OZICLIDE 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Oziclide MR, 60 mg, Modified-Release Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
3. What Oziclide MR, Modified-Release Tablets are and what they are used for
4. Important information before taking Oziclide MR, Modified-Release Tablets
   1. When not to take Oziclide MR, Modified-Release Tablets:
   2. Warnings and precautions
   3. Children and adolescents
   4. Oziclide MR, Modified-Release Tablets and other medicines
   5. Taking Oziclide MR, Modified-Release Tablets with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Oziclide MR, Modified-Release Tablets contain lactose
5. How to take Oziclide MR, Modified-Release Tablets
   1. Dose
   2. Method and route of administration
   3. Taking a higher dose of Oziclide MR, Modified-Release Tablets than recommended
   4. Missing a dose of Oziclide MR, Modified-Release Tablets
   5. Stopping treatment with Oziclide MR, Modified-Release Tablets
6. Possible side effects
   1. Reporting side effects
7. How to store Oziclide MR, Modified-Release Tablets
8. Contents of the pack and other information
   1. What Oziclide MR, Modified-Release Tablets contain
   2. What Oziclide MR, Modified-Release Tablets look like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. To obtain information on the names of the medicine in other European Economic Area countries
   6. contact the marketing authorization holder. Date of last revision of the package leaflet: 12.07.2023

Package Leaflet: Information for the Patient

Oziclide MR, 60 mg, Modified-Release Tablets

Gliclazide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Oziclide MR, Modified-Release Tablets are and what they are used for
• 2. Important information before taking Oziclide MR, Modified-Release Tablets
• 3. How to take Oziclide MR, Modified-Release Tablets
• 4. Possible side effects
• 5. How to store Oziclide MR, Modified-Release Tablets
• 6. Contents of the pack and other information

1. What Oziclide MR, Modified-Release Tablets are and what they are used for

What Oziclide MR, Modified-Release Tablets are
Oziclide MR, Modified-Release Tablets are a medicine that lowers blood sugar levels (an oral anti-diabetic medicine belonging to the sulfonylurea group).
Oziclide MR, in the form of modified-release tablets, is used to treat a certain form of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight loss alone are not sufficient to control blood sugar levels.

2. Important information before taking Oziclide MR, Modified-Release Tablets

Important information before taking Oziclide MR, Modified-Release Tablets

When not to take Oziclide MR, Modified-Release Tablets:

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas) or to other related medicines (sulfonamides with a hypoglycemic effect);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (which may indicate 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 "Oziclide MR, Modified-Release Tablets and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Oziclide MR, Modified-Release Tablets, discuss this with your doctor or pharmacist.
Follow your doctor's advice to achieve good blood sugar control. This means that, in addition to taking the tablets regularly, you should also follow a diet, exercise, and, if necessary, lose weight.
During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and, if necessary, in your urine) and hemoglobin A1c levels.
The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, close medical monitoring 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 do not eat enough carbohydrates;
• 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, pituitary, or adrenal gland disorders);
• your kidney or liver function is severely impaired.

If you experience low blood sugar, you may have 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 disturbances, tremors, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate (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.
In most cases, the symptoms of low blood sugar disappear quickly when you eat some sugar, e.g., glucose tablets, sugar cubes, or drink a sweet beverage.
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 recur.
Symptoms of low blood sugar may not occur, may be mild, or may develop 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 acting on the central nervous system and beta-blockers).
In stressful situations (e.g., accidents, surgery, fever, etc.), your doctor may temporarily change your treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide does not lower your blood sugar levels sufficiently, if you do not follow your doctor's treatment plan, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Oziclide MR, Modified-Release Tablets and other medicines"), or in particularly stressful situations. This can 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.
Changes in blood sugar levels (high and low blood sugar) may occur when a medicine from the group of antibiotics called fluoroquinolones is taken at the same time as Oziclide MR, Modified-Release Tablets, especially in elderly patients.
In such cases, your doctor will remind you of the importance of monitoring your blood sugar levels.
If you or a family member have been diagnosed with a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a condition that affects red blood cells), you may experience a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia). You should consult your doctor before taking this medicine.
In patients with porphyria (a genetic disorder that affects the production of porphyrins), cases of worsening porphyria have been reported after taking certain sulfonylurea medicines.

Children and adolescents

Oziclide MR, Modified-Release Tablets are not recommended for use in children and adolescents due to a lack of data.

Oziclide MR, Modified-Release Tablets and other medicines

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 effect of gliclazide in lowering blood sugar levels may be enhanced, and symptoms of low blood sugar may occur when you take one of the following medicines:

• other medicines used to lower high blood sugar levels (oral anti-diabetic 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 blockers);
• medicines used to treat depression (MAO inhibitors);
• pain relievers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause an increase in blood sugar levels:

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

Changes in blood sugar levels (high and low blood sugar) may occur when a medicine from the group of antibiotics called fluoroquinolones is taken at the same time as Oziclide MR, Modified-Release Tablets, especially in elderly patients.
Oziclide MR, Modified-Release Tablets may increase the effect of anticoagulant medicines (e.g., warfarin).
Consult your doctor before taking any other medicine. If you are hospitalized, inform the medical staff that you are taking Oziclide MR, Modified-Release Tablets.

Taking Oziclide MR, Modified-Release Tablets with food, drink, and alcohol

Oziclide MR, Modified-Release Tablets can be taken with food and non-alcoholic beverages.
It is not recommended to drink alcohol, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding

Oziclide MR, Modified-Release Tablets are not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.
Do not take Oziclide MR, Modified-Release Tablets during breastfeeding.

