Diacron 60 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

DIAMICRON 60 mg modified-release tablets

Gliclazide

Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Diamicron 60 mg modified-release tablets is a medicine that lowers blood sugar levels (an oral antidiabetic agent 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, physical exercise, and weight loss alone are not sufficient to maintain normal blood sugar levels.

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

Do not take Diamicron 60 mg

• if you are allergic to gliclazide, or to any of the other components of Diamicron 60 mg modified-release tablets (listed in section 6), or to other medicines in the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketones and sugar in your urine (which may indicate diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe renal or hepatic impairment;
• if you are receiving antifungal medications (miconazole) (see section “Use of Diamicron 60 mg with other medicines”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

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 appropriate blood glucose levels. This means that, in addition to taking the tablets regularly, you should control your diet, engage in physical exercise, and lose weight if necessary.

During treatment with gliclazide, periodic monitoring of your blood glucose level (and possibly urine glucose) and also your glycated hemoglobin (HbA1c) is required.

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

Low blood sugar levels (hypoglycemia) may occur:

• if you do not eat regular meals or skip meals,
• 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 herbal remedies at the same time,
• if you take excessively high doses of gliclazide,
• if you have certain hormonal disorders (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• if you have severely impaired renal or hepatic function.

If you experience low blood sugar, you may have the following symptoms:

headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, visual disturbances and speech difficulties, tremor, sensory disturbances, dizziness, and weakness.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain radiating to nearby areas (angina pectoris).

If blood sugar levels continue to fall, you may experience marked confusion (delirium), seizures, loss of self-control, shallow breathing, slowed heartbeat, and possibly loss of consciousness.

In most cases, symptoms of low blood sugar resolve rapidly after consuming sugar (e.g., glucose tablets, sugar lumps, sugary juice, sweetened tea).

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

Symptoms of low blood sugar may not appear, may be mild or develop slowly, or you may not notice in time that your blood sugar has dropped. This may occur in elderly patients taking certain medications (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.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently reduced blood sugar, when you do not follow your prescribed treatment, when you take preparations containing St. John’s wort (Hypericum perforatum) (see section “Use of Diamicron 60 mg with other medicines”), or during special stress situations. These may include thirst, dry mouth, dry and itchy skin, skin infections, reduced performance, and frequent urination.

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

Blood glucose disturbances (low blood sugar and high blood sugar) may occur when gliclazide is prescribed together with 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 deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder), 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 reported with other sulfonylureas in patients with porphyria (inherited genetic disorders causing accumulation of porphyrins and porphyrin precursors in the body).

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

Use of Diamicron 60 mg with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

The hypoglycemic effect of gliclazide may be enhanced, leading to signs of low blood sugar, when taken with any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• antifungal medicines (miconazole, fluconazole),
• medicines for stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may be reduced, increasing blood sugar levels, when taken with any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• medicines for 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, disturbances in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

Diamicron 60 mg may enhance the effect of medicines that reduce blood clotting (warfarin).

Consult your doctor before using any other medicine. If you are admitted to hospital, inform the staff that you are taking Diamicron 60 mg modified-release tablets.

Taking Diamicron 60 mg with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

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 must not use Diamicron 60 mg during breastfeeding.

Driving and use of machines

If your blood sugar level drops too low (hypoglycemia) or rises too high (hyperglycemia), or if you experience visual disturbances due to these conditions, your ability to concentrate or react may be impaired. Be aware that you could endanger yourself or others (e.g., when driving or operating machinery).

Please ask your doctor if you may drive if:

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

Important information about some of the components of Diamicron 60 mg

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

3. How to take Diamicron 60 mg

Dosage

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Dose adjustments of gliclazide may be required due to changes in external factors (weight loss, changes in lifestyle, stress) or improvements in blood sugar control.

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

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

If 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 is initiated, your doctor will determine the appropriate dose of each medication individually for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels remain high despite taking this medicine as prescribed.

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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at (91) 562 04 20 (indicating the medicine and the amount ingested).

The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may be relieved by immediately 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 emergency services. The same action should be taken if someone (e.g., a child) has accidentally taken the medicine. Do not give food or drink to unconscious individuals.

Ensure that there is always an informed person available who can call the doctor in case of 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 the missed dose.

If you stop taking Diamicron 60 mg

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medicine. Stopping treatment may lead to increased 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most frequently observed adverse effect is low blood sugar (hypoglycaemia). 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 is severe or prolonged, even if temporarily controlled by sugar intake.

Hepatic 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 resolve upon discontinuation of treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders

Skin reactions have been reported, such as rash, erythema, itching, hives, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which may cause breathing difficulties). Skin rash may progress to the formation of widespread blisters or skin peeling.

If you develop any of these conditions, stop taking Diamicron 60 mg, consult a doctor urgently, and inform them that you are taking this medicine.

Rarely, signs of serious hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face, followed by generalized rash with high fever.

Blood disorders

Decreases in blood cell counts (e.g., platelets, red and white blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhoea, 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 beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following adverse reactions have been observed: cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls, decreased sodium levels in blood (hyponatraemia), symptoms of liver failure (e.g., jaundice), which in most cases resolved after discontinuation of the sulphonylurea, but in rare cases may lead to life-threatening liver failure.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diamicron 60 mg

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

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diamicron 60mg

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

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

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

Only certain 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 patient information leaflet was approved in 02/2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/