Gliclazide Mylan Generics Italia

Patient Information Leaflet

Gliclazide Mylan Generics Italia

30 mg modified-release tablets
gliclazide
Generic medicine
Please read all of this 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. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Gliclazide Mylan Generics Italia is and what it is used for
2. What you need to know before taking Gliclazide Mylan Generics Italia
3. How to take Gliclazide Mylan Generics Italia
4. Possible side effects
5. How to store Gliclazide Mylan Generics Italia
6. Contents of the pack and other information

1. What Gliclazide Mylan Generics Italia is and what it is used for

Gliclazide Mylan Generics Italia is a medicine used to reduce blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea class).
Gliclazide Mylan Generics Italia is used in a specific type of diabetes (Type 2, or mellitus diabetes) in adults when diet, physical exercise, and weight loss alone have not achieved sufficient effect.

2. What you need to know before taking Gliclazide Mylan Generics Italia

Do not take Gliclazide Mylan Generics Italia

• if you are allergic to gliclazide, or to any of the excipients of this medicine (listed in section 6), or to other medicines of the same class (sulfonylureas), or to related medicines (hypoglycemic sulfonamides),
• if you have insulin-dependent (type 1) diabetes,
• if you have ketones or sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma,
• if you have severe kidney or liver disease,
• if you are taking medicines to treat fungal infections (miconazole - see section "Other medicines and Gliclazide Mylan Generics Italia"),
• during breastfeeding. If you think any of the above points apply to you, inform your doctor, nurse or pharmacist.

Warnings and precautions
This medicine should only be prescribed if it is expected that the patient will maintain a regular meal schedule (including breakfast). It is important that carbohydrate intake is regular, due to the increased risk of low blood sugar levels (hypoglycaemia) in case of delayed or missed meals, inadequate food intake, or consumption of foods containing insufficient carbohydrates.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is required. Your doctor may also perform blood tests to monitor your glycated haemoglobin (HbA ).
To achieve recommended blood sugar levels, you must follow the treatment plan prescribed by your doctor. This means taking your tablets regularly, adhering to your diet, exercising, and, if necessary, losing weight.
During the first weeks of treatment, the risk of excessively low blood sugar levels (hypoglycaemia) may increase. It is therefore vital that your doctor performs regular health checks.
Low blood sugar levels (hypoglycaemia) may occur:

• if meal times are irregular or if you skip a meal,
• if you fast,
• 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 in combination with missed meals,
• if you are taking other medicines or herbal remedies concurrently,
• if you take high doses of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary or adrenal cortex dysfunction),
• if kidney or liver function is severely impaired.

If you experience low blood sugar levels, you may have the following symptoms: headache, intense hunger, pallor, weakness, extreme fatigue, nausea, vomiting, tiredness, drowsiness, sleep disturbances, agitation, aggression, poor concentration, reduced alertness and responsiveness, depression, confusion, visual and speech disturbances, tremors, sensory disturbances, dizziness, feeling of helplessness. The following signs and symptoms may also occur: excessive sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and sudden, severe chest pain that may radiate to nearby areas (angina pectoris).
If your blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, breathing may become shallow, heartbeat may slow down, and you may faint, which could lead to coma.
In most cases, symptoms of hypoglycaemia disappear very quickly after consuming some form of sugar, e.g. sugar lumps, sugary juice or tea. You should therefore always carry sugar with you (grape juice, sugar lumps). Remember that artificial sweeteners are not effective. If taking sugar does not help or if symptoms recur, contact your doctor or the nearest hospital.
It is possible that symptoms of hypoglycaemia may be absent or less pronounced, develop very slowly, or that you do not realise in time that your blood sugar has dropped too low. This may occur if you are elderly and taking certain medicines (e.g. those acting on the central nervous system and beta-blockers). It may also occur if you have certain endocrine disorders (e.g. some thyroid disorders and anterior pituitary or corticosuprarenal insufficiency).
If you are under stress (e.g. accidents, surgery, infections with fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms caused by high blood sugar levels (hyperglycaemia) may occur when gliclazide does not sufficiently lower blood sugar, due to incorrect intake of the medicine, if you take St John's wort ( Hypericum perforatum ) (see section "Other medicines and Gliclazide Mylan Generics Italia"), or during particular stress situations. Symptoms of high blood sugar levels may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and reduced performance.
Inform your doctor or pharmacist if any of these symptoms occur.
Blood sugar disturbances (low and high blood sugar levels) may occur when gliclazide is taken concomitantly with medicines belonging to the class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring blood glucose.
In patients with inherited deficiency of the enzyme Glucose-6-phosphate dehydrogenase, a decrease in haemoglobin levels or rupture of red blood cells (haemolytic anaemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with some other sulfonylurea drugs in patients with porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).

