Gliclazide Tecnigen 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gliclazida TecniGen 60 mg modified-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Gliclazida is a medicine that lowers blood sugar levels (an oral antidiabetic drug 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 starting to take Gliclazida TecniGen

Do not take Gliclazida TecniGen

• If you are allergic to gliclazide, or to any of the other components of this medicine (listed in section 6), or to other medicines of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfamides);
• 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 medications for fungal infections (miconazole); see section “Other medicines and Gliclazida TecniGen”;
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor before starting to take gliclazide.

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

During treatment with gliclazide, periodic monitoring of your blood sugar levels (and possibly urine sugar) and glycosylated hemoglobin (HbA1c) is required.

In the first weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close clinical supervision is especially necessary during this time.

Low blood sugar 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 (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• 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, agitation, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, visual and speech disturbances, trembling, sensory disturbances, dizziness, and weakness.

The following signs and symptoms may also occur: sweating, clammy 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 severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, for example glucose tablets, sugar candies, sweetened juice, or sugared tea.

Therefore, you should always carry a source of sugar with you (glucose tablets, sugar candies). Remember that artificial sweeteners are ineffective. 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 (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 sugar, when you do not follow your prescribed treatment, when you take preparations containing St. John’s wort (Hypericum perforatum) (see section “Other medicines and Gliclazida TecniGen”), 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 blood sugar 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 is not recommended for use in children due to lack of data.

Other medicines and Gliclazida TecniGen

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

The blood sugar-lowering effect of gliclazida may be enhanced, leading to signs of low blood sugar, 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 for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines for fungal infections (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 blood sugar-lowering effect of gliclazida may be reduced, increasing blood sugar levels, when taking any of the following medicines:

• medicines for central nervous system disorders (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),
• preparations containing St. John’s wort (Hypericum perforatum).

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.

Taking Gliclazida TecniGen with food, drinks, and alcohol

Gliclazida 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 is not recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor for a more suitable treatment.

You must not use gliclazida if you are breastfeeding.

Driving and using machines

If your blood sugar level drops too low (hypoglycemia) or rises too high (hyperglycemia), or if you experience vision problems due to these conditions, your ability to concentrate or react may be impaired. Be aware that you could endanger yourself or others (e.g., while driving or operating machinery).

Consult your doctor if you can drive in the following cases:

• if you have frequent episodes of low blood sugar (hypoglycemia),
• if you have mild or no warning signs of low blood sugar (hypoglycemia).

Gliclazida TecniGen contains lactose

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

3. How to take Gliclazida TecniGen

Dosage

Follow exactly the instructions for use of this medicine as given 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 sugar 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 half a tablet to 2 tablets (maximum 120 mg) taken once daily with breakfast. This depends on the response to treatment. The tablet may be divided into equal parts.

Gliclazide is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). Swallow your tablets whole. Swallow half a tablet or the whole tablet(s) at once. Do not chew or crush. You must always eat after taking the tablet(s).

If combination therapy with gliclazide 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 medicine for you.

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

If you take more Gliclazida TecniGen than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. 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 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 applies if someone, for example 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.

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, stating the medicine and the amount ingested.

If you forget to take Gliclazida TecniGen

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 forgotten doses.

If you stop taking Gliclazida TecniGen

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Stopping treatment could cause an increase in blood sugar (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 adverse effects

Like all medicines, this medicine can 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 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 (jaundice). If you experience this, contact your doctor immediately. These symptoms usually resolve when treatment is discontinued. Your doctor will decide whether it is necessary to stop 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 widespread blistering or skin peeling.

If you develop any of these conditions, 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 flu-like symptoms and a rash on the face, followed by a generalized rash with high fever.

Blood disorders:

Decreases in blood cell counts (e.g. platelets, white and red blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually resolve when treatment is stopped.

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 sulphonylureas, the following adverse reactions have been observed: cases of severe changes in blood cell counts, allergic inflammation of blood vessel walls (vasculitis), reduction in blood sodium levels (hyponatraemia), and symptoms of liver failure (e.g. jaundice). These symptoms usually resolve after discontinuation of the sulphonylurea, but in isolated cases may progress to life-threatening liver failure.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide TecniGen

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

Do not use this medicine after the expiry date stated on the outer packaging and 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly 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 TecniGen

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other components are monohydrate lactose, maize starch, hypromellose, magnesium stearate.

Appearance of the product and contents of the pack

Gliclazida TecniGen 60 mg are white or almost white, prolonged-release oval tablets, with the inscription “C” on one side and “55” on the other side of the score line and a corresponding score line on the opposite face.

Gliclazida TecniGen is available in packs containing 30 and 60 tablets.

Gliclazida TecniGen 60 mg is supplied in a high-density polyethylene (HDPE) bottle with an aluminum induction seal and a child-resistant screw cap, containing 30 and 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

O

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Date of the most recent review of this leaflet: June 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/