Diamicron

PACKAGE LEAFLET

Package leaflet: information for the patient

DIAMICRON 30 mg modified-release tablets

gliclazide
Please read this leaflet carefully before taking this medicine, because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 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

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

DIAMICRON 30 mg is a medicine that lowers blood sugar levels (an oral antidiabetic agent 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, physical exercise, and weight loss alone are not sufficient to maintain adequate blood sugar control.

2. What you should know before taking DIAMICRON 30 mg

Do not take DIAMICRON 30 mg

• if you are allergic to gliclazide or any of the excipients in DIAMICRON 30 mg (listed in section 6), or to other drugs of the same group (sulfonylureas), or to related medicines (sulfonamide hypoglycemics);
• if you have insulin-dependent diabetes (type 1);
• if you have ketones and sugar in your urine (indicating possible diabetic ketoacidosis), or if you are in a pre-coma or diabetic coma state;
• if you have severe kidney or liver disease;
• if you are taking medicines for 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 advice to achieve appropriate blood sugar levels. In addition to taking the tablet regularly, follow a proper diet, engage in physical activity, and if necessary, lose weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) and glycosylated hemoglobin (HbA1c) is required.
During the first weeks of treatment, there may be an increased risk of excessively low blood sugar levels (hypoglycemia). Therefore, careful medical monitoring is necessary.
Your blood sugar level may drop too low (hypoglycemia):

• if you eat 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 adjusted accordingly,
• if you consume alcohol, especially on an empty stomach,
• if you take other medicines or herbal remedies concurrently,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

Symptoms of low blood sugar may include: headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, trembling, sensory disturbances, dizziness, and feelings of helplessness.

Additional signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden acute chest pain radiating to surrounding areas (angina pectoris).
If blood sugar continues to fall, you may experience severe confusion (delirium), seizures, loss of self-control, shortness of breath, slowed heartbeat, and loss of consciousness.
In most cases, symptoms of low blood sugar disappear quickly after taking sugar in various forms, such as glucose tablets, sugar cubes, sweetened juices, or sugary tea.
Therefore, you should always carry 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 of low blood sugar may not appear, may be less obvious, may develop slowly, or you may not notice in time that your blood sugar has dropped.
This may occur if you are an elderly patient taking certain medications (e.g., those acting on the central nervous system or beta-blockers).
If you are under stress (e.g., accidents, surgery, fever), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered blood sugar levels, when you have not followed your prescribed treatment, when you take St. John’s wort (Hypericum perforatum) (see section “Other medicines and DIAMICRON 30 mg”), or during periods of particular stress.
These symptoms may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced efficiency.
If you experience such symptoms, contact your doctor or pharmacist.
When gliclazide is prescribed together with medicines belonging to a class of antibiotics called fluoroquinolones, blood sugar disturbances (low or high blood sugar) may occur, especially in elderly patients. In such cases, your doctor will emphasize the importance of monitoring blood glucose levels.
If you have a family history or hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), a drop in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders involving 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.

Other medicines and DIAMICRON 30 mg
Inform 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 occur, when taking any of the following medicines:

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

The blood glucose-lowering effects of gliclazide may be weakened, and blood sugar levels may rise, when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline),
• medicines for breast disorders, heavy menstrual bleeding, endometriosis (danazol),
• St. John’s wort (Hypericum perforatum) preparations.

When a medicine belonging to a class of antibiotics called fluoroquinolones is taken together with DIAMICRON 30 mg, blood sugar disturbances (low or high blood sugar) may occur, especially in elderly patients.

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

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

Pregnancy and breastfeeding
DIAMICRON 30 mg is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
You must not take DIAMICRON 30 mg while breastfeeding.

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

• frequent episodes of low blood sugar (hypoglycemia),
• minimal or non-obvious symptoms of low blood sugar (hypoglycemia).

3. How to take DIAMICRON 30 mg

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose based on your blood sugar levels and, if possible, urine sugar levels.
Changes in external factors (weight reduction, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the gliclazide dose.
The recommended daily dose is one to four tablets (maximum 120 mg) taken as a single dose at breakfast time. This depends on your response to treatment.
DIAMICRON 30 mg is for oral use. Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day). Swallow the tablet(s) whole. Do not chew or crush them. You must always take a meal after taking the tablet(s).
If you are being treated with a combination of DIAMICRON 30 mg and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose for each medicine.
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 or the nearest hospital emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycemia), as described in section 2. These symptoms may improve by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately and call emergency services.
The same applies if someone, for example a child, has accidentally taken the product.
Do not give food or drink to unconscious patients.
Ensure that there is always someone informed nearby who can call a doctor in an emergency.

