Vancomycin 125mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Vancomycin hydrochloride

Saatavilla:

Strides Pharma UK Ltd

ATC-koodi:

A07AA09

INN (Kansainvälinen yleisnimi):

Vancomycin hydrochloride

Annos:

125mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010700; GTIN: 5031676005179

Pakkausseloste

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.
WHAT IS IN THIS LEAFLET:
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
HOW DOES THE MEDICINE WORK?
Vancomycin is an antibiotic that
belongs to a group of antibiotics called
“glycopeptides”. Vancomycin works
by eliminating certain bacteria that
cause infections.
WHAT IS THE MEDICINE USED FOR?
Vancomycin is used in adults and
adolescents from 12 years of age for
the treatment of infections of the
mucosa of the small and the large
intestines with damage to the mucosae
(pseudomembranous colitis), caused by
the
_Clostridium difficile_
_ _bacterium.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE VANCOMYCIN
CAPSULES
Do not take Vancomycin capsules if:
• You are allergic to vancomycin or
any of the other ingredients of this
medicine (listed in section 6).
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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vancomycin 125 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 125 mg vancomycin hydrochloride equivalent to
125,000IU
vancomycin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Grey/pink 17.8 ± 0.40 mm hard capsule, containing white to off white
congealed
liquid mixture as solid mass.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vancomycin capsules are indicated in patients 12 years and older for
the treatment of
Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 to less than 18 years old _
The recommended vancomycin dose is 125 mg every 6 hours for 10 days
for the first
episode of non-severe CDI. This dose can be increased to 500 mg every
6 hours for
10 days in case of severe or complicated disease. The maximum daily
dose should not
exceed 2 g.
In patients with multiple recurrences, consideration may be given to
treat the current
episode of CDI with vancomycin, 125 mg four times daily for 10 days
followed by
either tapering the dose, i.e., gradually decreasing it until 125 mg
per day or a pulse
regimen, i.e., 125–500 mg/day every 2–3 days for at least 3 weeks.
Treatment duration with vancomycin may need to be tailored to the
clinical course of
individual patients. Whenever possible the antibacterial suspected to
have caused CDI
should be discontinued. Adequate replacement of fluid and electrolytes
should be
instituted.
Monitoring vancomycin serum concentrations after oral administration
in patients
with inflammatory intestinal disorders should be performed (see
section 4.4).
Special populations
_Renal impairment _
Due to the very low systemic absorption, dose adjustment is unlikely,
unless
substantial oral absorption may occur in case of inflammatory
intestinal disorders or
Clostridium difficile-induced pseudomembranous colitis (see section
4.4).
_Paediatric pop