Leaflet: information for the user

Gliclazide Cinfa 30 mg modified-release tablets

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Gliclazida cinfa is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

Gliclazida 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 Cinfa

• If you are allergic to gliclazide, or to any of the other ingredients of this medicine (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 the urine (which may mean you have diabetic ketoacidosis), a precoma or diabetic coma;
• If you have severe renal or hepatic impairment;
• If you are receiving medicines for the treatment of fungal infections (miconazole), see section “Other medicines and Gliclazida Cinfa”;
• If you are breastfeeding (see section “Pregnancy and lactation”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida cinfa.

You must 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 must control your diet, exercise regularly and, if necessary, lose weight.

During treatment with gliclazide, regular monitoring of your blood sugar level (and possibly in 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 increase. A very close clinical supervision is especially necessary.

Low blood sugar levels (hypoglycemia) may appear:

• 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 an adequate 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.

The following signs and symptoms may also be observed: sweating, moist skin, anxiety, rapid or irregular heart rate, high blood pressure, sudden and 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), suffer convulsions, lose control, your breathing may become shallow and your heart rate may slow down, and you may become unconscious.

In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar, for example, glucose tablets, sugar cubes, sweet juice, or sweet tea.

Therefore, you should always carry something sweet with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If the intake of sugar does not help or the symptoms reappear, please contact your doctor or the nearest hospital.

The 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 decreased. This can happen in elderly patients who take certain medications (for example, those that act on the central nervous system and beta-blockers).

If you are in a state of stress (accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to insulin.

The 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 preparations containing St. John's Wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Cinfa”), or in special situations of stress. 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 blood sugar and high blood sugar) may occur when gliclazide is prescribed at the same time as other medicines that belong 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 levels and destruction of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicine.

Cases of acute porphyria have been described with other sulfonilureas in patients with porphyria (genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazide should not be used in the treatment of diabetes, nor in children, nor in adolescents under 18 years old.

Other medicines and Gliclazida Cinfa

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

The hypoglycemic effect of gliclazide may be potentiated and signs of low blood sugar levels 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 (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,
• preparations containing St. John's Wort (Hypericum perforatum).

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 medicines (corticosteroids),
• medicines for treating asthma or used during delivery (salbutamol intravenous, ritodrine, and terbutaline),
• medicines for treating 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 gliclazide, alterations in blood glucose levels (low blood sugar and high blood sugar) may occur, especially in elderly patients.

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

Consult your doctor before using any other medicine. If you enter a hospital, inform the staff that you are taking Gliclazida Cinfa.

Taking Gliclazida Cinfa with food, drinks, and alcohol

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

The consumption of alcohol is not recommended, as it may unpredictably alter the control of your diabetes.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor before using this medicine.

The use of Gliclazida cinfa 30 mg during pregnancy is not recommended.

You should not use Gliclazida cinfa 30 mg if you are breastfeeding.

Driving and operating machines

Your ability to concentrate and react may be affected due to the symptoms caused by hypoglycemia or hyperglycemia, such as visual disturbances. This may be hazardous in situations where these skills are important (for example, driving or operating machines). Therefore, consult your doctor if it is recommended to drive or operate 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 signs that warn you of low blood sugar levels (hypoglycemia).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose will be determined by your doctor, depending on your blood sugar levels and possibly in urine. Dose adjustments of gliclazide may be required due to changes in external factors (weight loss, lifestyle change, stress) or improvements in blood sugar control. The recommended daily dose is one tablet per day and may vary from one to four tablets (maximum 120 mg) in a single dose with breakfast. This depends on the response to treatment.

If you start a combined therapy of Gliclazida cinfa 30 mg with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the individualized 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.

Administration Form

Oral use.

Swallow your tablets whole. Do not chew or crush them.

Take the tablet(s) with a glass of water at breakfast (preferably at the same time every day). You must always eat after taking the tablets. It is essential not to skip any meals while on treatment with gliclazide.

If you take more Gliclazida Cinfa than you should

The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by taking immediately sugar (4 to 6 sugar cubes) or sweetened drinks, 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, for example a child, has taken the medication by accident. Do not feed or give drinks to unconscious people.

Ensure that there is always someone informed who can call your doctor in case of an emergency.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Gliclazida Cinfa

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

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

If you interrupt the treatment with Gliclazida Cinfa

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment could cause an increase in blood sugar (hyperglycemia) that increases the risk of developing diabetes complications.

If you have any other doubts 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.

Liver disorders

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If you experience this, seek medical attention immediately. These symptoms usually disappear when treatment is discontinued. Your doctor will decide if it is necessary to discontinue treatment.

Skin disorders

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

If you develop these disorders, stop taking gliclazide, seek urgent medical attention, and inform your doctor that you are taking this medicine.

Exceptionally, reports of severe hypersensitivity reactions (DRESS) have been noted: initially as symptoms similar to the flu and a skin rash on the face, followed by a generalized skin rash with high fever.

Blood disorders

Reports of decreases in the number of blood cells (e.g., platelets, red and white blood cells) have been reported, which can cause pallor, prolonged bleeding, hematomas, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders

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

Like other sulfonylureas, the following adverse reactions have been observed: 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 not listed in this prospectus. You can also report them directly through the Spanish System for 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 after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25oC.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gliclazida Cinfa

• The active ingredient is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.

• The other components are: calcium dihydrogen phosphate, povidone K30, hypromellose K4M PCR, hypromellose K100Prev LV, magnesium stearate and purified water.

Appearance of the product and contents of the packaging

Gliclazida Cinfa are modified-release, oblong, biconvex tablets, white or off-white in color, engraved with "30" on one face and smooth on the other face.

Gliclazida Cinfa modified-release tablets are available in PVC/aluminum blisters or PVC/Aclar blisters, packaged in boxes of 10, 20, 28, 30, 56, 60, 90 and 120 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78439/P_78439.html

QR code to:https://cima.aemps.es/cima/dochtml/p/78439/P_78439.html