Package leaflet: Information for the user

Gliclazide Sandoz 30 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Gliclazide Sandoz is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea group).
Gliclazide Sandoz is indicated for the treatment of certain types of diabetes (type 2 diabetes mellitus) in adults 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

Do not take Gliclazide Sandoz

if you are allergic to gliclazide or 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 ketone bodies and sugar in the urine (indicating possible diabetic ketoacidosis), or if you are in a state of 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 Sandoz”)
if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Sandoz.
Follow the treatment plan prescribed by your doctor to achieve appropriate blood sugar levels. In addition to taking the tablet regularly, this includes following a proper diet, engaging in physical activity, and, if necessary, losing weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) as well as glycated hemoglobin (HbA1c) is required.
In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Therefore, careful medical supervision is particularly important.
Low blood sugar levels (hypoglycemia) may occur:

if you eat irregularly or skip meals,
if you are fasting,
if you are malnourished,
if you change your dietary habits,
if you increase your physical activity without a corresponding increase in carbohydrate intake,
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.

If you experience low blood sugar, you may have 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, trembling, sensory disturbances, dizziness, and feelings of helplessness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden sharp 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, shortness of breath, slow heartbeat, or loss of consciousness.
In most cases, symptoms of low blood sugar disappear quickly after taking sugar in any form, such as glucose tablets, sugar cubes, sugary juices, or sweetened tea.
You should always carry sugar (glucose tablets, sugar cubes) with you.
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. This may happen 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 preparations containing St. John’s wort (Hypericum perforatum) (see section “Other medicines and Gliclazide Sandoz”), or during particular stress situations.
These symptoms may include:

thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced performance.

If you experience any of these symptoms, contact your doctor or pharmacist.
Changes in blood glucose levels (low or 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 such cases, your doctor will emphasize the importance of monitoring blood glucose levels.
If you have a family history or know you have an inherited deficiency of glucose-6-phosphate dehydrogenase (G6PD) (red blood cell disorder), taking this medicine may lead to reduced hemoglobin levels and destruction of red blood cells (hemolytic anemia). Contact your doctor before taking this medicine.
Children and adolescents
The use of Gliclazide Sandoz is not recommended in children and adolescents due to lack of data.
Other medicines and Gliclazide Sandoz
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 may occur when taking any of the following medicines:

other medicines for 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 gastric or duodenal ulcers (H--receptor antagonists),
medicines for depression (monoamine oxidase inhibitors),
painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
medicines containing alcohol.

The blood glucose-lowering effect of gliclazide may be reduced, leading to increased blood sugar levels, when taking any of the following medicines:

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

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, especially in elderly patients.
Gliclazide Sandoz may enhance the effects of medicines that reduce blood clotting (e.g., warfarin).
Consult your doctor before starting any new medicines. If you are hospitalized, inform medical staff that you are taking Gliclazide Sandoz.
Gliclazide Sandoz with food, drinks, and alcohol
Gliclazide Sandoz may be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Gliclazide Sandoz is not recommended during pregnancy.
You must not take Gliclazide Sandoz during breastfeeding.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar levels are too low (hypoglycemia), too high (hyperglycemia), 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 vehicles or operating machinery). Ask your doctor whether you can drive if you:

have frequent episodes of low blood sugar (hypoglycemia),
have minimal or non-obvious symptoms of low blood sugar (hypoglycemia).

3. How to take Gliclazide Sandoz

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
This medicine can only be taken by adults.
Your doctor will determine the dose based on your blood sugar levels and, if possible, your urine sugar levels. Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements in blood sugar control may mean that your dose needs to be adjusted.
The recommended dose is 1 to 4 tablets (maximum 120 mg) taken as a single daily dose at breakfast time. This depends on your response to treatment.
If you are receiving combination therapy with Gliclazide Sandoz 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.
If you notice that your blood sugar levels remain high despite taking the medicine as prescribed, you should contact your doctor or pharmacist.

Method and route of administration
For oral use.
Swallow the tablets whole without chewing them.
Take the tablet(s) with a glass of water at breakfast time (and preferably at the same time every day).
You must always eat a meal after taking the tablet(s).

If you take more Gliclazide Sandoz 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 levels (hypoglycaemia), as described in section 2. These symptoms may improve by immediately taking sugar (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 for emergency assistance.
The same applies if someone else, for example a child, has accidentally taken the medicine.
Do not give food or drink to unconscious patients.
Ensure that someone who is informed is always available to call a doctor in an emergency.

If you forget to take Gliclazide Sandoz
It is important to take the medicine every day, as regular treatment works best.
However, if you forget to take a dose of Gliclazide Sandoz, 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 Sandoz
Since diabetes treatment usually lasts a lifetime, you must consult your doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycaemia), increasing the risk of developing diabetes complications.
If you have any questions about using 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 low blood sugar (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions” paragraph 2 “What you need to know before taking Gliclazide Sandoz”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness or possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, 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 patients

Decrease in blood cell count (e.g. platelets, red and white blood cells), which 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 the available data

Liver function abnormalities, which may cause yellowing of the skin and eyes. If this occurs, contact your doctor immediately. Symptoms generally resolve if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.
Skin reactions such as rash, redness, itching, urticaria and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause difficulty breathing). The skin rash may progress to widespread blistering over the body or skin peeling. Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially presenting as flu-like symptoms and facial rash, followed by widespread rash and high fever.
Stomach pain or discomfort, nausea, indigestion, diarrhoea and constipation. These effects are reduced when Gliclazide Sandoz is taken with a meal, as recommended; see paragraph 3 “How to take Gliclazide Sandoz”.
Visual disturbances. Vision may be temporarily affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels. As with other sulphonylureas, 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)
- Signs of liver failure (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylureas, but in rare cases may lead to life-threatening 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 at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Sandoz contains
The active substance is gliclazide. The other components are calcium hydrogen phosphate dihydrate, povidone (E1201), hypromellose (E464) and magnesium stearate (E572).

Description of the appearance of Gliclazide Sandoz and package contents
Modified-release tablet.
Uncoated tablets, white to almost white, capsule-shaped, biconvex, with '30' engraved on one side and smooth on the other.
Gliclazide Sandoz is available in transparent clear PVC/Aclar-ALU or transparent clear PVC-ALU blisters containing 10, 30, 60, 90, 120 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz Spa, Largo U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Gliclazide Sandoz 30 mg, tabletten met gereguleerde afgifte
Belgium: Gliclazide Sandoz 30 mg tabletten met gereguleerde afgifte
Estonia: Dizirel
Spain: Gliclazida Lek 30 mg comprimidos de liberación modificada EFG
Greece: Gliclazide / Sandoz
Croatia: Gliklazid Sandoz 30 mg tablete s prilagođenim oslobađanjem
Hungary: DYACLID 30 mg módosított hatóanyagleadású tabletta
Italy: Gliclazide Sandoz
Luxembourg: Gliclazide Sandoz 30 mg comprimé à libération prolongée
Portugal: Gliclazida Mesiproc
Slovenia: Gliklazid Lek 30 mg tablete s podaljšanim sproščanjem