GLICLAZIDE 60 mg Modified-Release Tablet

Зміст інструкції

1. Gliclazide Sandoz BV 60 mg modified-release tablets
   1. What is Gliclazide Sandoz BV and what is it used for
   2. What you need to know before taking Gliclazide Sandoz BV
   3. How to take Gliclazide Sandoz BV
   4. Possible side effects
   5. How to store Gliclazide Sandoz BV
   6. Contents of the pack and other information

Gliclazide Sandoz BV 60 mg modified-release tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gliclazide Sandoz BV is a medicine that reduces 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, exercise and weight loss alone are not sufficient to maintain a correct blood sugar level.

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

Do not take Gliclazide Sandoz BV

• if you are allergicto gliclazide or to any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulphonylureas), or to other related medicines (sulphonamide hypoglycaemics);
• if you have insulin-dependent diabetes (type I);
• if you have ketone bodiesand sugar in your urine(this means you may have diabetic ketoacidosis), pre-comaor diabetic coma;
• if you have a severe kidney diseaseor 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 the instructions prescribed by your doctor to achieve appropriate blood sugar levels. This
means, in addition to regularly taking the tablet, following a dietary regime, engaging in physical activity and,
if necessary, reducing your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels(and
possibly in the urine) and also of glycated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment, the risk of excessive decrease in blood sugar levels
(hypoglycaemia)may increase. For this reason, careful medical monitoring is necessary.
An excessive lowering of blood sugar levels (hypoglycaemia)can occur:

• if you eat meals irregularly or skip them completely,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and the intake of carbohydrates is not adequate for this increase,
• if you drink alcohol, especially while fasting,
• if you are taking other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormonal disorders (thyroid gland dysfunction, or pituitary gland or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

In case of low blood sugar levels, you may experience the following symptoms: headache, intense hunger,
nausea, vomiting, weakness, sleep disturbances, agitation, aggressiveness, difficulty concentrating, reduced
attention and reaction time, depression, confusion, speech or vision disorders, tremor,
sensory disturbances, dizziness and a feeling of helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, acceleration or
irregularity of the heartbeat, increased blood pressure, sudden severe chest pain radiating to the surrounding areas (angina pectoris).

If blood sugar levels continue to fall, you may experience severe confusion (delirium),
seizures, loss of self-control, shallow breathing, slowed heartbeat and loss of consciousness.
In most cases, the symptoms of low blood sugar levels disappear very quickly
by taking sugar in various forms, for example glucose tablets, sugar cubes, juices or sweetened tea. You should therefore always carrysugar 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 the symptoms recur.
Symptoms due to low blood sugar levels may not appear, be less noticeable,
appear slowly or you may not notice in time that blood sugar levels have dropped
excessively. This can happen if you are an elderly patient taking certain medicines (e.g. those
that act on the central nervous system and beta-blockers). If you are in stressful situations (e.g. accidents,
surgery, fever, etc.) your doctor may temporarily switch to insulin therapy.

Symptoms of high blood sugar levels (hyperglycaemia)may appear when gliclazide has not yet sufficiently reduced blood sugar levels, when you have not followed the treatment prescribed by your doctor, if you take preparations based on St. John's Wort (Hypericum perforatum) (see section “Other medicines and Gliclazide Sandoz BV”) or in particularly stressful situations. These
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can 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 levels) may occur when gliclazide is prescribed in combination with antibiotics 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 your blood glucose levels.
If you have a family history or a hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency
(red blood cell disorder), you may experience a decrease in haemoglobin levels and red blood cell breakdown (haemolytic anaemia). Contact your doctor before taking this medicine.

Children and adolescents
The use of Gliclazide Sandoz BV is not recommendedin childrenand adolescents due to lack of data.

Other medicines and Gliclazide Sandoz BV
Tell 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 levels may appear when you take one of the following medicines:

• other medicines to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin)
• antibiotics (e.g. sulphonamides, clarithromycin)
• medicines for the treatment of high blood pressure or heart failure (beta-blockers, ACE-inhibitorssuch as captoprilor enalapril)
• medicines used for the treatment of fungal infections (miconazole, fluconazole)
• medicines for the treatment of stomach or duodenal ulcers (H2 receptor antagonists)
• medicines for the treatment of depression (monoamine oxidase inhibitors)
• pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen)
• medicinescontaining alcohol.

The blood sugar-lowering effects of gliclazide may be reduced and a rise in blood sugar levels may occur with the intake of one of the following medicines:

• medicines for the treatment of disorders of the nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids)
• medicines for the treatment of asthma or used during labour (salbutamol intravenously, ritodrine and terbutaline)
• medicines for the treatment of breast diseases, heavy menstrual bleeding and endometriosis (danazol)
• preparations based on St. John's Wort (Hypericum perforatum)

Changes in blood glucose levels (low blood sugar and high
blood sugar levels) may occur when a drug belonging to a class of antibiotics called
fluoroquinolones is taken in combination with Gliclazide Sandoz BV, especially in elderly patients.
Gliclazide Sandoz BV may increase 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 can be taken with foodand non-alcoholic beverages. Drinking alcohol is not recommended as
it can alter diabetes control unpredictably.

