DRAMION 30 mg Modified-Release Tablet

Зміст інструкції

1. DRAMION 30 mg modified-release tablets
   1. What is DRAMION 30 mg and what is it used for
   2. What you need to know before you take 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
2. DRAMION 60 mg modified-release tablets
   1. What is DRAMION 60 mg modified-release tablets and what is it 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. Package contents and other information

DRAMION 30 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is DRAMION 30 mg and what is it used for

DRAMION 30 mg is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group).
DRAMION 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 you take DRAMION 30 mg

Do not take DRAMION30 mg

• if you are allergic to gliclazide or any of the excipients of DRAMION 30 mg (listed in section
• 6) or to other medicines of the same group (sulfonylureas), or to other related medicines (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type I);
• if you have ketone bodies and sugar in your urine (this means you may have diabetic ketoacidosis), if you are in a pre-comatose 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 paragraph “ Taking DRAMION 30 mg with other medicines”);
• if you are breastfeeding (see paragraph “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking DRAMION 30 mg.
Follow your doctor's instructions to achieve appropriate blood sugar levels. In addition to regularly taking the tablet, follow a dietary regime, exercise and, if necessary, reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in the urine) and also glycosylated hemoglobin (HbA1c) is necessary.
In the very first weeks of treatment, the risk of excessive decrease in blood sugar levels (hypoglycemia) may increase. For this reason, 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 eating habits,
• if your physical activity increases and carbohydrate intake is not adequate for this increase,
• if you drink alcohol, especially while fasting,
• if you are taking other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormonal disorders (thyroid gland dysfunction, or pituitary gland 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, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disorders, tremor, sensory disturbances, dizziness and a feeling of powerlessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, accelerated or irregular 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 disappear very quickly by taking sugar in various forms, for example glucose tablets, sugar lumps, fruit 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 symptoms recur.
Symptoms due to low blood sugar may not appear, be less noticeable, appear slowly, or you may not realize in time that blood sugar levels have dropped. This can happen if you are an elderly patient taking certain medicines (e.g. those that act on the central nervous system and beta-blockers).
If you are in stressful situations (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 reduced blood sugar levels, when you have not followed the treatment prescribed by your doctor, or in particularly stressful situations. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections and reduced efficiency.
If these symptoms occur, you should contact your doctor or pharmacist.
If you have a family history or a hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (red blood cell alteration), a decrease in hemoglobin levels and red blood cell breakdown (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 DRAMION30 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those available without a prescription, as these could interact with DRAMION 30 mg. The effect of reducing blood sugar levels of gliclazide may be increased and signs of low blood sugar levels may appear when taking one of the following medicines:

• other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (e.g. sulfonamides, 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 effects of lowering blood glucose levels due to 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 nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for the treatment of asthma or used during labor (salbutamol intravenously, ritodrine and terbutaline),
• medicines for the treatment of breast disorders, heavy menstrual bleeding, endometriosis (danazol),

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

DRAMION30 mg with food, drinks and alcohol
DRAMION 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
DRAMION 30 mg is not recommended during pregnancy. If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
You should not take DRAMION 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), too high (hyperglycemia) or if you develop vision problems as a result of these conditions. Keep in mind that you may harm yourself or others (e.g. when driving vehicles or using machinery). Ask your doctor if you can drive if you have:

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

3. How to take DRAMION 30 mg

Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
The dose is determined by the doctor based on your blood sugar levels and possibly in urine.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements
in blood sugar control may require adjustments in the doses of gliclazide.
The recommended dose is from 1 to 4 tablets (maximum 120 mg) in a single administration at
breakfast time. This depends on the response to treatment.
In case of combined therapy of DRAMION 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 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
Oral use.
Swallow the tablets whole without chewing. Take the tablet(s) with a glass of water, at
breakfast time (and preferably every day at the same time).
You should always take 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 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 sugar cubes) or sugary drinks followed by a substantial snack or a meal. If the patient is in
a state of unconsciousness, contact your doctor immediately and call emergency services.
The same should 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 DRAMION 30 mg
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of DRAMION 30 mg, take the next dose regularly at the same time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking DRAMION 30 mg
Since diabetes treatment usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Interruption 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 DRAMION 30 mg, 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 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 by taking sugar, contact your doctor immediately.
Liver disorders
Isolated cases of liver function abnormalities have occurred, which can cause yellowing of the
skin and eyes. If these appear, contact your doctor immediately. Generally the symptoms
disappear if the medicine is stopped. The doctor will decide whether to discontinue treatment.
Skin conditions
Skin reactions such as rash, redness, itching, hives, angioedema
(rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue which can
cause difficulty breathing) have been reported. Rashes may progress to a spread of blisters on
the whole body or to peeling of the skin.
In exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as
flu-like symptoms and rashes on the face, then widespread rashes with high fever.
Blood disorders
Symptoms such as paleness, prolonged bleeding, bruising, sore throat and fever have been reported, following a decrease in the number of blood cells (e.g. platelets, red blood cells and
white blood cells). These
symptoms usually disappear when treatment is stopped.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when DRAMION 30 mg is taken with a meal, as recommended.
Vision disorders
Visual ability 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 (e.g. jaundice) which in most cases have
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 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 which is stated on the box and on the blister. 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 DRAMION 30 mg contains
The active ingredient is gliclazide. Each tablet contains 30 mg of gliclazide in a modified

