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VANCOMYCIN CAPSULES 125MG

Active substance(s): VANCOMYCIN

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21198-08

Patient information leaflet

Vancomycin Capsules
125 mg and 250 mg
Vancomycin hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Vancomycin capsules are and what
they are used for
2. Before you take Vancomycin capsules
3. How to take Vancomycin capsules
4. Possible side effects
5. How to store Vancomycin capsules
6. Further information
1. WHAT VANCOMYCIN CAPSULES ARE AND
WHAT THEY ARE USED FOR
How does the medicine work?
Vancomycin is an antibiotic. Antibiotics help your
body fight infections. Vancomycin works by
destroying certain bacteria that cause infection.
Vancomycin capsules work mainly in the intestines.
What is the medicine used for?
Vancomycin capsules are used for the treatment of
serious infections caused by certain bacteria in the
intestines.
2. BEFORE YOU TAKE VANCOMYCIN CAPSULES
Do not take Vancomycin capsules if
• You have had an allergic reaction to
Vancomycin or to any of the other ingredients
of this medicine.
Talk to your doctor before taking this medicine
if:
• You have kidney problems
• You are hard of hearing
• You have inflammatory disorders in the
intestines
• You are elderly.
Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
• You should tell your doctor if you are pregnant,
planning to become pregnant or are breastfeeding. Your doctor will then decide whether
you should take Vancomycin capsules.
Ask your doctor or pharmacist for advice before
taking any medicine.
3. HOW TO TAKE VANCOMYCIN CAPSULES
Always take Vancomycin capsules exactly as your
doctor has told you. The label on your medicine will
tell you how many capsules to take and how often.
Swallow the capsules whole with a glass of water.
Adults and elderly:
The usual dosage is 500 mg daily:
125 mg capsules: 1-4 capsules 4 times daily.
250 mg capsules: 1-2 capsules 2-4 times daily.
The total daily dose should not exceed 2 g.
Children:
The required dose will depend on their weight.
The usual dose is 40 mg/kg body weight daily divided
into 3 or 4 doses for 7 to 10 days.
For example: a child weighing 20 kg should have
800 mg daily.
The total daily dose should not exceed 2 g.
If you take more Vancomycin capsules than you
should
If you accidentally take too many capsules, you
should contact your doctor. Always take the labelled
medicine package with you, whether there are any
capsules left or not.
If you forget to take a dose:
Do not take a double dose to make up for a
forgotten dose.
If you forget to take your capsules on time, take one
as soon as you can. If you have missed several
doses, tell your doctor.
Driving and using machines:
Ringing in your ears and dizziness have been
reported and this may effect your ability to drive and
use machines.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vancomycin capsules can cause
side effects, although not everybody gets them.
very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated
from the available data

Vancomycin capsules work mainly in the intestines
and are not absorbed in the blood. Therefore they do
not generally cause side effects. If you have
inflammatory disorders in the intestines some
absorption may occur and you will experience some
side effects. Therefore please tell your doctor or
nurse immediately if you experience any of following
serious side effects:



any kind of an allergic reactions such as
difficulty in breathing, rash or itching, although
serious allergic reactions e.g anaphylactic
shock, flushing of the upper body (“red man
syndrome”) are common (may occur in more
than 1 out of 100 patient and less than 1 out
of 10)
• any kind of serious rash, as this can be related
to serious life-threatening skin diseases
(Stevens-Johnson syndrome and Toxic
Epidermal Necrolysis), although these are very
rare (may occur in less than 10,000 patients).
Common side effects (may occur in more than
1 out of 100 patients and less than 1 out of 10):
• fall in blood pressure
• kidney problems which may be detected
primarily by blood tests
• redness of upper body and face.
Rare side effects (may occur in more than 1 out
of 10,000 and less than 1 out of 1000 patients):
• increase or decrease in some of the white cells
in the blood, decrease in platelets (blood cells
responsible for blood clotting). The fall in the
white blood cells is normalized when the
treatment is stopped
• ringing in the ears, dizziness
• nausea (feeling sick)
• inflammation of the kidneys and kidney failure
• pain in the chest and back muscles
• drug fever, chills.
• stridor, shortness of breath.
Very rare side effects (may occur in less than 1
out of 10,000 patients):
• blood vessel inflammation
• temporary or permanent loss of hearing
• inflammation of the bowel which causes
abdominal pain and diarrhea, which may
contain blood.
• cardiac arrest.
Not known (frequency cannot be estimated
from available data):
• skin condition with blistering.
• drug rash with cosinophilia and systemic symptoms
(DRESS syndrome).
Contact your doctor or nurse if it is ringing in your
ears as this could be the onset of deafness.
If any of the side effects are troublesome or you
experience side effects that are not mentioned above,
tell your doctor.

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 out of the sight and reach of children.
Store the Vancomycin capsules at room temperature
(15°C to 25°C), protected from moisture.
Do not take any of the capsules after the expiry date
which is printed on the pack. The expiry date refers
to the last day of that month.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
Vancomycin capsules are available in two strengths
containing 125 mg and 250 mg of the active
ingredient, vancomycin hydrochloride.
The other ingredients are polyethylene glycol 6000,
gelatin, black and yellow iron oxide (E172), and
titanium dioxide (E171).
The 250 mg capsules also contain indigo carmine
(E132).
The printing ink for the 125 mg capsules contains:
shellac, propylene glycol, concentrated ammonia
solution, potassium hydroxide, black iron oxide
(E172).
The printing ink for the 250 mg capsules contains:
shellac, propylene glycol, sodium hydroxide,
povidone, titanium dioxide (E171).
What Vancomycin capsules look like and
contents of the pack:
The 125 mg capsules are half light grey and half
grey. “Vanco 125 mg” is printed on the capsules.
They are available in packs containing 28 capsules.
The 250 mg capsules are half turquoise and half
green. "Vanco 250 mg" is printed on the capsules.
They are available in packs containing 28 capsules.
Marketing Authorisation Holder and
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark
This leaflet was last approved in October 2015.
AIPILUK V07
Version 01

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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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