GLEUKOS 30 mg Modified-Release Tablet

Зміст інструкції

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

GLEUKOS 30 mg modified-release tablets, 60 mg modified-release tablets

Gliclazide
Generic medicine

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

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

Contents of this leaflet:

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

1. What is GLEUKOS and what is it used for

GLEUKOS is a medicine that reduces blood sugar levels (an oral antidiabetic medicine
that belongs to the sulfonylurea group).
GLEUKOS is indicated in adults for the treatment of some types of diabetes (type 2 diabetes mellitus

• 2) 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 GLEUKOS

Do not take GLEUKOS

• if you are allergic to gliclazide or any of the other ingredients of this medicine (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), if you are in a pre-comatose or diabetic coma state
• if you have a severe kidney or liver disease
• if you are taking medicines for the treatment of fungal infections (miconazole, see paragraph “ Other medicines and GLEUKOS”);
• if you are breastfeeding (see paragraph “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking GLEUKOS.
Follow your doctor's instructions to achieve appropriate blood sugar levels.
This means that in addition to regularly taking the tablet, you must follow a dietary regime, exercise and, if necessary, lose weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in the urine) and also of 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 the intake of carbohydrates 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 reduced.

In case of low blood sugar, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggressiveness, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disorders, tremors, sensory disturbances, dizziness and a feeling of powerlessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, acceleration or irregularity of the heartbeat, increased blood pressure, 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 hypoglycemia disappear very quickly by taking sugar in various forms, for example glucose tablets, sugar cubes, juices or sweetened 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 should recur.
Symptoms due to low blood sugar may not appear, be less evident, 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, surgeries, fever, etc.), your doctor may temporarily prescribe alternative 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, if you take preparations based on St. John's wort ( Hypericum perforatum) (see paragraph “Other medicines and Gleukos”) or in particularly stressful situations. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections and reduced physical efficiency.
If such symptoms occur, you should contact your doctor or pharmacist.
Disorders of blood glucose levels (low blood glucose levels, high blood glucose levels) can occur when gliclazide is prescribed at the same time with other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients.
If you have a family history or a hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (alteration of red blood cells), a decrease in hemoglobin levels and a breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents
The use of GLEUKOS is not recommended in children and adolescents due to a lack of data.

Other medicines and GLEUKOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The blood sugar lowering effect of gliclazide may be increased and signs of low blood sugar may appear when 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),
• pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol. The blood sugar lowering effects due to gliclazide may be weakened and a rise 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 diseases, heavy menstrual bleeding, endometriosis (danazol)
• St. John's Wort preparations - Hypericum perforatum-

Disorders of blood glucose levels (hypoglycemia and hyperglycemia) can occur when a medicine belonging to a class of antibiotics called Fluoroquinolones is taken together with Gleukos, especially in elderly patients.
GLEUKOS 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 GLEUKOS.

GLEUKOS with food, drinks and alcohol
GLEUKOS can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it can alter the control of diabetes in an unpredictable way.

Pregnancy and breastfeeding

Pregnancy
GLEUKOS is not recommended during pregnancy. If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Breastfeeding
You should not take GLEUKOS while breastfeeding.

Driving and operating machinery
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 operating machinery). Ask your doctor if you can drive if you have:

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

3. How to take GLEUKOS 30 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
The dose is established by the doctor based on your blood sugar levels and possibly
in the urine. Changes in external factors (e.g. weight loss, changes in lifestyle,
stress) or improvements in blood sugar control may require changes in
gliclazide doses.
For 30 mg tablets: The recommended dose is from 1 to 4 tablets (maximum 120 mg) in
a single administration at breakfast. This depends on the response to
treatment.
For 60 mg tablets: The tablet can be divided into two equal parts. The recommended dose
is from half a tablet to 2 tablets (maximum 120 mg) in a single administration at
breakfast. This depends on the response to treatment.
In case of combined therapy of GLEUKOS 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.

Method and route of administration
Oral use.
Swallow your half tablet or the whole tablets. Do not chew or break them. Take
the tablet(s) with a glass of water, at breakfast (and preferably
every day at the same time).
You must always take a meal after taking the tablet(s).

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

If you forget to take GLEUKOS
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of GLEUKOS, take the next dose regularly at the same
time. Do not take a double dose to compensate for forgetting the dose.

If you stop taking GLEUKOS
Since diabetes treatment usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Discontinuation may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any doubts about the use of GLEUKOS, contact 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 section “Warnings and precautions”. If not
treated, 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.
Blood disorders
Decrease in the number of blood cells (e.g. platelets, red blood cells and white blood cells). This can
cause:

• paleness
• prolonged bleeding
• bruising
• sore throat
• fever These symptoms usually disappear when treatment is stopped.

Liver disorders
Isolated cases of abnormalities in liver function 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 stopped. The doctor will decide whether to discontinue treatment.
Skin conditions
Skin reactions such as the following have been reported:

• skin rash
• redness
• itching
• hives
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue which can cause difficulty breathing). Skin rashes may progress to a spread of blisters all over the body or to a peeling of the skin.
• In exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and skin rashes on the face, then widespread rashes with high fever.

Digestive disorders

• Abdominal pain or discomfort
• nausea, vomiting
• indigestion
• diarrhea
• constipation. These effects are reduced when GLEUKOS is taken with a meal, as recommended, see section 3 “How to take Gleukos”.

Vision disorders
Visual ability may be impaired 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; reduction
of sodium levels 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 the address
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store GLEUKOS

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging, on the box and
on the blister after the wording EXP. The expiry date refers to the last day of that month.
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 to
protect the environment.

6. Contents of the pack and other information

What GLEUKOS contains

• The active ingredient is gliclazide. Each tablet contains 30 mg or 60 mg of gliclazide in modified-release formulation.
• The excipients are: lactose monohydrate, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of GLEUKOS and content of the pack
Gleukos 30 mg modified-release tablets are white, oval, biconvex, measuring 5x11 mm marked with a “G” on one side.
Gleukos 60 mg modified-release tablets are white, oval, biconvex, measuring 7x15 mm
with an inscription on both sides, marked with a “G” on one side and a “60” on the other side.
Pack size:
[30 mg modified-release tablets]
60 tablets
[60 mg modified-release tablets]
30 and 60 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Marketing Authorisation Holder
S.F. Group S.r.l
Via Tiburtina, 1143
00156 Rome

Manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations:
DK: Gleukos
IT: Gleukos