Glimepiride 4mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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16-12-2020

Virkt innihaldsefni:

Glimepiride

Fáanlegur frá:

Brown & Burk UK Ltd

ATC númer:

A10BB12

INN (Alþjóðlegt nafn):

Glimepiride

Skammtar:

4mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 06010201; GTIN: 5060124640068

Upplýsingar fylgiseðill

                                PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLIMEPIRIDE 1 MG/2 MG/3 MG/4 MG TABLETS
Glimepiride
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 illnesss 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.
WHAT IS IN THIS LEAFLET
1.
What Glimepiride is and what it is used for
2.
What you need to know before you take Glimepiride
3.
How to take Glimepiride
4.
Possible side effects
5.
How to store Glimepiride
6.
Contents of the pack and other information
1.
WHAT GLIMEPIRIDE IS AND WHAT IT IS USED FOR
Glimepiride is one of a group of medicines called oral hypoglycaemics,
which are used for treatment of
diabetes (a disease where the body does not produce enough insulin to
control the level of blood sugar).
Oral hypoglycaemics help control blood sugar level.
The active ingredient in your Glimepiride tablets is Glimepiride.
WHAT GLIMEPIRIDE IS USED FOR:
Glimepiride is used in the treatment of non-insulin dependent (Type
II) diabetes mellitus. You get diabetes
if your pancreas does not make enough insulin to control the level of
glucose in your blood. Type II
diabetes can sometimes be controlled by good diet, physical exercise
and weight reduction alone, but
where this is not possible, Glimepiride is used in addition.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMEPIRIDE.
DO NOT TAKE GLIMEPIRIDE:
•
if you are allergic to glimepiride or other sulfonylureas (medicines
used to lower your blood sugar
such as glibenclamide) or sulfonamides (medicines for bacterial
infections such as
sulfamethoxazole) or any of the other ingredients of this medicine
(listed in section 6)
•
if you hav
                                
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                                OBJECT 1
GLIMEPIRIDE 4 MG TABLETS
Summary of Product Characteristics Updated 05-Jan-2021 | Brown & Burk
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 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
Glimepiride 4 mg tablets
2. Qualitative and quantitative composition
Glimepiride 4 mg tablets:
1 tablet contains Glimepiride 4 mg.
Excipient with known effect
Each tablet of Glimepiride 4 mg contains 140.00 mg of Lactose
Monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Glimepiride 4mg is a Light blue coloured capsule shaped tablet with
debossing “GM” & “4” with score
line on one side and score line on the other side.
The tablet can be divided into equal halves.
4. Clinical particulars
4.1 Therapeutic indications
Glimepiride is indicated for the treatment of type 2 diabetes
mellitus, when diet, physical exercise and
weight reduction alone are not adequate.
4.2 Posology and method of administration
Posology
For oral administration
The basis for successful treatment of
                                
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