Pregnancy and breastfeeding
Gliclazide Sandoz BV is not recommendedduring pregnancy.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Gliclazide Sandoz BV while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level is
too low (hypoglycaemia), too high (hyperglycaemia) or if you develop vision problems as a result of these
conditions. Be aware that you may endanger yourself or others (e.g. by driving a vehicle or using
machinery). Ask your doctor if you can drive if you have:

• frequent episodes of low blood sugar levels (hypoglycaemia)
• minimal or no noticeable signs of low blood sugar levels (hypoglycaemia).

3. How to take Gliclazide Sandoz BV

Dosage
Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
consult your doctor or pharmacist.
The dose is established by the doctor based on blood sugar levels and possibly in the urine.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or
improvements in blood sugar control may require changes in the doses of gliclazide.
The recommended dose is from half a tablet to two tablets (maximum 120 mg) in a single administration
at breakfast time. This depends on the response to treatment.
In case of combined therapy of Gliclazide Sandoz BV with metformin, an alpha-glucosidase inhibitor, a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin, the doctor
will determine the appropriate dose of each medicine for you.
Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite
taking this medicine.

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

If you take more Gliclazide Sandoz BV than you should
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If you take too many tablets, contact your doctor or the emergency room of the nearest hospital immediately. The
signs of overdose are those of a low blood sugar level (hypoglycemia) described in
paragraph 2. These symptoms can be improved by immediately taking some sugar (from 4 to 6 lumps) 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 must be done if someone, for
example a child, has taken the product accidentally. Food or drinks should not be given to
unconscious patients.
Make sure there is always an informed person able 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 because regular treatment is more effective.
However, if you forget a dose of Gliclazide Sandoz BV, take the next dose at the usual time. Do not take
a double dose to make up for a forgotten dose.

If you stop taking Gliclazide Sandoz BV
Because diabetes treatment usually lasts a lifetime, you should consult your doctor before stopping
treatment with this medicine. Discontinuation may cause high blood sugar levels
(hyperglycemia) which increases the risk of developing diabetes complications.
If you have any doubts 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.
The most commonly observed side effect is a low blood sugar level(hypoglycemia). For
symptoms and signs see the section “ Warnings and precautions” in paragraph 2 “ What you need to know before
taking Gliclazide Sandoz BV”.
If not treated, these symptoms may progress to drowsiness, loss of consciousness and possible 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 the intake of this medicine are:

Rare: may affect up to 1 in 1000 people

• A decrease in the number of blood cells (e.g. platelets, red blood cells 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 stopped.

Not known: frequency cannot be estimated from available data

• Abnormalities in liver function, which may cause yellowing of the skin and eyes. If these appear, contact your doctor immediately. Symptoms generally disappear if the medicine is discontinued. The doctor will decide whether to discontinue treatment.
• Skin reactions such as rash, redness, itching, hives and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue that can cause difficulty breathing) have been reported. The rash may develop into a widespread blistering on the whole body or peeling of the skin. Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face followed by an extensive rash with fever.

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• Stomach pain or discomfort, nausea, vomiting, indigestion, diarrhea 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 ability may be impaired for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

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

• severe changes in the number of blood cells
• allergic inflammation of the walls of blood vessels
• reduction of sodium levels in the blood (hyponatremia)
• symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after discontinuation of sulfonylureas, but which in isolated cases may lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through 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 package and on the blister after Exp. The expiry
date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of Gliclazide Sandoz BV and contents of the pack
Uncoated tablet, of color from white to off-white, oval in shape, length 13.5 mm, width 6.5 mm
and thickness 4.2 mm, with a fracture line on both sides and '60' imprinted on one side from one side of the
fracture line.
Transparent PVC-Al blister
Transparent PVC/Aclar-Al blister
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Packs of 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, Netherlands
Legal representative for 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 tablets with modified release
Bulgaria Mellizide
Croatia Gliklazid Sandoz 60 mg tablets with modified release
Estonia Dizirel
France GLICLAZIDE SANDOZ 60 mg, modified-release tablet
Italy Gliclazide Sandoz BV
Latvia Dizirel 60 mg prolonged-release tablets
Lithuania Dizirel 60 mg modified-release
Luxembourg Gliclazide Sandoz 60 mg modified-release tablets
Netherlands Gliclazide Sandoz retard 60 mg, tablets with modified release
Poland Salson
Portugal Gliclazida Sandoz
Czech Republic Gliklazid Sandoz 60 mg
Slovak Republic Gliklazid Sandoz 60 mg tablet with controlled release
Slovenia Gliklazid Lek 60 mg tablets with modified release
Hungary Gliclazide Sandoz 60 mg modified-release tablet
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