Skip to Content

VANCOMYCIN 125MG HARD CAPSULES

Active substance(s): VANCOMYCIN HYDROCHLORIDE / VANCOMYCIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Vancomycin 125 mg hard capsules
Vancomycin 250 mg hard capsules
Vancomycin hydrochloride

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

If you are being treated for inflammation of the lining of
the small and large intestine (pseudomembranous colitis)
caused by a specific type of bacteria (Clostridium difficile),
the concentration of vancomycin in your blood may be
increased, causing other side effects.

Other medicines and Vancomycin capsules

− 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 only. 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.

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the
following:
• other antibiotics such as streptomycin, neomycin,
gentamycin, cephaloridine, polymixin B, colistin,
tobramycine or amykacine. These medicines may affect
your kidneys and/or hearing if you take them at the same
time with vancomycin.

What is in this leaflet

Vancomycin capsules with food, drink and alcohol

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

There is no data on the interaction of vancomycin with food,
drink or alcohol.

1. What Vancomycin capsules are and what they
are used for
Vancomycin hard capsules (referred to as “Vancomycin
capsules” throughout this leaflet) contain the active
ingredient vancomycin hydrochloride, which is an antibiotic.
Vancomycin capsules are used for the following conditions:
• inflammation of the lining of the small and large intestine
with damage to the mucosa (pseudomembranous
colitis) caused by a certain type of bacteria (Clostridium
difficile), as a result of treatment with antibiotics;
• inflammation of the lining of the small and large intestine
(enterocolitis) as a result of a certain type of bacteria
(Staphylococci).
Vancomycin given orally is not effective for the treatment of
other conditions than the indications listed above.

2. What you need to know before you take
Vancomycin capsules
Do not take Vancomycin capsules:
− if you are allergic to vancomycin hydrochloride or any of
the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vancomycin
capsules:
• if you have kidney problems, especially if you are
currently taking other medicines that can affect the
kidneys (see “Other medicines and Vancomycin capsules”,
below) because vancomycin can cause kidney damage;
• if you suffer from deafness or ear problems;
• if you are pregnant, trying to have a baby or breast
feeding

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.
Talk to your doctor before starting treatment with this
medicine if you are breast-feeding. This is because
Vancomycin passes into breast milk.

Driving and using machines
This medicine is not known to affect your ability to drive and
use machines.

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.

Dosage
Your doctor will determine your dose and adjust it if needed.
Swallow the capsules whole with water.
The usual recommended dose is:
Adults, adolescents and older people: 500 mg of
vancomycin, three to four times daily, for 7-10 days.
Children (under 12 years): this depends on the weight of
the child. The usual dosing is 40 mg of vancomycin per kg of
body weight per day, three to four times daily, for 7-10 days.
Vancomycin capsules may not be suitable for children below
the age of 6 years. Other formulations of Vancomycin (for
example solution) are available and should be used instead.
If you take more Vancomycin capsules than you should
If you take more capsules than prescribed, seek medical
attention immediately.

If you forget to take Vancomycin capsules
Do not take a double dose to make up for a forgotten dose.
Simply continue taking the capsules as before.

Dimension - 180 x 260 mm

Front Side

1026482

If you stop taking Vancomycin capsules
You must continue the course of treatment with vancomycin
as prescribed by your doctor or pharmacist. If you stop
taking vancomycin without finishing the course of treatment,
there may be a risk that you will feel worse again.
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.

Seek medical attention immediately if you
experience any of the following:
• signs of an allergic reaction such as shortness of breath,
wheeziness, itching, rash, swelling (edema);
• aching, headaches, feverishness, vomiting, diarrhoea
followed by a red rash across the face and body with
blisters in the nose, mouth, eyes and genital areas, as
these may be symptoms of life threatening skin disease
called Stevens-Johnson syndrome.
• serious illness with blistering of the skin (toxic epidermal
necrolysis), skin infections with skin exfoliation
(exfoliative dermatitis)
• decrease of blood cells involved in blood clotting
(thrombocytopenia such as increased risk of bleeding or
bruising)

Other side effects include:
Uncommon (may affect up to 1 in 100 people)
• nausea
• rash, itching (pruritus)
• hearing loss (ototoxicity)
Rare (may affect up to 1 in 1,000 people)
• severe allergic reaction (anaphylaxis)
• low blood pressure (hypotension)
• wheezing
• hives (urticaria)
• inflammation of blood vessels, often with skin rash
(vasculitis)
• ringing in the ear (tinnitus)
• dizziness
• the sensation of spinning, associated with feeling or being
sick (vertigo)
• changes in kidney function
• decrease of numbers or lack of specific blood cells that
fight infection (neutropenia),
• increase in specific blood cells (eosinophilia)
• muscle spasm or pain of the chest and back
• chills
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

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 package, after “EXP”. The expiry date refers to the
last day of that month.
Do not store above 25 ºC.
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
protect the environment.

6. Contents of the pack and other information
What Vancomycin capsules contains
− The active ingredient is Vancomycin hydrochloride. Each
hard capsule contains 125mg Vancomycin (equivalent to
NLT 131,250 IU) or 250 mg Vancomycin (equivalent to
NLT 262,500 IU) (as hydrochloride).
− The other ingredient is polyethylene glycol (Macrogol)
6000.
− The capsule coating is made of gelatin and colorants.
− The capsules contain the following colorants:
• Iron oxide Yellow (E172)
• Iron oxide Red (E172)
• Titanium dioxide (E171)
• Iron Oxide Black (E172)

What Vancomycin capsules look like and contents
of the pack
The 125 mg capsules are grey/pink hard gelatin capsules
containing white to off white liquid mixture as solid mass.
The 250 mg capsules are brown hard gelatin capsules
containing white to off white liquid mixture as solid mass.

Marketing Authorization Holder
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane
Watford, Hertfordshire, WD 18 9SS
United Kingdom

Manufacturer
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane
Watford, Hertfordshire, WD 18 9SS
United Kingdom
And
Dr. Friedrich Eberth Arzneimittel GmbH
Am Bahnhof 2
92289 Ursensollen

This leaflet was last approved in {06/2016}

1031416

Reporting of side effects

By reporting side effects you can help provide more
information on the safety of this medicine.

You can also report side effects directly via the national
reporting system Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard

Dimension - 180 x 260 mm

Back Side

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