DIAMICRON 30 mg Модифицированные Таблетки

Содержание инструкции

1. DIAMICRON 30 mg modified-release tablets
   1. What is DIAMICRON 30 mg and what is it used for
   2. What you need to know before taking DIAMICRON 30 mg
   3. How to take DIAMICRON 30 mg
   4. Possible side effects
   5. How to store DIAMICRON 30 mg
   6. Contents of the pack and other information
2. DIAMICRON 60 mg modified-release tablets
   1. What is DIAMICRON 60 mg modified-release tablets and what is it used for
   2. What you need to know before taking DIAMICRON 60 mg modified-release tablets
   3. How to take DIAMICRON 60 mg modified-release tablets
   4. Possible side effects
   5. How to store DIAMICRON 60 mg modified-release tablets
   6. Package contents and other information

DIAMICRON 30 mg modified-release tablets

gliclazide

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DIAMICRON 30 mg is and what it is used for
• 2. What you need to know before you take DIAMICRON 30 mg
• 3. How to take DIAMICRON 30 mg
• 4. Possible side effects
• 5. How to store DIAMICRON 30 mg
• 6. Contents of the pack and other information

1. What is DIAMICRON 30 mg and what is it used for

DIAMICRON 30 mg is a medicine that reduces blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).
DIAMICRON 30 mg is indicated in adults for the treatment of certain types of diabetes (type 2 diabetes mellitus).

• When diet, exercise and weight loss alone are not sufficient to maintain a correct blood sugar level.

2. What you need to know before taking DIAMICRON 30 mg

Do not take DIAMICRON30 mg

• if you are allergic to gliclazide or to any of the excipients of DIAMICRON 30 mg (listed in section 6) or to other drugs of the same group (sulfonylureas), or to other related medicinal products (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this means you may have diabetic ketoacidosis), if you are in a pre-coma or diabetic coma;
• if you have a severe kidney or liver disease;
• if you are taking medicines for the treatment of fungal infections (miconazole) (see section “Other medicines and DIAMICRON 30 mg”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking DIAMICRON 30 mg.
Follow your doctor’s instructions to achieve appropriate blood sugar levels. In addition to
regularly taking the tablet, follow a dietary regimen, exercise and, if necessary
reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and
possibly in the urine) and also of glycosylated haemoglobin (HbA1c) is necessary.
In the first weeks of treatment, the risk of excessive decrease in blood sugar levels (hypoglycaemia) may increase. For this reason, careful medical monitoring is necessary.
Blood sugar levels may drop too low (hypoglycaemia):

• if you take meals irregularly or skip them completely,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and the intake of carbohydrates is not adequate to this increase,
• if you drink alcohol, especially while fasting,
• if you take other medicines or herbal remedies at the same time,
• if you take doses of gliclazide that are too high,
• if you suffer from particular hormonal disorders (dysfunction of the thyroid gland, or the pituitary gland or the adrenal cortex),
• if your kidney or liver function is severely impaired. In case of low blood sugar levels you may experience the following symptoms: headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disorders, tremor, sensory disturbances, dizziness and feeling of powerlessness.

You may also experience the following signs and symptoms: sweating, clammy skin, anxiety, acceleration or
irregularity of the heartbeat, increased blood pressure, sudden acute chest pain
that radiates to the surrounding areas (angina pectoris).
If blood sugar levels continue to drop, you may experience severe confusion (delirium),
convulsions, loss of self-control, shortness of breath, slowed heartbeat and loss of consciousness.
In most cases, the symptoms of low blood sugar levels disappear very
quickly by taking sugar in various forms, for example glucose tablets, sugar lumps,
juices or sweetened tea.
You should therefore always carry some sugar with you (glucose tablets, sugar lumps). Remember that
artificial sweeteners are not effective. Contact your doctor or the nearest hospital if
taking sugar does not help or if the symptoms recur.
Symptoms due to low blood sugar levels may not appear, be less evident,
appear slowly or you may not notice in time that blood sugar levels have decreased.
This can happen if you are an elderly patient taking certain medicines (for example those that
act on the central nervous system and beta-blockers).
If you are in stressful situations (accidents, surgery, fever, etc.) your doctor may
temporarily switch to insulin therapy.
Symptoms of high blood sugar levels (hyperglycaemia) may appear when gliclazide
has not yet sufficiently reduced blood sugar levels, when you have not followed the treatment
prescribed by your doctor, if you take preparations based on St. John’s wort (Hypericum

