Vancocin Matrigel 125mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vancomycin hydrochloride

Available from:

Flynn Pharma Ltd

ATC code:

A07AA09

INN (International Name):

Vancomycin hydrochloride

Dosage:

125mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5060106550217

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VANCOCIN MATRIGEL 125MG HARD CAPSULES
Vancomycin (as hydrochloride)
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.
-
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.
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. Vancomycin
is an antibiotic that
belongs to a group of antibiotics called “glycopeptides”.
Vancomycin works by eliminating certain
bacteria that cause infections.
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 VANCOCIN CAPSULES
DO NOT TAKE VANCOCIN CAPSULES:
-
If you are allergic to vancomycin or any of the other ingredients of
this medicine (listed in Section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vancocin capsules
-
If you have a kidney disorder (you will need to have your blood and
kidneys tested during
treatment)
-
If you have an inflammatory disorder of the dige

Summary of Product characteristics

OBJECT 1
VANCOCIN MATRIGEL CAPSULES 125MG
Summary of Product Characteristics Updated 17-Jun-2022 | Flynn Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Vancocin Matrigel 125mg Hard Capsules
2. Qualitative and quantitative composition
Each capsule contains 125mg vancomycin hydrochloride equivalent to
125,000 IU vancomycin.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, hard
Dark blue and brown hard capsules, imprinted with 3125 in red ink.
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).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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