Gliclazide Sandoz BV: detailed information

Package leaflet: Information for the user

Gliclazide Sandoz BV 60 mg modified release tablets

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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gliclazide Sandoz BV is and what it is used for

Gliclazide Sandoz BV is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).
Gliclazide Sandoz BV is indicated in adults for the treatment of certain types of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone are not sufficient to maintain adequate blood sugar levels.

2. What you need to know before taking Gliclazide Sandoz BV

Do not take Gliclazide Sandoz BV

if you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
if you have insulin-dependent diabetes (type I);
if you have ketones and sugar in the urine (this may indicate diabetic ketoacidosis), pre-coma, or diabetic coma;
if you have severe kidney or liver disease;
if you are taking medicines for the treatment of fungal infections (miconazole) (see section “Other medicines and Gliclazide Sandoz BV”);
if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Sandoz BV.
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Follow your doctor’s instructions to achieve appropriate blood sugar levels. This means, in addition to regular tablet intake, adhering to a proper diet, engaging in physical activity, and, if necessary, losing weight.
During treatment with gliclazide, regular monitoring of blood glucose levels (and possibly urine glucose) as well as glycated hemoglobin (HbA1c) is required.
In the first weeks of treatment, the risk of excessive reduction of blood sugar levels (hypoglycemia) may increase. Therefore, careful medical supervision is necessary.
An excessive drop in blood sugar levels (hypoglycemia) may occur:

if you eat irregularly or skip meals completely,
if you are fasting,
if you are malnourished,
if you change your dietary habits,
if your physical activity increases and carbohydrate intake is not adjusted accordingly,
if you consume alcohol, especially on an empty stomach,
if you take other medicines or herbal remedies simultaneously,
if you take too high a dose of gliclazide,
if you have certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction),
if your kidney or liver function is severely impaired.

In case of low blood sugar, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, tremor, sensory disturbances, dizziness, and feelings of weakness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden severe chest pain radiating to surrounding areas (angina pectoris).
If blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, weak breathing, slowed heartbeat, and loss of consciousness.
In most cases, symptoms of low blood sugar resolve quickly by taking sugar in various forms, for example glucose tablets, sugar cubes, sugary juices, or sweetened tea. You should always carry sugar with you (glucose tablets, sugar cubes).
Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms recur.
Symptoms of low blood sugar may not appear, may be less obvious, may develop slowly, or you may not notice in time that your blood sugar has dropped excessively. This may occur if you are an elderly patient 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 appear when gliclazide has not sufficiently lowered blood sugar levels, when you have not followed your prescribed treatment, when you take St. John’s wort (Hypericum perforatum) preparations (see section “Other medicines and Gliclazide Sandoz BV”), or during periods of particular stress. These
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may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced performance.
If you experience such symptoms, contact your doctor or pharmacist.
Changes in blood glucose levels (low blood sugar and high blood sugar) may occur when gliclazide is taken together with medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring blood glucose levels.
If you have a family history or an inherited condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency ( red blood cell disorder ), a decrease in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents
The use of Gliclazide Sandoz BV is not recommended in children and adolescents due to lack of data.

Other medicines and Gliclazide Sandoz BV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood sugar-lowering effect of gliclazide may be increased, and signs of low blood sugar may occur when taking any of the following medicines:

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

The blood glucose-lowering effects of gliclazide may be reduced, and blood sugar levels may rise when taking any of the following medicines:

medicines for treating disorders of the central nervous system ( chlorpromazine),
medicines to reduce inflammation ( corticosteroids)
medicines for treating asthma or used during labor ( intravenous salbutamol, ritodrine, terbutaline)
medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis ( danazol)
St. John’s wort (Hypericum perforatum) preparations.

Changes in blood glucose levels (low blood sugar and high blood sugar) may occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken together with Gliclazide Sandoz BV, especially in elderly patients.
Gliclazide Sandoz BV may enhance the effects of medicines that reduce blood clotting (e.g., warfarin).
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Consult your doctor before taking other medicines. If you are admitted to hospital, inform the medical staff that you are taking Gliclazide Sandoz BV.

Gliclazide Sandoz BV with food, drinks, and alcohol
Gliclazide Sandoz BV may be taken with food and non-alcoholic beverages. Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
Gliclazide Sandoz BV is not recommended during pregnancy.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Gliclazide Sandoz BV during breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may harm yourself or others (e.g., while driving vehicles or operating machinery). Ask your doctor whether you are allowed to drive if you have:

frequent episodes of low blood sugar (hypoglycemia)
minimal or non-apparent signs of low blood sugar (hypoglycemia).