Driving and using machines

If your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if you experience vision disturbances due to blood sugar level changes, your ability to concentrate or react may be impaired. Remember that you may pose a risk to yourself or others (e.g., while driving or operating machinery). Ask your doctor about the possibility of driving:

• if you experience frequent low blood sugar (hypoglycemia);
• if you have mild or no symptoms of low blood sugar (hypoglycemia).

Oziclide MR, Modified-Release Tablets contain lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
Oziclide MR, Modified-Release Tablets contain sodium.The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Oziclide MR, Modified-Release Tablets

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 and urine tests. Any changes related to external factors (e.g., weight loss, lifestyle changes, stress) or improvements in blood sugar control may require changes in the gliclazide dose.
It is recommended to take half a tablet to two tablets (the maximum dose is 120 mg) once a day, during breakfast. The dose depends on the body's response to treatment.
In combination therapy with Oziclide MR, Modified-Release Tablets and metformin, other anti-diabetic medicines (alpha-glucosidase inhibitor, thiazolidinedione, dipeptidyl peptidase-4 inhibitor, 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 too high despite taking the prescribed medicine, consult your doctor or pharmacist.

Method and route of administration

Oral administration.
Swallow half a tablet or a whole tablet whole, without chewing or crushing.
The tablet can be divided into two equal parts.
Take the tablet with a glass of water during breakfast (preferably at the same time every day).
Always eat a meal after taking the medicine.

Taking a higher dose of Oziclide MR, Modified-Release Tablets than recommended

If you take more Oziclide MR, Modified-Release Tablets than you should, contact your doctor or the nearest hospital emergency department for advice. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) and are described in section 2.
In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a snack or meal, may help.
If you are unconscious, immediately inform your doctor and call for emergency assistance. Do the same if someone, e.g., a child, has taken this medicine by mistake. Do not give food or drink to unconscious patients.
Make sure that someone who can call a doctor in case of sudden health deterioration is always informed.

Missing a dose of Oziclide MR, Modified-Release Tablets

It is important to take your medicine every day, as regular treatment works better.
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Oziclide MR, Modified-Release Tablets

Since diabetes treatment usually lasts for the rest of your life, consult your doctor before stopping this treatment. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oziclide MR, Modified-Release Tablets can cause side effects, although not everybody gets them.
The most commonly observed symptom is low blood sugar (hypoglycemia). Symptoms
are described in the "Warnings and precautions" section of point 2 "Important information before taking Oziclide MR".
If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar levels is significant or prolonged, even if there is temporary improvement after sugar intake, you should immediately consult your doctor.
Blood disorders
A decrease in the number of blood cells (e.g., platelets, red and white blood cells) has been observed.
This may cause:

• pale skin
• prolonged bleeding
• bruises
• sore throat
• fever. These symptoms usually disappear after treatment is discontinued.

Liver disorders
Single cases of liver function disorders have been observed, which may cause yellowing of the skin and eyes. If you experience these symptoms, immediately contact your doctor. The symptoms usually disappear after the medicine is discontinued. Your doctor will decide when to discontinue treatment.
Skin disorders
Skin reactions, such as:

• rash
• redness
• itching
• hives
• blisters
• angioedema (sudden swelling of tissues such as eyelids, face, lips, tongue, or throat, which may cause breathing difficulties). Rash may lead to the formation of extensive blisters and skin peeling. If you experience these symptoms, discontinue Oziclide MR, Modified-Release Tablets and immediately contact your doctor and inform them that you are taking this medicine.
• rarely, symptoms of severe hypersensitivity reactions (DRESS) have been reported, initially in the form of flu-like symptoms and a rash on the face, which then spread, and a high fever.

Gastrointestinal disorders

• abdominal pain or discomfort
• nausea or vomiting
• indigestion
• diarrhea
• constipation. These symptoms can be reduced by taking Oziclide MR, Modified-Release Tablets with a meal as recommended in section 3 "How to take Oziclide MR, Modified-Release Tablets".

Eyes disorders
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been reported:

Notable changes in blood cell count and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), signs of liver damage (e.g., jaundice), which in most cases disappeared after discontinuation of sulfonylureas, but in single cases may lead to life-threatening liver failure.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
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 Oziclide MR, Modified-Release Tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or bottle. The expiry date refers to the last day of the month.
Do not use tablets remaining in the bottle after 100 days from the first opening.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oziclide MR, Modified-Release Tablets contain

• The active substance is gliclazide. One modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are: maize starch, lactose monohydrate, sodium citrate, hypromellose, magnesium stearate.

What Oziclide MR, Modified-Release Tablets look like and contents of the pack

White to off-white oval tablet, with a score line on both sides, with the letters "Z" and "I" embossed on one side and plain on the other side, measuring 15.0 x 7.0 mm.
Blisters of PVC/OPA/Aluminum containing 30, 60, or 90 modified-release tablets, in a cardboard box.
Blisters of PVC/PE/PVDC/Aluminum containing 30, 60, or 90 modified-release tablets, in a cardboard box.
HDPE bottle with a child-resistant closure containing 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
Netherlands
Terapia SA,
Fabricii Street 124,
Cluj Napoca, 400 632
Romania

To obtain information on the names of the medicine in other European Economic Area countries

contact the marketing authorization holder. Date of last revision of the package leaflet: 12.07.2023