If you forget to take DIAMICRON 30 mg
It is important to take the medicine every day, as regular treatment is more effective.
If you forget a dose of DIAMICRON 30 mg, take your next dose at the usual time and in the usual amount.
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 must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), increasing the risk of developing diabetes complications.
If you have any questions 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 drop in blood sugar levels (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness, and possibly coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.

Liver disorders
Isolated cases of liver function abnormalities have occurred, which may cause yellowing of the skin and eyes (jaundice). If these occur, contact your doctor immediately. Symptoms usually disappear when the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin disorders
Skin reactions such as rash, redness, itching, hives, blisters, and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat, or tongue, which may cause breathing difficulties) have been reported. Skin rashes may progress to widespread blistering over the body or skin peeling.
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 very rare cases, signs of severe hypersensitivity reactions (DRESS syndrome) have been reported: initially flu-like symptoms and facial rash, followed by widespread rash with high fever.

Blood disorders
Symptoms such as paleness, prolonged bleeding, bruising, sore throat, and fever have been reported due to reduced numbers of blood cells (e.g. platelets, red and white blood cells).
These symptoms usually resolve when treatment is discontinued.

Digestive disturbances
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation.
These effects are reduced when DIAMICRON 30 mg is taken with food, as recommended.

Eye disorders
Vision may be temporarily disturbed, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonamides, the following adverse events have been observed: severe changes in blood cell counts and allergic inflammation of blood vessel walls (vasculitis), reduced blood sodium levels (hyponatraemia), and signs of liver dysfunction (e.g. jaundice). These are mostly reversible upon discontinuation of sulphonamides, but in rare cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the carton and blister after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines must 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 30 mg contains
The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
The other components are: dibasic calcium phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.
Description of the appearance of DIAMICRON 30 mg and package contents
The modified-release tablets of DIAMICRON 30 mg are white, oblong, and printed on both sides;
“DIA 30” on one side and blank on the other.

The tablets are available in blisters packed in boxes containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 100 (unit 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
Local 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 under the following 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

Patient Information Leaflet: Information for the patient

DIAMICRON 60 mg modified-release tablets

Gliclazide
Please read all of this leaflet carefully before taking this medicine, because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIAMICRON 60 mg modified-release tablets are and what they are 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. Contents of the pack and other information

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

DIAMICRON 60 mg modified-release tablets is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulphonylurea 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, physical exercise, and weight loss alone are not sufficient to maintain adequate blood sugar control.

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 to any of the excipients of DIAMICRON 60 mg modified-release tablets (listed in section 6), or to other drugs in the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent (type 1) diabetes;
• if you have ketones and sugar in your urine (indicating possible diabetic ketoacidosis), pre-coma, or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines for 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 advice to achieve appropriate blood glucose levels. In addition to regularly taking the tablet, maintain a proper diet, engage in physical activity, and, if necessary, lose weight.
Regular monitoring of blood glucose levels (and possibly urine glucose) and glycosylated hemoglobin (HbA1c) is required during treatment with gliclazide.
During the first weeks of treatment, the risk of excessively low blood glucose levels (hypoglycemia) may increase. Therefore, careful medical monitoring is necessary.
Your blood glucose level may drop too low (hypoglycemia):

• if you eat irregularly or skip meals,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and carbohydrate intake is not adjusted accordingly,
• if you consume alcohol, especially on an empty stomach,
• if you take other medicines or herbal remedies simultaneously,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

Symptoms of low blood glucose may include:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, tremor, sensory disturbances, dizziness, and feelings of helplessness.
Additional signs and symptoms may include: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden sharp chest pain radiating to surrounding areas (angina pectoris).
If blood glucose continues to drop, you may experience severe confusion (delirium), seizures, loss of self-control, shortness of breath, slowed heartbeat, and loss of consciousness.
In most cases, symptoms of low blood glucose resolve quickly by taking sugar in various forms (e.g., glucose tablets, sugar lumps, sugary juices, or sweetened tea).
You should always carry 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 symptoms recur.
Symptoms of low blood glucose may not appear, may be less obvious, may develop slowly, or you may not notice in time that your blood glucose has dropped too low. This may occur if you are elderly or taking certain medicines (e.g., those acting on the central nervous system or beta-blockers).
If you are under stress (e.g., accidents, surgery, fever), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood glucose, when you do not follow your prescribed treatment, when you take St. John’s wort (Hypericum perforatum) (see section “Other medicines and DIAMICRON 60 mg modified-release tablets”), or during periods of significant stress. These symptoms may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced efficiency.
If you experience such symptoms, contact your doctor or pharmacist.
When gliclazide is taken together with medicines belonging to a class of antibiotics called fluoroquinolones, a disturbance in blood glucose (low or high blood glucose) may occur, especially in elderly patients. In such cases, your doctor will emphasize the importance of monitoring blood glucose levels.
If you have a family history or an inherited condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), a drop in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders characterized by 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.

