SALSON 60 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Salson, 60 mg, modified-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Salson and what is it used for
4. Important information before taking Salson
   1. When not to take Salson
   2. Warnings and precautions
   3. Children and adolescents
   4. Salson and other medicines
   5. Salson with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Salson
   1. Dose
   2. Method and route of administration
   3. Taking a higher dose of Salson than recommended
   4. Missing a dose of Salson
   5. Stopping treatment with Salson
6. Possible side effects
   1. Reporting side effects
7. How to store Salson
8. Contents of the pack and other information
   1. What Salson contains
   2. What Salson looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet accompanying the packaging: patient information

Salson, 60 mg, modified-release tablets

Gliclazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Salson and what is it used for
• 2. Important information before taking Salson
• 3. How to take Salson
• 4. Possible side effects
• 5. How to store Salson
• 6. Contents of the pack and other information

1. What is Salson and what is it used for

Salson is a medicine that lowers blood sugar levels (an oral antidiabetic medicine from the sulfonylurea group).
Salson is used in adults with a certain type of diabetes (type 2 diabetes), when diet, physical exercise, and weight loss are not enough to maintain normal blood sugar levels.

2. Important information before taking Salson

When not to take Salson

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6) or to other medicines from the same group (sulfonylureas) or to other similar medicines (sulfonylureas with a blood glucose-lowering effect)
• if you have insulin-dependent diabetes (type 1)
• if you have ketone bodies in your urine (which may indicate ketoacidosis), you are in a pre-coma state or in a diabetic coma
• if you have severe kidney or liver disease
• if you are taking medicines to treat fungal infections (miconazole), see "Salson and other medicines"
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Salson, discuss it with your doctor or pharmacist.
To maintain normal blood sugar levels, you should follow the treatment plan prescribed by your doctor. This means, in addition to taking the medicine regularly, following a diet, exercising, and, if necessary, losing weight.
During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and possibly in urine) and hemoglobin A1c values.
In the first few weeks of treatment, there is an increased risk of low blood sugar (hypoglycemia). Therefore, close medical supervision is necessary during this time.
Low blood sugar (hypoglycemia) may occur if you:

• do not eat regular meals or skip meals
• fast
• are undernourished
• change your diet
• increase physical activity, and carbohydrate intake does not meet the increased demand
• consume alcohol, especially when skipping meals
• take other medicines or herbal remedies
• take too high a dose of gliclazide
• have certain hormonal disorders (thyroid, pituitary, or adrenal disorders)
• have severe kidney or liver disorders.

Low blood sugar can cause the following symptoms: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, concentration disorders, decreased alertness, and prolonged reaction time, depression, confusion, speech or vision disorders, tremors, sensory disturbances, dizziness, and a feeling of helplessness.
Other objective and subjective symptoms may also occur: sweating, skin moisture, restlessness, rapid or irregular heartbeat, high blood pressure, sudden chest pain that may radiate to adjacent parts of the body (angina pectoris).
Further lowering of blood sugar can cause significant confusion (delirium), convulsions, loss of self-control, shallow breathing, and slow heartbeat or loss of consciousness.
In most cases, the symptoms of low blood sugar disappear very quickly after consuming sugar in any form, e.g., glucose tablets, sugar cubes, sweet juice, or sweet tea. Therefore, you should always carry some form of sugar (glucose tablets, sugar cubes). Remember that sweeteners are not effective in this case. If the symptoms do not disappear or recur after consuming sugar, you should contact your doctor or go to the nearest hospital.
The symptoms of low blood sugar may not occur, may be mild, or may develop very slowly, or you may not be aware that your blood sugar has decreased.
This situation may apply to the elderly, people taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).
In stressful situations (such as an accident, surgery, fever, etc.), your doctor may temporarily change the treatment to insulin.
During the time when gliclazide has not yet sufficiently lowered your blood sugar, if you do not follow the treatment plan prescribed by your doctor, take preparations containing St. John's Wort (Hypericum perforatum) (see "Salson and other medicines"), or in special stressful situations, high blood sugar symptoms (hyperglycemia) may occur. These include: thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and decreased activity.
If such symptoms occur, you should consult your doctor or pharmacist.
If you are taking gliclazide and an antibiotic from the fluoroquinolone group, it is possible to experience disturbances in blood sugar levels (low or high blood sugar), especially in the elderly. In this case, your doctor will remind you to control your blood sugar levels.
If you or a family member have been diagnosed with a hereditary disorder, known as glucose-6-phosphate dehydrogenase deficiency (a red blood cell disorder), low hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. Before taking this medicine, you should consult your doctor.

Children and adolescents

It is not recommendedto use Salson in children and adolescentsdue to the lack of data.

