Patient Information Leaflet: Instructions for Use

Salson, 60 mg, modified-release tablets
Gliclazide
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents:

What Salson is and what it is used for
Important information before taking Salson
How to take Salson
Possible side effects
How to store Salson
Contents of the pack and other information

1. What Salson is and what it is used for

Salson is a blood glucose-lowering agent (an oral antidiabetic drug from the sulfonylurea derivatives group).
Salson is used in adults with a certain type of diabetes (type 2 diabetes) when diet, physical exercise, and weight reduction are insufficient to maintain normal blood glucose levels.

2. Important information before using Salson

When not to use Salson

if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulfonylurea derivatives) or to other similar medicines (sulfonamides with blood glucose-lowering effect)
if the patient has insulin-dependent diabetes (type 1)
if ketone bodies and glucose are present in the patient's urine (this may indicate ketoacidosis), the patient is in a pre-comatose state or in diabetic coma
if the patient has severe kidney or liver disease
if the patient is taking medicines for the treatment of fungal infections (miconazole), see section "Salson and other medicines"
if the patient is breast-feeding (see section "Pregnancy and breast-feeding").

Warnings and precautions
Before using Salson, discuss this with your doctor or pharmacist.
To maintain proper blood glucose levels, the patient should follow the treatment plan recommended by the doctor. This means, in addition to taking the medicine regularly, adhering to a diet, performing physical exercise, and, if necessary, losing weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) and glycosylated hemoglobin (HbA ) levels is necessary.
During the first few weeks of treatment, there is an increased risk of low blood glucose (hypoglycaemia). Therefore, close medical supervision is required during this period.
Low blood glucose (hypoglycaemia) may occur if the patient:

does not eat meals regularly or skips meals
is fasting
is undernourished
changes diet
increases physical activity without increasing carbohydrate intake to meet the higher demand
consumes alcohol, especially when skipping meals
takes other medicines or natural remedies simultaneously
takes too high a dose of gliclazide
has specific disorders related to hormone activity (thyroid, pituitary or adrenal cortex dysfunction)
has severe kidney or liver dysfunction.

Low glucose levels in the blood may cause the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and prolonged reaction time, depression, confusion, speech or vision disturbances, trembling, sensory disturbances, dizziness and a feeling of helplessness.
The following objective and subjective symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden chest pain radiating to adjacent parts of the body (angina pectoris).
Further reduction of blood glucose may lead to severe confusion (delirium), seizures, loss of self-control, shallow breathing and slowed heartbeat, or loss of consciousness.
In most cases, symptoms of low blood glucose quickly resolve after consuming sugar in any form, e.g. glucose tablets, sugar lumps, sweet juice or sweet tea. Therefore, the patient should always carry some form of sugar (glucose tablets, sugar lumps). Note that artificial sweeteners are not effective in such cases. If symptoms do not resolve after consuming sugar or recur, contact a doctor or go to the nearest hospital.
Symptoms of low blood glucose may not occur, may be mild or develop very slowly, or the patient may not be aware that blood glucose has decreased. This situation may affect elderly patients or those taking certain medicines (e.g. those acting on the central nervous system and beta-blockers).
In stressful situations (such as accidents, surgery, fever, etc.), the doctor may temporarily switch treatment to insulin.
When gliclazide has not yet sufficiently lowered blood glucose, if the patient has not followed the doctor's recommended treatment plan, has taken preparations containing St. John's wort ( Hypericum perforatum ) (see section "Salson and other medicines"), or during particularly stressful situations, symptoms of high blood glucose (hyperglycaemia) may occur. These include: thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and reduced activity.
If such symptoms occur, consult a doctor or pharmacist.
If the patient is taking gliclazide together with an antibiotic from the fluoroquinolone group, disturbances in blood glucose levels (low or high blood glucose) may occur, especially in elderly patients. In such cases, the doctor will remind the patient to monitor blood glucose levels.
If the patient or members of their family have been diagnosed with a hereditary disorder known as glucose-6-phosphate dehydrogenase deficiency ( a red blood cell abnormality ), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Before using this medicine, consult a doctor.

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

Salson and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Taking any of the following medicines may enhance the blood glucose-lowering effect of gliclazide and cause symptoms of low blood glucose:

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

Taking any of the following medicines may weaken the blood glucose-lowering effect of gliclazide and cause symptoms of high blood glucose:

medicines used to treat disorders of the central nervous system ( chlorpromazine )
anti-inflammatory medicines ( corticosteroids )
medicines used to treat asthma or administered during childbirth ( intravenous salbutamol, ritodrine, terbutaline )
medicines used to treat breast diseases, severe menstrual bleeding and endometriosis ( danazol )
St. John's wort ( Hypericum perforatum )

If the patient is taking Salson together with a fluoroquinolone antibiotic, disturbances in blood glucose levels (low or high blood glucose) may occur, especially in elderly patients.
Salson may increase the effect of anticoagulant medicines (e.g. warfarin).
Before starting any other medicine, consult a doctor. If the patient is admitted to hospital, they should inform the medical staff that they are taking Salson.