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 glucose-lowering effect of gliclazide may be increased, and signs of low blood glucose may occur, when taking any of the following medicines:

• other medicines used to treat high blood glucose (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for gastric or duodenal ulcers (H\₂-receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood glucose-lowering effects of gliclazide may be reduced, and blood glucose levels may rise, when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline),
• medicines for breast disorders, heavy menstrual bleeding, or endometriosis (danazol),
• St. John’s wort (Hypericum perforatum).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken together with DIAMICRON 60 mg, a disturbance in blood glucose (low or high blood glucose) may occur, especially in elderly patients.

DIAMICRON 60 mg modified-release tablets may enhance the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before taking any other medicines. If you are hospitalized, inform 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 may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
DIAMICRON 60 mg modified-release tablets are not recommended during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
You must not take DIAMICRON 60 mg modified-release tablets while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood glucose level is too low (hypoglycemia), too high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may endanger yourself or others (e.g., when driving vehicles or operating machinery).
Ask your doctor whether you may drive if you have:

• frequent episodes of low blood glucose (hypoglycemia),
• minimal or non-obvious symptoms of low blood glucose (hypoglycemia).

DIAMICRON 60 mg modified-release tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

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

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose is determined by your doctor according to your blood glucose levels and, if possible, glucose levels in urine.
Changes in external factors (weight reduction, lifestyle changes, stress) or improvements in blood glucose control may require adjustments in gliclazide dosage.
The recommended daily dose ranges from half to two tablets (maximum 120 mg), taken as a single dose at breakfast time. This depends on your response to treatment. The tablet may 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 time (and preferably at the same time each day).
Swallow half a tablet or the whole tablet(s) whole. Do not chew or crush them.
You must always take a meal after taking the tablet(s).
If you are being treated with a combination of DIAMICRON 60 mg modified-release tablets and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose for each medicine.
Contact your doctor or pharmacist if you feel that your blood glucose levels are high despite taking this medicine.

If you take more DIAMICRON 60 mg modified-release tablets than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycaemia) described in section 2. These symptoms may be relieved by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately and call emergency services.
The same applies if someone (e.g. a child) has accidentally taken the product.
Do not give food or drink to unconscious patients.
Ensure that there is always an informed person available who can call a doctor in an emergency.

If you forget to take DIAMICRON 60 mg modified-release tablets
It is important to take the medicine every day, as regular treatment is more effective.
If, however, you miss a dose of DIAMICRON 60 mg modified-release tablets, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking DIAMICRON 60 mg modified-release tablets
Since diabetes treatment usually lasts a lifetime, you must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood glucose levels (hyperglycaemia), increasing the risk of developing diabetes complications.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most commonly observed side effect is a drop in blood sugar levels (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness, and possibly coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.

Hepatobiliary disorders
Isolated cases of liver function abnormalities have been reported, which may cause yellowing of the skin and eyes (jaundice). If these occur, contact your doctor immediately. Symptoms usually resolve when the medicine is discontinued. Your doctor will decide whether to stop treatment.

Skin and subcutaneous tissue disorders
Skin reactions such as rash, redness, itching, urticaria, blisters, and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat, or tongue, which may cause breathing difficulties) have been reported. Rashes may progress to widespread blistering or skin peeling.
If you develop these symptoms, stop taking DIAMICRON 60 mg, contact your doctor immediately, and inform them that you are being treated with this medicine.
In rare cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially resembling flu-like symptoms and facial rash, followed by widespread rash with high fever.

Blood and lymphatic system disorders
Following a decrease in blood cell counts (e.g. platelets, red and white blood cells), symptoms such as paleness, prolonged bleeding, bruising, sore throat, and fever have been reported. These symptoms usually resolve when treatment is discontinued.

Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation.
These effects are reduced when DIAMICRON 60 mg modified-release tablets are taken with a meal, as recommended.

Eye disorders
Vision may be temporarily impaired, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following adverse events have been observed: severe changes in blood cell counts and allergic inflammation of blood vessel walls (vasculitis), reduced blood sodium levels (hyponatraemia), signs of liver failure (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylureas, but in rare instances may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:

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 stated on the packaging and blister after "Exp.".
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must 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 substance is gliclazide. One modified-release tablet contains 60 mg of gliclazide.
The other components are: monohydrate lactose, maltodextrin, hypromellose, magnesium stearate,
anhydrous colloidal silica.

Description of the appearance of DIAMICRON 60 mg modified-release tablets and pack contents
DIAMICRON 60 mg modified-release tablets are white, oblong, 15 mm long and 7 mm wide, with a breakline and "DIA 60" engraved on both sides. The tablets are available in blisters packed in boxes containing 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 100 (unit dose), 112, 120, 180 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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

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 authorized in the European Economic Area member states 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

This patient information leaflet was last approved in MM/YYYY