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VANCOMYCIN 250MG CAPSULES HARD

Active substance(s): VANCOMYCIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin 125mg and 250mg
Capsules, hard
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 is and what it is used for
2. Before you take Vancomycin
3. How to take Vancomycin
4. Possible side effects
5. How to store Vancomycin
6. Further information

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Vancomycin should only be used during pregnancy if
clearly needed.
Vancomycin passes into the breastmilk. If you are breastfeeding, discuss with your doctor before you start
treatment with Vancomycin.
Driving and using machines
Rarely vancomycin causes vertigo and dizziness, if affected
you should not drive or operate machinery.
3. HOW TO TAKE VANCOMYCIN
Always take Vancomycin exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.

1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR
Vancomycin is an antibiotic with bactericidal activity
against a bacteria in the intestine called Clostridium difficile.
Vancomycin capsules act solely in the intestinal system.
Vancomycin capsules are used to treat inflammation of the
intestines and colon caused by the bacterium Clostridium
difficile.
2. BEFORE YOU TAKE VANCOMYCIN
Do not take Vancomycin
• if you are allergic (hypersensitive) to vancomycin or any of
the other ingredients of Vancomycin.

For adults and adolescents
The usual dose is 1 capsule of 125mg 4 times a day for 7 to
10 days.
For more severe infections and recurrences the dose can
be increased up to 500mg four times a day for 10-14 days.
For children aged 12 years or less
The usual dose is 30-40mg/kg/day taken in 3 to 4 divided
doses a day for 7 to 10 days. The daily dose should not
exceed 2g. The dose is determined by your childs doctor,
who adjusts it individually to your child.
If you take more Vancomycin than you should
If you have taken too many Vancomycin capsules please
contact your doctor or the nearest hospital for advice as
soon as possible.
If you forget to take Vancomycin
Take the capsule as soon as you remember it.
Do not take a double dose to make up for a forgotten dose.

Take special care with Vancomycin
• if you have kidney problems. Inform your doctor before
you start taking Vancomycin.
• if you have ever had inflammation of the large bowel
called collitis or any other severe disease affecting your
gut.

If you stop taking Vancomycin
Do not stop treatment with Vancomycin without
discussing it first with your doctor.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription, especially:
• medicines that can affect your kidneys
• medicines that can affect your ears
• contraceptive pill, concomitant use of antibiotics has in
rare cases reduced the effect of the contraceptive pill.

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

AAAE5982

Vancomycin 125mg & 250mg Capsules PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:
approved for print/date

AAAE5982
2
29.11.12

originated by:

DR

revision date:

06.12.12

revised by:
supplier:

DR
Strides Arcolabs

dimensions:

180 x 260

3.

pharmacode:
min pt size:

2.
4.

9pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

29.11.12

technically app. date:

05.12.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE VANCOMYCIN

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

Keep out of the reach and sight of children.

If you notice any of the following serious side
effects, stop taking Vancomycin and contact a doctor
immediately:
• Reddening of the skin with blisters or peeling and may
be associated with a high fever and joint pains. There
may also be severe blisters and bleeding in the lips, eyes,
mouth, nose and genitals. This could be Stevens-Johnson
syndrome or toxic epidermal necrolysis. This effect is rare,
affecting 1 to 10 users in 10,000.
• Swelling of the face, lips or throat which make it difficult
to swallow or breathe, as well as itching and rashes. This
could be a sign of a severe allergic reaction. This effect is
rare, affecting 1 to 10 users in 10,000.
• Chest pain or abnormal heartbeat. This could possibly
lead to cardiac arrest (sudden cessation of heartbeat). This
effect is very rare, affecting less than 1 user in 10,000.
• skin rash with fever and swollen glands and increase of
some white blood cells (eosinophilia) (DRESS syndrome).
This effects frequency is not known and cannot be
estimated from the available data.
• Vancomycin may cause a reduction in the number of
white blood cells and your resistance to infection may be
decreased. If you experience an infection with symptoms
such as fever and serious deterioration of your general
condition, or fever with local infection symptoms such
as sore throat/pharynx/mouth or urinary problems you
should see your doctor immediately. A blood test will be
taken to check possible reduction of white blood cells
(agranulocytosis). It is important to inform your doctor
about your medicine.
Other side effects:

Do not store above 25°C.
Do not use Vancomycin after the expiry date which is
stated on the carton and blister after EXP. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater 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
What Vancomycin contains
• The active substance is vancomycin (as hydrochloride).
Each 125mg hard capsule contains 125mg vancomycin
(as hydrochloride). Each 250 mg hard capsule contains
250mg vancomycin (as hydrochloride)
• The other ingredients are: Capsule content: Macrogol
6000; Capsule cap and body: Titanium Dioxide (E 171), Iron
oxide Black (E 172), Iron oxide Yellow (E 172), Iron oxide
Red (E 172), Gelatin.
What Vancomycin looks like and contents of the pack
125mg capsule: Grey/pink 18.1 mm hard capsule
containing white to off white congealed liquid mixture as
solid mass.
250mg capsule: Brown 21.6 mm hard capsule containing
white to off white congealed liquid mixture as solid mass.
Blister packs of 28

Uncommon (affects 1 to 10 users in 1,000)
• hearing loss
• feeling sick (nausea)
• rash, itching
• fever
Rare (affects 1 to 10 users in 10,000)
• reduction of white blood cells (leukopenia,
agranulocytosis), reduction of platelets in the blood
(thrombocytopenia), increase in white blood cells
(eosinophilia)
• ringing or buzzing in the ears
• feeling dizzy, especially when you stand up suddenly
(this is caused by a drop in blood pressure), blood vessel
inflammation (vasculitis)
• shortness of breath, high pitched wheezing sound when
breathing (stridor)
• redness on the upper body, itchy skin rash
• muscle cramps and pains in the chest and back
• kidney failure, increase of creatinine in the blood,
inflammation of tubes in the kidney
• chills, dizziness

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse str.
Dupnitsa 2600
Bulgaria
This leaflet was last approved in November 2012

Very rare (affects less than 1 user in 10,000)
• infection of the colon (pseudomembranous enterocolitis),
cardiac arrest (sudden cessation of heartbeat)
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.

AAAE5982

Vancomycin 125mg & 250mg Capsules PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:
approved for print/date

AAAE5982
2
29.11.12

originated by:

DR

revision date:

06.12.12

revised by:
supplier:

DR
Strides Arcolabs

dimensions:

180 x 260

3.

pharmacode:
min pt size:

2.
4.

9pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

29.11.12

technically app. date:

05.12.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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