GLICLAZIDE 30 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Gliclazide Zentiva Lab 30 mg modified-release tablets
   1. What is Gliclazide Zentiva Lab and what is it used for
   2. What you need to know before taking Gliclazide Zentiva Lab
   3. How to take Gliclazide Zentiva Lab
   4. Possible side effects
   5. How to store Gliclazide Zentiva Lab
   6. Contents of the pack and other information

Gliclazide Zentiva Lab 30 mg modified-release tablets

Generic medicine

Read this leaflet carefully before 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 Zentiva Lab is and what it is used for
• 2. What you need to know before you take Gliclazide Zentiva Lab
• 3. How to take Gliclazide Zentiva Lab
• 4. Possible side effects
• 5. How to store Gliclazide Zentiva Lab
• 6. Contents of the pack and other information

1. What is Gliclazide Zentiva Lab and what is it used for

Gliclazide Zentiva Lab 30 mg modified-release tablets is a medicine that reduces blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).
Gliclazide Zentiva Lab 30 mg 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 Zentiva Lab

Do not take Gliclazide Zentiva Lab

• 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 (sulphonylureas), or to other related medicines (sulphonamide hypoglycaemics);
• if you have insulin-dependent diabetes (type I);
• if you have ketone bodies and sugar in your urine (this means you may have diabetic keto-acidosis), if you are in a pre-comatose or diabetic comatose state;
• if you have a severe kidney or liver disease;
• if you are taking medicines for the treatment of fungal infections (miconazole, see paragraph “ Other medicines and Gliclazide Zentiva Lab”);
• if you are breastfeeding (see paragraph “ Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor before taking Gliclazide Zentiva Lab.
Follow the treatment plan prescribed by your doctor to achieve appropriate blood sugar levels.
In addition to regularly taking the tablet, follow a dietary regime, eat
food (with carbohydrates) regularly and in sufficient quantities, including breakfast, engage
in physical activity and, if necessary, reduce your weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in urine) and also of glycated haemoglobin (HbA1c) is necessary.
In the very first weeks of treatment, the risk of decreased blood sugar levels (hypoglycaemia) may increase. For this reason, careful medical monitoring is necessary.
A lowering of blood sugar levels (hypoglycaemia) may occur:

• if you take 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 skipping meals,
• if you take other medicines or natural remedies at the same time,
• if you take doses of gliclazide that are too high,
• 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 powerlessness.
The following signs and symptoms may also occur: sweating, damp skin, anxiety,
acceleration or irregularity of the heartbeat, increased blood pressure,
sudden severe chest pain radiating to surrounding areas ( angina pectoris).
If blood sugar levels continue to fall, you may experience severe confusion
(delirium), develop convulsions, lose control, breathing may become labored and
the heartbeat slowed, you may lose 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 lumps,
sugary juices or sweetened tea.
You should therefore always carry some sugar with you in various forms (glucose tablets,
sugar lumps). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest
hospital if taking sugar does not help or if the symptoms should
recur.
Symptoms due to low blood sugar levels may not appear, be less
evident, appear slowly or you may not notice in time that blood sugar levels have decreased.
This can happen if you are an elderly patient taking certain medicines (for example those
that act on the central nervous system and beta-blockers).
If you are in stressful situations (for example accidents, surgery, fever, etc.) your doctor
may temporarily switch you 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 containing St John's Wort (Hypericum perforatum) (see paragraph “ Other medicines and Gliclazide Zentiva

Lab”) or in particularly stressful situations. These may include thirst, frequent urination,
dry mouth, dry skin and itching, skin infections and reduced efficiency.
If these symptoms occur, you should contact your doctor or pharmacist.
Changes in blood glucose levels (low blood sugar levels and high
blood sugar levels) may occur when gliclazide is prescribed at the same time as 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 sugar levels.
If you have a family history or a hereditary condition of glucose-6-phosphate
dehydrogenase (G6PD) deficiency (alteration of red blood cells), a decrease in haemoglobin levels and a breakdown of red blood cells (haemolytic anaemia) may occur.
Contact your doctor or pharmacist before taking Gliclazide Zentiva Lab.

Children and adolescents
Gliclazide Zentiva Lab is not recommended for use in children and adolescents due to
lack of data.

Other medicines and Gliclazide Zentiva Lab
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 used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin);
• antibiotics (e.g. sulfonamides, clarithromycin);
• medicines for the treatment of high blood pressure or heart failure (beta-blockers, ACE-inhibitors such as captopril or enalapril);
• medicines used for the treatment of fungal infections (miconazole, fluconazole);
• medicines for the treatment of gastric or duodenal ulcers (H2 receptor antagonists);
• medicines for the treatment of depression (monoamine oxidase inhibitors);
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The blood glucose-lowering effect of gliclazide may be
weakened and blood sugar levels may increase when taking
one of the following medicines:

• medicines for the treatment of disorders of the central 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 disorders, heavy menstrual bleeding and endometriosis (danazol);
• preparations containing St John's Wort - Hypericum perforatum.

