Glibenclamide 2.5mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Glibenclamide

Prieinama:

Wockhardt UK Ltd

ATC kodas:

A10BB01

INN (Tarptautinis Pavadinimas):

Glibenclamide

Dozė:

2.5mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06010201; GTIN: 5012727902692

Pakuotės lapelis

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
• Pharmacode re- positioned at 8mm from the cutting edge
• Updated new Wockhardt logo
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIBENCLAMIDE 2.5MG TABLETS/
GLIBENCLAMIDE 5MG TABLETS
READ ALL OF THIS
LEAFLET CAREFULLY
BEFORE YOU START TO
TAKE THIS MEDICINE.
-
Keep this leaflet.
You may need to
read it again while
you are receiving
your treatment.
-
If you have any
further questions,
please 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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What Glibenclamide Tablets are and what they are
used for
2. Before you take Glibenclamide Tablets
3. How to take Glibenclamide Tablets
4. Possible side effects
5. How to store Glibenclamide Tablets
6. Further information
1. What Glibenclamide Tablets are and what they are
used for
The name of your medicine is Glibenclamide Tablets. These
tablets belong to a group of medicines called sulphonylureas.
Glibenclamide Tablets are used to lower blood sugar
levels and are used in the treatment of late-onset
diabetes (type II diabetes mellitus) in patients whose
blood sugar is not controlled by diet alone and who are
not suitable for insulin injections.
2. Before you take Glibenclamide Tablets
YOU SHOULD NOT TAKE GLIBENCLAMIDE TABLETS IF YOU:
• are allergic (hypersensitive) to glibenclamide, other
sulphonylureas or any of the other ingredients in
Glibenclamide Tablets (see section 6, Further information)
• suffer from early onset or type I diabetes (requiring insulin)
• suffer from severe kidney disease
• suffer from liver problems
• are suffering from ketoacidosis (caused by excessively
high blood sugars in diabetics)
• are suffering from a severe infection
•

Prekės savybės

OBJECT 1
GLIBENCLAMIDE 2.5MG TABLETS
Summary of Product Characteristics Updated 14-Dec-2015 | Wockhardt UK
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 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
Glibenclamide 2.5mg Tablets or Liamid 2.5mg Tablets or Gliken 2.5mg
Tablets
2. Qualitative and quantitative composition
Glibenclamide BP 2.5mg
3. Pharmaceutical form
Tablet
White, circular tablet, marked CP on one face and GL2.5 on the other.
4. Clinical particulars
4.1 Therapeutic indications
Glibenclamide is a hypoglycaemic agent indicated in the treatment of
non-insulin dependent diabetes in
patients who respond inadequately to dietary measures alone.
4.2 Posology and method of administration
_Treatment of previously untreated diabetes:_
Stabilisation can be started with one 5mg tablet daily with or
immediately after breakfast or the first main
meal. If control is satisfactory one tablet is continued as the
maintenance dose. If control is unsatisfactory,
the dose can be adjusted by increments of 2.5 or 5mg at weekly
interv