Gliclazide Stada 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gliclazida Stada 60 mg modified-release tablets EFG

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Gliclazida Stada is and what it is used for

Gliclazida Stada is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea group).

Gliclazida Stada 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 Gliclazida Stada

Do not take Gliclazida Stada:

• If you are allergic to gliclazide, or to any of the other ingredients of this medicine (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 Gliclazida Stada with other medicines”);

• If you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Talk to your doctor before starting to take Gliclazida Stada.

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

During treatment with gliclazide, periodic monitoring of your blood glucose levels (and possibly urine glucose) and also 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 eat regularly 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 too high a dose of gliclazida,
• if you have certain hormonal disorders (thyroid, pituitary or adrenal gland dysfunction),
• 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, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, visual and speech disturbances, 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 that may spread 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, and slowed heart rate, potentially leading to unconsciousness.

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

Therefore, you should always carry a source of sugar with you (glucose tablets, sugar lumps). 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 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 (e.g., accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin treatment.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazida has not yet sufficiently lowered your blood sugar, when you do not follow your prescribed treatment, when you take St. John’s wort (Hypericum perforatum) preparations (see section "Other medicines and Gliclazida Stada"), or during special stress situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.

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

Blood glucose disturbances (low blood sugar and high blood sugar) may occur when gliclazida is prescribed together with a class of antibiotics called fluoroquinolones, especially in elderly patients. In such cases, 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. Contact your doctor before taking this medicine.

Children and adolescents

Gliclazida is not recommended for use in children due to lack of data.

Use of Gliclazida Stada with other medicines

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

The hypoglycemic effect of gliclazida may be enhanced and signs of low blood sugar may appear when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g., 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 gliclazida may be reduced and blood sugar levels may increase when taking 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),
• St. John’s wort preparations (Hypericum perforatum).

Blood glucose disturbances (low and high blood sugar) may occur when taking a medicine from a class of antibiotics called fluoroquinolones together with Gliclazida Stada, especially in elderly patients.

This medicine 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 staff that you are taking gliclazida.

Taking Gliclazida Stada with food, drinks and alcohol

This medicine 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

Gliclazida Stada 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, as they may prescribe a more suitable treatment for you.

You must not use this medicine during breastfeeding.

Driving and using machines

If your blood sugar level becomes too low (hypoglycemia) or 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 or others at risk (e.g., when driving or operating machinery).

Please ask your doctor whether you may drive if:

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

Gliclazida Stada contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Gliclazida Stada

Dosage

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

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

If combination therapy with gliclazida 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 medication for you.

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

Route and method of administration

Gliclazida is administered orally.

The tablet may be divided into two equal doses.

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) whole. Do not chew or crush.

You should always eat a meal after taking the tablet(s).

If you take more Gliclazida Stada 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 at (91) 562 04 20 (indicating the medicine and the amount ingested).

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 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 should be done if someone, e.g., 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 the doctor in an emergency.

If you forget to take Gliclazida Stada

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 this medicine, 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 Gliclazida Stada

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar (hyperglycemia), increasing the risk of developing diabetes complications.

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

4. Possible adverse effects

Like all medicines, this medicine can 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.

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 when treatment is discontinued. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders

Skin reactions have been reported, such as:

• Rash.
• Erythema.
• Itching.
• Urticaria.
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause difficulty breathing). The rash may progress to the formation of widespread blisters or skin peeling.

Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported:

Initially presenting as flu-like symptoms and subsequently as a facial rash with widespread rash and high fever.

Blood disorders

Decreases in blood cell counts (e.g.: platelets, red and white blood cells) have been reported, which may cause:

• Pallor.
• Prolonged bleeding.
• Bruising.
• Sore throat.
• Fever.

These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders

• Abdominal pain.
• Nausea, vomiting.
• Indigestion.
• Diarrhoea.
• Constipation.

These effects are reduced when gliclazide 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 the blood vessel walls, decreased sodium levels in blood (hyponatraemia), symptoms of liver impairment (e.g.: jaundice), which in most cases resolved after discontinuation of the sulphonylurea, but which in isolated cases may lead to life-threatening liver failure.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Stada

• The active substance is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

• The other components are:

Intragranular: monohydrate lactose, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464).

Extragranular: hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464), magnesium stearate (E572).

Appearance of the product and contents of the pack

The 60 mg modified-release tablets are white, biconvex, oval-shaped, scored on both sides, engraved with “GLI” and “60” on each side of the score line on both faces, and measure 15.0 x 7.0 mm. The tablets may be divided into equal doses.

Gliclazida Stada 60 mg modified-release tablets are available in blister packs contained in cartons of 10, 28, 30, 56, 60, 90, 120, 150 and 180 tablets*.

*Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36, 1190 Wien

Austria

or

Sanico N.V.

Veedijk 59

2300 Turnhout

Belgium

or

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

or

Laboratori Fundació DAU

Calle Lletra C de la Zona Franca 12-14

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

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

Denmark: Gliclazid STADA 60 mg modified-release tablets

Austria: Gliclazid STADA 60 mg Tabletten mit veränderter Wirkstofffreisetzung

Bulgaria: MADRAS MR 60 mg modified release tablets x 30 tablets

Belgium: Uni Gliclazide EG 60mg tabletten met gereguleerde afgifte

Spain: Gliclazida STADA 60 mg comprimidos de liberación modificada EFG

France: GLICLAZIDE EG 60 mg, comprimé sécable à libération modifiée

Luxembourg: Uni Gliclazide EG 60mg comprimés à libération modifiée

Portugal: Gliclazida Ciclum

Slovenia: Gliklazid STADA 60 mg tablete s prirejenim sprošcanjem

Slovakia: Gliclazide MR Stada

Date of the most recent review of this leaflet: March 2017

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/