perforatum) (see section “Other medicines and DIAMICRON 30 mg”) or in particularly stressful situations.
These may include thirst, frequent urination, dry mouth, dry skin and itching,
skin infections and reduced efficiency.
If you experience such symptoms, you should contact your doctor or pharmacist.
When gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics
called fluoroquinolones, a glycaemic disorder (low blood sugar levels and high
blood sugar levels) may occur, especially in elderly patients. In this case, your doctor will remind you
of the importance of monitoring blood glucose levels.
If you have a family history or a hereditary condition of glucose-6-phosphate dehydrogenase
(G6PD) deficiency (alteration of red blood cells), a decrease in haemoglobin levels and a
breakage of red blood cells (haemolytic anaemia) may occur. Contact your doctor before taking this medicine.
With the use of other sulfonylureas, cases of acute porphyria have been reported, in patients affected by porphyria
(hereditary genetic disorders with accumulation of porphyrins or porphyrin precursors in the body).

Children and adolescents
The use of DIAMICRON 30 mg is not recommended in children due to lack of data in this regard.

Other medicines and DIAMICRON 30 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The effect of reducing blood sugar levels of gliclazide may be increased and signs of low blood sugar levels may appear when you take one of the following medicines:

• other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulphonamides, clarithromycin),
• medicines for the treatment of high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines used for the treatment of fungal infections (miconazole, fluconazole),
• medicines for the treatment of gastric or duodenal ulcers (H2 receptor antagonists),
• medicines for the treatment of depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar lowering effects of gliclazide may be weakened
and an increase in blood sugar levels may occur with the intake of one of the following
medicines:

• medicines for the treatment of disorders of the central nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for the treatment of asthma or used during labour (salbutamol intravenously, ritodrine and terbutaline),
• medicines for the treatment of breast diseases, heavy menstrual bleeding, endometriosis (danazol),
• preparations based on St. John’s wort - Hypericum perforatum. When a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as DIAMICRON 30 mg, a glycaemic disorder (low blood sugar levels and high blood sugar levels) may occur, especially in elderly patients.

DIAMICRON 30 mg may increase the effects of medicines that reduce blood clotting
(warfarin).
Consult your doctor before taking other medicines. If you are hospitalised, inform the medical staff that you are taking DIAMICRON 30 mg.

DIAMICRON30 mg with food, drinks and alcohol
DIAMICRON 30 mg can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it can alter diabetes control unpredictably.

Pregnancy and breastfeeding
DIAMICRON 30 mg is not recommended during pregnancy. If you are pregnant, suspect or
are planning a pregnancy, ask your doctor for advice before taking this medicine.
You should not take DIAMICRON 30 mg while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycaemia), too high (hyperglycaemia) or if you develop vision problems as
a result of these conditions. Keep in mind that you may harm yourself or others (for example when driving
motor vehicles or using machinery).
Ask your doctor if you can drive if you have:

• frequent episodes of low blood sugar levels (hypoglycaemia),
• minimal or no noticeable signs of low blood sugar levels (hypoglycaemia).

3. How to take DIAMICRON 30 mg

Dosage
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose is established by the doctor based on your blood sugar levels and possibly in urine.
Changes in external factors (weight loss, changes in lifestyle, stress) or improvements in
blood sugar control may require changes in gliclazide doses.
The recommended daily dose is from one to four tablets (maximum 120 mg) in a single
administration at breakfast time. This depends on the response to treatment.
DIAMICRON 30 mg is for oral use. Take the tablet(s) with a glass of water, at
breakfast time (and preferably every day at the same time). Swallow the tablet(s) whole. Do not
chew or crush them. You must always take a meal after taking the tablet(s).
In case of combined therapy of DIAMICRON 30 mg with metformin, an alpha-glucosidase inhibitor, a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin, the doctor
will establish the appropriate dose of each medicine for you.
Contact your doctor or pharmacist if you feel that your blood sugar levels are high
despite taking this medicine.

