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, as 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 they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Diamicron 60 mg

3. How to take Diamicron 60 mg

4. Possible side effects

5. Storage of Diamicron 60 mg

6. Contents of the pack and additional information

Diamicron 60 mg modified-release tablets is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

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

Do not take Diamicron 60 mg

• if you are allergic to gliclazide, or to any of the other ingredients of Diamicron 60 mg modified-release tablets (listed in section 6), or to other medicines in the same group (sulphonylureas), or to other related medicines (sulphonamide hypoglycemics);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (which may mean you have diabetic ketoacidosis), a precoma or diabetic coma;
• if you have severe renal or hepatic impairment;
• if you are receiving antifungal medicines (miconazole) (see section “Diamicron 60 mg with other medicines”);
• if you are breastfeeding (see section “Pregnancy and lactation”).

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 regular intake of the tablets, you must control your diet, exercise regularly and, if necessary, lose weight.

During treatment with gliclazide, regular monitoring of your blood sugar level (and possibly urine) and also of your haemoglobin A1c (HbA1c) is necessary.

In the first weeks of treatment, there may be an increased risk of having low blood sugar levels (hypoglycaemia). Close clinical supervision is especially necessary;

Low blood sugar levels (hypoglycaemia) may occur:

• if you do not maintain a regularity in your meals or skip them,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without a corresponding 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 doses of gliclazide,
• if you have certain hormonal disorders (functional alterations of the thyroid gland, pituitary gland or adrenal cortex),
• if your renal or hepatic function is severely impaired,

If you experience low blood sugar levels, you may experience 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, tremor, sensory disturbances, dizziness, and vulnerability.

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

If blood sugar levels continue to fall, you may experience a great confusion (delirium), seizures, loss of self-control, your breathing may become shallow and your heart rate may slow down, and you may become unconscious.

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

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

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

If you are in a state of stress (accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to insulin.

The symptoms of high blood sugar levels (hyperglycaemia) may appear when gliclazide has not yet reduced blood sugar levels sufficiently, when you have not followed the treatment prescribed by your doctor, when you take preparations containing St. John's Wort (Hypericum perforatum) (see section “Diamicron 60 mg with other medicines”),or in special situations of stress. 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 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 controlling your blood glucose levels.

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

Cases of acute porphyria have been described with other sulphonylureas in patients with porphyria (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.

Diamicron 60 mg with other medicines

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medicine.

The hypoglycaemic effect of gliclazide may be potentiated 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 (sulphonamides, 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-inflammatory medicines (phenylbutazone, ibuprofen),
• medicines containing alcohol.

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

• medicines for treating central nervous system disorders (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during childbirth (salbutamol intravenously, 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 blood sugar and high blood sugar) may occur, especially in elderly patients.

Diamicron 60 mg may increase the effect of medicines that reduce blood coagulation (warfarin).

Consult your doctor before using any other medicine. If you enter a hospital, inform the staff that you are taking Diamicron 60 mgmodified-release tablets.

Taking Diamicron 60 mg with food, drinks and alcohol

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

The consumption of alcohol is not recommended, as it may unpredictably alter the control of your diabetes.

Pregnancy and lactation

The use of Diamicron 60 mg during pregnancy is not recommended.

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

You should not use Diamicron 60 mg during breastfeeding.

Driving and operating machinery

If your blood sugar levels fall too low (hypoglycaemia), or rise too high (hyperglycaemia), or if you experience visual problems due to these disorders, your ability to concentrate or react may be affected. Please note that you or others (e.g. when driving or operating machinery) may be put in danger.

Please ask your doctor if you can drive if:

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

Important information about some of the components of Diamicron 60 mg

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

Dosage

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

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

Adjustments in gliclazide doses may be necessary due to changes in external factors (weight loss, lifestyle change, stress) or improvements in blood sugar control.

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

Diamicron 60 mgmodified-release tabletsare for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time every day). Swallow half the tablet or the entire tablet(s). Do not chew or crush. Always eat after taking the tablet(s).

If you start a combined 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 individually determine the appropriate dose of each medication for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite taking this medication 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 Toxicological Information Service, phone (91) 562 04 20 (indicating the medication and the amount ingested).

The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by taking sugar (4 to 6 sugar cubes) or sweetened beverages immediately, followed by a substantial snack or meal. If the patient is unconscious, inform your doctor immediately and call emergency services. The same should be done if someone (e.g., a child) has taken the medication accidentally. Do not feed or give drinks to unconscious people.

Make sure that there is always someone informed who can call your doctor in case of an emergency.

If you forget to take Diamicron 60 mg

It is essential to take your medication every day since 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 compensate for the missed dose.

If you interrupt treatment with Diamicron 60 mg

Since diabetes treatment is usually lifelong, consult your doctor before stopping this medication. Stopping treatment could cause high blood sugar (hyperglycemia) that increases the risk of developing diabetes complications.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most frequently observed side effect is low blood sugar (hypoglycemia). For symptoms and signs, see the section “Warnings and precautions”.

If these symptoms are not treated, they could 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

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If you experience this, seek medical attention immediately. These symptoms usually disappear when treatment is discontinued. Your doctor will decide if it is necessary to discontinue treatment.

Skin disorders

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

If you develop these disorders, stop taking Diamicron 60 mg, seek urgent medical attention, and inform your doctor that you are taking this medicine.

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

Blood disorders

Reports of decreases in the number of blood cells (e.g., platelets, red and white blood cells) have been reported, which can cause pallor, prolonged bleeding, hematomas, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects are reduced when Diamicron 60 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.

Like other sulfonylureas, the following adverse reactions have been observed: severe changes in the number of blood cells and allergic inflammation of blood vessel walls, decreased sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea, but in isolated cases may lead to liver insufficiency with vital threat.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diamicron 60mg

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

Appearance of the product and contents of the package of Diamicron 60mg

Diamicron 60mg is a modified-release tablet, oblong in shape, white in color, 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 package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex– France

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names:

This leaflet was approved in 02/2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/