Gliclazide Cinfa 30 mg modified-release tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gliclazida Cinfa 30 mg modified-release tablets EFG
Read this 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Gliclazida Cinfa is and what it is used for.
- What you need to know before taking Gliclazida Cinfa.
- How to take Gliclazida Cinfa.
- Possible side effects.
- How to store Gliclazida Cinfa.
- Contents of the pack and other information.
1. What Gliclazida Cinfa is and what it is used for
Gliclazida Cinfa is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea 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 maintain normal blood sugar levels.
2. What you need to know before taking Gliclazida Cinfa
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 of the same group (sulfonylureas), or to related medicines (sulfonamides with hypoglycemic action);
- 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 renal or hepatic impairment;
- If you are receiving antifungal medications (miconazole), see section “Other medicines and Gliclazida Cinfa”;
- If you are breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Gliclazida Cinfa.
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 control your diet, exercise, and, if necessary, lose weight.
During treatment with gliclazide, periodic monitoring of your blood glucose level (and possibly urine glucose) and also your glycated hemoglobin (HbA1c) is required.
In the first weeks of treatment, the risk of low blood glucose levels (hypoglycemia) may increase. Close clinical supervision is especially necessary.
Low blood glucose 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 at the same time,
- If you take excessively high doses of gliclazide,
- If you have certain hormonal disorders (thyroid gland dysfunction, pituitary or adrenal cortex disorders),
- If you have severely impaired renal or hepatic 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 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 glucose levels continue to fall, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat, possibly leading to unconsciousness.
In most cases, symptoms of low blood sugar disappear rapidly after consuming sugar, for example glucose tablets, sugar lumps, sugary juice, or sweetened tea.
Therefore, you should always carry some 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 glucose level has dropped. This may occur in elderly patients taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).
If you are under stress (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 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 Gliclazida Cinfa”), 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.
Changes in blood glucose (low and high blood sugar) may occur when gliclazida is prescribed together with other 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 monitoring your blood glucose.
If you have a family history or know you have a hereditary disorder of 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
Gliclazida must not be used in the treatment of diabetes in children or adolescents under 18 years of age.
Other medicines and Gliclazida Cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
The hypoglycemic effect of gliclazide 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 (sulfonamides, clarithromycin),
- Medicines to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
- Medicines to treat fungal infections (miconazole, fluconazole),
- Medicines to treat stomach or duodenal ulcers (H2 receptor antagonists),
- Medicines to treat depression (monoamine oxidase inhibitors),
- Analgesics or anti-rheumatic drugs (phenylbutazone, ibuprofen),
- Medicines containing alcohol,
- Preparations containing St. John’s wort (Hypericum perforatum).
The hypoglycemic effect of gliclazida may decrease and blood sugar levels may increase when taking any of the following medicines:
- Medicines to treat disorders of the central nervous system (chlorpromazine),
- Anti-inflammatory medicines (corticosteroids),
- Medicines to treat asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
- Medicines to treat 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 gliclazida, changes in blood glucose (low and high blood sugar) may occur, especially in elderly patients.
Gliclazida may increase the effect of medicines that reduce blood clotting (warfarin).
Consult your doctor before using any other medicine. If you are admitted to hospital, inform the staff that you are taking Gliclazida Cinfa.
Taking Gliclazida Cinfa with food, drinks, and alcohol
Gliclazida may be taken with meals and non-alcoholic drinks.
Alcohol consumption is not recommended, as it may alter the control of your diabetes in an unpredictable way.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
The use of Gliclazida Cinfa 30 mg is not recommended during pregnancy.
You must not use Gliclazida Cinfa 30 mg if you are breastfeeding.
Driving and using machines
Your ability to concentrate and react may be affected by symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or operate machinery.
Consult your doctor about whether you may drive in the following cases:
- If you have frequent episodes of low blood sugar (hypoglycemia), or if you have mild or no warning signs of low blood sugar (hypoglycemia).
3. How to take Gliclazida Cinfa
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 on urine glucose levels. Dose adjustments of gliclazide may be necessary due to changes in external factors (weight loss, changes in lifestyle, stress) or due to improvements in blood sugar control. The recommended daily dose is one tablet per day and may range from one to four tablets (maximum 120 mg) taken as a single dose with breakfast. This depends on your response to treatment.
If combination therapy with Gliclazida Cinfa 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 determine the appropriate dose of each medicine individually for you.
Contact your doctor or pharmacist if you notice that your blood sugar levels remain high despite taking this medicine as prescribed.
Instructions for use
Oral use.
Swallow the tablets whole. Do not chew or crush them.
Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). You must always eat a meal after taking the tablets. It is important that you do not skip any meals while being treated with gliclazide.
If you take more Gliclazida Cinfa than you should
Symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may be relieved by immediately taking sugar (4 to 6 sugar lumps) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your 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.
Make sure that there is always an informed person available who can call the doctor in case of emergency.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Gliclazida Cinfa
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 gliclazide, take the next dose at the usual time. Do not take a double dose to make up for missed doses.
If you stop taking Gliclazida Cinfa
Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Discontinuing 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 may cause adverse effects, although not everyone will experience 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 could 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, contact your doctor immediately. These symptoms usually resolve upon discontinuation of treatment. Your doctor will decide whether it is necessary to discontinue 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 that may cause breathing difficulties) have been reported. The skin rash may progress to the formation of widespread blisters or skin peeling.
If you develop any of these disorders, stop taking gliclazide, consult a doctor urgently, and inform them that you are taking this medicine.
Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face, 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 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 sulfonylureas, the following adverse reactions have been observed: cases of serious changes in blood cell counts and allergic inflammation of blood vessel walls, decreased sodium levels in blood (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases resolved after discontinuation of the sulfonylurea, but in rare 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not store above 25°C.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE 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 Gliclazida Cinfa
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The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
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The other components are: calcium hydrogen phosphate dihydrate, povidone K30, hypromellose K4M PCR, hypromellose K100Prev LV, magnesium stearate and purified water.
Appearance of the product and contents of the pack
Gliclazida Cinfa are modified-release, oblong, biconvex tablets, white or almost white, marked with "30" on one side and the other side plain.
Gliclazida Cinfa modified-release tablets are available in PVC/aluminum blisters or PVC/Aclar blisters, packed in boxes containing 10, 20, 28, 30, 56, 60, 90 and 120 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: November 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may 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