If you take more DIAMICRON 30 mg than you should
If you take too many tablets, contact your doctor immediately or the nearest hospital emergency room. The
signs of overdose are those of a lowering of the blood sugar rate (hypoglycemia)
described in paragraph 2. These symptoms can be improved by immediately taking some sugar (from 4 to 6
lumps) or sugary drinks followed by a substantial snack or meal. If the patient is unconscious, contact the doctor immediately and call emergency services.
The same must be done if someone, for example a child, has accidentally taken the product.
Do not administer food or drinks to unconscious patients.
Make sure there is always an informed person able to call a doctor in case of emergency.

If you forget to take DIAMICRON 30 mg
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of DIAMICRON 30 mg, take the next dose regularly at the same
time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking DIAMICRON 30 mg
Since diabetes treatment usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Discontinuation may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any doubts about the use of DIAMICRON 30 mg, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is a lowering of blood sugar level (hypoglycemia). For symptoms and signs see paragraph “Warnings and precautions”.
If not treated, these symptoms can progress to drowsiness, loss of consciousness and possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled with the intake of sugar, contact your doctor immediately.
Liver disorders
Isolated cases of liver function abnormalities have been reported, which can cause yellowing of the skin and eyes. If this occurs, contact your doctor immediately. Generally the symptoms disappear if the medicine is discontinued. The doctor will decide whether to discontinue treatment.
Skin disorders
Skin reactions such as rash, redness, itching and hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue that can cause difficulty breathing) have been reported. Rashes may progress to a spread of blisters all over the body or to peeling of the skin.
If you develop these symptoms, stop taking Diamicron 30 mg, consult your doctor immediately and inform them that you are being treated with this medicine.
In exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and skin rashes on the face, then widespread rashes with high fever.
Blood disorders
Following a decrease in the number of blood cells (for example platelets, red blood cells and white blood cells), symptoms such as pallor, prolonged bleeding, bruising, sore throat and fever have been reported.
These symptoms usually disappear when treatment is stopped.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when DIAMICRON 30 mg is taken with a meal, as recommended.
Eye disorders
Vision may be disturbed for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed: severe changes in the number of blood cells and allergic inflammation of the blood vessel walls, reduced levels of sodium in the blood (hyponatremia), symptoms of liver failure (for example jaundice) which in most cases disappeared after discontinuation of sulfonylureas, but which in isolated cases can lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DIAMICRON 30 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DIAMICRON 30 mg contains
The active ingredient is gliclazide. Each tablet contains 30 mg of gliclazide in a modified
release formulation.
The other ingredients are: dibasic calcium phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate,
anhydrous colloidal silica.

Description of the appearance of DIAMICRON 30 mg and contents of the pack
The modified release tablets of DIAMICRON 30 mg are white, oblong, imprinted on
both sides; “DIA 30” on one side and

on the other. The tablets are available in blisters contained in
packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 100 (single dose) 112, 120, 180 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex- France
Representative in Italy
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Roma

Manufacturers
Servier (Ireland) Industries Ltd.
Gorey Road,
Arklow, Co. Wicklow - Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the follow ing
names:
Austria DIAMICRON MR 30 mg
Belgium UNI DIAMICRON
Cyprus DIAMICRON MR 30 mg
Czech Republic DIAPREL MR
Denmark DIAMICRON UNO 30 mg
Estonia DIAPREL MR
France (RMS) DIAMICRON 30 mg
Greece DIAMICRON MR
Hungary DIAPREL MR
Iceland DIAMICRON UNO 30 mg
Ireland DIAMICRON MR 30 mg
Italy DIAMICRON 30 mg
Lithuania DIAPREL MR
Luxembourg DIAMICRON 30 mg
Netherlands DIAMICRON MR 30 mg
Poland DIAMICRON 30 mg
Portugal DIAMICRON LM 30 mg
Slovakia DIAPREL MR
Slovenia DIAPREL MR
Spain DIAMICRON 30 mg
United Kingdom DIAMICRON 30 mg MR

