Gliclazide zentiva

Patient Information Leaflet

Gliclazide Zentiva
60 mg, modified-release tablets
Gliclazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else 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.

Table of contents

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

1. What Gliclazide Zentiva is and what it is used for

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

2. Important information before taking Gliclazide Zentiva

When not to take Gliclazide Zentiva:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines from the same group (sulfonylurea derivatives), or other sulfonamides with blood glucose-lowering action;
• if the patient has insulin-dependent diabetes (type 1);
• if the patient has ketones and sugar in the urine (which may indicate diabetic ketoacidosis), pre-comatose or comatose states;
• if the patient has severe kidney or liver disease;
• if the patient is taking medicines used to treat fungal infections (miconazole, see section "Gliclazide Zentiva and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Gliclazide Zentiva, discuss this with your doctor.
Follow your doctor's advice regarding treatment to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you should maintain regular meals (containing carbohydrates), including breakfast, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) and glycated haemoglobin (HbA_) levels is required.
The risk of low blood glucose (hypoglycaemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.
Low blood glucose (hypoglycaemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient does not eat;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity without sufficient carbohydrate intake;
• the patient consumes alcohol; especially dangerous when combined with skipped meals;
• the patient is taking other medicines or natural remedies 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 glucose, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, impaired concentration, reduced alertness and prolonged 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 to nearby areas of the body (angina pectoris).
If blood glucose continues to decrease, significant confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, symptoms of low blood glucose disappear quickly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweet juice, or sweetened tea.
Therefore, always carry sugar-containing products (glucose tablets, sugar cubes) with you. Remember that artificial sweeteners are ineffective. Contact your doctor or go to the nearest hospital if consuming sugar does not help or if symptoms recur.
Symptoms of low blood glucose may not occur, may be mild, develop slowly, or the patient may not be aware that their blood glucose has decreased. This may happen if the patient is elderly or taking certain medicines (e.g. those acting on the central nervous system or beta-blockers).
In stressful situations (e.g. accidents, surgery, fever, etc.), your doctor may temporarily switch your current treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycaemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan advised by the doctor, if the patient is taking preparations containing St John's wort (Hypericum perforatum) (see section "Gliclazide Zentiva and other medicines"), or during particularly stressful situations. Symptoms may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
When gliclazide is taken concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both low and high blood glucose) may occur. In such cases, the doctor will remind the patient how important it is to monitor 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 a family member, a decrease in haemoglobin levels and breakdown of red blood cells (haemolytic anaemia) may occur.
In patients with porphyria (a hereditary genetic disorder involving accumulation of porphyrins or porphyrin precursors in the body), cases of porphyria exacerbation have been reported after using other sulfonylurea derivatives.
Before starting treatment with Gliclazide Zentiva, discuss this with your doctor or pharmacist.

Children and adolescents
Gliclazide Zentiva is not recommended for use in children and adolescents due to lack of data.

Gliclazide Zentiva and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood glucose may occur, when one of the following medicines is taken:

• other medicines used to treat high blood glucose (oral antidiabetic drugs, 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 (H_-receptor blockers);
• 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 increased blood glucose:

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

When Gliclazide Zentiva is taken concomitantly with antibiotics known as fluoroquinolones, disturbances in blood glucose levels (both low and high blood glucose) may occur, especially in elderly patients.
Gliclazide Zentiva may enhance the effect of anticoagulant medicines (e.g. warfarin).
Consult your doctor before starting any other medicinal product. If the patient is admitted to hospital, they should inform medical staff that they are taking Gliclazide Zentiva.

Gliclazide Zentiva with food, drink and alcohol
Gliclazide Zentiva can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended, as alcohol may unpredictably affect diabetes control.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use of Gliclazide Zentiva is not recommended during pregnancy. If the patient plans to become pregnant or is pregnant, she should inform her doctor, who may recommend more appropriate treatment.
Gliclazide Zentiva must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is too low (hypoglycaemia) or too high (hyperglycaemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired.
Remember that the patient may pose a risk to themselves or others (e.g. when driving a car or operating machinery).
Ask your doctor about the ability to drive:

• if low blood glucose (hypoglycaemia) occurs frequently;
• if symptoms of low blood glucose (hypoglycaemia) are mild or do not occur at all.

