|
DIAMICRON®
MR |
Diamicron
MR an original compound
from LES LABORATOIRES SERVIER,
France – represents an
important discovery because
this product is the first anti-diabetic
agent with both metabolic and
vascular properties. Diamicron
MR not only controls
blood glucose effectively, but
also combats microthrombosis,
the common factor for vascular
complications of diabetes mellitus. |
| Composition: |
Each
scored modified release tablet
contains:
gliclazide B.P. …….
30 mg.
excipients…… q.s. |
| Mode
of Action: |
Diamicron
MR restores the early
peak of insulin secretion and
ensures glycaemic control throughout
24 hours.
Diamicron MR
combats microthrombosis by:
- decreasing platelet hyperadhesiveness
and hyperaggregation,
- increasing fibrinolytic
activity,
- normalizing prostaglandin
metabolism,
- scavenging free-radicals.
Diamicron MR
is a modified release matrix
formulation which releases the
gliclazide in such a manner
that the treatment taken once
daily with breakfast controls
high blood glucose over 24 hours. |
| Indications: |
This medication
is recommended in adults for
non insulin-dependent diabetes
(type 2), in association with
dietary measures and with physical
exercise, when these measures
alone are not sufficient to
obtain normal blood glucose
levels (levels of sugar in the
blood). |
| Contraindications: |
This medication
SHOULD NEVER BE USED in the
following cases:
-
if you
are allergic to gliclazide
or to one of the excipients,
to other medicines of the
same group (sulfonylureas),
to sulphonamides;
- if you have type 1 diabetes;
-
in the
case of diabetes with keto-acidosis
or diabetic precoma;
-
if you
suffer from severe liver
or kidney insufficiency;
-
if you
are currently taking a treatment
with miconazole (refer to
drug interactions);
- if you are breast feeding
Unless your
doctor advises you to the contrary,
it is generally inadvisable
to combine this medication with
phenylbutazone and danazol (refer
to drug interactions).
Take special precautions
with Diamicron MR.
|
| Warnings: |
Hypoglycaemia:
This medicine is susceptible
to cause episodes of hypoglycemia
(decrease of blood sugar levels):
in the case of sweating, intense
hunger, trembling, pallor, visual
disturbances, feeling of malaise,
abnormal behaviour, immediately
eat sugar or something containing
sugar and inform your doctor.
Hypoglycaemia
occurs due to a strict or poorly
balanced diet, by prolonged
or strenuous exercise, by the
intake of alcohol or during
use of other hypoglycaemic drugs
(drug interactions).
In consequence, treatment with
a hypoglycaemic sulphonylurea
requires:
-
a regular
diet: it is important to
eat regular meals, including
breakfast, never to miss
a meal, due to an increase
in the risk of the onset
of hypoglycaemia caused
by an inadequate diet or
a sugar imbalance.
-
precise
regularity in the administration
of treatment: it is important
to take the treatment regularly,
once a day, preferably at
breakfast time (refer to
method and route of administration).
Every
administration of Diamicron
MR must be followed by a meal. |
| Precautions: |
Follow as closely
as possible the diet prescribed
to you by your doctor, Regularly
carry out the laboratory tests
as prescribed or recommended
by your doctor,
Inform your doctor in the following
cases:
-
in the
case of surgery, trauma,
fever or infection, difficulty
in eating;
- in the case of a planned
pregnancy;
-
in the
case of administration of
other drugs, in particular
an anti-inflammatory agent,
beta-blocker, corticoid.
Also inform
your dentist of your treatment. |
| Adminstration
of Diamicron MR, modified release
tablet with drinks: |
Avoid alcohol
and alcoholic drinks. |
| Pregnancy
And Lactation: |
Pregnancy:
If you are pregnant, your diabetes
should be treated with insulin.
Tell your doctor if you wish
to become pregnant. If you are
pregnant, inform your doctor
so that he may prescribe a more
suitable treatment for you.
If you discover that you are
pregnant while taking this medication,
you should discontinue your
treatment.
CONSULT YOUR DOCTOR OR PHARMACIST
FOR ADVICE BEFORE TAKING MEDICINE.
Lactation:
This drug in contra-indicated
when breast-feeding.
CONSULT YOUR DOCTOR OR PHARMACIST
FOR ADVICE BEFORE TAKING MEDICINE.
|
| Driving
or Operating Machinery: |
Patients
should be made aware of the
symptoms of hypoglycaemia and
should be careful when driving
or operating machinery. |
| Drug
Interactions: |
Certain
interactions with other drugs
must be avoided as they can
cause significant changes in
blood glucose levels. Danazol
(hormonal drug), corticoids,
diuretics, miconazole (even
if bought without a prescription)
and alcohol. |
| Dosage
and Method of Administration: |
Dosage:
The usual daily dosage is 1
to 4 tablets per day as a single
dose. It is recommended that
the drug be taken at breakfast
time.
Method and route of
administration: Oral
route. The tablets must be taken
whole with half a glass of water
just before breakfast. It is
preferable to take this drug
before breakfast in order to
avoid or to minimize the possible
onset of digestive disorders.
Frequency of administration:
The once daily administration
of Diamicron MR,
modified release tablet must
always be followed by a meal.
Duration of treatment:
Follow your doctor’s prescription.
IN ALL CASES, DOCTOR’S
PESCRIPTION SHOULD BE STRICTLY
FOLLOWED.
|
| Overdose: |
The
administration of an excessive
dose results in hypoglycaemia
(refer to Warnings) which should
be treated immediately by the
administration of sugar (4 to
6 lumps). If the patient is
unconscious, immediately inform
the doctor and call the emergency
services.
IMMEDIATELY CONSULT YOUR DOCTOR
OR YOUR PHARMACIST. |
| What
to do If you have forgotten to
take One or More Doses: |
Do
not take a double dose to compensate
for the single dose that you
forgot to take. |
| Effects
Which May Appear When Treatment
Is Discontinued: |
There
is a risk of an imbalance in
your diabetes (hyperglycaemia:
increased blood glucose levels). |
| Adverse
Reactions: |
As
with all sulphonylureas, Diamicron
MR may induce hypoglycaemia.
Cutaneous reactions which regress
after discontinuation of the
drug have been reported in rare
cases. |
| Presentation: |
Box
of 5 x 4 x 10 tablets |
| Instructions
for Use/ Handling: |
Do
not use after the expiry date
indicated on the box. Keep out
of reach and sight from children. |
| Correspondent: |
Serdia
Pharmaceuticals (India) Pvt. Ltd.,
Serdia House, Off Dr. S.S.Rao
Road, Parel, Mumbai -400 012
At: H-19, M.I.D.C., Waluj, Aurangabad-431
133 |
| As
prescribing information may vary
from country to country, please
refer to the complete data sheet
supplied in your country. |
