Skip to Content

DIAMICRON MR 30MG TABLETS

Active substance: GLICLAZIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
S 589 LEAFLET Diamicron 20121123

PACKAGE LEAFLET: INFORMATION FOR USER

DIAMICRON MR 30mg TABLETS
(gliclazide)
Your medicine is known as Diamicron MR 30mg Tablets but will be
referred to as Diamicron MR throughout the following leaflet.
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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Diamicron MR is and what it is used for
2. Before you take Diamicron MR
3. How to take Diamicron MR
4. Possible side effects
5. How to store Diamicron MR
6. Further information
1. WHAT DIAMICRON MR IS AND WHAT IT IS USED FOR
Diamicron MR is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the sulphonylurea group).
Diamicron MR 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.

The following signs and symptoms may also occur: sweating,
clammy skin, anxiety, fast or irregular heart beat, high blood
pressure, sudden strong pain in the chest that may radiate into
nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from
considerable confusion (delirium), develop convulsions, lose self
control, your breathing may be shallow and your heart beat slowed
down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly
when you consume some form of sugar, e.g. glucose tablets, sugar
cubes, sweet juice, sweetened tea.
You should therefore always carry some form of sugar with you
(glucose tablets, sugar cubes). Remember that artificial sweeteners
are not effective. Please contact your doctor or the nearest hospital
if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or
develop very slowly or you are not aware in time that your blood
sugar level has dropped. This may happen if you are an elderly
patient taking certain medicines (e.g. those acting on the central
nervous system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations,
fever etc.) your doctor may temporarily switch you to insulin
therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when
gliclazide has not yet sufficiently reduced the blood sugar, when
you have not complied with the treatment plan prescribed by your
doctor or in special stress situations. These may include thirst,
frequent urination, dry mouth, dry itchy skin, skin infections and
reduced performance.
If these symptoms occur, you must contact your doctor or
pharmacist.
If you have a family history of or know you have the hereditary
condition glucose-6-phosphate dehydrogenase (G6PD) deficiency
(abnormality of red blood cells), lowering of the haemoglobin level
and breakdown of red blood cells (haemolytic anaemia) can occur.
Contact your doctor before taking this medicinal product.
Diamicron MR is not recommended for use in children due to a lack
of data.

2. BEFORE YOU TAKE DIAMICRON MR
Do not take Diamicron MR

Taking other medicines



if you are allergic (hypersensitive) to gliclazide or any of the
other ingredients of Diamicron MR, or to other medicines of the
same group (sulphonylureas), or to other related medicines
(hypoglycaemic sulphonamides);

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, as they may interact with your Diamicron
MR.



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;

The blood sugar lowering effect of gliclazide may be strengthened
and signs of low blood sugar levels may occur when one of the
following medicines is taken:



if you have severe kidney or liver disease;



if you are taking medicines to treat fungal infections
(miconazole, see Section “Taking other medicines”);



other medicines used to treat high blood sugar (oral
antidiabetics or insulin),



antibiotics (e.g. sulphonamides),



medicines to treat high blood pressure or heart failure (beta
blockers, ACE-inhibitors such as captopril, or enalapril),



medicines to treat fungal infections (miconazole, fluconazole),



medicines to treat ulcers in the stomach or duodenum (H2
receptor antagonists),

You should observe the treatment plan prescribed by your doctor to
achieve proper blood sugar levels. This means, apart from regular
tablet intake, you observe the dietary regimen, have physical
exercise and, where necessary, reduce weight.



medicines to treat depression (monoamine oxidase inhibitors),



painkiller or antirheumatics (phenylbutazone, ibuprofen),



medicines containing alcohol.

During gliclazide treatment regular monitoring of your blood (and
possibly urine) sugar level and also your glycated haemoglobin
(HbA1c) is necessary.

The blood glucose lowering effect of gliclazide may be weakened
and raised blood sugar levels may occur when one of the following
medicines is taken:



if you are breastfeeding (see Section “Pregnancy and
breastfeeding”).

Take special care with Diamicron MR

In the first few weeks of treatment the risk of having reduced blood
sugar levels (hypoglycaemia) may be increased. So particularly
close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:



medicines to treat disorders of the central nervous system
(chlorpromazine),



medicines reducing inflammation (corticosteroids),



medicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine and terbutaline),



medicines to treat breast disorders, heavy menstrual bleeding
and endometriosis (danazol).



if you take meals irregularly or skip meals altogether,



if you are fasting,



if you are malnourished,



if you change your diet,



if you increase your physical activity and carbohydrate intake
does not match this increase,



if you drink alcohol, especially in combination with skipped
meals,



if you take other medicines or natural remedies at the same
time,

Taking Diamicron MR with food and drink



if you take too high doses of gliclazide,



if you suffer from particular hormone-induced disorders
(functional disorders of the thyroid gland, of the pituitary gland
or adrenal cortex),

Drinking alcohol is not recommended as it can alter the control of
your diabetes in an unpredictable manner.



if your kidney function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting, weariness, sleep
disorders, restlessness, aggressiveness, poor concentration,
reduced alertness and reaction time, depression, confusion, speech
or visual disorders, tremor, sensory disturbances, dizziness, and
helplessness.

Diamicron MR may increase the effects of medicines which reduce
blood clotting (e.g. warfarin).
Consult your doctor before you start taking another medicinal
product. If you go into hospital tell the medical staff you are taking
Diamicron MR.

Diamicron MR can be taken with food and non-alcoholic drinks.

