Oziclide mr

Package leaflet: Information for the patient

Oziclide MR, 60 mg, modified-release tablets
Gliclazide
Please read all of this leaflet carefully before 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the 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

Oziclide MR modified-release tablets are a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Oziclide MR in the form of modified-release tablets is used in the treatment of a certain type of diabetes (type 2 diabetes) in adults when diet, physical exercise, and weight reduction are insufficient to maintain normal blood sugar levels.

2. Important information before using Oziclide MR, modified-release tablets

When not to use Oziclide MR modified-release tablets:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same class (sulfonylurea derivatives), or to other derivatives (antifungal sulfonamides with hypoglycemic action);
• if the patient has insulin-dependent (type 1) diabetes;
• if ketones and glucose are present in the urine (this may indicate diabetic ketoacidosis), pre-comatose states, or diabetic coma;
• if the patient has severe kidney or liver disease;
• if the patient is taking antifungal medications used to treat fungal infections (miconazole, see section "Oziclide MR, modified-release tablets and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Oziclide MR in the form of modified-release tablets, discuss this with your doctor or pharmacist.
You should follow your doctor's advice to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you should adhere to a diet, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) is required, as well as measurement of glycated hemoglobin (HbA1c).
The risk of low blood sugar (hypoglycemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.
Low blood sugar (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity without sufficient carbohydrate intake;
• the patient consumes alcohol, especially when skipping meals;
• the patient is taking other medicines or natural supplements at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction);
• kidney or liver function is severely impaired.

If the patient has low blood sugar, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating outward (angina pectoris).
If blood glucose continues to drop, significant confusion (delirium), seizures, loss of consciousness, shallow breathing, and slow heartbeat may occur, and the patient may lose consciousness.
In most cases, symptoms of low blood sugar disappear very quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, sweet fruit juice, or sweetened tea.
Therefore, it is advisable to always carry some sugary products (glucose tablets, sugar cubes). Note that artificial sweeteners are ineffective. Contact your doctor or the nearest hospital if sugar intake does not help or if symptoms recur.
Symptoms of low blood sugar may not occur, may be mild or develop very slowly, or the patient may not be aware that blood glucose has dropped. This may happen in elderly patients or in patients taking certain medications (e.g., those acting on the central nervous system and beta-blockers).
In stressful situations (e.g., accidents, surgical procedures, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, if the patient is taking St. John's wort (Hypericum perforatum) (see section "Oziclide MR, modified-release tablets and other medicines"), or during particularly stressful situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
Glucose level disturbances (high and low blood sugar) may occur when a medicine belonging to the group of antibiotics called fluoroquinolones is prescribed at the same time as Oziclide MR modified-release tablets, especially in elderly patients.
In such cases, the doctor will emphasize the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells) has been diagnosed in the patient or in someone in their family, a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicine.
In patients with porphyria (a hereditary genetic disorder characterized by accumulation of porphyrins or their precursors in the body), cases of worsening of porphyria have been reported after administration of certain other sulfonylurea derivatives.

Children and adolescents
Oziclide MR in the form of modified-release tablets is not recommended for use in children and adolescents due to lack of data.

Oziclide MR, modified-release tablets and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood sugar may occur, when one of the following medicines is taken:

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

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

• medicines used in central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used in asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used in breast diseases, severe menstrual bleeding, and endometriosis (danazol);
• herbal preparations containing St. John's wort (Hypericum perforatum).

Glucose level disturbances (low and high 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 in the form of modified-release tablets may enhance the effect of anticoagulant medicines (e.g., warfarin).
Consult your doctor before starting any other medicine. If you are admitted to hospital, 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 in the form of modified-release tablets can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
Oziclide MR in the form of modified-release tablets is not recommended during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Oziclide MR in the form of modified-release tablets must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances, concentration difficulties, or delayed reaction times occur due to abnormal blood glucose levels, your ability to concentrate or react may be impaired. Remember that you may pose a risk to yourself or others (e.g., when driving a car or operating machinery). Ask your doctor whether you are allowed to drive:

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

Oziclide MR, modified-release tablets contain lactose.
If the patient has been diagnosed with intolerance to certain sugars, they should consult their 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, meaning the medicine is considered "sodium-free".

