DRAMION

PACKAGE LEAFLET: INFORMATION FOR THE USER

DRAMION 30 mg modified-release tablets

Gliclazide
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Contents of this leaflet:

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

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

DRAMION 30 mg is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulphonylurea group).
DRAMION 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 appropriate blood sugar levels.

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

Do not take DRAMION 30 mg

• if you are allergic to gliclazide or to any of the excipients of DRAMION 30 mg (listed in section 6), or to other drugs of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent diabetes (type I);
• if you have ketones and sugar in your urine (this indicates 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 “Taking DRAMION 30 mg with other medicines”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking DRAMION 30 mg.
Follow your doctor's advice to achieve appropriate blood sugar levels. In addition to taking the tablet regularly, adhere to a proper diet, engage in physical activity, and reduce weight if necessary.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) and also glycated hemoglobin (HbA1c) is required.
In the first few weeks of treatment, there may be an increased risk of excessive lowering of blood sugar levels (hypoglycemia). Therefore, careful medical monitoring is necessary.
Blood sugar levels may drop too low (hypoglycemia):

• if you eat meals irregularly or skip them completely,
• if you are fasting,
• if you are malnourished,
• if you change your dietary 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 gland, pituitary gland, or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

If your blood sugar level is low, you may experience the following symptoms:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, trembling, sensory disturbances, dizziness, and feelings of helplessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden acute chest pain radiating to surrounding areas (angina pectoris).
If blood sugar 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 sugar disappear quickly by taking sugar in various forms, for example glucose tablets, sugar cubes, sugary juices, or sweetened tea.
You should therefore 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 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 under stress (e.g., accidents, surgery, fever, etc.), 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, or during periods of particular stress. These may include thirst, frequent need to urinate, dry mouth, dry skin and itching, skin infections, and reduced efficiency.
If such symptoms occur, contact your doctor or pharmacist.
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 rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
The use of DRAMION 30 mg is not recommended in children due to lack of data.

Other medicines and DRAMION 30 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as they may interact with DRAMION 30 mg. 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 (e.g., sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines used to treat 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).

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

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

Pregnancy and breastfeeding
DRAMION 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 DRAMION 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 (hypoglycemia), too high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may harm 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 sugar (hypoglycemia),
• minimal or not obvious signs of low blood sugar (hypoglycemia).

3. How to take DRAMION 30 mg

Dosage
Always take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, you should consult your doctor or pharmacist.
The dose is determined by your doctor according to your blood sugar levels and possibly sugar levels in urine.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements
in blood sugar control may require adjustments in gliclazide dosage.
The recommended dose is 1 to 4 tablets (maximum 120 mg) taken as a single dose at breakfast time.
This depends on your response to treatment.
If DRAMION 30 mg is used in combination with 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 of each medicine for you.
Contact your doctor or pharmacist if you feel that your blood sugar levels are high
despite taking this medicine.

Method and route of administration
For oral use.
Swallow the tablets whole without chewing them. Take the tablet(s) with a glass of water at breakfast time (and preferably every day at the same time).
You must always eat a meal after taking the tablet(s).

If you take more DRAMION 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 levels (hypoglycaemia) described in section 2. These symptoms can be improved 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 drinks to unconscious patients.
Ensure that there is always an informed person available who can call a doctor in case of emergency.

If you forget to take DRAMION 30 mg
It is important to take the medicine every day, as regular treatment is more effective.
However, if you miss a dose of DRAMION 30 mg, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking DRAMION 30 mg
Since diabetes treatment usually lasts a lifetime, you must consult your doctor before stopping
treatment with this medicine. Stopping treatment may cause blood sugar levels to rise (hyperglycaemia), increasing the risk of developing diabetes complications.
If you have any doubts about how to use DRAMION 30 mg, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 possible 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 been reported, which may cause yellowing of the skin and eyes. If these occur, contact your doctor immediately. Symptoms usually resolve when the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

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

Blood disorders
Symptoms such as pallor, prolonged bleeding, bruising, sore throat and fever have been reported following a reduction in blood cells (e.g. platelets, red and white blood cells). These symptoms usually resolve when treatment is discontinued.

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

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

Reporting of side effects
If you experience any side effects, 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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DRAMION 30 mg

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister. 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 DRAMION 30 mg contains
The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
The excipients are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of DRAMION 30 mg and package contents
DRAMION 30 mg modified-release tablets are white, oblong-shaped, and printed on both sides; DIA 30 on one side and on the other. The tablets are available in blisters packed in boxes containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
I.F.B. STRODER S.r.l.
Via di Ripoli, 207/v
50126 Florence, Italy

