Diagemet XL 500mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Metformin hydrochloride

Beschikbaar vanaf:

Genus Pharmaceuticals Ltd

ATC-code:

A10BA02

INN (Algemene Internationale Benaming):

Metformin hydrochloride

Dosering:

500mg

farmaceutische vorm:

Modified-release tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06010202; GTIN: 5030451004062

Bijsluiter

MHRA HEADER BOX
PCP HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Leaflet
28s / 56s
24998803
148mm x 370mm
4
02.03.2017
Diagemet XL 500mg Prolonged-release
Tablets
Yes
A
GKE
830434
13634
Safety update following Article 31
Referral (use in patients with renal
failure).
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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 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 Diagemet XL 500mg Prolonged-release Tablets are and what they
are used for
2. Before you take Diagemet XL 500mg Prolonged-release Tablets
3. How to take Diagemet XL 500mg Prolonged-release Tablets
4. Possible side-effects
5. How to store Diagemet XL 500mg Prolonged-release Tablets
6. Further information
1.
WHAT DIAGEMET XL 500MG PROLONGED-RELEASE TABLETS ARE
AND WHAT THEY ARE USED FOR
Diagemet XL 500mg Prolonged-release Tablets contain the active
ingredient metformin hydrochloride
and belong to a group of medicines called biguanides, used in the
treatment of diabetes.
Diagemet XL 500mg Prolonged-release Tablets are used for the treatment
of type 2 (non-insulin
diabetes mellitus when diet and exercise changes alone have not been
enough to control
blood glucose (sugar).
Insulin is a hormone that enables body tissues to take glucose from
the blood
and to use it for energy or for storage for future use.
People with type 2 diabete
s d
o not make
enough insulin in their pancreas or thei

Productkenmerken

OBJECT 1
DIAGEMET XL 500MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 06-Apr-2017 | Genus
Pharmaceuticals
1. Name of the medicinal product
Diagemet XL 500 mg prolonged release tablets
2. Qualitative and quantitative composition
One prolonged release tablet contains 500mg metformin hydrochloride
corresponding to 390 mg
metformin base.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet
Off-white coloured, oval, biconvex, film coated tablets plain on both
sides.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
management and exercise alone does not result in adequate glycaemic
control. Diagemet XL prolonged
release tablets may be used as monotherapy or in combination with
other oral antidiabetic agents, or with
insulin.
4.2 Posology and method of administration
_Adults with normal renal function (GFR≥ 90mL/min): _
_Monotherapy and combination with other oral antidiabetic agents:_
• The usual starting dose is one tablet of Diagemet XL once daily.
• After 10 to 15 days the dose should be adjusted on the basis of
blood glucose measurements. A slow
increase of dose may improve gastro-intestinal tolerability. The
maximum recommended dose is 4 tablets
of Diagemet XL 500 mg daily.
• Dosage increases should be made in increments of 500 mg every
10-15 days, up to a maximum of 2000
mg once daily with the evening meal. If glycaemic control is not
achieved on 2000 mg once daily, 1000
mg twice daily should be considered, with both doses being given with
food. If glycaemic control is still
not achieved, patients may be switched to standard metformin tablets
to a maximum dose of 3000 mg
daily.
• In patients already treated with metformin tablets, the starting
dose of Diagemet XL should be
equivalent to the daily dose of metformin immediate release tablets.
In patients treated with metformin at
a dose above 2000 mg daily, switching to Diagemet XL is no