Diab 80 mg. 60 tablets

1. What Diab is and what it is used for

Diab contains the active substance gliclazide, one of a group of medicines called sulphonylureas. This is an oral hypoglycaemic medicine (to lower blood sugar).

Diab are used to treat non-insulin dependent diabetes (type 2) in adults when diet, exercise and weight loss alone are not sufficient to achieve glycemic control.

2. What you need to know before you take Diab

Do not take Diab

if you are allergic to gliclazide or to any of the excipients (listed in point 6), to other drugs of the same group (sulfonylureas) and other related drugs (sulfonamides for lowering blood sugar);

If you have insulin-dependent diabetes (type 1);

If you have ketone bodies and sugar in the urn (this may mean you have ketoacidosis), diabetic precoma and coma;

if you have severe kidney or liver disease;

if you are taking miconazole (to treat fungal infections) (see section "Other medicines and Diabetes");

if you are breast-feeding (see section Pregnancy and breast-feeding").

Children and adolescents

Diab is not recommended for use in children.

Warnings and precautions

Talk to your doctor before switching Diab.

You must follow the treatment plan prescribed by your doctor to achieve normal blood sugar levels. This means that, in addition to taking the tablets regularly, you must follow a diet, exercise and, if necessary, reduce your body weight.

During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine) and glycated hemoglobin (HbAlc) is required.

During the first weeks of treatment, the risk of low blood sugar (hypoglycemia) is increased. Therefore, careful medical monitoring is necessary.

Low blood sugar (hypoglycaemia) can occur:

if you eat irregularly or skip main meals;

if you are starving;

if you are malnourished;

if you change your diet;

if you increase your physical activity, and the amount of carbohydrates you take in does not correspond to this increase;

if you consume alcohol, especially in combination with skipping main meals;

if you are taking other medicines or natural healing products at the same time;

if you take too large doses of gliclazide;

if you suffer from specific hormonal disorders (impaired function of the thyroid gland, pituitary gland or adrenal cortex);

if your kidney or liver function is severely reduced.

If you have low blood sugar, you may experience the following symptoms: headache, extreme hunger, nausea, vomiting, tiredness, sleep disturbance, nervousness, aggressiveness, decreased concentration, decreased alertness and delayed reactions, depression, confusion, impaired vision or speech , tremors, sensory disturbances, dizziness and a feeling of helplessness.

The following symptoms may also occur: sweating, clammy skin, restlessness, fast or irregular heartbeat, high blood pressure, sudden severe chest pain that may spread to neighboring areas (angina).

If your blood sugar continues to fall, you may become very confused (delirium), have convulsions, lose self-control, your breathing may become shallow, your heart rate may slow, you may pass out. In most cases, the symptoms of low blood sugar go away very quickly when you take sugar in some form (eg, glucose tablets, sugar cubes, sweet juice, sweetened tea). For this reason, you should always carry some kind of sugar with you (glucose tablets, lumps of sugar). Remember that artificial sweeteners are not effective.

Please contact your doctor or the nearest hospital if taking sugar does not help or symptoms recur.

Symptoms of low blood sugar may be absent, less pronounced, or you may not feel in time that your blood sugar has dropped. This can happen if you are elderly and take certain medicines (eg those that act on the central nervous system or beta-blockers).

If you are in a state of stress (eg accidents, surgeries, high fever, etc.). Your doctor may temporarily switch this medicine to insulin.

Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not lowered blood sugar sufficiently, when you have not followed the treatment plan prescribed by your doctor, if you are taking products containing the herb St. John's Wort (Hypericum perforatum) (St. John's wort) (see section "Other medicines and Diabetes") or in specific stressful situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and reduced performance .

If such symptoms occur, you should contact your doctor or pharmacist.

While taking Diab B

The hypoglycemic effect of gliclazide may be weakened and blood sugar levels may increase when one of the following medicinal products is taken:

drugs for the treatment of diseases of the central nervous system (chlorpromazine);

drugs that reduce inflammation (corticosteroids);

medicines to treat asthma or used during labor (intravenous salbutamol, ritodrine and terbutaline);

medicines to treat breast diseases, heavy menstrual bleeding and endometriosis (danazol);

products containing the herb St. John's Wort - Hypercum perforatum (St. John's wort).