Children and adolescents
Gliclazide Mylan Generics Italia must not be used for the treatment of diabetes in children and adolescents under 18 years of age.

Other medicines and Gliclazide Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The effectiveness and safety of Gliclazide Mylan Generics Italia may be altered if taken together with certain other medicines. Conversely, the effectiveness of other medicines may be altered by concomitant intake of Gliclazide Mylan Generics Italia.
The hypoglycaemic effect (blood sugar lowering) of gliclazide may be increased and signs of hypoglycaemia may occur if you take any of the following medicines:

• other medicines to treat hyperglycaemia (oral antidiabetics, GLP-1 receptor agonists) or insulin,
• antibiotics (e.g. sulfonamides, clarithromycin),
• medicines to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat indigestion and gastric or duodenal ulcers (H -receptor antagonists such as ranitidine),
• medicines to treat depression (monoamine oxidase inhibitors such as selegiline, phenelzine),
• painkillers or anti-rheumatic drugs (ibuprofen, phenylbutazone),
• medicines containing alcohol,
• medicines to treat high cholesterol (fibrates),
• medicines to treat fever or pain (salicylates).

The hypoglycaemic effect (blood sugar lowering) of gliclazide may be reduced and signs of hyperglycaemia may occur if you take any of the following medicines:

• medicines to treat disorders of the central nervous system (chlorpromazine),
• medicines that reduce inflammation (glucocorticoids such as hydrocortisone, prednisolone),
• medicines to treat asthma (salbutamol, when administered by injection),
• medicines used during childbirth (ritodrine and terbutaline administered by injection),
• medicines to treat breast disorders, heavy menstruation and endometriosis (danazol),
• St John's wort preparations - Hypericum perforatum, sometimes used to treat depression.

Blood sugar disturbances (low and high blood sugar levels) may occur when gliclazide is taken concomitantly with medicines belonging to the class of antibiotics called fluoroquinolones; therefore, it is important to monitor blood glucose levels.
Gliclazide may enhance the effect of warfarin (a medicine that inhibits blood coagulation).
Before starting treatment with another medicine, consult your doctor. If you are admitted to hospital, inform the medical staff that you are taking Gliclazide Mylan Generics Italia.

Gliclazide Mylan Generics Italia with food, drinks and alcohol
Gliclazide Mylan Generics Italia may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended, as it may alter diabetes control unpredictably and even lead to coma.

Pregnancy and breastfeeding
Gliclazide Mylan Generics Italia is not recommended during pregnancy.
Do not take Gliclazide Mylan Generics Italia during breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, inform your doctor or pharmacist before taking this medicine. Your doctor may prescribe a more suitable treatment.

Driving and using machines
The influence of Gliclazide Mylan Generics Italia on the ability to drive and use machines is unknown. Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycaemia) or too high (hyperglycaemia) or if you develop visual disturbances due to these conditions. This may occur more frequently at the beginning of treatment with Gliclazide Mylan Generics Italia. Keep in mind that this may endanger your life and the lives of others (e.g. while driving vehicles or operating machinery). Ask your doctor whether you may drive if:

• you have frequent episodes of hypoglycaemia,
• you have few or no warning symptoms of hypoglycaemia.

Gliclazide Mylan Generics Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Gliclazide Mylan Generics Italia

Dosage
Always take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose of Gliclazide Mylan Generics Italia will be determined by your doctor, depending on your blood glucose levels and possibly on glycosuria (sugar in blood and urine).
Changes in external factors (e.g. reduction in body weight, changes in lifestyle, stress) or improvements in the control of hyperglycaemia may require adjustments in the dose of gliclazide.
The recommended starting dose is one tablet (30 mg) once daily. The usual dose may range from one to a maximum of four tablets (from 30 to 120 mg), taken together with breakfast. This depends on your response to therapy.
If blood glucose is not adequately controlled, your doctor may increase your dose in stepwise increments, usually spaced by about one month.
If Gliclazide Mylan Generics Italia is started in combination with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose of each medicine for you.
If you feel that your blood sugar levels are still too high or have become too low despite taking the medicine correctly, inform your doctor or pharmacist.

Method of administration
For oral use.
Swallow the tablets whole with a glass of water during breakfast, preferably at the same time each day. You must always eat something after or while taking the tablets. When being treated with Gliclazide Mylan Generics Italia, it is also important not to skip meals.
Do not break or chew the tablets. Doing so may lead to overdose, as the medicine would be absorbed too quickly by the body.

Use in children and adolescents
The use of Gliclazide Mylan Generics Italia is not recommended in children and adolescents, as there are no available data.

