Gliclazide Krka 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazide Krka 60 mg modified-release tablets EFG

Read the entire 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 other people, even if they have the same symptoms as you, because it may 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:

1. What Gliclazide Krka is and what it is used for
2. What you need to know before taking Gliclazide Krka
3. How to take Gliclazide Krka
4. Possible side effects
5. How to store Gliclazide 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 provide adequate control of blood sugar levels.

2. What you need to know before taking Gliclazida Krka

Do not take Gliclazida Krka

• 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 (hypoglycemic sulfonamides),
• if you have insulin-dependent diabetes (type 1),
• if you have ketones and sugar in your urine (which may indicate diabetic ketoacidosis), precoma or diabetic coma,
• if you have severe liver or kidney impairment,
• 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 to take Gliclazida Krka.

You must follow your doctor's prescribed treatment plan to achieve recommended 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, regular monitoring of blood glucose (and possibly urine glucose) levels 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 monitors you closely.

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 too high a dose of gliclazide,
• if you have endocrine disorders (thyroid, pituitary or adrenal cortex disorders),
• if your kidney or liver function is severely impaired.

If your blood sugar drops, you may experience the following symptoms: headache, increased 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 continues to fall, you may experience marked confusion (delirium), seizures, loss of coordination, shallow breathing, and slowed heart rate, which may lead to unconsciousness and possibly progress to coma. The clinical picture of severe hypoglycemia may resemble a heart attack.

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

It is possible that symptoms of low blood sugar may not appear, may develop slowly, or that 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).

It may also happen if you have certain endocrine disorders (e.g., disorders of thyroid or anterior pituitary function or adrenocortical insufficiency).

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 gliclazide has not sufficiently lowered blood sugar, when you have not followed your prescribed treatment, when 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.

Blood glucose disturbances (low and high blood sugar) may occur when gliclazide is prescribed together with other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In such cases, 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), you may experience reduced hemoglobin levels and breakdown of red blood cells (hemolytic anemia). 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

The use of Gliclazida Krka is not recommended in children due to lack of data.

Other medicines and Gliclazida Krka

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

The hypoglycemic effect (ability to lower blood sugar) 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 (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may be reduced, leading to increased blood sugar, when taking any of the following medicines:

• medicines for central nervous system disorders (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• medicines for chest conditions, 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 gliclazide, disturbances 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 new medicine. If you are admitted to hospital, inform the medical staff 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

The use of Gliclazida Krka 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 take Gliclazida Krka while breastfeeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycemia), 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 whether you may drive if:

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

Gliclazida Krka contains lactose

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

3. How to take Gliclazida Krka

Dosage

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is one 30 mg modified-release tablet up to two 60 mg modified-release tablets (maximum 120 mg) taken as a single dose during breakfast. This depends on the response to treatment.

If combination therapy with Gliclazida Krka modified-release tablets 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 are high even though you are taking the medicine as prescribed, you must contact your doctor or pharmacist.

Method of administration

Oral use.

Swallow the tablet(s) whole with a glass of water during breakfast (and preferably at the same time each day). You should always eat 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 are 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 immediately. The same action should be taken if someone, e.g., a child, has accidentally taken the medicine. Unconscious persons must not be given food or drink.

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, indicating 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 properly.

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 could cause an increase in blood sugar (hyperglycaemia), which increases 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 can cause adverse effects, although not everyone will experience them.

The assessment of adverse effects is based on their frequency.

Frequent (may affect up to 1 in 10 people)

The most commonly observed adverse effect is low blood sugar levels (hypoglycaemia). (For signs and symptoms, see “Warnings and precautions”.)

If you do not treat these symptoms, they may progress to stupor, 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.

Uncommon (may affect up to 1 in 100 people)

Gastrointestinal disorders

Abdominal pain, feeling of nausea, indigestion, diarrhoea, and constipation. These effects are reduced if Gliclazida Krka is taken with food as recommended.

Rare (may affect up to 1 in 1,000 people)

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.

Skin disorders

Skin reactions such as rash, redness, itching, eruption (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, 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 facial skin rash, followed by a generalized rash with high fever.

Liver disorders

Isolated cases of 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.

Eye disorders

Your vision may be affected for a short period, 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 very rarely been observed (may affect up to 1 in 10,000 people):

serious changes in blood cell counts and inflammatory allergic reactions of blood vessel walls, 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 adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 which is stated on the blister and the carton 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 containers and unused medicines at the SIGRE point in the 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 60 mg of gliclazide.
• The other components are hypromellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate. See section 2 “Gliclazida Krka contains lactose”.

Appearance of the product and contents of the pack

White to off-white, oblong, biconvex tablet, 13 mm long and 3.5 mm – 4.9 mm thick.

Gliclazida Krka is available in packs of 14, 15, 28, 30, 56, 60, 84, 90, 120 or 180 modified-release tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicine, 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 medicine is authorized in the European Economic Area and the United Kingdom under the following names:

Date of the last revision of this leaflet: December 2020

"Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/"