GLICLAZIDE COMBIX 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Gliclazide Combix 30 mg Modified Release Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Gliclazide Combix and what is it used for
2. What you need to know before taking Gliclazide Combix
3. How to take Gliclazide Combix
4. Possible side effects
5. Storage of Gliclazide Combix
6. Package contents and additional information

1. What is Gliclazide Combix and what is it used for

Gliclazide Combix is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonylurea group).

Gliclazide Combix 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.

2. What you need to know before taking Gliclazide Combix

Do not take Gliclazide Combix

• if you are allergic to gliclazide or any of the other components of this medication (listed in section 6), or to other medications in the same group (sulfonylureas), or to other related medications (hypoglycemic sulfonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (which may indicate diabetic ketoacidosis), precoma, or diabetic coma;
• if you have severe kidney or liver impairment;
• if you are taking medications for the treatment of fungal infections (miconazole), see section "Use of other medications";
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor before starting to take Gliclazide Combix.

You should follow the treatment prescribed by your doctor to achieve adequate blood sugar levels.

This means that, in addition to taking the tablets regularly, you should also control your diet, exercise, and, if necessary, lose weight.

During treatment with gliclazide, periodic monitoring of your blood sugar level (and possibly urine) and hemoglobin A1c is necessary.

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

Low blood sugar levels (hypoglycemia) may occur:

• if you do not maintain regular 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 medications or natural remedies at the same time,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary, or adrenal dysfunction),
• if your kidney or liver function is severely impaired,

If you experience low blood sugar levels, you may have 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 disorders, dizziness, and vulnerability.

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

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

In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar, such as glucose tablets, sugar cubes, sugary juice, or sugary tea.

Therefore, you should always carry something with sugar (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.

The symptoms of low blood sugar levels may not appear, be mild, or develop slowly, or you may not realize 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 under stress (accidents, surgeries, fever, etc.), your doctor may temporarily switch you to insulin treatment.

The symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet sufficiently reduced blood sugar levels, when you have not followed the treatment prescribed by your doctor, or in special stress situations. 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 and high blood sugar) may occur when gliclazide is prescribed at the same time as other medications 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 levels.

If you have a family history or know that you have a hereditary disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a condition affecting red blood cells), you may experience a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia). Consult your doctor before taking this medication.

Children and adolescents

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

Other medications and Gliclazide Combix

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

The hypoglycemic effect of gliclazide may be enhanced, and signs of low blood sugar levels may appear when taking one of the following medications:

• other medications used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g., sulfonamides, clarithromycin),
• medications for treating high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medications for treating fungal infections (miconazole, fluconazole),
• medications for treating stomach or duodenal ulcers (H2 receptor antagonists),
• medications for treating depression (monoamine oxidase inhibitors),
• analgesics or anti-rheumatics (phenylbutazone, ibuprofen),
• medications 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 any of the following medications:

• medications for treating central nervous system disorders (chlorpromazine),
• anti-inflammatory medications (corticosteroids),
• medications for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline),
• medications for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).

When a medication belonging to the class of antibiotics called fluoroquinolones is taken at the same time as Gliclazide Combix, alterations in blood glucose levels (low and high blood sugar) may occur, especially in elderly patients.

Gliclazide Combix may increase the effect of medications that reduce blood coagulation (warfarin).

Consult your doctor before taking any other medication. If you are hospitalized, inform the staff that you are taking Gliclazide Combix.

Taking Gliclazide Combix with food, drinks, and alcohol

Gliclazide Combix can be taken with meals and non-alcoholic drinks.

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

Pregnancy and breastfeeding

The use of Gliclazide Combix 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 medication.

You should not use Gliclazide Combix if you are breastfeeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

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 symptoms of low blood sugar levels (hypoglycemia).

Gliclazide Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Gliclazide Combix

Follow the administration instructions for this medication exactly as indicated 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.

Dose adjustments of gliclazide may be necessary due to changes in external factors (weight loss, lifestyle changes, stress) or improvements in blood sugar control. The recommended daily dose is one to four tablets (maximum 120 mg) in a single dose with breakfast. This depends on the response to treatment.

Gliclazide Combix 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 should always eat after taking the tablet(s).

If you start combination therapy with Gliclazide Combix and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will 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.

If you take more Gliclazide Combix than you should

If you take too many tablets, contact your doctor, the nearest hospital emergency department, or call the Toxicology Information Service (telephone 91 562 04 20) immediately, indicating the medication and the amount taken.

The symptoms of overdose are those of low blood sugar levels (hypoglycemia) described in section 2. The symptoms may improve after taking sugar (4-6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call the emergency services. The same should be done if someone, for example, a child, has taken the medication accidentally. Do not give food or drink to unconscious persons.

You should ensure that there is always an informed person who can call the doctor in case of an emergency.

If you forget to take Gliclazide Combix

It is important that you take your medication every day, as regular treatment is more effective.

However, if you forget to take a dose of Gliclazide Combix, take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Gliclazide Combix

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment may cause an increase in blood sugar levels (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 side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most frequently observed side effect is low blood sugar levels (hypoglycemia). 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 levels 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, consult your doctor immediately. These symptoms usually disappear after stopping treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders

Skin reactions such as rash, erythema, itching, hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can cause difficulty breathing), have been reported. The rash may evolve into widespread blistering or peeling of the skin.

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

initially as symptoms similar to those of the flu and a rash on the face, and later a generalized rash with high fever.

Blood disorders

Decreases in blood cell counts (e.g., platelets, red and white blood cells) have been reported, which can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after stopping treatment.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects are reduced when Gliclazide Combix 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.

As with other sulfonylureas, the following adverse reactions have been observed: severe changes in blood cell counts and allergic inflammation of blood vessel walls, decreased sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea, but in isolated cases may lead to life-threatening liver failure.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gliclazide Combix

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

Do not use this medication after the expiration date stated on the carton and blister pack after EXP. 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 via wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition of Gliclazida Combix 30 mg

• The active ingredient is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other components are: lactose monohydrate, anhydrous sodium carbonate, hypromellose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Container Content

Gliclazida Combix is a white or cream-white, oblong, uncoated, modified-release tablet, engraved with '30' on one side and smooth on the other. The tablets are available in blister packs in containers of 20, 60, 100, or 120 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Prospectus: February 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/