Gliclazide Teva Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gliclazide Teva Italia 30 mg modified release tablets

Gliclazide
Equivalent medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gliclazide Teva Italia is and what it is used for
What you need to know before taking Gliclazide Teva Italia
How to take Gliclazide Teva Italia
Possible side effects
How to store Gliclazide Teva Italia
Contents of the pack and other information

1. What Gliclazide Teva Italia is and what it is used for

Gliclazide Teva Italia is a medicine that lowers blood sugar levels (an oral antidiabetic medicine).
Gliclazide Teva Italia is indicated for the treatment of adult patients with a specific type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction alone have not produced an adequate response.

2. What you need to know before taking Gliclazide Teva Italia

Do not take Gliclazide Teva Italia

if you are allergic to gliclazide, to other sulfonylureas, sulfonamides, or to any of the other ingredients of this medicine (listed in section 6);
if you have insulin-dependent diabetes (type 1);
if ketones and sugar are present in your urine (this may indicate that you have diabetic ketoacidosis, pre-coma, or diabetic coma);
if you have severe kidney or liver problems;
if you are taking medicines for fungal infections (miconazole - see section "Other medicines and Gliclazide Teva Italia");
if you are breastfeeding. If you think any of the above applies to you, contact your doctor, nurse, or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Teva Italia.
You should only take this medicine if you are likely to be able to maintain a regular eating pattern (including breakfast). It is important to have a regular intake of carbohydrates, because if a meal is delayed or missed, if you eat too little food, or if the food consumed is low in carbohydrates, the risk of low blood sugar levels (hypoglycaemia) increases.
While being treated with gliclazide, you need regular monitoring of your blood sugar levels (and possibly also in urine). Your doctor will perform blood tests to monitor your glycated haemoglobin (HbA_) levels.
To achieve adequate blood sugar control, you must follow the treatment plan prescribed by your doctor. This includes taking the tablets regularly, as well as following an appropriate diet and engaging in physical exercise.
During the first weeks of treatment, the risk of low blood sugar levels (hypoglycaemia) may be higher. Therefore, it is vital that your doctor closely monitors you.
Low blood sugar (hypoglycaemia) may occur:

if you eat irregularly or skip meals completely;
if you are fasting;
if you are malnourished;
if you change your diet;
if you increase physical activity without adequately increasing carbohydrate intake;
if you drink alcohol, especially in combination with missed meals;
if you take other medicines or herbal remedies at the same time;
if you take high doses of gliclazide;
if you have certain hormonal disorders (thyroid, pituitary, or adrenal gland dysfunction);
if your kidney or liver function is severely impaired.

If you experience low blood sugar levels, the following symptoms may occur: headache, intense hunger, paleness, weakness, exhaustion, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, reduced concentration, decreased alertness and reaction time, depression, confusion, speech or vision disturbances, tremors, sensory disturbances, dizziness, and feeling weak. The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain possibly radiating to surrounding areas (angina pectoris).
If blood sugar levels continue to drop, severe confusion (delirium), cerebral seizures, loss of control, shortness of breath, and reduced heart rate may occur, leading to loss of consciousness and possibly coma. The clinical picture of severe hypoglycaemia may resemble that of a stroke.
In most cases, symptoms caused by low blood sugar disappear quickly if you consume certain types of sugar, such as sugar cubes, fruit juices, or sweetened tea. For this reason, it is advisable to always carry sugar with you (e.g. sugar cubes). Remember that artificial sweeteners are not effective. If taking sugar does not help or if symptoms recur, consult your doctor or the nearest hospital.
It is possible that symptoms caused by low blood sugar levels may not appear, may develop slowly, or that you may not notice the drop in time.
This may occur in elderly patients 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. certain thyroid function disorders or anterior pituitary or adrenal insufficiency).
If you are under stress (e.g. accidents, major surgery, febrile infections, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms caused by high blood sugar levels (hyperglycaemia) may occur when gliclazide has not yet sufficiently lowered blood glucose, when the treatment plan prescribed by your doctor has not been followed, or during particular stressful situations.
Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.
If you experience these symptoms, you must contact your doctor or pharmacist.
If you have a family history or know you have an inherited deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality), you may experience a drop in haemoglobin levels and rupture of red blood cells (haemolytic anaemia). Contact your doctor before taking this medicine.

Children and adolescents:
Gliclazide Teva Italia must not be used to treat diabetes in children and adolescents under 18 years of age.

Other medicines and Gliclazide Teva Italia
Consult your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
The effectiveness and safety of Gliclazide Teva Italia may be compromised if taken together with other medicines. In addition, taking other medicines may be affected by the concomitant use of Gliclazide Teva Italia.
Taking any of the following medicines may enhance the blood sugar-lowering effect of gliclazide or cause symptoms related to low blood sugar:

other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists) or insulin;
antibacterial medicines (e.g. sulfonamides, clarithromycin);
medicines for treating high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril);
medicines for treating fungal infections (miconazole, fluconazole);
medicines for treating indigestion and stomach or duodenal ulcers (H_-receptor antagonists, such as ranitidine);
medicines for treating depression (monoamine oxidase inhibitors);
painkillers or anti-rheumatic medicines (ibuprofen, phenylbutazone);
medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened and blood glucose may rise if the following medicines are used:

medicines for treating disorders of the central nervous system (chlorpromazine);
medicines that reduce inflammation (glucocorticoids);
medicines for treating asthma (salbutamol, when administered by injection);
medicines used during labour/delivery (ritodrine and terbutaline administered by injection);
medicines for treating breast disorders, excessively heavy menstrual bleeding, and endometriosis (danazol).