Gliclazide Zentiva contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Gliclazide Zentiva

Dosage
This medicine should always be taken as prescribed 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 sugar levels.
Any changes due to external factors (e.g. weight loss, lifestyle changes, stress) or improved blood sugar control may require adjustment of the gliclazide dosage.
The recommended daily dose is half to two tablets (maximum 120 mg), taken once during breakfast. The dose depends on the individual response to treatment.
In combination therapy with Gliclazide Zentiva and metformin, 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 high blood sugar levels despite taking the medicine as prescribed, the patient should consult their doctor or pharmacist.

Route and method of administration
Oral administration.
Swallow half a tablet or the whole tablet(s) at once. Do not chew or crush them.
The tablet(s) should be taken with a glass of water during breakfast (preferably at the same time every day).
Always eat a meal after taking the tablet(s).
The tablet may be divided into equal doses.

If you take more Gliclazide Zentiva than you should
If too many tablets have been taken, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose are those of low blood sugar (hypoglycaemia), as described in section 2. In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, 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. Do not give food or drink to an unconscious person.
The patient should ensure that someone is always available to call a doctor in an emergency.

If you forget to take Gliclazide Zentiva
It is important to take the medicine every day, as regular use ensures better effectiveness. However, if a dose of Gliclazide Zentiva is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping Gliclazide Zentiva
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine. Stopping treatment may lead to increased blood sugar 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The most commonly observed symptom is low blood sugar (hypoglycaemia). Subjective and objective symptoms are described in section 2, "Warnings and precautions", under "Important information before taking Gliclazide Zentiva".
If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness or coma. If hypoglycaemia is severe or prolonged, even if temporarily controlled by sugar intake, you should contact a doctor immediately.

Blood disorders
Decreased blood cell counts (e.g. platelets, red and white blood cells) have been reported, which may cause:

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

Liver disorders
Isolated cases of liver function disturbances have been observed, which may cause yellowing of the skin and eyes (jaundice). If these symptoms occur, medical advice should be sought immediately. Symptoms usually resolve after stopping the medicine. The decision to discontinue treatment will be made by the physician.

Skin disorders
Skin reactions observed include:

• rash;
• redness;
• itching;
• urticaria;
• blisters;
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties).
  The rash may progress to extensive blistering or lead to skin peeling. If any of these symptoms occur, Gliclazide Zentiva should be discontinued immediately and medical advice sought urgently, informing the doctor about use of this medicine.
• very rarely, symptoms of severe hypersensitivity reactions (known as drug rash with eosinophilia and systemic symptoms, DRESS) have been reported, initially presenting as influenza-like symptoms and facial rash, followed by widespread rash over larger areas of the body accompanied by high fever.

Gastrointestinal disorders

• abdominal pain or discomfort;
• nausea or vomiting;
• dyspepsia;
• diarrhoea;
• constipation.
  These symptoms may be reduced by taking Gliclazide Zentiva with food, as recommended. See section 3, "How to take Gliclazide Zentiva".

Eye disorders
Blurred vision may occur, especially at the beginning of treatment. This adverse effect is related to changes in blood glucose levels.

As with other sulfonylurea derivatives, the following adverse events have been observed: cases of severe blood cell count abnormalities and allergic vasculitis, hyponatremia (low blood sodium levels), and symptoms of liver dysfunction (e.g. jaundice), which in most cases resolve upon discontinuation of sulfonylurea derivatives; however, in rare cases, these may lead to life-threatening liver failure.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 181 C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gliclazide Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Zentiva contains

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• Other ingredients are: lactose monohydrate, hypromellose 4000, hypromellose 100, magnesium stearate.

What Gliclazide Zentiva looks like and contents of the pack
White, biconvex, oval modified-release tablets with a central break line and
symbols "GLI" and "60" on either side of the break line, measuring 15.0 mm x 7.0 mm.
The tablet may be divided into equal doses.
Tablets are available in blisters packed in cardboard boxes containing 30 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Manufacturer / Importer
S.C. Zentiva S.A.
B-dul Theodor Pallady no. 50, sector 3
032266 Bucharest, Romania
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Bulgaria Гликлазид Зентива
France, Latvia, Poland, Italy Gliclazide Zentiva
Portugal Gliclazida Zentiva
For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel: +48 22 375 92 00