Simglic

Package Leaflet: Information for the Patient

Symglic, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg, tablets
Glimepiride

Read the package 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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Symglic and what is it used for

Symglic is an oral anti-diabetic medicine. It belongs to a group of medicines called sulfonylureas. The action of Symglic is to increase the amount of insulin released by the pancreas. Insulin lowers blood sugar levels.
Symglic is used to treat a certain type of diabetes (type 2 diabetes), when diet, physical exercise, and weight reduction alone have not been able to control blood sugar levels.

2. Important information before taking Symglic

When not to take Symglic

• if you are allergic to glimepiride or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines of the sulfonylurea group (medicines used to lower blood sugar levels, e.g., glibenclamide) or sulfonamides (medicines used to treat bacterial infections, e.g., sulfamethoxazole);
• if you have insulin-dependent diabetes (type 1 diabetes);
• if you have diabetic ketoacidosis (a complication of diabetes in which the level of acids in the body increases and the following symptoms occur: fatigue, nausea, frequent urination, and muscle stiffness);
• if you have diabetic coma;
• if you have severe kidney problems;
• if you have severe liver problems;
• if you are pregnant;
• if you are breast-feeding.

Do not take this medicine if you have any of the above conditions. If in doubt, consult your doctor or pharmacist before taking Symglic.

Warnings and precautions

Consult your doctor before starting treatment with Symglic if:

• you have had trauma, surgery, infection with fever, or any other stress situation; you should inform your doctor, as a temporary change in treatment may be necessary;
• you have severe liver or kidney problems. If you are not sure whether any of the above applies to you, consult your doctor or pharmacist before taking Symglic.

In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin level and breakdown of red blood cells (hemolytic anemia) may occur.

Children and adolescents

Data on the use of Symglic in children under 18 years of age are limited. Therefore, the use of this medicine in patients in this age group is not recommended.

Important information about hypoglycemia (low blood sugar)

While taking Symglic, you may experience hypoglycemia (low blood sugar). Below are additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• undernutrition, irregular meals, skipping or delaying meals, fasting;
• change in diet;
• taking a higher dose of Symglic than necessary;
• kidney problems;
• severe liver problems;
• certain hormonal disorders (e.g., thyroid disorders, pituitary disorders, or adrenal insufficiency);
• alcohol consumption, especially with skipped meals;
• taking certain medicines (see "Symglic and other medicines" below);
• performing more physical activity than usual, if the meal was not sufficient or the food contained less carbohydrates than usual.

Symptoms of hypoglycemia include:

• uncontrolled hunger, headache, nausea, vomiting, drowsiness, sleepiness, sleep disorders, restlessness, aggression, concentration disorders, attention and reaction time disorders, depression, disorientation, speech and vision disorders, speech disorders, tremors, weakness, sensory disorders, dizziness, feeling of helplessness;
• in addition, the following symptoms may occur: sweating, moist skin, restlessness, rapid heartbeat, high blood pressure, palpitations, sudden, severe chest pain that may radiate to adjacent parts of the body (angina pectoris and arrhythmias).

If blood sugar levels continue to decrease, significant disorientation (confusion), seizures, loss of self-control, shallow breathing, and decreased heart rate and loss of consciousness may occur.
The clinical picture of hypoglycemic shock may resemble a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar disappear quickly after consuming sugar in any form, e.g., sugar cubes, sweet juice, sweetened tea.
Therefore, you should always carry some form of sugar with you (e.g., sugar cubes). Remember that consuming artificial sweeteners is not effective.
Consult your doctor or go to the hospital if you do not improve after consuming sugar or if symptoms recur.

Laboratory tests

Regularly check your blood or urine sugar levels. Your doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Symglic and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor may decide to change the dose of Symglic if you are taking other medicines that may weaken or enhance the effect of Symglic on blood sugar levels.
The following medicines may increase the effect of Symglic on lowering blood sugar levels, which may lead to hypoglycemia (low blood sugar):

