Prospect: information for the user

Gliclazida Stada 60 mg modified-release EFG tablets

Read this prospect carefully before starting to take this medicine, because 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 you should not give it to other people even if they have the same symptoms as you, 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 Gliclazida Stada and for what it is used

2.What you need to know before starting to take Gliclazida Stada

3.How to take Gliclazida Stada

4.Possible adverse effects

5.Storage of Gliclazida Stada

6.Contents of the package and additional information

Gliclazida Stada is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas 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 ensure normal blood sugar levels.

Do not take Gliclazida Stada:

• If you are allergic to gliclazide, or to any of the other ingredients of this medicine (including those listed in section 6), or to other medicines in the same group (sulfonilureas), or to other related medicines (sulfamidas hypoglycemic);

• If you have insulin-dependent diabetes (type 1);
• If you have ketones and sugar in your urine (which may mean you have diabetic ketoacidosis), a precoma or diabetic coma;
• If you have severe kidney or liver damage;
• If you are receiving medicines for the treatment of fungal infections (miconazole, see section “Use of Gliclazida Stada with other medicines”);
• If you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Consult your doctor before starting to take Gliclazida Stada.

You should 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 should 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 hemoglobin A1c (HbA1c) is necessary. In the first weeks of treatment, the risk of having low blood sugar levels (hypoglycemia) may be increased. 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 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, tremors, sensory disturbances, dizziness, and vulnerability.

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

If blood sugar levels continue to drop, you may experience a great 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, e.g. glucose tablets, sugar lumps, sweet 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.

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 dropped. This can happen 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, 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 St. John's Wort preparations (Hypericum perforatum) (see section "Other medicines and Gliclazida Stada"), or in special situations of stress. They may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased performance.

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 taken at the same time as 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 and destruction of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents

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

Use of Gliclazida Stada with other medicines

Inform your doctor or pharmacist if 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 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 (e.g. sulfamides, clarithromycin),
• medicines for treating high blood pressure or heart failure (beta-blockers, IECAs 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.

The hypoglycemic effect of gliclazide may be reduced and blood sugar levels may increase if one of the following medicines is taken:

• medicines for treating central nervous system disorders (chlorpromazine),

• anti-inflammatory drugs (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),
• St. John's Wort preparations (Hypericum perforatum)

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when taking a medicine belonging to a class of antibiotics called fluoroquinolones at the same time as Gliclazida Stada, especially in elderly patients.

This medicine may increase the effect of medicines that reduce blood clotting (e.g. warfarin).

Consult your doctor before using any other medicine. If you are admitted to a hospital, inform the staff that you are taking gliclazide.

Taking Gliclazida Stada with food, drinks, and alcohol

This medicine can be taken with meals and non-alcoholic drinks.

The consumption of alcohol is not recommended, as it may unpredictably alter 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 should not use this medicine during breastfeeding.

Driving and operating machinery

If your blood sugar levels drop too low (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.

Please note that you may put yourself or others at risk (e.g. while driving or operating machinery).

Please ask your doctor if you can drive if:

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

Gliclazida Stada contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult them before taking this medicine.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 in your urine.

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

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

If you start a combined therapy with gliclazide 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.

Route and form of administration

Gliclazide is administered orally.

The tablet can be divided into two equal doses.

Take the tablet with a glass of water at breakfast (preferably at the same time every day).

Swallow half the tablet or the entire tablet. Do not chew or crush.

Always eat after taking the tablet.

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 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 sweet drinks 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 give food or drink to unconscious people.

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

If you forget to take Gliclazida Stada

It is essential to take your medication every day since regular treatment is more effective.

However, if you forget to take a dose of this medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Gliclazida Stada

Since diabetes treatment is usually lifelong, consult your doctor before stopping this medication. Stopping treatment may 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 medication, 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.

OrganDamage

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

Notified skin reactions include:

• Skin rash.
• Erythema.
• Itching.
• Urticaria.
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that may cause breathing difficulties). The skin rash may evolve into widespread blistering or skin peeling.

Exceptionally, severe hypersensitivity reactions (DRESS) have been reported:

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

Blood

Notified decreases in the number of blood cells (e.g., platelets, red and white blood cells) that may cause:

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

These symptoms usually disappear when treatment is discontinued.

Gastrointestinal

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

These effects are reduced whengliclazideis taken with meals, as recommended.

Eye

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: cases of 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 adverse effects :

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 CAD. 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 packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gliclazide Stada

•The active ingredient is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

•The other components are:

Intragranular: lactose monohydrate, 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 package

The 60 mg modified-release tablets are white, biconvex, oval, scored on both sides, engraved with “GLI” and “60” on both sides of the score on both sides, and have dimensions of 15.0 x 7.0 mm. The tablets can be divided into equal doses.

Gliclazide Stada 60 mg modified-release tablets are available in blisters packaged in boxes of 10, 28, 30, 56, 60, 90, 120, 150, and 180 tablets*.

*Some package sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

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

Denmark:Gliclazide STADA 60 mg modified-release tablets

Austria:Gliclazide 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:Gliclazide STADA 60 mg modified-release tablets EFG

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

Luxembourg:Uni Gliclazide EG 60mg comprimés à libération modifiée

Portugal:Gliclazide Ciclum

Slovenia:Gliklazid STADA 60 mg tablete s prirejenim sproščanjem

Slovakia:Gliclazide MR Stada

France:Last revision date of this leaflet:March 2017

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/