Gliclazide, when used concomitantly with warfarin (a medicine that inhibits blood clot formation), may enhance the anticoagulant effect.
Consult your doctor before starting to use other medicines. If you are admitted to hospital, inform the medical staff that you are taking Gliclazide Teva Italia.

Gliclazide Teva Italia with food and drinks
Gliclazide Teva Italia can be taken with food and non-alcoholic drinks.
You must avoid alcohol, as it may unpredictably alter diabetes control and even lead to coma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Gliclazide Teva Italia is not recommended during pregnancy. Do not take Gliclazide Teva Italia if you are breastfeeding.

Driving and using machines
If your blood sugar level is low (hypoglycaemia) or high (hyperglycaemia), or if visual disturbances occur as a consequence of these conditions, your ability to concentrate or react may be impaired. Be aware that this could put yourself and others at risk (e.g. when driving a vehicle or operating machinery).
Consult your doctor about whether you may drive if:

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

Gliclazide Teva 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 Teva Italia

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The dose of Gliclazide Teva Italia is determined by your doctor based on your blood glucose levels and, if applicable, glucose levels in urine. Changes in external factors (e.g. weight loss, lifestyle changes, stress) or improved blood glucose control may require adjustments in the gliclazide dose.

The recommended starting dose is one tablet once daily. The usual dose may range from one to a maximum of four tablets taken as a single dose at breakfast. The exact dose depends on your response to treatment.

If blood glucose levels are not adequately controlled, your doctor may gradually increase the dose, usually at intervals of no less than one month.

If you start combination therapy with Gliclazide Teva Italia and 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 dosage of each medicine according to your individual needs.

Consult your doctor or pharmacist if you feel that the effect of Gliclazide Teva Italia is too strong or too weak.

Route and method of administration
Swallow the tablets whole with a glass of water during breakfast, preferably at the same time each day. Do not chew the tablets. You must always eat a meal after taking the tablet(s). It is important not to skip meals during treatment with Gliclazide Teva Italia.

If you take more Gliclazide Teva Italia than you should
If you have taken an excessive dose of gliclazide, contact your doctor, hospital, or nearest emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2. These symptoms can be improved by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a snack or a substantial meal. If the patient is unconscious, contact your doctor or emergency services immediately. The same applies if someone, for example a child, has accidentally taken the medicine. In case of unconsciousness, do not give food or drinks.

Ensure that there is always an informed person available who can call a doctor in an emergency.

If you forget to take Gliclazide Teva Italia
If you forget to take a dose one day, take the next dose at your usual time.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Gliclazide Teva Italia
If you stop treatment, you should know that blood glucose control will be lost. If you think it is necessary to change your treatment, you must contact your doctor without delay.

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 will experience them.
The classification of side effects is based on their frequency.
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 or possibly coma. If a hypoglycaemic episode is severe or prolonged, even if temporarily controlled by sugar intake, contact your doctor immediately.

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

Abdominal pain.
Nausea.
Vomiting.
Indigestion.
Diarrhoea.
Constipation. These effects may be reduced if Gliclazide Teva Italia is taken with a meal, as recommended.

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

Decreased numbers of blood cells (e.g. platelets, red and white blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve upon discontinuation of treatment.
Skin reactions such as rash, redness, itching and urticaria, angioedema (rapid swelling of tissues such as the eyelids, lips, face, mouth, tongue or throat) which may cause breathing difficulties. The rash may progress to widespread blistering or skin peeling.
Abnormal liver function test results, liver-related changes (which may cause yellowing of the eyes and skin). If you notice this, consult your doctor immediately.
Visual disturbances may occur for short periods, especially at the beginning of treatment. This effect is due to changes in blood sugar levels. These effects usually disappear when treatment is discontinued.

Severe changes in blood cell counts and allergic inflammation of blood vessel walls have very rarely been reported following the use of other sulphonamides. With other sulphonylureas, signs and symptoms of liver impairment (e.g. jaundice) have rarely been observed, which in most cases resolve after discontinuation of sulphonylurea therapy, but in isolated cases may lead to potentially fatal liver failure.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system: www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Teva Italia

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 pack, on the bottle of tablets and on the outer packaging. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Teva Italia contains
The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
The other ingredients are monohydrate lactose, hypromellose, calcium carbonate, anhydrous colloidal silica and magnesium stearate.
Description of the appearance of Gliclazide Teva Italia and pack sizes
The modified-release tablets are white, oval and biconvex.
Gliclazide Teva Italia is available in blisters packed in cartons containing 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets or in bottles containing 90, 120 or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 - 20154 Milan, Italy
Manufacturer
Teva Operations Poland Sp. z o.o., Mogilska 80 Str. - 31-546 Kraków, Poland
Updated on: