Diamicron 30mg MR tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

Necessity Supplies Ltd

ATC code:

A10BB09

INN (International Name):

Gliclazide

Dosage:

30mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201

Patient Information leaflet

PATIENT INFORMATION LEAFLET
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
Your medicine is called Diaprel MR 30mg Tablets but will be refered to
as
Diaprel throughout this leaflet.
WHAT IS IN THIS LEAFLET:
What Diaprel is and what it is used for
What you need to know before you take Diaprel
How to take Diaprel
Possible side effects
How to store Diaprel
Contents of the pack and other information
WHAT DIAPREL IS AND WHAT IT IS USED FOR
Diaprel is a medicine that reduces blood sugar levels (oral
antidiabetic
medicine belonging to the sulfonamides group).
Diaprel is used in a certain form of diabetes (type 2 diabetes
mellitus) in
adults, when diet, exercise and weight loss alone do not have an
adequate
effect on keeping blood sugar at the correct level.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAPREL
DO NOT TAKE DIAPREL
*
if you are allergic to gliclazide or any of the other ingredients of
Diaprel
(listed in section 6), or to other medicines of the same group
(sulfonylureas), or to other related medicines (hypoglycaemic
(sulfonamides),
*
if you have insulin-dependent diabetes (type 1),
*
if you have ketone bodies and sugar in your urine (this may mean you
have diabetic keto-acidosis), a diabetic pre-coma or coma,
*
if you have severe kidney or liver disease,
*
if you are taking medicines to treat fungal infections (miconazole)
(see
Section “Other medicines and Diaprel”);
*
if you are breastfeeding (see section “Pregnancy and
breastfeeding”).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Diaprel. You should obse

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diamicron 30mg MR Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains gliclazide 30 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified release tablet.
White, oblong tablet engraved on both faces, ‘DIA 30’ on one face
and
on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin-dependent
diabetes (type 2) in adults when dietary measures,
physical exercise and weight loss alone are not sufficient to control
blood
glucose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose may vary from 1 to 4 tablets per day, _i.e_. from 30 to
120 mg taken
orally in a single intake at breakfast time.
It is recommended that the tablet(s) be swallowed whole.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
As with any hypoglycaemic agent, the dose should be adjusted according
to the
individual patient's metabolic response (blood glucose, HbAlc).
•
Initial dose
The recommended starting dose is 30 mg daily.
If blood glucose is effectively controlled, this dose may be used for
maintenance
treatment.
If blood glucose is not adequately controlled, the dose may be
increased to 60, 90 or
120 mg daily, in successive steps. The interval between each dose
increment should
be at least 1 month except in patients whose blood glucose has not
reduced after two
weeks of treatment. In such cases, the dose may be increased at the
end of the second
week of treatment.
The maximum recommended daily dose is 120 mg.
•
Switching from Diamicron 80 mg tablets to Diamicron 30 mg modified
release tablets:
1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30
mg MR
Tablets.
Consequently
the
switch
can
be
performed
provided
a
careful
blood
monitoring.
•
Switching from another oral antidiabetic agent to Diamicron 30 mg MR
Tablets:
Diamicron 30 mg MR Tablets can be used to replace other oral
antidiabetic agents.
The dosage and the half-life of the previous