DIAMICRON 60 mg MODIFIED-RELEASE TABLETS

Introduction

Patient Information Leaflet

DIAMICRON 60 mg modified-release tablets

Gliclazide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Diamicron 60 mg and what is it used for
2. What you need to know before you take Diamicron 60 mg
3. How to take Diamicron 60 mg
4. Possible side effects
5. Storing Diamicron 60 mg
6. Contents of the pack and further information

1. What is Diamicron 60 mg and what is it used for

Diamicron 60 mg modified-release tablets is a medicine that lowers blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group).

Diamicron 60 mg modified-release tablets is used in a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone are not adequate to maintain normal blood sugar levels.

2. What you need to know before you take Diamicron 60 mg

Do not take Diamicron 60 mg

• if you are allergic to gliclazide or any of the other ingredients of Diamicron 60 mg modified-release tablets (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 that you have diabetic ketoacidosis), precoma, or diabetic coma;
• if you have severe kidney or liver damage;
• if you are taking medicines for the treatment of fungal infections (miconazole) (see section "Using Diamicron 60 mg with other medicines");
• if you are breast-feeding (see section "Pregnancy and breast-feeding").

Warnings and precautions

Consult your doctor before starting to take Diamicron 60 mg, modified-release tablets.

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

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

In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close 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 an adequate increase in 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 dysfunction),
• if your kidney or liver function is severely impaired,

If you experience low blood sugar levels, 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 experience 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 control, your breathing may become shallow, and your heart rate may slow down, leading to loss of consciousness.

In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar (e.g., glucose tablets, sugar cubes, sugary drinks, sweet tea).

Therefore, you should always carry some sugar with you (glucose tablets, sugar cubes). 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 levels may not appear, be mild, or develop very slowly, or you may not realize in time that your blood sugar level has decreased. This can happen in elderly patients who take certain medicines (e.g., those that act on the central nervous system and beta-blockers).

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

The symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered your blood sugar levels, when you have not followed the treatment prescribed by your doctor, if you take preparations containing St. John's Wort (Hypericum perforatum) (see section "Using Diamicron 60 mg with other medicines"), 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 levels (low 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 levels.

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

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

Diamicron 60 mg is not recommended for use in children due to the lack of data.

Using Diamicron 60 mg with other medicines

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 levels 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 (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.

The hypoglycemic effect of gliclazide may be reduced and blood sugar levels may increase if you take any of the following medicines:

• medicines for treating disorders of the central nervous system (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),
• preparations containing St. John's Wort (Hypericum perforatum).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken at the same time as Diamicron 60 mg, alterations in blood glucose levels (low and high blood sugar) may occur, especially in elderly patients.

Diamicron 60 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 60 mg modified-release tablets.

Taking Diamicron 60 mg with food, drinks, and alcohol

Diamicron 60 mg can be taken with meals and non-alcoholic drinks.

Alcohol consumption is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and breast-feeding

The use of Diamicron 60 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 60 mg during breast-feeding.

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. Keep in mind that you may put yourself or others at risk (e.g., when driving or operating machinery).

Please ask your doctor if you can drive if:

• you have frequent episodes of low blood sugar levels (hypoglycemia),
• you do not have warning signs of low blood sugar levels or they are mild (hypoglycemia).

Important information about some of the ingredients of Diamicron 60 mg

Diamicron 60 mg contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Diamicron 60 mg

Dose

Follow exactly the instructions for administration of this medicine given 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, change in lifestyle, stress) or improvements in blood sugar control.

The recommended daily dose is half a tablet to two tablets (maximum 120 mg) in a single intake with breakfast. This depends on the response to treatment. The tablet can be divided into equal parts.

Diamicron 60 mg modified-release tablets is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). Swallow the half tablet or the whole tablet(s). Do not chew or crush. You should always eat after taking the tablet(s).

If you start combination therapy with Diamicron 60 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 60 mg than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone (91) 562 04 20 (indicating the medicine and the amount taken).

The symptoms of overdose are those of low blood sugar levels (hypoglycemia) described in section 2. The symptoms may improve after taking sugar (4 to 6 sugar cubes) 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 (e.g., a child) has taken the medicine accidentally. Do not give food or drink to unconscious persons.

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

If you forget to take Diamicron 60 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 60 mg modified-release tablets, 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 60 mg

Since diabetes treatment is usually for life, you should consult your doctor before stopping this medicine. Stopping treatment could cause an increase in blood sugar levels (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 levels (hypoglycemia). For symptoms and signs, see section "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 levels is severe or prolonged, even if it is temporarily controlled with sugar intake.

Liver disorders

Isolated cases of abnormal liver function have been reported, which may 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

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) have been reported. The rash may evolve into widespread blisters or skin peeling.

If you develop these disorders, stop taking Diamicron 60 mg, consult a doctor urgently, and tell them that you are taking this medicine.

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

Blood disorders

Decreases in the number of blood cells (e.g., platelets, red and white blood cells) have been reported, which may cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after stopping treatment.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects are reduced when Diamicron 60 mg is taken with meals, as recommended.

Eyeball 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: cases of severe changes in the number of blood cells and allergic inflammation of the blood vessel walls, decreased 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 Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Diamicron 60 mg

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of Diamicron 60mg

• The active ingredient is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

Appearance and packaging of Diamicron 60mg

Diamicron 60 mg is a modified-release, oblong, white tablet, 15 mm in length and 7 mm in width, scored and engraved with "DIA 60" on both sides. The tablets are available in blisters packaged in boxes of 7, 10, 14, 15, 20, 28, 30, 56, 60, 84, 90, 100, 100 (unit dose packaging), 112, 120, 180 or 500 tablets.

Only some pack 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 Warsaw - Poland

or

Laboratorios Servier, S.L.

Avenida de los Madroños, 33

28043 Madrid - Spain

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

This leaflet was approved in 02/2020

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/