Salson and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking one of the following medicines may enhance the effect of gliclazide in lowering blood sugar and cause symptoms of low blood sugar:

• other medicines used to treat high blood sugar (oral antidiabetic medicines, 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 (H2 receptor antagonists)
• medicines used to treat depression (monoamine oxidase inhibitors)
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen)
• medicines containing alcohol.

Taking one of the following medicines may weaken the effect of gliclazide in lowering blood sugar and cause symptoms of high blood sugar:

• medicines used to treat central nervous system disorders (chlorpromazine)
• medicines that reduce inflammation (corticosteroids)
• medicines used to treat asthma or during childbirth (intravenously administered salbutamol, rytodrine, terbutaline)
• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (danazol)
• St. John's Wort (Hypericum perforatum)

If you are taking Salson and an antibiotic from the fluoroquinolone group, it is possible to experience disturbances in blood sugar levels (low or high blood sugar), especially in the elderly. Salson may increase the effect of anticoagulant medicines (e.g., warfarin).
Before starting to take another medicine, consult your doctor. If you are going to the hospital, inform the medical staff that you are taking Salson.

Salson with food, drinks, and alcohol

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

Pregnancy and breastfeeding

It is not recommendedto use Salson during pregnancy.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do notuse Salson during breastfeeding.

Driving and using machines

If your blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or if you experience vision disturbances due to these changes, your ability to concentrate or react may be impaired. Remember that you may pose a risk to yourself or others (e.g., while driving a car or operating machines). Ask your doctor about the possibility of driving:

• if you experience low blood sugar (hypoglycemia) frequently;
• if the warning symptoms of low blood sugar (hypoglycemia) are mild or absent.

3. How to take Salson

Dose

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose is determined by your doctor based on your blood sugar levels and, if necessary, in urine. Any changes related to external factors (e.g., weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in the dose of gliclazide.
The recommended daily dose is from half to two tablets (maximum 120 mg), taken orally in a single dose during breakfast. The dose depends on the body's response to treatment.
If you start taking Salson with metformin, an alpha-glucosidase inhibitor, thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose of each of these medicines individually.
If you notice that your blood sugar levels are high despite taking the medicine as prescribed, you should consult your doctor or pharmacist.

Method and route of administration

Oral use.
Swallow the tablets or their halves whole, without chewing or crushing.
Take the tablet(s) with a glass of water during breakfast (preferably at the same time every day). After taking the tablet(s), always eat a meal.
The tablets can be divided into equal doses.

Taking a higher dose of Salson than recommended

If you have taken too many tablets, contact your doctor or the emergency department of the nearest hospital immediately.
The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) described in section 2. They can be alleviated by eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by eating a large snack or meal. If you are unconscious, inform your doctor and call for emergency help immediately. Do the same if someone else, e.g., a child, has taken this medicine by mistake. Do not give food or drink to unconscious patients.
Inform another person about your illness, who can call for medical help if necessary.

Missing a dose of Salson

It is important to take the medicine every day, as regular treatment works better. However, if you miss a dose of Salson, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Salson

Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salson can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar(hypoglycemia). Objective and subjective symptoms are described in the "Warnings and precautions" section in point 2.
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar is significant or prolonged (even if it has been temporarily controlled by administering sugar), seek medical help immediately.
Other side effects that may occur during treatment:

• Rarely: may occur less frequently than in 1 in 1000 people
• Decreased number of blood cells (e.g., platelets, red and white blood cells), which may cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after stopping treatment.

Frequency not known: cannot be estimated from the available data

• Liver function disorders, which may cause yellowing of the skin and eyes. In this case, seek medical help immediately. Symptoms usually disappear after stopping the medicine. Your doctor will decide whether to stop 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 can cause breathing difficulties). The rash may progress to widespread blistering or peeling of the skin. In exceptional cases, symptoms of severe hypersensitivity reactions (drug rash with eosinophilia and systemic symptoms, DRESS) have been reported; initially as flu-like symptoms with a rash on the face, and then a widespread rash with high fever.
• Abdominal pain or discomfort, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be alleviated by taking Salson as recommended, during meals (see point 3 "How to take Salson").
• Visual disturbances. Temporary visual disturbances may occur, especially at the beginning of treatment. This effect is caused by changes in blood sugar levels.

As with other sulfonylureas, the following side effects have been observed:

• significant changes in blood cell count
• allergic vasculitis
• decreased sodium levels in the blood (hyponatremia)
• symptoms of liver function disorders (e.g., jaundice), which usually disappeared after stopping sulfonylureas but in single cases may lead to life-threatening liver failure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salson

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 in a temperature below 25°C.
Medicines should 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 dividing line on both sides, with the inscription '60' on one side of the tablet, on one side of the dividing line.
Salson is available in transparent blisters of PVC/Aluminum or PVC/Aclar/Aluminum.
Pack sizes: 30, 60, and 90 modified-release tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:04/2022
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