DIAMICRON 30 mg MODIFIED-RELEASE TABLETS

2. What you need to know before you take Diamicron 30 mg

Do not take Diamicron 30 mg

• If you are allergic to gliclazide or any of the other ingredients of Diamicron 30 mg (listed in section 6), or to other medicines of the same group (sulfonylureas), or to other related medicines (hypoglycemic sulfonamides);
• If you have insulin-dependent diabetes (type 1);
• If you have ketone bodies and sugar in your urine (which may indicate diabetic ketoacidosis), precoma, or diabetic coma;
• If you have severe kidney or liver impairment;
• If you are taking medicines for the treatment of fungal infections (miconazole), see section "Use of other medicines";
• If you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor before starting to take Diamicron 30 mg.

You should follow the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to taking the tablets regularly, you should control your diet, exercise, and, if necessary, lose weight.

During treatment with gliclazide, periodic monitoring of your blood sugar level (and possibly urine) and hemoglobin A1c is necessary.

In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Clinical monitoring is especially necessary.

Low blood sugar levels (hypoglycemia) may occur:

• If you do not maintain regular meals or skip them,
• If you are fasting,
• If you are malnourished,
• If you change your diet,
• If you increase your physical activity without adequate carbohydrate intake,
• If you drink alcohol, especially if you skip meals,
• If you take other medicines or natural remedies at the same time,
• If you take too high a dose of gliclazide,
• If you have certain hormonal disorders (thyroid, pituitary, or adrenal gland functional disorders),
• If your kidney or liver function is severely impaired,

If you experience low blood sugar, you may have the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, lack of concentration, decreased alertness and reaction time, depression, confusion, visual and speech disturbances, tremors, sensory disorders, dizziness, and vulnerability.

You may also observe the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe chest pain that may radiate to adjacent areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), have convulsions, lose self-control, your breathing may become shallow, and your heart rate may slow down, leading to unconsciousness.

In most cases, the symptoms of low blood sugar disappear quickly after consuming sugar, for example, glucose tablets, sweets, sugary juice, or sugary tea.

Therefore, you should always carry something with sugar (glucose tablets, sweets). Remember that artificial sweeteners are not effective. If sugar intake does not help or the symptoms recur, please contact your doctor or the nearest hospital.

The symptoms of low blood sugar may not appear, be mild, or develop slowly, or you may not notice in time that your blood sugar level has decreased. This can happen in elderly patients taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).

If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin treatment.

The symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered your blood sugar, when you have not followed the treatment prescribed by your doctor, if you take preparations containing St. John's Wort (Hypericum perforatum) (see section "Other medicines and Diamicron 30 mg"), or in special stress situations. They may include thirst, dry mouth, dry skin with itching, skin infections, decreased performance, and frequent urination.

If these symptoms appear, you should contact your doctor or pharmacist.

Alterations in blood glucose (low blood sugar and high blood sugar) may occur when gliclazide is prescribed at the same time as other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history or know you have a hereditary disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a disorder of red blood cells), you may experience a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia). Consult your doctor before taking this medicine.

There have been reports of acute porphyria with other sulfonylureas in patients with porphyria (hereditary genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Diamicron 30 mg is not recommended for use in children due to the lack of data.

Other medicines and Diamicron 30 mg

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

The hypoglycemic effect of gliclazide may be enhanced, and signs of low blood sugar may appear when taking one of the following drugs:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines for treating high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines for treating fungal infections (miconazole, fluconazole),
• medicines for treating stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for treating depression (monoamine oxidase inhibitors),
• analgesics or anti-rheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.
• preparations containing St. John's Wort (Hypericum perforatum).

The hypoglycemic effect of gliclazide may decrease, and blood sugar levels may increase if you take any of the following drugs:

• medicines for treating central nervous system disorders (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline),
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken at the same time as Diamicron 30 mg, alterations in blood glucose (low blood sugar and high blood sugar) may occur, especially in elderly patients.

Diamicron 30 mg may increase the effect of medicines that reduce blood clotting (warfarin).

Consult your doctor before using any other medicine. If you are hospitalized, inform the medical staff that you are taking Diamicron 30 mg.

Taking Diamicron 30 mg with food, drinks, and alcohol

Diamicron 30 mg can be taken with meals and non-alcoholic drinks.

Alcohol consumption is not recommended, as it may alter the control of your diabetes in an unpredictable way.

Pregnancy and breastfeeding

The use of Diamicron 30 mg is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

You should not use Diamicron 30 mg if you are breastfeeding.

Driving and using machines

If your blood sugar levels drop too low (hypoglycemia) or rise too high (hyperglycemia), or if you experience visual problems as a result of these disorders, your ability to concentrate or react may be impaired. Be aware that you may put yourself or others at risk (e.g., when driving or operating machinery).

