Diadeon

Do not take Diadeon modified-release tablets in the following cases:

• If you are allergic (hypersensitivity) to gliclazide, any other component of Diadeon modified-release tablets (see the list in Section 6), other medications of this group (sulfonylureas) or other related medications (hypoglycemic sulfonamides).
• If you have insulin-dependent diabetes (1 type).
• If ketone bodies and sugar are found in your urine (this may mean that you have diabetic ketoacidosis), in case of diabetic coma or precoma.
• If you have a serious kidney or liver disease.
• If you take medications for treatment of fungal infections (miconazole, see Section Diadeon modified-release tablets and other medications).
• If you are a breastfeeding woman (see Section Pregnancy and breastfeeding).

Warnings and precautions

Consult your doctor before taking Diadbeton modified-release tablets.

To normalize your blood sugar level, you must follow the treatment plan prescribed by your doctor. It means that in addition to regular intake of tablets, you should keep to a diet, do physical exercises and lose weight when it is necessary.

In the course of the treatment with gliclazide blood sugar level (and possibly urine) as well as glycated hemoglobin level (HbA1c) should be regularly monitored.

During the first weeks of treatment there is an increased risk of blood sugar level lowering (hypoglycemia), so intense medical monitoring is necessary.

A decrease in sugar level (hypoglycemia) may occur in the following cases:

• If you eat irregularly or skip meals, if you refuse to eat.
• If you are malnourished.
• If you have changed food structure.
• If you increase physical activity and do not adapt the intake of carbohydrates.
• If you drink alcohol, especially together with skipping meals.
• If you take other pharmaceutical or natural drugs at the same time.
• If you take too high doses of gliclazide.
• If you have some hormone-dependent disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex).
• If you have a serious kidney or liver function abnormality.

If your blood sugar level is too low, you may experience the following symptoms:
headache, feeling of sharp hunger, nausea, vomiting, fatigue, sleep disorder, anxiety, aggressiveness, poor concentration, poor attention and decreased reaction time, depression, confusion, speech or vision disorders, tremor, sensory impairments, dizziness, and helplessness.
The following signs and clinical aspects may also occur: excessive sweating, cold and watery skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain which may shoot up the nearest body parts (angina pectoris).

If blood sugar level continues to drop, you may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, and you may lose consciousness as well.

In most cases, clinical aspects of low blood sugar level pass very quickly after you take sugar in any form (for example, glucose tablets, lumps of sugar, sweet juice, sweet tea).
Therefore, you should always take some sugar with you, in any form (glucose tablets, lumps of sugar). Remember that artificial sweeteners are ineffective. If taking sugar is of no help or clinical aspects come again, contact your doctor or the nearest hospital.

Clinical aspects of low blood sugar level may not occur at all, or be less evident, or appear very slowly, or you may not immediately realize that your sugar level has dropped. Elderly patients taking certain medications (for example, medicinal products that affect the central nervous system and beta blockers) may come up against it.

If you are in a stressful situation (for example, an accident, surgery, fever, etc.) a doctor may temporarily prescribe insulin therapy for you.

Clinical aspects of high blood sugar level (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood sugar level yet, if you fail to follow the treatment plan prescribed by your doctor, if you take extracts of St. John’s wort (Hypericum perforatum) (see Section Diadeon modified-release tablets and other medications), or in some stressful situations. Among the possible aspects: thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and decreased performance capability. If you have such signs, contact your doctor or pharmacist.

When gliclazide is prescribed simultaneously with antibiotics from the fluoroquinolone group, especially in one’s old age, abnormalities of blood glucose level (blood sugar level increase or decrease) may occur. In this case your doctor will remind you how important it is to control blood glucose level.

If you or your relatives have inherited deficiency of glucose-6-phosphate dehydrogenase (G6PD, abnormality in erythrocytes) you may experience a decrease of hemoglobin level and a drop in RBC count (hemolytic anemia). Contact your doctor before taking this medication.

Patients with porphyria (inherited genetic diseases when porphyrins or porphyrin precursors accumulate in the body) have had cases of acute porphyria when taking some other sulfonylurea medications.

It is not recommended to prescribe Diadeon modified-release tablets to children due to lack of relevant data.