If you take more Gliclazide Mylan Generics than you should
If you take too many tablets, inform your doctor or go to the nearest hospital emergency department. Symptoms of overdose are those related to low blood sugar (hypoglycaemia), as described in section 2. Symptoms can be relieved immediately by taking sugar (4–6 teaspoons) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately and call emergency services. The same action should be taken if someone (e.g. a child) has taken the medicine unintentionally. Do not give food or drink to unconscious patients. Ensure that, in case of emergency, there is always an informed person available who can call a doctor.

If you forget to take Gliclazide Mylan Generics Italia
If you forget to take a dose, take the next one as usual.
Do not take a double dose to make up for the missed tablet.

If you stop taking Gliclazide Mylan Generics Italia
If you stop or discontinue treatment, be aware that your blood glucose control may worsen. Stopping treatment may lead to high blood sugar levels (hyperglycaemia), increasing the risk of developing diabetes-related complications.
If you think any changes are needed, you must consult your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects, which may be serious:
Rare (may affect up to 1 in 1,000 people):

• Decrease in the number of red blood cells, white blood cells, or platelets in the blood, which may cause fatigue, shortness of breath, or paleness; fever, severe chills, sore throat, or mouth ulcers (due to reduced white blood cells); bleeding or bruising more easily than usual, or nosebleeds.
• Inflammation of the liver (hepatitis), which may cause nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin or whites of the eyes (jaundice), pale stools, or dark urine.
• Severe skin reactions, including red skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (Stevens-Johnson syndrome and toxic epidermal necrolysis); very rarely, signs of severe hypersensitivity reactions (DRESS) (drug reaction with eosinophilia and systemic symptoms) have been reported: initially as flu-like symptoms and skin rash on the face, followed by widespread rash with high fever.
• Angioedema, causing rapid swelling of the eyelids, face, lips, mouth, tongue, or throat, which may lead to breathing difficulties.

Not known (frequency cannot be estimated from the available data):

• Signs of a severe allergic reaction, which may include itchy rash, difficulty breathing, or wheezing. The medicine must be discontinued. Your doctor will advise you on what to do.

Other side effects
Common (may affect up to 1 in 10 people):

• Hypoglycaemia (low blood sugar levels). For symptoms and signs, see section 'Warnings and precautions'. If untreated, these symptoms may progress to drowsiness, loss of consciousness, and possibly coma. If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, you must contact a doctor immediately.

Uncommon (may affect up to 1 in 100 people):

• Abdominal pain
• Nausea
• Vomiting
• Indigestion
• Diarrhoea
• Constipation
  These effects are reduced when Gliclazide Mylan Generics Italia is taken with a meal, as recommended.

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

• Decrease in blood cells (e.g. platelets and red blood cells), which may cause paleness, prolonged bleeding, bruising, fatigue, headache, shortness of breath, or dizziness. These symptoms usually disappear when treatment is stopped.
• Skin reactions such as rash, redness, itching, urticaria, and blistering.
• Abnormal liver function tests. For a short period, especially at the start of treatment, vision may worsen. This effect is due to changes in blood glucose levels. These disturbances generally disappear if the medicine is discontinued.

Not known (frequency cannot be estimated from the available data):

• Allergic inflammation of the walls of blood vessels.
• Low levels of sodium in the blood, which may cause confusion, fatigue, loss of appetite, restlessness or irritability, muscle weakness, cramps, or uncontrollable movements.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Mylan Generics Italia

Blister – Do not store above 30°C.
Bottle - Keep this medicine out of the sight and reach of children.
Expiry date
Do not use this medicine after the expiry date stated on the blister, container of tablets, and carton.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gliclazide Mylan Generics Italia contains

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other ingredients are: monohydrate lactose (see section “Gliclazide Mylan Generics Italia contains lactose”), hypromellose, calcium carbonate, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Gliclazide Mylan Generics Italia and package contents
The modified-release tablets are white, oval, biconvex.
Gliclazide Mylan Generics Italia is available in blisters in packs of 10, 14, 20, 28, 30, 56,
60, 84, 90, 100, 120 or 180 tablets and in tablet containers of 90, 120 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan SpA
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturers
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary
Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Gliclazide Viatris 30 mg, comprimé à libération modifiée
Netherlands: Gliclazide Retard Viatris 30 mg, tabletten met gereguleerde afgifte
Ireland: Diaclide MR 30 mg Modified-release Tablets
Italy: Gliclazide Mylan Generics Italia 30 mg compresse a rilascio modificato
Portugal: Gliclazida Mylan
Czech Republic: Gliclazide Viatris
United Kingdom: Dacadis MR 30 mg Modified-release tablets
(Northern Ireland)