3. How to use Oziclide MR, modified-release tablets

Dosage
This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The dose is determined by the doctor, depending on blood and urine glucose levels. Any changes due
to external factors (e.g. weight loss, lifestyle changes, stress) or improvement in blood glucose control
may require adjustment of gliclazide dosage.
It is recommended to take from half a tablet to two tablets (maximum dose is 120 mg), once daily with
breakfast. The dose depends on the body's response to treatment.
In combination therapy with Oziclide MR modified-release tablets and metformin, other antidiabetic
medicines (an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-IV inhibitor, a
GLP-1 receptor agonist or insulin), the appropriate dose of each medicine will be individually determined
by the doctor.
If the patient notices that blood glucose levels remain too high despite taking the prescribed medicine,
consult your doctor or pharmacist.

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

Use of more than the recommended dose of Oziclide MR, modified-release tablets
If more than the recommended dose is taken, seek advice from a doctor or the nearest hospital
emergency department immediately. Symptoms of overdose are those of low blood sugar (hypoglycaemia)
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 the patient is unconscious, contact a doctor immediately and call emergency
services. The same applies if someone (e.g. a child) accidentally takes this medicine. Food or drinks
must not be given to unconscious patients.
Ensure that someone who can call a doctor in case of sudden deterioration in the patient's health is
always informed.

Missed dose of Oziclide MR, modified-release tablets
It is important to take the medicine every day, as regular use ensures better effectiveness.
If the patient forgets to take the medicine, the next dose should be taken at the usual time. Do not take
a double dose to make up for a missed tablet.

Stopping Oziclide MR, modified-release tablets
As diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Stopping treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of
diabetes complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly observed symptom is low blood sugar (hypoglycaemia). Symptoms
are described in section "Warnings and precautions", point 2 "Important information before
using Oziclide MR".
If these symptoms are left untreated, drowsiness, loss of consciousness or coma may occur. If blood sugar reduction is significant or prolonged, even if temporarily improved by administration of sugar, you should immediately consult a doctor.

Blood disorders
A decrease in blood cell count (e.g. platelets, red and white blood cells) has been observed.
This may cause:

• pallor
• prolonged bleeding
• bruising
• sore throat
• fever. These symptoms usually resolve after discontinuation of treatment.

Liver disorders
Isolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes. If these symptoms occur, you should contact your doctor immediately. Symptoms usually resolve after discontinuation of the medicine. Your doctor will decide when to discontinue treatment.

Skin disorders
Skin reactions observed include:

• rash
• redness
• itching
• urticaria
• blisters
• angioedema (sudden swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties). Rash may lead to the formation of extensive blisters and skin peeling. If a patient develops these symptoms, administration of Oziclide MR should be discontinued and immediate contact made with a doctor, informing him or her about the use of this medicine.
• very rarely, severe hypersensitivity reactions (DRESS) have been reported, initially presenting as flu-like symptoms and facial rash, which subsequently spreads, along with high fever.

Gastrointestinal disorders

• abdominal pain or discomfort
• nausea or vomiting
• indigestion
• diarrhoea
• constipation. These symptoms may be reduced by taking Oziclide MR modified-release tablets with food, as recommended in section 3 "How to take Oziclide MR modified-release tablets".

Eye disorders
Vision may be disturbed, especially at the beginning of treatment. This effect is related to changes in blood glucose levels.

As with other sulfonylurea derivatives, the following adverse events have been observed:
significant changes in blood cell counts and allergic vasculitis, decreased sodium concentration in blood (hyponatraemia), signs of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea derivatives, but in rare cases may lead to life-threatening liver failure.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Oziclide MR, modified release tablets

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle.
The expiry date refers to the last day of the specified month.
Do not use tablets remaining in the bottle after 100 days from first opening.
Store below 30°C.
Medicines must 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.
• Other ingredients are: maize starch, monohydrate lactose, 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 breakline on both sides, embossed with the letters “Z” and “I”
on one side and plain on the other side, measuring 15.0 x 7.0 mm.
PVC/OPA/Aluminium blisters containing 30, 60 or 90 modified-release tablets, in a cardboard box.
PVC/PE/PVDC/Aluminium blisters containing 30, 60 or 90 modified-release tablets, in a cardboard box.
HDPE bottle with child-resistant closure containing 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel. 22 642 07 75

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
The Netherlands

Terapia SA,
Fabrici Street no. 124,
Cluj Napoca, 400 632
Romania

For information on the names of the medicinal product in the other Member States of the European Economic Area, please contact the Marketing Authorisation Holder.