Gliclada

Leaflet accompanying the packaging: patient information

Gliclada, 60 mg, modified-release tablets

Gliclazide

Read the leaflet carefully before taking the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects or any other side effects not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Gliclada and what is it used for
• 2. Important information before taking Gliclada
• 3. How to take Gliclada
• 4. Possible side effects
• 5. How to store Gliclada
• 6. Contents of the packaging and other information

1. What is Gliclada and what is it used for

Gliclada is a medicine that reduces blood sugar levels (it is an oral antidiabetic medicine belonging to the sulfonylurea group). Gliclada is used to treat a certain type of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight reduction alone are not sufficient to maintain normal blood sugar levels.

2. Important information before taking Gliclada

When not to take Gliclada:

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines from the same group (sulfonylureas), other derivatives (sulfonamides with a hypoglycemic effect);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may indicate that you have diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines used to treat fungal infections (miconazole, see section "Other medicines and Gliclada");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Gliclada, inform your doctor or pharmacist. You should follow the treatment plan recommended by your doctor to achieve the recommended blood sugar levels. This means that you should not only take the medicine regularly but also follow a diet and exercise regularly and, if necessary, reduce your weight. During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and possibly urine) and also check your glycosylated hemoglobin (HbA1c) levels. The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, close medical supervision is necessary. Low blood sugar (hypoglycemia) may occur if:

• you take your meals irregularly or skip meals;
• you fast;
• you are undernourished;
• you change your diet;
• you increase your physical activity, and your carbohydrate intake is not sufficient;
• you drink alcohol, especially if you skip meals;
• you take other medicines or natural products at the same time;
• you take too high a dose of gliclazide;
• you have certain hormonal disorders (thyroid disorders, pituitary or adrenal gland disorders);
• your kidney or liver function is severely impaired.

If you have low blood sugar, you may experience the following symptoms: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, decreased concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disorders, tremors, sensory disturbances, dizziness, weakness. You may also experience the following symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate to nearby areas (angina pectoris). If your blood sugar levels continue to decrease, you may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, and you may lose consciousness, which can lead to coma. The clinical picture of severe hypoglycemia may resemble a stroke. In most cases, the symptoms of low blood sugar disappear very quickly when you eat some sugar, e.g., glucose tablets, sugar cubes, or drink a sweet juice or sweetened tea. Therefore, you should always carry some sugar products with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. You should contact your doctor or the nearest hospital if eating sugar does not help or if the symptoms return. The symptoms of low blood sugar may not occur, may be mild, or may develop very slowly, or you may not be aware that your blood sugar levels have decreased. This can happen if you are elderly and taking certain medicines (e.g., those that act on the central nervous system and beta-blockers). It can also happen in people with certain endocrine disorders (e.g., certain thyroid disorders, pituitary or adrenal gland disorders). In stressful situations (e.g., accidents, surgery, fever, etc.), your doctor may temporarily change your treatment to insulin therapy. High blood sugar symptoms (hyperglycemia) may occur if gliclazide has not yet reduced your blood sugar levels sufficiently, if you do not follow the treatment plan recommended by your doctor, if you take St. John's Wort (Hypericum perforatum) (see section "Gliclada and other medicines"), or in special stressful situations. This may cause thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you should contact your doctor or pharmacist. Blood sugar disorders (low blood sugar and high blood sugar), especially in elderly patients, may occur when Gliclada is taken with antibiotics called fluoroquinolones. In such cases, your doctor will inform you about the importance of monitoring your blood sugar levels. If you or a family member has been diagnosed with a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), you may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). You should contact your doctor before taking this medicine.

Children and adolescents

Gliclada is not recommended for use in children due to a lack of data.

Other medicines and Gliclada

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. The blood sugar-lowering effect of gliclazide may be enhanced, and low blood sugar symptoms may occur when taken with one of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetic medicines, GLP-1 receptor agonists, or insulin);
• antibiotics (sulfonamides, clarithromycin);
• medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors, such as captopril or enalapril);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines used to treat stomach or duodenal ulcers (H2 receptor antagonists);
• medicines used to treat depression (MAO inhibitors);
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause high blood sugar levels:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or given during childbirth (intravenously administered salbutamol, rytodrine, terbutaline);
• medicines used to treat breast disorders, heavy menstrual bleeding, and endometriosis (danazol)
• St. John's Wort (Hypericum perforatum).