Salson with food, drink and alcohol
Salson may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breast-feeding
Salson is not recommended during pregnancy.
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Salson must not be used during breast-feeding.

Driving and operating machinery
If blood glucose is too low (hypoglycaemia) or too high (hyperglycaemia), or if these changes cause visual disturbances, concentration difficulties or delayed reactions, the patient's ability may be impaired. Remember that the patient may pose a risk to themselves or others (e.g. when driving a car or operating machinery). Ask your doctor whether you may drive:

if low blood glucose (hypoglycaemia) occurs frequently
if warning symptoms of low blood glucose (hypoglycaemia) are mild or absent.

3. How to use Salson

Dosage
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The dose is determined by the doctor depending on blood sugar levels and possibly urine glucose. Any changes related to external factors (e.g. weight loss, lifestyle changes, stress) or improved blood sugar control may require adjustment of gliclazide dosage.
The recommended daily dose is from half to two tablets (maximum 120 mg), taken orally as a single dose with breakfast. The dose depends on the body's response to treatment.
If treatment with Salson is initiated together with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-IV inhibitor, a GLP-1 receptor agonist, or insulin, the doctor will determine the appropriate dose of each of these medicines individually.
If the patient notices high blood sugar levels despite taking the medicine as directed, they should consult a doctor or pharmacist.

Route and method of administration
Oral administration.
Tablets or halves should be swallowed whole, without chewing or crushing.
The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day). After taking the tablet(s), a meal should always be consumed.
Tablets may be divided into equal doses.

Overdose of Salson
In case of taking too many tablets, contact a doctor or the emergency department of the nearest hospital immediately.
Symptoms of overdose are symptoms of low blood sugar (hypoglycaemia), described in section 2. These may be relieved by consuming sugar (4 to 6 sugar cubes) or drinking a sweetened beverage, followed by eating a substantial snack or meal. If the patient is unconscious, seek medical help immediately and call an ambulance. The same applies if someone else, for example a child, has accidentally taken this medicine. Do not give food or drink to unconscious patients.
Inform another person about your condition so they can seek medical help if necessary.

Missed dose of Salson
It is important to take the medicine daily, as regular use ensures better effectiveness. If a dose of Salson is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Salson
Since diabetes treatment usually lasts a lifetime, consult a doctor before stopping this medicine. Discontinuation of treatment may lead to increased blood sugar (hyperglycaemia), increasing the risk of diabetes complications.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly observed adverse reaction is low blood sugar
(hypoglycaemia). Subjective and objective symptoms are described in section "Warnings and precautions" under point 2.
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness or
coma. If blood sugar reduction is significant or prolonged (even if temporarily controlled by sugar intake), medical help should be sought immediately.
Other adverse reactions that may occur during treatment:
Rarely: may occur in fewer than 1 in 1,000 people

Decreased number of blood cells (e.g. platelets, red and white blood cells), which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment.

Frequency unknown: cannot be estimated from available data

Liver function disorders, which may cause yellowing of the skin and eyes. In such a case, medical advice should be sought immediately. Symptoms usually resolve after discontinuation of the medicine. The physician will decide whether to discontinue treatment.
Skin reactions such as rash, redness, itching, urticaria and angioedema (sudden swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties). Rash may progress to extensive lesions with blistering or skin peeling. In rare cases, severe hypersensitivity reactions have been reported (drug reaction with eosinophilia and systemic symptoms, DRESS); initially presenting as influenza-like symptoms with facial rash, followed by widespread rash and high fever.
Abdominal pain or discomfort, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms may be alleviated by taking Salson as recommended, with meals (see section 3 "How to take Salson").
Visual disturbances. Transient visual disturbances may occur, especially at the beginning of treatment. This effect is caused by changes in blood glucose levels.

As with other sulfonylurea derivatives, the following adverse reactions have been observed:

significant changes in blood cell counts
allergic vasculitis
decreased sodium concentration in blood (hyponatraemia)
symptoms of liver dysfunction (e.g. jaundice), which usually resolve after discontinuation of sulfonylurea derivatives, but in isolated cases may lead to life-threatening liver failure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Salson

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

6. Contents of the pack and other information

What Salson contains
The active substance 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, magnesium stearate.

What Salson looks like and contents of the pack
White or almost white, oval, uncoated tablet, 13.5 mm long, 6.5 mm wide and 4.2 mm thick, with a score line on both sides and the imprint '60' on one side of the tablet, located on one side of the score line.
The medicine is available in transparent blisters made of PVC/Aluminium or PVC/Aclar/Aluminium.
Pack sizes: 30, 60 and 90 modified-release tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana, Slovenia
LEK S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For further information about this medicine and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00