release formulation.
The excipients are: dibasic calcium phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.

Description of the appearance of DRAMION 30 mg and contents of the pack
The modified-release tablets of DRAMION 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

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

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 authorised in the Member States of the European Economic Area 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

DRAMION 60 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 they have the same symptoms as you, as it may 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 DRAMION 60 mg modified-release tablets is and what it is used for
• 2. What you need to know before you take 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 is DRAMION 60 mg modified-release tablets and what is it used for

DRAMION 60 mg modified-release tablets is a medicine that reduces blood sugar levels
(oral antidiabetic drug 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, exercise and weight loss alone are not
sufficient to maintain a correct blood sugar level.

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

Do not take DRAMION60 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 other related medicines (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), 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 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 instructions to achieve appropriate blood sugar levels. In addition to
regularly taking the tablet, follow a dietary regimen, engage in physical activity and, if necessary
reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and
possibly urine) and also of 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 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 for this increase,
• if you drink alcohol, especially while fasting,
• if you are taking 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 (thyroid gland dysfunction, or pituitary gland or adrenal cortex dysfunction),
• 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, aggressiveness, difficulty
concentrating, reduced attention and reaction time, depression, confusion, speech or vision disorders, tremors, sensory disturbances, dizziness and a feeling of powerlessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, increased 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 levels 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 the symptoms recur.
Symptoms due to low blood sugar levels 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, operations, fever, etc.) your doctor may
temporarily switch you 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 DRAMION 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 such symptoms, contact your doctor or pharmacist.
When gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics
called fluoroquinolones, a disturbance of glycaemia (low blood sugar and high
blood sugar levels) 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 an inherited 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.
The use of DRAMION 60 mg modified-release tablets is not recommended in children
due to the lack of data in this regard.

Other medicines and DRAMION60 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 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),
• pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol. The blood sugar-lowering effects due to 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 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
simultaneously with DRAMION 60 mg, a disturbance of glycaemia (low blood sugar
and high blood sugar levels) may occur, especially in elderly patients.
DRAMION 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 DRAMION 60 mg modified-release tablets.

DRAMION60 mg modified-release tablets with food, beverages and alcohol
DRAMION 60 mg modified-release tablets can be taken with non-alcoholic foods and beverages.
Drinking alcohol is not recommended as it can alter diabetes control unpredictably.

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

Driving and operating machinery
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
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).

DRAMION 60 mgmodified-release tablets contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

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

Dosage
Take this medicine exactly as your doctor or pharmacist has told you. 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 time. This depends on the response to treatment. The tablet can 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 each day).
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 DRAMION 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 more DRAMION 60 mg modified-release tablets than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency room immediately. 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 should 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 DRAMION 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 DRAMION 60 mg modified-release tablets, take the next dose regularly at
the same time.
Do not take a double dose to make up for a missed dose.

If you stop taking DRAMION 60 mg modified-release tablets
Because the treatment of diabetes usually lasts a lifetime, you should consult your doctor before stopping
treatment with this medicine. Stopping 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 “Warnings and precautions” section.
If left untreated, 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 by taking 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, 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. In exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported:
initially as flu-like symptoms and a 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 stopped.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when DRAMION 60 mg, modified-release tablets are 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: serious 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 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 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. Package contents and other information

What DRAMION 60 mgmodified-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 DRAMION 60 mgmodified-release tabletsand package contents
DRAMION 60 mg modified-release tablets are white, oblong, 15 mm long and 7 mm wide, with a
break line and with “ 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, 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 Roma

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 with the following
denominations:
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 60mg
Spain GLICLAZIDA SERVIER 60 mg
United Kingdom GLICLAZIDE SERVIER 60 mg MR