• other anti-diabetic medicines (e.g., insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines with a similar effect to acetylsalicylic acid);
• medicines used to treat urinary tract infections (e.g., certain long-acting sulfonamides);
• medicines used to treat bacterial or fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolone antibiotics, clarithromycin);
• medicines that prevent blood clotting (coumarin derivatives, e.g., warfarin);
• medicines that promote muscle growth (anabolic steroids);
• medicines used in hormone replacement therapy in men;
• medicines used to treat depression (fluoxetine, monoamine oxidase inhibitors);
• medicines that lower high cholesterol levels (fibrates);
• medicines that lower high blood pressure (angiotensin-converting enzyme inhibitors);
• anti-arrhythmic medicines used to prevent heart rhythm disorders (disopyramide);
• medicines used to treat gout (e.g., allopurinol, probenecid, sulfinpyrazone);
• medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide);
• medicines used to reduce body weight (fenfluramine);
• medicines that increase blood flow through blood vessels, administered intravenously in high doses (pentoxifylline);
• medicines used to treat allergic rhinitis (e.g., tritoqualine);
• medicines called sympatholytics, used to treat high blood pressure, heart failure, or prostate symptoms.

The following medicines may decrease the effect of Symglic on blood sugar levels, which may lead to hyperglycemia (high blood sugar):

• medicines containing female sex hormones (estrogens, progestogens);
• diuretics (thiazide diuretics);
• medicines used to stimulate the thyroid gland (e.g., levothyroxine);
• medicines used to treat allergies and inflammatory conditions (glucocorticoids);
• medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to increase heart rate, treat asthma, or relieve nasal congestion, cough, and cold, used to reduce body weight or in life-threatening conditions (adrenaline and sympathomimetics);
• medicines used to lower high cholesterol levels (nicotinic acid);
• medicines used to treat constipation, used for a long time (laxatives);
• medicines used to treat epilepsy (phenytoin);
• medicines used to treat nervousness and sleep disorders (barbiturates);
• medicines used to treat high pressure in the eye (acetazolamide);
• medicines used to treat high blood pressure or lower blood sugar levels (diazoxide);
• medicines used to treat infections, tuberculosis (rifampicin);
• medicines used to treat life-threatening low blood sugar levels (glucagon).

The following medicines may increase or decrease the effect of Symglic on blood sugar levels:

• medicines used to treat stomach ulcers (H2 receptor antagonists);
• medicines used to treat high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These medicines may also mask the symptoms of hypoglycemia, so be extremely cautious when taking these medicines.

Symglic may enhance or weaken the effect of the following medicines:

• medicines that prevent blood clotting (coumarin derivatives, e.g., warfarin).

Symglic with food, drink, and alcohol

Alcohol may enhance or weaken the effect of glimepiride in an unpredictable way.

Pregnancy and breast-feeding

Pregnancy

Do not take glimepiride during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Breast-feeding

Glimepiride may pass into breast milk, so it is not recommended to take glimepiride during breast-feeding.

Driving and using machines

Your ability to concentrate or react may be impaired due to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), or due to vision disorders as a symptom of these conditions. Keep in mind that you may pose a risk to yourself or others (e.g., while driving or operating machinery). Consult your doctor about the possibility of driving in the following cases:

• if you frequently experience hypoglycemia;
• if you rarely experience symptoms warning of hypoglycemia or have not experienced them at all.

Symglic contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Symglic contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

Symglic, 6 mg contains orange yellow S (E110)

Symglic, 6 mg contains orange yellow S (E110). This medicine may cause allergic reactions.

3. How to take Symglic

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally, shortly before or during the first main meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to the schedule prescribed by your doctor. If you are taking Symglic, follow the recommended diet.
Swallow the tablets whole with at least half a glass of water. Do not break or chew the tablets.
Your doctor will determine the dose of Symglic based on your needs, condition, and blood sugar and urine test results. Do not take more tablets than prescribed by your doctor.

• The initial dose is usually one Symglic 1 mg tablet per day.
• If necessary, your doctor may increase the dose after 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of Symglic per day.
• Your doctor may recommend combination therapy with glimepiride and metformin or glimepiride and insulin. In this case, your doctor will determine the appropriate doses of glimepiride, metformin, and insulin individually for you.
• If you experience changes in body weight, lifestyle, or are under stress, inform your doctor so that they can adjust the dose of the medicine if necessary.
• If you feel that the effect of Symglic is too strong or too weak, consult your doctor. Do not change the dose of the medicine yourself.