Changes in blood glucose levels (low blood sugar levels and high
blood sugar levels) may occur when a medicine belonging to a class of antibiotics
called fluoroquinolones is taken at the same time as Gliclazide Zentiva Lab, especially
in elderly patients.
Gliclazide Zentiva Lab may increase the effects of medicines that reduce blood clotting (for example warfarin).
Consult your doctor before starting to take another medicine. If you are admitted
to hospital, tell the medical staff that you are taking Gliclazide Zentiva Lab.

Gliclazide Zentiva Lab with food, drinks and alcohol:
Gliclazide Zentiva Lab can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it can alter diabetes control in an
unpredictable way.

Pregnancy, breastfeeding and fertility
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.
The use of Gliclazide Zentiva Lab is not recommended during pregnancy. If you are planning a
pregnancy, or are pregnant, tell your doctor who may prescribe more appropriate treatment.
You should not take Gliclazide Zentiva Lab during breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood
sugar 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. when driving or using
machines).
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).

Gliclazide Zentiva Lab contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor
before taking this medicine.

3. How to take Gliclazide Zentiva Lab

Dosage
Take this medicine exactly as your doctor or pharmacist has instructed.
If you have any doubts, consult your doctor or pharmacist.
The dose is established by the doctor based on your blood sugar levels and possibly
in your 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 daily dose is from one to four 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 Zentiva Lab with metformin, an alpha-
glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor
agonist or insulin, the doctor will establish 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 the medicine as prescribed.

Method and route of administration
Oral use.
Swallow the tablet whole. Do not chew or crush.
Take the tablet(s) with a glass of water at breakfast time (and
preferably at the same time each day).
You must always take a meal after taking the tablet(s).

If you take more Gliclazide Zentiva Lab than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency room
immediately. The signs of overdose are those of a lowering of the blood sugar rate
(hypoglycemia) described in paragraph 2. Symptoms may improve by taking sugar immediately
(from 4 to 6 lumps) or sugary drinks, followed by a substantial snack or a
meal. If the patient is unconscious, contact the doctor immediately and call emergency
services. The same must be done if someone, for example a child, has taken
the medicine accidentally. Do not administer food or drinks 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 Zentiva Lab
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of Gliclazide Zentiva Lab, take the next dose at the same time.
Do not take a double dose to make up for a missed dose.

If you stop taking Gliclazide Zentiva Lab
Since diabetes treatment usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Discontinuation may cause an increase in
blood sugar levels (hyperglycemia), which increases the risk of developing complications of
diabetes.
If you have any doubts 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 a lowering of blood sugar level (hypoglycemia). For symptoms and signs see “ Warnings and precautions” in paragraph 2 “ What

you need to know before taking Gliclazide ZentivaLab”.
If left untreated, these symptoms can 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.
Blood disorders
A decrease in the number of blood cells (for example platelets, red blood cells and white blood cells) has been reported. This can cause:

• paleness,
• prolonged bleeding,
• bruising,
• sore throat,
• fever. These symptoms usually disappear when treatment is stopped.

Liver disorders
Isolated cases of abnormal liver function have occurred, which can cause
yellowing of the skin and eyes. If these appear, contact your doctor immediately.
Generally the symptoms disappear if the medicine is stopped. The doctor will decide whether to discontinue
treatment.
Skin disorders
Skin reactions such as the following have been reported:

• skin rash,
• redness,
• itching,
• hives,
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that can cause difficulty breathing). The rash may progress to a spread of blisters all over the body or to 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 then an extensive rash with a high temperature.

Digestive disorders

• stomach pain or discomfort,
• feeling unwell,
• indigestion,
• diarrhea,
• constipation. These effects are reduced when Gliclazide Zentiva Lab is taken with a meal, as recommended, see paragraph 3 “ How to take Gliclazide ZentivaLab”.

Eye disorders
Visual acuity 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 and allergic inflammation of the blood vessel walls,
• reduction of sodium in the blood (hyponatremia),
• symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after discontinuation of the sulfonylurea, but which in isolated cases can 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-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Gliclazide Zentiva Lab

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.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Zentiva Lab contains
The active ingredient is gliclazide.
Each modified-release tablet contains 30 mg of gliclazide.
The other ingredients are:
Intragranular: Lactose monohydrate, hypromellose (HPMC K100 LV), hypromellose (HPMC K4M CR).
Extragranular: hypromellose (HPMC K100 LV), hypromellose (HPMC K4M CR), magnesium stearate.

Description of the appearance of Gliclazide Zentiva Lab and contents of the pack
The 30 milligram modified-release tablets are white, biconvex, capsule-shaped, with “GLI 30” imprinted on one side and plain on the other side, measuring 10.0 x 4.5 mm.
Gliclazide Zentiva Lab 30 mg modified-release tablets are available in packs
of 20, 60 tablets in blisters.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale Luigi Bodio, 37/b
20158 Milano
Italy

Manufacturers
APC Pharmaceuticals & Chemicals Ltd
Ninth Floor, CP House
97-107 Uxbridge Rd
London W5 5TL
United Kingdom
or
S.C Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3
Bucharest 032266
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France, Latvia, Poland: Gliclazide Zentiva
Italy: Gliclazide Zentiva Lab
Bulgaria: Гликлазид Зентива
Portugal, Spain: Gliclazida Zentiva
Romania: Gliclazidă Zentiva