Gliclazide Krka 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida Krka 30 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, 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Gliclazida Krka is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazida Krka is used to treat a type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight loss alone do not have an adequate effect in maintaining blood sugar levels within an appropriate range.

2. What you need to know before taking Gliclazida Krka

Do not take Gliclazida Krka

• if you are allergic (hypersensitive) to gliclazide or to any of the other components of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas), or to related medicines (antidiabetic sulfonamides),
• 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 liver or kidney problems,
• if you are receiving treatment for fungal infections (miconazole, see section “Other medicines and Gliclazida Krka”),
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting Gliclazida Krka.

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

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

During the first weeks of treatment, the risk of low blood sugar (hypoglycemia) may increase. Therefore, it is essential that your doctor closely monitors you.

Low blood sugar (hypoglycemia) may occur:

• if you eat irregularly or skip meals,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase physical activity without a corresponding increase in carbohydrate intake,
• if you drink alcohol, especially if you have skipped a meal,
• if you take other medicines or herbal remedies at the same time,
• if you take high doses of gliclazida,
• if you have endocrine disorders (thyroid, pituitary, or adrenal cortex disorders),
• if you have severely impaired kidney or liver function.

If your blood sugar levels drop, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, nervousness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and visual disturbances, trembling, sensory disturbances, dizziness, and feelings of helplessness.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and sudden, severe chest pain spreading to nearby areas (angina pectoris).

If blood sugar levels continue to fall, you may become significantly confused (delirium), have seizures, lose self-control, have shallow breathing and a slower heartbeat, which may lead to loss of consciousness.

In most cases, symptoms of low blood sugar disappear quickly after taking sugar in any form, e.g., glucose tablets, sugar lumps, sugary juice, or sweetened tea. You should therefore always carry some form of sugar (glucose tablets, sugar lumps) with you. Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms return.

It is possible that symptoms of low blood sugar may not appear, may develop slowly, or you may not notice in time that your blood sugar has dropped.

This may happen if you are elderly and taking certain medicines (e.g., drugs acting on the central nervous system and beta-blockers).

If you are under stress (e.g., accidents, surgery, fever, etc.), your doctor may temporarily switch your treatment to insulin.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazida does not sufficiently lower blood sugar, when you do not follow your prescribed treatment, if you are taking preparations containing St. John’s wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Krka”), or during special stress situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.

If these symptoms occur, contact your doctor or pharmacist.

Changes in blood glucose (low and high blood sugar) may occur when gliclazide is taken 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 are aware of a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality), hemoglobin reduction and breakdown of red blood cells (hemolytic anemia) may occur. Contact 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 Krka is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Gliclazida Krka

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The blood sugar-lowering effect (hypoglycemic effect) of gliclazide may be increased, 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 (e.g., 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 medicines (ibuprofen, phenylbutazone),
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may decrease and blood sugar levels may rise when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• medicines for chest diseases, 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 together with gliclazide, changes in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

Gliclazide may enhance the effect of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before starting any other medicine. If you are admitted to hospital, inform the medical team that you are taking Gliclazida Krka.

Taking Gliclazida Krka with food, drinks, and alcohol

Gliclazida Krka may be taken with food and non-alcoholic drinks.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor for advice on a more suitable treatment.

Gliclazida Krka is not recommended during pregnancy.

You must not take Gliclazida Krka 30 mg modified-release tablets while breastfeeding.

Driving and using machines

Your ability to concentrate or react may be reduced if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if you develop visual problems as a result of these conditions. Be aware that this may endanger your safety or that of others (e.g., when driving or operating machinery). Ask your doctor if you can drive if:

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

Gliclazida Krka contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Gliclazida Krka

Dosage

Follow exactly the instructions for use of this medicine as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the dose based on your blood sugar levels and possibly your urine sugar levels. Changes in external factors (e.g., weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require an adjustment in the dose of gliclazide.

The recommended starting dose is one tablet per day.

The usual dose may range from one to four tablets daily, taken as a single dose with breakfast. The exact dose depends on your response to treatment.

If combination therapy with Gliclazida Krka 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 individual dose for each medicine.

If you notice that your blood sugar levels remain high despite taking the medicine as prescribed, you should contact your doctor or pharmacist.

Route and method of administration

Oral use.

Swallow the tablets whole. Do not chew the tablets.

Take your tablet(s) with a glass of water during breakfast, preferably at the same time each day. You should always eat a meal after taking the tablet(s).

If you take more Gliclazida Krka than you should

If you have taken too many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose include low blood sugar levels (hypoglycaemia), as described in section 2. Symptoms can be prevented by taking sugar (4 to 6 sugar cubes) or sugary drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services. The same action should be taken if someone, for example a child, has accidentally taken the medicine. Food or drink must not be given to unconscious persons.

Ensure that there is always an informed person available who can contact a doctor in an emergency.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Gliclazida Krka

It is important to take your medicine regularly every day for it to work effectively.

However, if you forget to take your dose of Gliclazida Krka, take your next dose at the usual time.

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

If you stop taking Gliclazida Krka

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Stopping treatment may lead to increased blood sugar levels (hyperglycaemia), which increases the risk of developing diabetes-related 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 can cause adverse effects, although not everyone experiences them.

The most frequently observed adverse effect is low blood sugar (hypoglycaemia). For signs and symptoms, see "Warnings and precautions".

If you do not treat these symptoms, they may progress to drowsiness, loss of consciousness, or even coma. If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, you should seek immediate medical attention.

Liver disorders

Rarely, abnormalities in liver function have been reported, which may cause yellowing of the skin and eyes (jaundice). If this occurs, consult your doctor immediately. These symptoms usually resolve if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin disorders

Skin reactions such as rash, redness, itching, eruptions (rash), blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which may lead to breathing difficulties) have been observed. The rash may progress to widespread blistering or skin peeling.

If you develop any of these symptoms, stop taking Gliclazida Krka, contact your doctor immediately, and inform them that you are taking this medicine.

Very rarely, signs of serious hypersensitivity reactions (DRESS) have been reported: initially flu-like symptoms and a skin rash on the face, followed by a generalized rash with high fever.

Blood disorders

Reduction in blood cells (e.g. platelets, white and red blood cells) has been reported. This may cause paleness, prolonged bleeding, bruising, sore throat, and fever.

These symptoms usually resolve upon discontinuation of treatment.

Gastrointestinal disorders

Abdominal pain, nausea, indigestion, diarrhoea, and constipation have been reported.

These effects are reduced if Gliclazida Krka is taken with a meal as recommended.

Visual 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 effects have been observed: cases of serious changes in blood cell counts and allergic inflammatory reactions of the blood vessel wall, reduction in blood sodium (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases resolve upon discontinuation of treatment, but may lead to severe liver failure in isolated cases.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 Krka

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

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date is 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Krka

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other components are: lactose monohydrate, hypromellose, calcium carbonate, anhydrous colloidal silica, and magnesium stearate. See section 2 “Gliclazida Krka contains lactose”.

Nature and contents of the container

The modified-release tablets are white, oval-shaped, biconvex tablets.

Gliclazida Krka is available in blister packs in boxes containing 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, Pta Baja, Oficina 1, 28108, Alcobendas, Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this product information: December 2020

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/