Taking a higher dose of Symglic than prescribed

If you take more glimepiride than prescribed, there is a risk of hypoglycemia (hypoglycemia symptoms - see section 2 "Warnings and precautions"). Immediately consume an appropriate amount of sugar (e.g., a small amount of sugar, sweet juice, sweetened tea) and consult your doctor or pharmacist without delay. In the case of accidental ingestion of the medicine by a child, the amount of sugar administered must be strictly controlled to avoid the risk of hyperglycemia. Do not give food or drink to unconscious persons.
Hypoglycemia may last for some time, so it is very important to monitor the patient until the risk has passed. Hospital observation may be necessary as a precaution. Take the medicine package or remaining tablets with you so that the doctor knows what medicine has been taken.
Severe cases of low blood sugar with loss of consciousness, seizures, and severe neurological complications require immediate treatment and hospitalization. Make sure that people around you are aware of your condition and will seek medical help when necessary.

Missing a dose of Symglic

Do not take a double dose to make up for a missed dose.

Stopping treatment with Symglic

If you stop taking the medicine, be aware that the effect of lowering blood sugar levels will not be maintained, and your clinical condition may worsen. Take Symglic for as long as your doctor has prescribed.
If you have any further questions 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.

Seek medical help immediately if you experience any of the following symptoms:

• allergic reactions (including vasculitis, often with skin rash), which can develop into severe allergic reactions with difficulty breathing, low blood pressure, and sometimes leading to shock;
• liver problems, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), hepatitis, or liver failure;
• skin allergy (hypersensitivity) manifested by itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue;
• severe hypoglycemia with loss of consciousness, seizures, coma.

The following side effects have also been reported:
Rare side effects(may affect up to 1 in 100 people):

• lower than normal blood sugar levels (hypoglycemia) (see section 2 "Warnings and precautions");
• decreased blood cell count:
• platelets (increasing the risk of bleeding and bruising);
• white blood cells (increasing the risk of infection);
• red blood cells (which can cause pale skin, weakness, or shortness of breath). These symptoms usually disappear after stopping Symglic.

Very rare side effects(may affect up to 1 in 10,000 people):

• allergic reactions (with vasculitis, often with skin rash), which can develop into severe allergic reactions with difficulty breathing, low blood pressure, and sometimes leading to shock. If you experience any of the above symptoms, seek medical help immediately;
• liver problems with yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), hepatitis, or liver failure. If you experience any of the above symptoms, seek medical help immediately;
• nausea or vomiting, diarrhea, feeling of fullness or bloating, abdominal pain;
• low sodium levels in the blood (shown in blood tests).

Frequency not known(frequency cannot be estimated from the available data):

• skin allergy (hypersensitivity) manifested by itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue. If you experience any of the above symptoms, seek medical help immediately;
• allergic reactions to sulfonylurea medicines, sulfonamides, and related medicines may occur;
• vision disorders, especially at the beginning of treatment with Symglic, caused by changes in blood sugar levels and should disappear soon;
• increased liver enzyme activity;
• severe, unexpected bleeding or bruising under the skin.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 Symglic

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 after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Do not use this medicine if you notice visible signs of deterioration.
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 Symglic contains

• The active substance is glimepiride. One tablet contains 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg of glimepiride.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), microcrystalline cellulose, povidone K30, magnesium stearate.
• In addition, the tablets contain dyes:
• 1 mg tablets: red iron oxide (E172);
• 2 mg tablets: yellow iron oxide (E172), indigo carmine (E132);
• 3 mg tablets: yellow iron oxide (E172);
• 4 mg tablets: indigo carmine (E132);
• 6 mg tablets: orange yellow S (E110).

What Symglic looks like and contents of the pack

• 1 mg tablets: pink, oblong, with a score line on both sides.
• 2 mg tablets: green, oblong, with a score line on both sides.
• 3 mg tablets: pale yellow, oblong, with a score line on both sides.
• 4 mg tablets: light blue, oblong, with a score line on both sides.
• 6 mg tablets: light orange, oblong, with a score line on both sides.

Transparent PVC/Aluminum blisters.
Pack sizes: 10, 20, 30, 50, 60, 90, or 120 tablets (in blisters of 10 tablets).
Not all pack sizes may be marketed.

Marketing authorization holder

Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer

PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece
Date of last revision of the leaflet:04/2022