Consult your doctor if you can drive in the following cases:

• if you have frequent episodes of low blood sugar (hypoglycemia),

if you have mild or no symptoms of low blood sugar (hypoglycemia).

3. How to take Diamicron 30 mg

Dose

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose will be determined by your doctor, depending on your blood sugar levels and possibly urine.

Dose adjustments of gliclazide may be necessary due to changes in external factors (weight loss, lifestyle changes, stress) or improvements in blood sugar control. The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake with breakfast. This depends on the response to treatment.

Diamicron 30 mg is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). Swallow the tablets whole. Do not chew or crush.

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

If you start combination therapy with Diamicron 30 mg 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 notice that your blood sugar levels are high despite taking this medicine as prescribed by your doctor.

If you take more Diamicron 30 mg than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department or call the Toxicology Information Service (Tel.: 91 562 04 20) immediately. The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. The symptoms may improve after taking sugar (4 to 6 sweets) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call the emergency services. The same should be done if someone, for example, a child, has taken the medicine accidentally. Do not give food or drink to unconscious persons.

You should ensure that there is always an informed person who can call the doctor in case of an emergency.

If you forget to take Diamicron 30 mg

It is important that you take your medicine every day, as regular treatment is more effective.

However, if you forget to take a dose of Diamicron 30 mg, take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Diamicron 30 mg

Since diabetes treatment is usually for life, you should consult your doctor before stopping this medicine. Stopping treatment could cause high blood sugar (hyperglycemia), which increases the risk of developing diabetes complications.

If you have any further questions about the use of this product, 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 frequently observed side effect is low blood sugar (hypoglycemia). For symptoms and signs, see “Warnings and precautions”.

If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or possibly coma. You should seek immediate medical attention if the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled with sugar intake.

Liver disorders:

There have been reports of isolated cases of abnormal liver function, which can cause yellowing of the skin and eyes. If you experience this, consult your doctor immediately. These symptoms usually disappear after stopping treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders:

There have been reports of skin reactions such as rash, erythema, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can cause difficulty breathing). The rash may evolve into widespread blisters or skin peeling.

If you develop these disorders, stop taking Diamicron 30 mg, consult a doctor urgently, and tell them that you are taking this medicine.

Exceptionally, there have been reports of signs of severe hypersensitivity reactions (DRESS): initially as symptoms similar to flu and a rash on the face, and then a generalized rash with high fever.

Blood disorders:

There have been reports of decreases in the number of blood cells (e.g., platelets, red and white blood cells) that can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is stopped.

Gastrointestinal disorders:

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects are reduced when Diamicron 30 mg is taken with meals, as recommended.

Eye disorders:

Your vision may be temporarily affected, especially at the start of treatment. This effect is due to changes in blood sugar levels.

As with other sulfonylureas, the following adverse reactions have been observed: severe changes in the number of blood cells and allergic inflammation of blood vessel walls, low sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea but in isolated cases may lead to life-threatening liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Diamicron 30 mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diamicron 30 mg

• The active ingredient is gliclazide. Each tablet contains 30 mg of gliclazide, in a modified-release pharmaceutical form.
• The other components are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

Appearance and Packaging of Diamicron 30 mg

Diamicron 30 mg is a modified-release oblong tablet, white in color, engraved on both sides, "DIA 30" on one side and on the other. The tablets are available in blisters packaged in boxes of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 100 (single-dose packaging), 112, 120, 180 or 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex – France

Manufacturer:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy – France

or

Servier (Ireland) Industries Ltd.

Gorey Road,

Arklow - Co. Wicklow - Ireland

or

ANPHARM Przedsiebiorstwo Farmaceutyczne S.A.

Ul. Annopol 6B

03-236 Warszawa - Poland

or

LABORATORIOS SERVIER S.L.

Avd. de los Madroños, 33

28043 Madrid – Spain

Local Representative:

Laboratorios Servier, S.L.

Tel. 91 748. 96. 30

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria DIAMICRON® MR 30 mg

Belgium UNI DIAMICRON®

Cyprus DIAMICRON® MR 30 mg

Czech Republic DIAPREL® MR

Denmark DIAMICRON UNO® 30 mg

Estonia DIAPREL® MR

France (RMS) DIAMICRON® 30 mg

Greece DIAMICRON® MR

Hungary DIAPREL® MR

Iceland DIAMICRON UNO® 30 mg

Ireland DIAMICRON® MR 30 mg

Italy DIAMICRON® 30 mg

Lithuania DIAPREL® MR

Luxembourg DIAMICRON® 30 mg

Netherlands DIAMICRON® MR 30 mg

Poland DIAMICRON® 30 mg

Portugal DIAMICRON® LM 30 mg

Slovakia DIAPREL® MR

Slovenia DIAPREL® MR

Spain DIAMICRON® 30 mg

United Kingdom DIAMICRON® 30 mg MR

This leaflet was approved in December 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.