DIAMICRON 60 mg modified-release tablets

Gliclazide

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DIAMICRON 60 mg modified-release tablets is and what it is used for
• 2. What you need to know before you take DIAMICRON 60 mg modified-release tablets
• 3. How to take DIAMICRON 60 mg modified-release tablets
• 4. Possible side effects
• 5. How to store DIAMICRON 60 mg modified-release tablets
• 6. Contents of the pack and other information

1. What is DIAMICRON 60 mg modified-release tablets and what is it used for

DIAMICRON 60 mg modified-release tablets is a medicine that reduces the level of sugar in the
blood (an oral antidiabetic medicine belonging to the sulfonylurea group).
DIAMICRON 60 mg modified-release tablets is indicated in adults for the treatment of certain types of
diabetes (type 2 diabetes mellitus) when diet, exercise and weight loss alone are not
sufficient to maintain a correct level of sugar in the blood.

2. What you need to know before taking DIAMICRON 60 mg modified-release tablets

Do not take DIAMICRON 60 mg modified-release tablets:

• if you are allergic to gliclazide or any of the other ingredients of DIAMICRON 60 mg modified-release tablets (listed in section 6), or to other medicines of the same group (sulphonylureas), or to other related medicines (sulphonamide hypoglycaemics);
• if you have insulin-dependent (type 1) diabetes;
• if you have ketones and sugar in your urine (this means you may have diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines for the treatment of fungal infections (miconazole, see section “Other medicines and DIAMICRON 60 mg modified-release tablets”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking DIAMICRON 60 mg modified-release tablets.
Follow your doctor’s instructions to achieve appropriate blood sugar levels. In addition
to regularly taking the tablet, follow a diet, exercise and, if necessary
reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and
possibly urine) and also glycosylated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment, the risk of excessive decrease in blood sugar levels (hypoglycaemia) may increase. For this reason, careful medical monitoring is necessary.
Blood sugar levels may drop too low (hypoglycaemia):

• if you eat meals irregularly or skip meals completely,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and carbohydrate intake is not adequate for this increase,
• if you drink alcohol, especially when fasting,
• if you are taking other medicines or herbal remedies at the same time,
• if you take too high a dose of gliclazide,
• if you suffer from certain hormonal disorders (thyroid or pituitary gland dysfunction, or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

In case of low blood sugar, you may experience the following symptoms:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggressiveness, difficulty
concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, tremor, sensory disturbances, dizziness and feeling faint.
You may also experience the following signs and symptoms: sweating, clammy skin, anxiety, accelerated or
irregular heartbeat, increased blood pressure, sudden acute chest pain
that radiates to surrounding areas (angina pectoris).
If blood sugar levels continue to drop, you may experience severe confusion (delirium),
convulsions, loss of self-control, shortness of breath, slowed heartbeat and loss of consciousness.
In most cases, the symptoms of low blood sugar disappear very
quickly by taking sugar in various forms (for example, glucose tablets, sugar cubes,
sugary juices or tea).
You should therefore always carry some sugar with you (glucose tablets, sugar cubes). Remember that
artificial sweeteners are not effective. Contact your doctor or the nearest hospital if
taking sugar does not help or if symptoms recur.
Symptoms due to low blood sugar may not appear, be less noticeable,
appear slowly or you may not notice in time that blood sugar levels have dropped
excessively. This can happen if you are an elderly patient taking certain medicines (for example
those that act on the central nervous system and beta-blockers).
If you are in stressful situations (accidents, surgery, fever, etc.) your doctor may
temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may appear when gliclazide
has not yet sufficiently reduced blood sugar levels, when you have not followed the treatment
prescribed by your doctor, if you take St John's wort preparations ( Hypericum

perforatum) (see section “Other medicines and DIAMICRON 60 mg modified-release tablets”),
or in particularly stressful situations. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections and reduced efficiency.
If you experience these symptoms, contact your doctor or pharmacist.
When gliclazide is prescribed at the same time as antibiotics belonging to a class called fluoroquinolones, a disturbance in blood glucose (low blood sugar and high
blood sugar) may occur, especially in elderly patients. In this case, your doctor will remind
you of the importance of monitoring your blood glucose levels.
If you have a family history or hereditary condition of glucose-6-phosphate dehydrogenase
(G6PD) deficiency (red blood cell disorder), you may experience a decrease in haemoglobin levels and
red blood cell breakdown (haemolytic anaemia). Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with the use of other sulphonylureas, in patients affected by porphyria
(inherited genetic disorders with accumulation of porphyrins or porphyrin precursors in the body).
The use of DIAMICRON 60 mg modified-release tablets is not recommended in children due to
lack of data in this regard.

