Prospect: information for thepatient

DIAMICRON®30 mg modified-release tablets

Gliclazide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Diamicron 30 mg and for what it is used

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

3. How to take Diamicron 30 mg

4. Possible adverse effects

5. Storage of Diamicron 30 mg

6. Contents of the package and additional information

Diamicron 30 mg is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

Diamicron 30 mg 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 30 mg

• If you are allergic to gliclazide, or to any of the other components of Diamicron 30 mg (including those listed in section 6), or to other medicines in the same group (sulfonylureas), or to other related medicines (sulfonamide hypoglycemics);
• If you have insulin-dependent diabetes (type 1);
• If you have ketone bodies and sugar in the 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 medicines for the treatment of fungal infections (miconazole), see section “Use of other medicines”;
• If you are breastfeeding (see section “Pregnancy and lactation”).

Warnings and precautions

Consult your doctor before starting to take Diamicron 30 mg.

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 in urine) and also of your hemoglobin A1c (HbA1c) is necessary.

In the first weeks of treatment, the risk of having low blood sugar levels (hypoglycemia) may increase. Close clinical supervision is especially necessary.

Low blood sugar levels (hypoglycemia) may occur:

• If you do not maintain a regularity in 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 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, tremors, sensory disturbances, dizziness, and vulnerability.

The following signs and symptoms may also be observed: sweating, moist skin, anxiety, rapid or irregular heart rate, high blood pressure, sudden and severe chest pain that may spread to adjacent areas (angina pectoris).

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

In most cases, symptoms of low blood sugar levels disappear quickly after consuming sugar, for example, glucose tablets, sugar cubes, sweet juice, or sweet tea.

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

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 decreased. This can happen in elderly patients taking certain medications (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.

Symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet reduced blood sugar levels sufficiently, when you have not followed the treatment prescribed by your doctor, if you take preparations containing St. John's Wort (Hypericum perforatum), 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 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 (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 absence of data.

Other medicines andDiamicron 30 mg

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

The hypoglycemic 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 (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-inflammatory drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.
• Preparations containing St. John's Wort (Hypericum perforatum).

The hypoglycemic 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 delivery (salbutamol intravenously, 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 levels (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 coagulation (warfarin).

Consult your doctor before using any other medicine. If you enter a hospital, inform the 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.

Consuming alcohol is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and lactation

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 operating machinery

If your blood sugar levels decrease too much (hypoglycemia), or increase too much (hyperglycemia), or if you experience visual problems due to these disorders, your ability to concentrate or react may be affected. Be aware that you or others (e.g., when driving or operating machinery) may be at risk.

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

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

if you have mild or no signs that warn you of low blood sugar levels (hypoglycemia).

Dose

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 dose 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 one to four tablets (maximum 120 mg) taken once a day 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 with breakfast (preferably at the same time every day).Swallow your tablets whole. Do not chew or crush.

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

If you start a combined therapy of Diamicron 30 mg with 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 suitable 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 30 mg than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately or call the Toxicological Information Service (Tel.: 91 562 04 20). The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by taking immediately sugar (4 to 6 sugar cubes) or sweet drinks, 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, for example a child, has taken the medication by accident. Do not give food or drink to unconscious people.

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

If you forgot to take Diamicron 30 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 30 mg, take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Diamicron 30 mg

Since diabetes treatment is usually lifelong, consult your doctor before stopping this medication. Stopping treatment could cause an increase in 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 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:

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If you experience this, seek immediate medical attention. 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 may cause difficulty breathing) have been reported. The skin rash may evolve into widespread blistering or skin peeling.

If you develop these disorders, stop taking Diamicron 30 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 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.

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 in the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 pointat 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 30 mg

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

Appearance of the product and contents of the package of Diamicron 30 mg

Diamicron 30 mg is a modified-release white oval tablet, engraved on both faces, “DIA 30” on one face 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 package), 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

905route 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 medicine is authorized in the member states of the European Economic Area with the following names:

AustriaDIAMICRON® MR 30 mg

BelgiumUNI DIAMICRON®

CyprusDIAMICRON® MR 30 mg

Czech RepublicDIAPREL® MR

DenmarkDIAMICRON UNO® 30 mg

EstoniaDIAPREL® MR

France (RMS)DIAMICRON® 30 mg

GreeceDIAMICRON® MR

HungaryDIAPREL® MR

IcelandDIAMICRON UNO® 30 mg

IrelandDIAMICRON® MR 30 mg

ItalyDIAMICRON® 30 mg

LithuaniaDIAPREL® MR

LuxembourgDIAMICRON® 30 mg

NetherlandsDIAMICRON® MR 30 mg

PolandDIAMICRON® 30 mg

PortugalDIAMICRON® LM 30 mg

SlovakiaDIAPREL® MR

SloveniaDIAPREL® MR

SpainDIAMICRON® 30 mg

United KingdomDIAMICRON® 30 mg MR

This leaflet was approved in December 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/.