Manufacturers:
Les Laboratoires Servier Industrie
905 Route de Saran
45520 Gidy (France)
or
Servier (Ireland) Industries Ltd.
Gorey Road,
Arklow, Co. Wicklow, Ireland
or
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Ul. Annopol 6B
03-236 Warszawa - Poland
or
IBERFAR Indústria Farmacêutica SA.
rua Consiglieri Pedroso (IBERFAR), n° 123,
2734-501 Queluz de Baixo - Portugal
or
Qualiti (Burnley) Limited
Talbot Street Briercliffe
Burnley
Lancashire BB10 2JY - United Kingdom
or
SERVIER S.L.
Avd. de los Madroños, 33
28043 Madrid - Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Gliclazid Uno Servier
France: Gliclazide Servier 30 mg
Italy: DRAMION 30 mg
Poland: GLUCTAM MR 30 mg
United Kingdom: Gliclazide Servier 30 mg MR

This leaflet was last approved on

Patient information leaflet

DRAMION 60 mg modified-release tablets

Gliclazide
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

DRAMION 60 mg modified-release tablets is a medicine that lowers blood sugar levels
(oral antidiabetic agent belonging to the sulfonylurea group).
DRAMION 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 levels.

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

Do not take DRAMION 60 mg modified-release tablets:

• if you are allergic to gliclazide or any of the excipients of DRAMION 60 mg modified-release tablets (listed in section 6), or to other medicines of 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 DRAMION 60 mg modified-release tablets”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking DRAMION 60 mg modified-release tablets.
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 reduce weight if necessary.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) and glycosylated hemoglobin (HbA1c) is required.
In the first weeks of treatment, the risk of excessively low blood sugar levels (hypoglycemia) may increase. 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.

If your blood sugar level is too low, 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 disturbances, tremor, sensory disturbances, dizziness, and feeling of helplessness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden sharp 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 rapidly after taking sugar in various forms (e.g. glucose tablets, sugar cubes, sugary juices or tea).
You should therefore 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 too low. This may occur if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system or beta-blockers).
If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar, when you have not followed your prescribed treatment, when you take St. John’s wort (Hypericum perforatum) (see section “Other medicines and DRAMION 60 mg modified-release tablets”), or during periods of particular stress. These 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, blood sugar disturbances (low or high blood sugar) may occur, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring blood glucose levels.
If you have a personal or family history of, or a hereditary condition of, glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), a drop in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
The use of DRAMION 60 mg modified-release tablets is not recommended in children due to lack of data.

Other medicines and DRAMION 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 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-_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 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).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken together with DRAMION 60 mg, blood sugar disturbances (low or high blood sugar) may occur, especially in elderly patients.
DRAMION 60 mg modified-release tablets may enhance the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before taking other medicines. If you are admitted to hospital, inform the medical staff that you are taking DRAMION 60 mg modified-release tablets.

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

Pregnancy and breastfeeding
DRAMION 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 DRAMION 60 mg modified-release tablets while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level 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 may drive if you have:

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

DRAMION 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 DRAMION 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 sugar levels, and possibly your 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 half to two tablets (maximum 120 mg) taken once daily with breakfast. This depends on your response to treatment. The tablet may be divided into equal parts.
DRAMION 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 every day).
Swallow the half 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 therapy of DRAMION 60 mg modified-release tablets together with 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 remain high despite taking this medicine.

If you take more DRAMION 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), as described in section 2. These symptoms may be relieved by taking sugar immediately (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact a 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 DRAMION 60 mg modified-release tablets
It is important to take the medicine every day, as regular treatment is more effective.
If you forget a dose of DRAMION 60 mg modified-release tablets, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking DRAMION 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 sugar levels (hyperglycaemia), increasing the risk of developing diabetes complications.
If you have any doubts about using this medicine, 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 potentially 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 if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin and subcutaneous tissue disorders
Skin reactions such as rash, redness, itching, urticaria, and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat or tongue, which may cause difficulty breathing) have been reported. Rashes may progress to widespread blistering or skin peeling. In rare cases, signs of severe hypersensitivity reactions (DRESS syndrome) 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 pallor, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation.
These effects are reduced when DRAMION 60 mg, modified-release tablets are taken with food, as recommended.

Eye disorders
Vision may be blurred for a short period, 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 sodium levels in the blood (hyponatraemia), signs of liver failure (e.g. jaundice). These usually resolve after discontinuation of sulphonylureas, but in rare cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, 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 www.agenziafarmaco.gov.it/it/responsabili.

5. How to store DRAMION 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 carton 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 DRAMION 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 DRAMION 60 mg modified-release tablets and package contents
DRAMION 60 mg modified-release tablets are white, oblong, 15 mm long and 7 mm wide, with a score line and "60" imprinted 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, 112, 120, 180 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
I.F.B. STRODER S.r.l.
Via Luca Passi, 85
00166 Rome, Italy

Manufacturer:
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 GLUCTAM MR 60 mg
Denmark GLICLAZID UNO SERVIER 60 mg
France (RMS) GLICLAZIDE SERVIER 60 mg
Hungary GLUCTAM 60 mg
Italy DRAMION 60 mg
Latvia GLICLAZIDE MR SERVIER 60 mg
Netherlands GLICLAZIDE SERVIER 60 mg
Slovakia GLUCTAM MR 60 mg
Spain GLICLAZIDA SERVIER 60 mg
United Kingdom GLICLAZIDE SERVIER 60 mg MR

This Patient Information Leaflet was last approved in {MM/YYYY}