3. How to take Gliclazide Sandoz BV

Dosage
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dosage is determined by your doctor based on your blood sugar levels and, if possible, sugar levels in the urine.
Changes in external factors (e.g. weight reduction, lifestyle changes, stress) or improvements in blood sugar control may require adjustments in the gliclazide dosage.
The recommended dose ranges from half a tablet to two tablets (maximum 120 mg), taken as a single dose at breakfast time. This depends on your response to treatment.
If you are receiving combination therapy with Gliclazide Sandoz BV 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 for each medicine.
Contact your doctor or pharmacist if you notice that your blood sugar levels remain high despite taking this medicine.

Method and route of administration
For oral use.
Swallow the half tablet or the whole tablet(s) whole. Do not chew or crush them.
Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day).
You must always eat a meal after taking the tablet(s).
The tablet may be divided into two equal doses.

If you take more Gliclazide Sandoz BV 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. These symptoms can be improved by taking sugar immediately (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies if someone else, for example a child, has accidentally taken the product. Do not give food or drink to unconscious patients.
Ensure that someone informed is always available to call a doctor in case of emergency.

If you forget to take Gliclazide Sandoz BV
It is important to take the medicine every day, as regular treatment is more effective.
If you forget a dose of Gliclazide Sandoz BV, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Gliclazide Sandoz BV
Since diabetes treatment usually lasts a lifetime, you must consult 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions” under paragraph 2 “What you need to know before taking Gliclazide Sandoz BV”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness and potentially coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.

Other side effects that may occur during treatment with this medicine are:
Rare: may affect up to 1 in 1,000 people

Decreased number of blood cells (e.g. platelets, red and white blood cells) has been reported. This may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually disappear when treatment is discontinued.

Not known: frequency cannot be estimated from the available data

Liver function abnormalities, which may cause yellowing of the skin and eyes. If these occur, contact your doctor immediately. Symptoms usually resolve if the medicine is discontinued. Your doctor will decide whether to stop treatment.
Skin reactions such as rash, redness, itching, hives and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat or tongue which may cause difficulty breathing) have been reported. The rash may progress to widespread blistering or skin peeling. Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and facial rash, followed by widespread rash with fever.
Gastric discomfort, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Gliclazide Sandoz BV is taken with a meal, as recommended (see paragraph 3 “How to take Gliclazide Sandoz BV”).
Vision problems. Visual function may be temporarily disturbed, 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:

severe changes in blood cell counts
allergic inflammation of blood vessel walls
reduced sodium levels in the blood (hyponatraemia)
symptoms of impaired liver function (e.g. jaundice), which in most cases resolved after discontinuation of sulphonamides, but in rare cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, 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 at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversaavverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gliclazide Sandoz BV contains
The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
The other components are: calcium hydrogen phosphate dihydrate, povidone K30, hypromellose K100, hypromellose K4M, and magnesium stearate.

Description of the appearance of Gliclazide Sandoz BV and the contents of the pack
Uncoated tablet, white to almost white, oval-shaped, 13.5 mm in length, 6.5 mm in width and 4.2 mm thick, with a break line on both sides and the number '60' imprinted on one side of the break line.

PVC-Al transparent blister
PVC/Aclar-Al transparent blister

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Packs containing 10, 30, 60, 90, 100 and 180 modified-release tablets.
Not all pack sizes may be marketed.

Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Legal representative in Italy: Sandoz S.p.A., Largo U. Boccioni 1, 21040 Origgio (VA), Italy
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland

Belgium Gliclazide Sandoz 60 mg tabletten met gereguleerde afgifte
Bulgaria Mellizide
Croatia Gliklazid Sandoz 60 mg tablete s prilagođenim oslobađanjem
Estonia Dizirel
France GLICLAZIDE SANDOZ 60 mg, comprimé à libération modifiée
Italy Gliclazide Sandoz BV
Latvia Dizirel 60 mg ilgstošās darbības tabletes
Lithuania Dizirel 60 mg modifikuoto atpalaidavim
Luxembourg Gliclazide Sandoz 60 mg comprimés à libération modifiée
Netherlands Gliclazide Sandoz retard 60 mg, tabletten met gereguleerde afgifte
Poland Salson
Portugal Gliclazida Sandoz
Czech Republic Gliklazid Sandoz 60 mg
Slovak Republic Gliklazid Sandoz 60 mg tableta s riadeným uvoľňovaním
Slovenia Gliklazid Lek 60 mg tablete s prirejenim sproščanjem
Hungary Gliclazide Sandoz 60 mg módosított hatóanyagleadású tabletta
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