Gliclazide Teva

Package leaflet: Information for the patient

Gliclazide Teva 60 mg modified release tablets

Generic 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 may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Gliclazide Teva is a medicine that lowers blood sugar levels (an oral antidiabetic belonging to the sulfonylurea class).
Gliclazide Teva is indicated for the treatment of adult patients with a specific type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone are not sufficient to maintain appropriate blood sugar levels.

2. What you need to know before taking Gliclazide Teva

Do not take Gliclazide Teva

• 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 class (sulfonylureas), or to related drugs (sulfonamide hypoglycemics);
• if you have insulin-dependent (type 1) diabetes;
• if ketones and sugar are present in your urine (which may indicate diabetic ketoacidosis), or if you have pre-coma or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines for fungal infections (miconazole; see section “Other medicines and Gliclazide Teva”);
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Teva.
To achieve adequate blood sugar control, you must follow the treatment plan prescribed by your doctor, which includes not only regular intake of the tablets, but also an appropriate diet, regular and sufficient nutritional intake (including carbohydrates and breakfast), physical exercise, and, if necessary, weight loss.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar levels as well) is required, and, if needed, hemoglobin A1c (HbA1c) levels.
During the first weeks of treatment, the risk of low blood sugar (hypoglycemia) may be higher. It is therefore essential that you are closely monitored by your doctor.
Low blood sugar levels (hypoglycemia) may occur if:

• you eat irregularly or skip meals altogether;
• you are fasting;
• you are malnourished;
• you change your diet;
• you increase physical activity without adequately increasing carbohydrate intake;
• you drink alcohol, especially if combined with missed meals;
• you take other medicines or herbal remedies simultaneously;
• you take excessively high doses of gliclazide;
• you have certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction);
• your kidney or liver function is severely impaired.

If you experience low blood sugar, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced reflexes and reaction time, depression, confusion, speech or vision disturbances, tremors, sensory disturbances, dizziness, and weakness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe and sudden chest pain possibly radiating to surrounding areas (angina pectoris).
If blood sugar levels continue to drop, severe confusion (delirium), seizures, loss of self-control, shortness of breath, and decreased heart rate may develop, potentially leading to loss of consciousness.
In most cases, symptoms caused by low blood sugar resolve quickly with the intake of certain types of sugar, such as glucose tablets, sugar cubes, fruit juices, or sugared tea.
Therefore, it is advisable to always carry sugar with you (glucose tablets, 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.
Symptoms of low blood sugar may not appear, may be less obvious, may develop slowly, or you may not notice the drop in blood sugar in time. This may particularly affect elderly patients taking certain medicines (e.g., those acting on the central nervous system or beta-blockers).
If you are under stress (e.g., accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar, when the prescribed treatment plan is not followed, or during particular stress situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.
If you notice these symptoms, contact your doctor or pharmacist.
If you have a family history or are known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder; an inherited condition), a drop in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur.
Contact your doctor or pharmacist before taking Gliclazide Teva.

Children and adolescents
Due to lack of data, the use of Gliclazide Teva is not recommended in children and adolescents.

Other medicines and Gliclazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking any of the following medicines may enhance the hypoglycemic 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);
• antibiotics (e.g., sulfonamides, clarithromycin);
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril);
• medicines for fungal infections (miconazole, fluconazole);
• medicines for stomach or duodenal ulcers (H2 receptor antagonists);
• medicines for depression (monoamine oxidase inhibitors);
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The use of any of the following medicines may reduce the blood sugar-lowering effect of gliclazide and increase blood glucose:

• medicines for disorders of the central nervous system (chlorpromazine);
• medicines that reduce inflammation (corticosteroids);
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline);
• medicines for breast disorders, heavy menstrual bleeding, or endometriosis (danazol).

Gliclazide Teva may enhance the effects of anticoagulants (e.g., warfarin).
Consult your doctor before starting any other medicines. If you are admitted to hospital, inform medical staff that you are taking Gliclazide Teva.

Gliclazide Teva with food, drinks, and alcohol
Gliclazide Teva may be taken with food and non-alcoholic drinks.
Alcohol consumption is not recommended, as it may unpredictably affect diabetes control.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Gliclazide Teva is not recommended during pregnancy. If you are planning or become pregnant, inform your doctor so that a more appropriate treatment can be prescribed for you.
Do not take Gliclazide Teva while breastfeeding.