Other medicines and DIAMICRON 60 mg modified-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The blood sugar-lowering effect of gliclazide may be increased and signs of low blood sugar may appear when you take one of the following medicines:

• other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulphonamides, clarithromycin),
• medicines for the treatment of high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines used for the treatment of fungal infections (miconazole, fluconazole),
• medicines for the treatment of stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for the treatment of depression (monoamine oxidase inhibitors),
• pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar-lowering effects of gliclazide may be weakened
and blood sugar levels may increase with the intake of one of the following
medicines:

• medicines for the treatment of disorders of the nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for the treatment of asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
• medicines for the treatment of breast diseases, heavy menstrual bleeding, endometriosis (danazol),
• St John's wort - Hypericum perforatum-. When a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as DIAMICRON 60 mg, a disturbance in blood glucose (low blood sugar and high blood sugar) may occur, especially in elderly patients.

DIAMICRON 60 mg modified-release tablets may increase the effects of medicines that reduce
blood clotting (warfarin)
Consult your doctor before taking other medicines. If you are hospitalised, inform the medical staff that you are taking DIAMICRON 60 mg modified-release tablets.

DIAMICRON 60 mg modified-release tablets with food, drinks and alcohol
DIAMICRON 60 mg modified-release tablets can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it can alter diabetes control unpredictably.

Pregnancy and breastfeeding
DIAMICRON 60 mg modified-release tablets is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking
this medicine.
Do not take DIAMICRON 60 mg modified-release tablets while breastfeeding.

Driving and operating machinery
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), too high (hyperglycaemia) or if you develop vision problems as
a result of these conditions. Be aware that you may endanger yourself or others (for example when driving
vehicles or using machinery).
Ask your doctor if you can drive if you have:

• frequent episodes of low blood sugar (hypoglycaemia),
• minimal or no signs of low blood sugar (hypoglycaemia).

DIAMICRON 60 mg modified-release tablets contains lactose
If you have been diagnosed with lactose intolerance, contact your doctor before taking this
medicine.

3. How to take DIAMICRON 60 mg modified-release tablets

Dosage
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The dose is established by the doctor based on your blood sugar levels and possibly in urine.
Changes in external factors (weight loss, changes in lifestyle, stress) or improvements in
blood sugar control may require changes in the doses of gliclazide.
The recommended daily dose is from half to two tablets (maximum 120 mg) in a single
administration at breakfast. This depends on the response to treatment. The tablet
can be divided into equal parts.
DIAMICRON 60 mg modified-release tablets are for oral use. Take the tablet(s) with a
glass of water, at breakfast (and preferably every day at the same time).
Swallow the half tablet or the whole tablet(s). Do not chew or crush them.
You must always take a meal after taking the tablet(s).
In case of combined therapy of DIAMICRON 60 mg modified-release tablets with metformin, an
alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin, the doctor will establish the appropriate dose of each medicine for you.
Contact your doctor or pharmacist if you feel that your blood sugar levels are high
despite taking this medicine.

If you take moreDIAMICRON60 mg modified-release tablets than you should
If you take too many tablets, contact your doctor immediately or the nearest hospital emergency room. The
signs of overdose are those of a lowering of the blood sugar rate (hypoglycemia)
described in paragraph 2. These symptoms can improve by immediately taking some sugar (from 4 to 6
lumps) or sugary drinks followed by a substantial snack or a meal. If the patient is unconscious, contact the doctor immediately and call emergency services.
The same must be done if someone (for example a child) has taken the product accidentally.
Do not administer food or drinks to unconscious patients.
Make sure there is always an informed person able to call a doctor in case of emergency.

If you forget to take DIAMICRON 60 mg modified-release tablets
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of DIAMICRON 60 mg modified-release tablets, take the next dose regularly
at the same time.
Do not take a double dose to make up for the missed dose.

If you stop taking DIAMICRON 60 mg modified-release tablets
Since diabetes treatment usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Discontinuation may cause an increase in blood sugar levels (hyperglycemia) which increases the risk of developing diabetes complications.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is a lowering of blood sugar level (hypoglycemia). For symptoms and signs see the section “Warnings and precautions”.
If not treated, these symptoms can progress to drowsiness, loss of consciousness and possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled with the intake of sugar, contact your doctor immediately.
Hepatobiliary disorders
Isolated cases of liver function abnormalities have been reported, which can cause yellowing of the skin and eyes. If these appear, contact your doctor immediately. Generally the symptoms disappear if the medicine is discontinued. The doctor will decide whether to discontinue treatment.
Skin and subcutaneous tissue disorders
Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue that can cause difficulty breathing) have been reported. Rashes may progress to a spread of blisters all over the body or to skin peeling.
If you develop these symptoms, stop taking DIAMICRON 60 mg, consult your doctor immediately and inform him that you are being treated with this medicine.
In exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and rash on the face, then widespread rash with high fever.
Hematopoietic system disorders
Following a decrease in the number of blood cells (e.g. platelets, red blood cells and white blood cells), symptoms such as pallor, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually disappear when treatment is discontinued.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when DIAMICRON 60 mg, modified-release tablets are taken with a meal, as recommended.
Eye disorders
Visual impairment may be disturbed for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed: severe changes in the number of blood cells and allergic inflammation of the blood vessel walls, reduced levels of sodium in the blood (hyponatremia), symptoms of liver failure (for example jaundice) which in most cases disappeared after discontinuation of sulfonylureas, but which in isolated cases can lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at

5. How to store DIAMICRON 60 mg modified-release tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DIAMICRON 60 mg modified-release tablets contain
The active ingredient is gliclazide. One modified-release tablet contains 60 mg of gliclazide.
The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.

Description of the appearance of DIAMICRON 60 mg modified-release tablets and package contents
The modified-release tablets of DIAMICRON 60 mg are white, oblong, 15 mm long and 7 mm wide, with a fracture line and with “DIA 60” imprinted on both sides. The tablets are available in blisters contained in packs of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 100 (single dose), 112, 120, 180 or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:
Marketing authorisation holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France
Representative in Italy
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Rome

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
or
Servier (Ireland) Industries Ltd.
Gorey Road,
Arklow - Co. Wicklow - Ireland
or
Anpharm Przedsiebiorstwo Farmaceutyczne S.A.
Ul. Annopol 6B
03-236 Warsaw – Poland
or
Laboratorios Servier S.L.
Avenida de los Madroños, 33
28043 Madrid – Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria DIAMICRON MR 60 mg
Belgium UNI DIAMICRON 60 mg
Bulgaria DIAPREL MR 60 mg
Croatia DIAPREL MR 60 mg
Cyprus DIAMICRON MR 60 mg
Czech Republic DIAPREL MR 60 mg
Denmark DIAMICRON UNO 60 mg
Estonia DIAPREL MR 60 mg
France (RMS) DIAMICRON 60mg
Germany DIAMICRON UNO 60 mg
Greece DIAMICRON MR 60 mg
Hungary DIAPREL MR 60 mg
Ireland DIAMICRON MR 60 mg
Italy DIAMICRON 60 mg
Latvia DIAPREL MR 60 mg
Lithuania DIAPREL MR 60 mg
Luxembourg DIAMICRON 60 mg
Malta DIAMICRON MR 60 mg
Netherlands DIAMICRON MR 60 mg
Poland DIAPREL MR
Portugal DIAMICRON LM 60 mg
Romania DIAPREL MR 60 mg
Slovakia DIAPREL MR 60 mg
Slovenia DIAPREL MR 60 mg
Spain DIAMICRON 60 mg