Blood sugar disorders (low blood sugar and high blood sugar), especially in elderly patients, may occur when Gliclada is taken with antibiotics called fluoroquinolones. Gliclada, modified-release tablets may increase the effect of anticoagulant medicines (e.g., warfarin). You should consult your doctor before taking any other medicine. If you are hospitalized, you should inform the medical staff that you are taking Gliclada.

Gliclada with food, drink, and alcohol

Gliclada, modified-release tablets can be taken with food and non-alcoholic beverages. It is not recommended to drink alcohol, as it may change your diabetes control in an unpredictable way.

Pregnancy and breastfeeding

Gliclada should not be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take Gliclada while breastfeeding.

Driving and using machines

If your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if you experience vision disturbances as a result of abnormal blood sugar levels, your ability to concentrate or react may be impaired. You should remember that you may pose a risk to yourself or others (e.g., when driving a car or operating machinery). You should ask your doctor about the possibility of driving:

• if you experience low blood sugar (hypoglycemia) frequently;
• if the symptoms of low blood sugar (hypoglycemia) are very mild or absent.

Gliclada, modified-release tablets contain lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Gliclada

Dose

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The dose is determined by your doctor, depending on your blood sugar levels. Any changes related to external factors (e.g., weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in the dose of gliclazide. The recommended dose is from half a tablet to 2 tablets (maximum 120 mg) taken once daily at breakfast time. The dose depends on the body's response to treatment. In combination therapy with Gliclada, modified-release tablets and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dose of each medicine will be individually determined by your doctor. If you notice that your blood sugar levels are high, even though you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

Method and route of administration

Oral administration. The tablet can be divided into equal doses. Swallow half a tablet or one (or more) tablet(s) at a time. Do not chew or crush. Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day). You should always eat a meal after taking the tablet(s).

Taking a higher dose of Gliclada than recommended

If you have taken too many tablets, you should immediately contact your doctor or go to the nearest hospital. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) and are described in section 2. In such situations, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by a snack or meal, may help. If you are unconscious, you should immediately contact your doctor and call for emergency help. The same applies if someone, e.g., a child, has taken this medicine by mistake. Unconscious patients should not be given food or drink. You should make sure that someone who can call a doctor in case of an emergency is always informed.

Missing a dose of Gliclada

It is important to take your medicine every day, as regular treatment works better. However, if you miss a dose of Gliclada, you should take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Gliclada

Since diabetes treatment usually lasts for the rest of your life, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may cause high blood sugar levels (hyperglycemia), 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. In case of any doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common(occurring in less than 1 in 10 people) The most frequently observed adverse reaction is low blood sugar (hypoglycemia). The objective and subjective symptoms are described in the section "Warnings and precautions". If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar is significant or prolonged, even if it is temporarily controlled by the administration of sugar, you should immediately consult your doctor. Uncommon(occurring in less than 1 in 100 people): Gastrointestinal disordersAbdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Gliclada, modified-release tablets with food as recommended. Rare(occurring in less than 1 in 1,000 people): Blood disordersA decrease in the number of blood cells (e.g., platelets, red and white blood cells) may cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after treatment is discontinued. Skin disordersSkin reactions, such as rash, redness, itching, urticaria, angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty breathing), have been observed. The rash may develop into widespread blistering or lead to skin peeling. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face, which then spreads. Liver disordersIsolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes. If you experience these symptoms, you should immediately contact your doctor. The symptoms usually disappear after the medicine is discontinued. Your doctor will decide whether to stop treatment. Eye disordersVision may be impaired, especially at the beginning of treatment. This effect is related to changes in blood sugar levels. Your doctor will decide whether to stop treatment. As with other sulfonylureas, the following adverse reactions have been very rarely reported (occurring in less than 1 in 10,000 people): significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms of liver damage (e.g., jaundice), which in most cases disappeared after sulfonylureas were discontinued, but in isolated cases may have led to life-threatening liver failure.

Reporting side effects

If you experience any side effects or any other side effects not mentioned in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclada

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 refers to the last day of that month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Gliclada contains

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are: hypromellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (see section 2).

What Gliclada looks like and contents of the pack

Gliclada is available in the form of white to almost white, oval, biconvex tablets, 13 mm in length and 3.5 mm to 4.9 mm in thickness, with a score line on both sides. The tablet can be divided into equal doses. Gliclada is available in packs of 14, 15, 28, 30, 56, 60, 84, 90, 120, or 180 modified-release tablets in blisters, in a carton box. Not all 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 TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For more information about the medicinal product in other European Union member states, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500

Date of last revision of the leaflet:

• 29.07.2016