Driving and using machines
Excessively low (hypoglycemia) or high (hyperglycemia) blood sugar levels, or vision problems resulting from these conditions, may impair your ability to concentrate or react. Be aware that this could put yourself or others at risk (e.g., when driving vehicles or operating machinery). Consult your doctor about whether you can drive if:

• you experience frequent episodes of low blood sugar (hypoglycemia);
• you experience few or no warning signs of low blood sugar (hypoglycemia).

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

3. How to take Gliclazide Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is
Your doctor will determine the dose based on your blood sugar levels and, if necessary, sugar levels in your urine.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvement in blood sugar control may require adjustments in the dose of gliclazide.
The recommended dose ranges from half a tablet to two 60 mg tablets (maximum 120 mg) taken once daily at breakfast. The dosage depends on your response to treatment.
If you start combination therapy with Gliclazide Teva 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 dose of each medicine according to your individual needs.
Consult your doctor or pharmacist if you notice high blood sugar levels despite taking the medicine as prescribed.

Route and method of administration
For oral use.
Swallow the half tablet or whole tablet(s) without chewing or breaking them.
Take the tablet(s) with a glass of water at breakfast (and preferably at the same time every day). Always consume a meal after taking the tablet(s).
Individual 60 mg Gliclazide Teva tablets may be divided into equal doses.

If you take more Gliclazide Teva than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Signs of overdose are those of low blood sugar (hypoglycaemia) described in section 2. Symptoms may improve by immediately consuming sugar (4 to 6 sugar cubes) or sugary drinks, followed by a snack or substantial meal. If the patient is unconscious, contact a doctor or emergency services immediately. The same applies if someone else, for example a child, has accidentally taken the product. In case of unconsciousness, do not administer food or drink.
Ensure that there is always an informed person available who can call a doctor in an emergency.

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

If you stop taking Gliclazide Teva
Since diabetes treatment usually continues for life, discuss with your doctor before stopping treatment with this medicine. Stopping treatment may lead to high blood sugar levels (hyperglycaemia), increasing the risk of developing diabetes complications.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly observed side effect is low blood sugar levels (hypoglycaemia). For related signs and symptoms, see section 2 “Warnings and precautions”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness or even coma.
If a hypoglycaemic episode is severe or prolonged, even if temporarily controlled by consuming sugar, you should seek immediate medical attention.

Gastrointestinal disorders

• Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. Taking Gliclazide Teva with a meal, as recommended, reduces the occurrence of these effects.

Blood disorders

A reduction in blood cell count (e.g. platelets, red and white blood cells) has been reported, which may cause:

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

Hepatic disorders

Isolated cases of liver function abnormalities have been reported, which may cause yellowing of the skin and eyes (jaundice). If you experience these effects, contact your doctor immediately. Symptoms generally resolve upon withdrawal of the medicine. Your doctor will decide whether treatment should be discontinued.

Skin disorders

Skin reactions have been reported, such as:

• rash;
• redness;
• itching;
• urticaria;
• angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties). The rash may progress to widespread blistering or skin peeling.

Eye disorders

Visual disturbances may occur for short periods, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonamides, the following adverse events have been observed:

• cases of severe blood cell count abnormalities and allergic inflammation of blood vessel walls (vasculitis);
• reduced sodium levels in the blood (hyponatraemia);
• signs of liver impairment (e.g. jaundice), which mostly resolve after discontinuation of sulphonylurea therapy, but in rare 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: http://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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp. The expiry date refers to the last day of that 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 Teva contains

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other components are: Intragranular: lactose monohydrate, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464); Extragranular: hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464), magnesium stearate (E572).

Description of the appearance of Gliclazide Teva and contents of the pack
White, biconvex, oval tablets with a deep score line on both sides and the markings "GLI" and "60" imprinted on each side of the score line, measuring 15.0 mm and 7.0 mm.
The tablets are packaged in blisters with PVC-PVDC/Al or PVC/Al foil containing 10, 30, 60 or 120 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Straße 3,
89143 – Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25,
10000 – Zagreb
Croatia