Blood sugar disorder (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Diab, especially in elderly patients.

Diabetes can increase the effect of medicines that suppress blood clotting (eg warfarin).

Consult your doctor before starting to take another medicinal product. If you go to hospital, tell the medical staff that you are taking Diab 80 mg.

Diabetes with food, drink and alcohol

Diab can be taken with food and soft drinks.

Alcohol consumption is not recommended as it can disrupt your diabetes control in unpredictable ways.

Pregnancy and breastfeeding

Diab is not recommended for use during pregnancy.

If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

You should not take Diab while breastfeeding.

Driving and using machines

Your ability to drive and use machines should not be affected if your blood sugar level is well controlled with Diab. However, if your blood sugar levels get too low, it can adversely affect your concentration and therefore your ability to perform these tasks.

Ask your doctor if you can drive if:

you have frequent episodes of low blood sugar (hypoglycaemia);

you have little or no signs of low blood sugar (hypoglycaemia).

Diab contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Diab

Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Changes in external factors (reduction in body weight, change in lifestyle, stress) or improvement in blood sugar control may necessitate a change in gliclazide doses.

The recommended daily dose can vary from half to four tablets. This depends on the response to treatment. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken in the morning and in the evening,

Diab is for oral use. Take the tablet(s) with a glass of water (and preferably at the same time each day). Swallow the tablet(s) whole at once. Do not chew the tablet(s).

You should always eat after taking your tablet(s).

If combined treatment with Diab and metformin, alpha-glucosidase inhibitor, thiazolidinedione, dipeptidyl peptidase-4 inhibitor, GLP-1 receptor agonist or insulin has been started, your doctor will determine the appropriate dose of each individual drug for you individually.

If you notice that your blood sugar levels are high despite taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you have taken more than the required dose of Diab

If you have taken more tablets than you should, contact your doctor or the emergency department of the nearest hospital immediately.

Manifestations of overdose are those of lowering blood sugar (hypoglycemia) described in point 2.

Symptoms may be controlled by immediate ingestion of sugar (4 to 6 lumps) or liquids containing sugar, followed by a large breakfast or main meal. If the patient is unconscious, immediately inform a doctor and call an ambulance.

If you forget to take Diab

It is important to take your medicine every day, as regular treatment has a better effect.

If you do miss a dose of Diab, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you have stopped taking Diab

As the treatment of diabetes usually lasts a lifetime, you should consult your doctor before stopping the use of this medicinal product. Stopping it can lead to an increase in blood sugar (hyperglycemia), which increases the risk of developing diabetic complications.

If you have any further questions related to 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.

Low blood pressure

Other side effects

Digestive disorders: abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation*. These effects are reduced when Diab is taken with food as recommended.

Skin disorders: skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, tongue or throat that may lead to difficulty breathing) have been reported. The rash may progress to blistering or peeling of large areas of skin. Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and facial rash, followed by spreading of the rash and fever.

Blood disorders: a decrease in the number of cells in the blood (eg platelets, red blood cells and white blood cells), which can cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually disappear after stopping the treatment.

Hepatic disorders: there have been isolated reports of impaired liver function, which may cause yellowing of the skin and eyes. If this happens, contact your doctor immediately. These symptoms usually disappear after stopping the treatment. Your doctor will decide whether to stop your treatment.

Eye disorders: your vision may deteriorate for a short time, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylurea medicinal products, the following side effects have been reported: cases of severe changes in the number of blood cells and allergic inflammation of the blood vessel wall, reduced levels of sodium in the blood (hyponatremia), symptoms of liver damage (e.g. jaundice ), which in most cases disappear after discontinuation of the drug, but in isolated cases can lead to life-threatening liver failure.

5. How to store Diab

Keep out of the reach of children.

To be stored below 25°C.

Do not use Diab after the expiry date stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What does Diab contain?

The active substance is: gliclazide 80 mg.

The other ingredients are: lactose monohydrate, silicon dioxide, pregelatinized corn starch, talc and magnesium stearate.

What Diab looks like and what it contains

Diab tablets are white, round with a score line on one side and the inscription G25 on the other. Diab is available in a pack of 60 tablets.