Simglic

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 sulfonylurea derivatives. 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 loss alone are not enough to control blood sugar levels.

2. Important information before taking Symglic

When not to take Symglic

• if the patient is allergic to glimepiride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other medicines of the sulfonylurea derivative group (medicines used to lower blood sugar levels, e.g. glibenclamide) or sulfonamides (medicines used to treat bacterial infections, e.g. sulfamethoxazole);
• if the patient has insulin-dependent diabetes (type 1 diabetes);
• if the patient has 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 the patient has diabetic coma;
• if the patient has severe kidney dysfunction;
• if the patient has severe liver dysfunction;
• if the patient is pregnant;
• if the patient is breastfeeding.

Do not take this medicine if any of the above conditions occur. In case of doubts, consult a doctor or pharmacist before taking Symglic.

Warnings and precautions

Consult a doctor before starting to take Symglic if:

• the patient has had an injury, surgery, infection with fever, or other stressful situation; the doctor should be informed, as a temporary change in treatment may be necessary;
• the patient has severe liver or kidney dysfunction. If the patient is not sure whether any of the above points apply to them, they should consult a doctor or pharmacist before taking Symglic.

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

Children and adolescents

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

Important information about hypoglycemia (low blood sugar)

During treatment with Symglic, the patient may experience hypoglycemia (low blood sugar). Below are additional information on hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

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

Symptoms of hypoglycemia include:

• uncontrolled hunger, headache, nausea, vomiting, drowsiness, sleepiness, sleep disturbances, restlessness, aggression, concentration disorders, attention and reaction time disorders, depression, disorientation, speech and vision disorders, speech disorders, tremors, weakness, sensory disturbances, dizziness, feeling of helplessness;
• in addition, the following symptoms may occur: sweating, moist skin, restlessness, rapid heartbeat, increased 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 quickly disappear after consuming sugar in any form, e.g. sugar cubes, sweet juice, sweetened tea.
Therefore, it is always recommended to have some form of sugar with you (e.g. sugar cubes). It should be remembered that consuming sweeteners is not effective.
A doctor or pharmacist should be consulted if there is no improvement after consuming sugar or if symptoms recur.

Laboratory tests

Blood sugar or urine sugar levels should be regularly monitored. The doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Symglic and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor may decide to change the dose of Symglic if the patient is 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 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 (glucocorticosteroids);
• 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 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 special caution should be exercised 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 breastfeeding

Pregnancy

Glimepiride should not be taken during pregnancy. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Breastfeeding

Glimepiride may pass into breast milk, so it is not recommended to take glimepiride while breastfeeding.

Driving and using machines

Concentration or reaction speed may be impaired due to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), or due to vision disturbances as a symptom of these conditions. It should be taken into account that the patient may pose a risk to themselves or others (e.g. when driving or operating machines). The patient should consult a doctor about the possibility of driving in the following cases:

• if the patient frequently experiences hypoglycemia;
• if the patient rarely experiences symptoms warning of hypoglycemia or has not experienced them at all.

Symglic contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Symglic contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

Symglic, 6 mg contains orange yellow S (E110)

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

3. How to take Symglic

The medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.
The medicine should be taken orally, shortly before or during the first main meal of the day (usually breakfast). If the patient does not eat breakfast, the medicine should be taken according to the schedule recommended by the doctor. If Symglic is taken, the patient should follow the recommended diet.
The tablets should be swallowed whole, with at least half a glass of water. The tablets should not be broken or chewed.
The dose of Symglic is determined by the doctor, depending on the patient's needs, condition, and blood glucose and urine test results. The patient should not take more tablets than recommended by the doctor.

• The initial dose is usually one Symglic 1 mg tablet per day.
• If necessary, the doctor may increase the dose after 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of Symglic per day.
• The doctor may recommend combination therapy with glimepiride and metformin or glimepiride and insulin. In such cases, the doctor will determine the appropriate doses of glimepiride, metformin, and insulin for the individual patient.
• If the patient's weight, lifestyle, or stress level changes, they should inform their doctor, who may need to adjust the dose of the medicine.
• If the patient feels that the effect of Symglic is too strong or too weak, they should consult a doctor. The patient should not change the dosage of the medicine on their own.

Taking a higher dose of Symglic than recommended

In case of taking a higher dose of glimepiride than recommended or taking an additional dose, there is a risk of hypoglycemia (hypoglycemia symptoms - see section 2. "Warnings and precautions"). The patient should immediately consume an appropriate amount of sugar (e.g. a small amount of sugar cubes, sweet juice, sweetened tea) and consult a doctor or pharmacist without delay. In case of treating hypoglycemia caused by accidental ingestion of the medicine by a child, the amount of sugar administered must be strictly controlled to avoid the risk of causing dangerous hyperglycemia. Food or drink should not be given to unconscious persons.
The state of hypoglycemia may last for some time, so it is very important to observe the patient until the danger has passed. Hospital observation may be necessary as a precaution. The patient should take the packaging of the medicine or the remaining tablets with them, so that the doctor knows what medicine has been taken.
Severe cases of low blood sugar with loss of consciousness, seizures, and serious neurological complications require immediate treatment and hospitalization. It should be ensured that people around the patient are aware of their condition and will seek medical help when necessary.

Missing a dose of Symglic

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Symglic

If the patient stops taking the medicine, they should be aware that the effect of lowering blood sugar levels will not be maintained, and their clinical condition will worsen. Symglic should be taken for as long as recommended by the doctor.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately consult a doctor if they experience any of the following symptoms:

• allergic reactions (including vasculitis, often with skin rash), which may develop into severe allergic reactions with difficulty breathing, decreased blood pressure, and potentially leading to shock;
• liver dysfunction, 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, and coma.

The following side effects have also been reported:
Rare side effects(may occur in less than 1 in 100 patients):

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

Very rare side effects(may occur in less than 1 in 10,000 patients):

• allergic reactions (with vasculitis, often with skin rash), which may develop into severe allergic reactions with difficulty breathing, decreased blood pressure, and potentially leading to shock. If any of the above symptoms occur, the patient should immediately consult a doctor;
• liver dysfunction with yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), hepatitis, or liver failure. If any of the above symptoms occur, the patient should immediately consult a doctor;
• nausea or vomiting, diarrhea, feeling of fullness or bloating, abdominal pain;
• decreased sodium levels in the blood (revealed 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 any of the above symptoms occur, the patient should immediately consult a doctor;
• allergic reactions to sulfonylurea derivatives, sulfonamides, and related medicines may occur;
• vision disturbances, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Symglic

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Do not use this medicine if you notice any visible changes in the appearance of the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Symglic contains

• The active substance of Symglic 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: iron oxide red (E172);
• 2 mg tablets: iron oxide yellow (E172), indigo carmine (E132);
• 3 mg tablets: iron oxide yellow (E172);
• 4 mg tablets: indigo carmine (E132);
• 6 mg tablets: orange yellow S (E110).

What Symglic looks like and what the packaging contains

• 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 blisters made of PVC/Aluminum foil.
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