Diadeon modified-release tablets and other medications

Tell your doctor or pharmacist which medications you are taking, have recently taken or could take.

The hypoglycemic effect of gliclazide may increase and clinical aspects of low blood sugar level may appear if you take one of the following drugs:

• Other medicinal products used to treat high blood sugar level (preoral anti-diabetic medications, GLP-1 receptor agonists or insulin).
• Antibiotics (sulfonamides, clarithromycin), medications used to treat high blood pressure or heart failure (beta blockers, ACE inhibitors, such as captopril or enalapril).
• Medicinal products for treatment of mycotic infections (miconazole, fluconazole).
• Medicinal products for treatment of gastric or duodenal ulcer (H2-receptor antagonists).
• Medicinal products for depression treatment (monoamine oxidase inhibitors).
• Painkillers or anti-rheumatic agents (phenylbutazone, ibuprofen).
• Alcohol-containing medications.

The hypoglycemic effect of gliclazide may become weaker and blood sugar level may rise if you take one of the following medications:

• Medicinal products for treatment of central nervous system disorders (chlorpromazine).
• Medicinal products which reduce inflammation (corticosteroids).
• Medicinal products for treatment of asthma or used in childbirth (intravenous salbutamol, ritodrin and terbutalin).
• Medicinal products for treatment of breast disorders, excessive menstruation and endometriosis (danazol).
• Extracts of St. John’s wort (Hypericum perforatum).

When Diadeon modified-release tablets are taken simultaneously with antibiotics from the fluoroquinolone group, especially in one’s old age, abnormalities of blood glucose level (blood sugar level increase or decrease) may occur.

Diadeon modified-release tablets can enhance the effect of medications which reduce blood clotting ability (warfarin).

Consult your doctor before you start taking another medication. If you apply to the hospital, warn the medical staff that you are taking Diadeon modified-release tablets.

Intake of Diadeon modified-release tablets with food, drink, and alcohol

Diadeon modified-release tablets can be taken with food and soft drinks.
Alcohol consumption is not recommended as it can interfere with diabetes management in an unpredictable way.

Pregnancy and breastfeeding

Intake of Diadeon modified-release tablets is not recommended during pregnancy. If you are pregnant, going to become pregnant, or going to deliver a baby, consult your doctor before taking this medicinal product.

Do not take Diadeon modified-release tablets if you are a breastfeeding woman.

Effects on ability to drive and use machines

Your ability to concentrate or quick reaction capability may be reduced if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if your vision deteriorates due to these conditions. Remember that you may pose a danger to yourself or others (for example, when driving a car or operating machinery).

Ask your doctor if you can drive vehicles when:

• low blood sugar level (hypoglycemia) is often noted,
• there are few or no warning symptoms of low blood sugar level (hypoglycemia).

Diadeon modified-release tablets contain lactose. If your doctor has told you that you have intolerance to certain types of sugars, then consult your doctor prior to taking this medicinal product.

Dosage

Observe strictly your doctor’s instructions when taking this medicinal product. If you doubt the correctness of this medicinal product intake, consult a doctor or a pharmacist.

Your doctor determines the therapeutic dose based on the level of sugar in your blood and possibly in urine.
Any change in external factors (weight loss, lifestyle changes, stress) or improvement in sugar level may require gliclazide dosage modification.

The recommended daily dose is from half to two tablets (maximum 120 mg) for a single intake during breakfast. It depends on the response to the treatment. You can divide the tablet into equal parts.

Diadeon modified-release tablets are for oral use. Take the tablet(s) at breakfast with a glass of water, preferably at the same time every day. Halves of the tablets or the whole tablet(s) should be swallowed whole. Do not chew or break them. After taking the tablet(s) it is critical to eat.

If you take Diadeon modified-release tablets in combination with alpha-glucosidase inhibitor metformin, thiazolidinedione, dipeptidyl pepdidase IV inhibitor, GLP-1 receptor agonist or insulin, your doctor shall individually determine the appropriate dose of each medicinal product.

If you notice high blood sugar level despite taking the medication according to the prescription, consult a doctor or a pharmacist.

If you take more Diadeon modified-release tablets than recommended

If you have taken too many tablets, contact the nearest emergency station or inform your doctor immediately. Signs of overdose are signs of low blood sugar (hypoglycemia) described in Section 2. To reduce these clinical aspects, you can immediately take sugar (4-6 pieces) or drink a sweet drink, and then have a snack or eat. If the patient is unconscious, inform the doctor immediately and call an ambulance. Do the same if someone (for example, a child) accidentally has swallowed this drug. Do not give food or drink to unconscious patients.

Take care in advance to ensure that there is always a well-informed person nearby who can call a doctor if necessary.

If you forget to take Diadeon modified-release tablets

It is important to take the medication every day as regular intake makes the treatment more effective.
However, if you forget to take Diadeon modified-release tablets, take the next dose at the usual time. Do not double the subsequent dose.

If you stop taking Diadeon modified-release tablets

Since diabetes mellitus treatment usually lasts a lifetime, consult your doctor prior to stopping the current medication. Treatment discontinuation may lead to blood sugar level increase (hyperglycemia) which increases the risk of diabetic complications.

If you have any further questions about taking the medication, contact your doctor or pharmacist.

Like all other medications this medicinal product can cause side effects, although not every patient faces it.

Low blood sugar level (hypoglycemia) is noted most often. See Section Warnings and precautions for clinical aspects.
In the absence of treatment these clinical aspects can lead to drowsiness, loss of consciousness and even coma. Seek medical advice immediately if an episode of low blood sugar level is rather severe or too prolonged, even if it can be temporarily controlled by consuming sugar.

Liver and gallbladder disorders
There are individual reports of liver compilations (elevated liver enzyme level: AST, ALT, alkaline phosphatase), hepatitis (in some cases) which leads to skin and eyes yellowing. If this happens contact your doctor immediately. Usually the symptoms pass away after stopping the current medication. Your doctor is to decide whether to stop treatment.

Skin and subcutaneous tissue disorders
There were reports of skin reactions such as rash, redness, itching, urticaria, wheals, Quincke’s edema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue or throat, which can cause respiratory obstruction). Rash can turn into a generalizable eruption of vesicles or skin sloughing. Rash can progress and turn into an extensive blistering rash or skin sloughing.

If you start having these symptoms stop taking Diadem, contact your doctor immediately and tell him that you are taking this medicine.
In exceptional cases, there were signs of severe hypersensitivity reactions (DRESS) which start with flu-like symptoms and rash on the face and then turn into extended rash with a high temperature.

Hematopoietic and lymphatic system disorders
There were reports of declining number of blood cells (for example, thrombocytes, erythrocytes and leukocytes) which can lead to pallescence, prolonged bleeding, bruising, sore throat, and fever. These symptoms normally disappear with further use.

Gastrointestinal disorders
Gastrointestinal disorders, including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, and constipation. Take gliclazide during breakfast to avoid such effects or minimize them.

Eye disorders
Your vision may deteriorate for short while especially at the beginning of the treatment. This effect is associated with changes in blood sugar level.

As with other sulfonylureas, the following adverse events were observed: cases of severe changes in the number of blood cells and allergic inflammation of blood vessel walls, blood sodium level decrease (hyponatremia), symptoms of liver disorders (for example jaundice), which most often disappeared with further use of sulfonylurea medications, although in some cases could lead to life threatening hepatic decompensation.

Reports of side effects

If you experience any side effects inform your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. By reporting side effects you help to gather information on safety of this medication.

Keep out of children’s reach and sight.

Do not take this medication after the expiration date indicated on the outer carton and blister. When specifying the expiration date, we mean the last day of the specified month.

Do not store above 30°C.

Do not flush medicines into sewage waters or a sewer. Ask the pharmacist how to get rid of the medications which you take any longer. These measures aim to protect the environment.

Diadeon modified-release tablets contain:
Gliclazide is the active pharmaceutical ingredient. One tablet with modified release of the active substance contains 60 mg of gliclazide.
Other components: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silicon dioxide.

Diadeon modified-release tablet and the contents of the package look like:
Diadeon is a white oblong modified-release tablet with a break line and debossed with ‘DIA 60’ on both sides.
15 tablets in a blister. 4 blisters with a leaflet are packed in an outer carton.

Storage life
3 years

Marketing authorization holder and manufacturer

State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus,
Phone / Fax +375 17 268-63-64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en