Pregnancy and breastfeeding
Diamicron MR is not recommended for use during pregnancy. If you
are planning a pregnancy, or become pregnant, inform your doctor
so that he may prescribe a more suitable treatment for you.
You must not take Diamicron MR while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

Liver disorders

Your ability to concentrate or react may be impaired if your blood
sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if
you develop visual problems as a result of such conditions.

There have been isolated reports of abnormal liver function, which
can cause yellow skin and eyes. If you get this, see your doctor
immediately. The symptoms generally disappear if the medicine is
stopped. Your doctor will decide whether to stop your treatment.

Bear in mind that you could endanger yourself or others (e.g. when
driving a car or using machines).
Please ask your doctor whether you can drive a car if you:

Skin disorders



have frequent episodes of low blood sugar (hypoglycaemia),

Skin reactions have been reported such as:



have few or no warning signals of low blood sugar
(hypoglycaemia).



Rash



Redness



Itching

3. HOW TO TAKE DIAMICRON MR



Hives

Dosage

Severe reactions may also appear.

Always take Diamicron MR exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

Digestive disorders

The dose is determined by the doctor, depending on your blood and
possibly urine sugar levels.



Stomach pain or discomfort

Change in external factors (e.g. weight reduction, change in life
style, stress) or improvements in the blood sugar control may
require changed gliclazide doses.



Feeling or being sick



Indigestion



Diarrhoea

The usual dose is one to four tablets (maximum 120 mg) in a single
intake at breakfast time. This depends on the response to
treatment.
If a combination therapy of Diamicron MR with metformin, an alpha
glucosidase inhibitor or insulin is initiated your doctor will determine
the proper dose of each medicine individually for you.
Please talk to your doctor or pharmacist if you have the impression
that Diamicron MR is acting too strongly or not strongly enough.
Methods and routes of administration
Oral use.
Swallow your tablets whole. Do not chew them.
Take your tablet(s) with a glass of water at breakfast time (and
preferably at the same time each day).
You must always eat a meal after taking your tablet(s).

 Constipation
These effects are reduced when Diamicron MR is taken with a
meal as recommended, See Section 3 “HOW TO TAKE”.
Eye disorders
Your vision may be affected for a short time especially at the start of
treatment. This effect is due to changes in blood sugar levels.
As for other sulphonylureas, the following adverse events have
been observed: cases of severe changes in the number of blood
cells and allergic inflammation of the wall of blood vessels,
reduction in blood sodium (hyponatraemia), symptoms of liver
impairment (e.g. jaundice) which in most cases disappeared after
withdrawal of the sulphonylurea, but may lead to life-threatening
liver failure in isolated cases.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

If you take more Diamicron MR than you should
If you take too many tablets, contact your doctor or the nearest
hospital Accident & Emergency department immediately. The signs
of overdose are those of low blood sugar (hypoglycaemia)
described in Section 2. The symptoms can be helped by taking
sugar (4 to 6 lumps) or sugary drinks straight away, followed by a
substantial snack or meal. If the patient is unconscious immediately
inform a doctor and call the emergency services. The same should
be done if somebody, e.g. a child, has taken the product
unintentionally. Unconscious patients must not be given food or
drink.

5. HOW TO STORE DIAMICRON MR
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Diamicron MR should be stored in the original package.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



It should be ensured that there is always a pre-informed person that
can call a doctor in case of emergency.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

If you forget to take Diamicron MR
It is important to take your medicine every day as regular treatment
works better.
However, if you forget to take a dose of Diamicron MR, take the
next dose at the usual time. Do not take a double dose to make up
for a forgotten dose.

6. FURTHER INFORMATION


Each modified release tablet contains 30mg of the active
ingredient, gliclazide.

If you stop taking Diamicron MR



Diamicron MR also contains the following inactive ingredients:
calcium hydrogen phosphate dihydrate, maltodextrin,
hypromellose, magnesium stearate and anhydrous colloidal
silica.

What Diamicron MR contains

As the treatment for diabetes is usually life long, you should discuss
with your doctor before stopping this medicinal product.
Stopping could cause high blood sugar (hyperglycaemia).
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

What Diamicron MR looks like and contents of the pack


Diamicron MR are white oblong tablets marked ‘DIA 30’ on one
side and with a logo on the other.

4. POSSIBLE SIDE EFFECTS



Like all medicines Diamicron MR can cause side effects, although
not everybody gets them.

Diamicron MR Tablets are available as blister packs of 30 or 60
tablets.

Product Licence holder

The most commonly observed side effect is low blood sugar
(hypoglycaemia). For symptoms and signs see "Take special
care" in "Section 2 BEFORE YOU TAKE".

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

If left untreated these symptoms could progress to drowsiness, loss
of consciousness or possibly coma. If an episode of low blood
sugar is severe or prolonged, even if it is temporarily controlled by
eating sugar, you should seek immediate medical attention.

This product is manufactured by Les Laboratoires, Servier Industrie,
905 route de Saran, 45520 Gidy, France.
POM

PL No: 19488/0589

Blood disorders:

Leaflet revision date: 23 November 2012

Decrease in the number of cells in the blood has been reported
(e.g. platelets, red and white blood cells).

Diamicron is a registered trade mark of Biofarma, France.

This may cause:


Paleness



Prolonged bleeding



Bruising



Sore throat



Fever

These symptoms usually vanish when the treatment is
discontinued.

S 589 LEAFLET Diamicron 20121123

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide