Diamicron 30 mg modified-release tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

DIAMICRON® 30 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 such adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Diamicron 30 mg is and what it is used for
2. What you need to know before taking Diamicron 30 mg
3. How to take Diamicron 30 mg
4. Possible adverse effects
5. How to store Diamicron 30 mg
6. Contents of the pack and other information

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

Diamicron 30 mg is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea 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 maintain normal blood sugar levels.

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

Do not take Diamicron 30 mg

• If you are allergic to gliclazide, or to any of the other ingredients of Diamicron 30 mg (listed in section 6), or to other medicines of 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 kidney or liver impairment;
• If you are receiving antifungal medications (miconazole); see section “Use of other medicines”;
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor before starting Diamicron 30 mg.

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 activity, and, if necessary, lose weight.

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

In 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 maintain regular meal times 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 simultaneously,
• 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 kidney or liver 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, 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, and sudden severe chest pain that may spread to nearby areas (angina pectoris).

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

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, for example glucose tablets, sugar cubes, sugary juice, or sweetened tea.

Therefore, you should always carry some form of sugar 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 may not appear, may be mild or develop slowly, or you may not notice in time that your blood sugar level has dropped. This may occur in elderly patients taking certain medications (e.g., those acting on the central nervous system or beta-blockers).

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

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered blood glucose, when you have not followed your prescribed treatment, when you take preparations containing St. John’s wort (Hypericum perforatum) (see section “Other medicines and Diamicron 30 mg”), 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 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 such cases, your doctor will emphasize the importance of monitoring your blood glucose.

If you have a family history or know you have a hereditary glucose-6-phosphate dehydrogenase (G6PD) deficiency (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).

Children and adolescents

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

Other medicines and Diamicron 30 mg

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take 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 drugs:

• 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),
• Medicines for fungal infections (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,
• Preparations containing St. John’s wort (Hypericum perforatum).

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

• 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).

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

Diamicron 30 mg may enhance the effect of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before using any other medicine. If you are admitted to hospital, 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 unpredictably affect your diabetes control.

Pregnancy and breastfeeding

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

You must not use Diamicron 30 mg if you are 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 may put yourself and others at risk (e.g., when driving or operating machinery).

Consult your doctor about whether you may drive in the following cases:

• If you have frequent episodes of low blood sugar (hypoglycemia),
• If you have mild or no warning signs of low blood sugar (hypoglycemia).

3. How to take Diamicron 30 mg

Dosage

Follow exactly the instructions for use of this medicine 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 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 one to four tablets (maximum 120 mg), taken as a single dose with breakfast. This depends on your 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 must always eat a meal after taking the tablet(s).

If 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 is initiated, your doctor will individually determine the appropriate dose of each medicine 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 30 mg than you should

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

Ensure that there is always an informed person available who can call a doctor in 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 lifelong, you must 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 it is 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 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) have been reported. The skin rash may progress to widespread blistering or skin peeling.

If you develop any of these disorders, stop taking Diamicron 30 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 facial rash, 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 30 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 serious changes in blood cell counts and allergic inflammation of blood vessel walls, low blood sodium (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases resolved after withdrawal of the sulphonylurea, but in isolated cases may lead to life-threatening liver failure.

Reporting of adverse effects

If you experience any type of 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 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 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 drains or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diamicron 30 mg

• The active substance 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 of the product and contents of the pack of Diamicron 30 mg

Diamicron 30 mg is a white, oblong modified-release tablet, engraved on both sides: “DIA 30” on one side and blank on the other. The tablets are available in blisters packed in boxes containing 7, 10, 14, 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 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 European Economic Area member states 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.