n dizziness
n ringing in the ears (tinnitus)
n 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

Expand view ⇕

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.

Hide