Gleukos

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Gliclazide
Generic medicine
Please read this entire 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 give it to others, 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, contact 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 taking 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 GLEUKOS is and what it is used for

GLEUKOS is a medication that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea group).
GLEUKOS 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 GLEUKOS

Do not take GLEUKOS

• if you are allergic to gliclazide or to any of the other ingredients of this medicine (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), if you are in 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 GLEUKOS”)
• if you are breastfeeding (see section “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 proper diet, engage in physical activity, and, if necessary, reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) and also glycated hemoglobin (HbA1c) is required.
During the first few 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 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 adequately adjusted,
• if you consume alcohol, especially on an empty stomach,
• if you take other medicines or herbal remedies at the same time,
• 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 reduced.

If your blood sugar level is too 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 weakness.
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 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 hypoglycemia disappear quickly by taking sugar in any form, for example glucose tablets, sugar cubes, sugary fruit 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 prescribe an alternative insulin treatment.
Symptoms of high blood sugar (hyperglycemia) may occur 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 GLEUKOS”), or during periods of particular stress. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced physical performance.
If you experience such symptoms, contact your doctor or pharmacist.
Blood glucose disturbances (low blood glucose, high blood glucose) may occur when gliclazide is taken together with other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients.
If you have a family history or hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), you may experience a drop in hemoglobin levels and breakdown of red blood cells (hemolytic anemia). Contact your doctor before taking this medicine.

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

Other medicines and GLEUKOS
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 (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 (H2-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 preparations – Hypericum perforatum

Blood glucose disturbances (hypoglycemia and hyperglycemia) may occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken together with GLEUKOS, especially in elderly patients.
GLEUKOS may enhance the effects of medicines that reduce blood clotting (e.g., warfarin).
Consult your doctor before taking any other medicines. If you are admitted to hospital, inform medical staff that you are taking GLEUKOS.

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

Pregnancy and breastfeeding
Pregnancy
GLEUKOS is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Breastfeeding
You must not take GLEUKOS 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. 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-obvious signs of low blood sugar (hypoglycemia)

3. How to take GLEUKOS 30 mg

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage
The dose is determined by your doctor according to your blood sugar levels, and possibly urine sugar levels. Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazide.
For 30 mg tablets: 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.
For 60 mg tablets: The tablet may be divided into two equal parts. The recommended dose is from half a tablet to 2 tablets (maximum 120 mg) taken as a single dose at breakfast time. This depends on your response to treatment.
If you are being treated with a combination of GLEUKOS 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 of each medicine for you.
Contact your doctor or pharmacist if you feel that your blood sugar levels remain high despite taking this medicine.
Method and route of administration
For oral use.
Swallow your half tablet or whole tablets. Do not chew or break them. Take the tablet(s) with a glass of water at breakfast time (and preferably at the same time every day).
You must always eat a meal after taking the tablet(s).
If you take more GLEUKOS 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, for example a child, has accidentally taken the product. Do not give food or drink to unconscious patients.
Ensure that someone informed is always available to call a doctor in case of emergency.
If you forget to take GLEUKOS
It is important to take the medicine every day, as regular treatment is more effective.
If, however, you forget a dose of GLEUKOS, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking GLEUKOS
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 questions about the use of GLEUKOS, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly observed side effect is a lowering of blood sugar levels (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions”. If 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.

Blood disorders
Decrease in the number of blood cells (e.g. platelets, red and white blood cells). This may cause:

• paleness
• prolonged bleeding
• bruising
• sore throat
• fever

These symptoms usually disappear when treatment is discontinued.

Liver 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 generally resolve if 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 the eyelids, face, lips, mouth, throat or tongue, which may cause difficulty breathing). Skin rashes may progress to widespread blistering over the body or skin peeling.
• In rare cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and facial rash, followed by widespread rash with high fever.

Digestive disorders

• abdominal pain or discomfort
• nausea, vomiting
• indigestion
• diarrhoea
• constipation

These effects are reduced when GLEUKOS is taken with food, as recommended. See section 3 “How to take Gleukos”.

Vision disorders
Vision may be blurred for a short time, 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; reduction in blood sodium levels (hyponatraemia); signs of liver failure (e.g. jaundice), which in most cases resolved 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/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 sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack, carton, and blister after the word 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 protect the environment.

6. Package contents and other information

What GLEUKOS contains

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

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

Marketing Authorization Holder:
Marketing Authorization Holder
S.F. Group S.r.l
Via Tiburtina, 1143
00156 Roma
Manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
DK: Gleukos
IT: Gleukos

This patient information leaflet was last approved on