Symglic

Patient Information Leaflet

Symglic, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg, tablets
Glimepiride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

1. What Symglic is and what it is used for
2. What you need to know 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 Symglic is and what it is used for

Symglic is an oral antidiabetic medicine used to lower blood glucose levels. It belongs to a group of medicines called sulfonylureas. Symglic works by increasing the amount of insulin released by the pancreas. Insulin lowers blood glucose levels.
Symglic is used to treat a certain type of diabetes (type 2 diabetes) when blood glucose levels cannot be controlled by diet, physical exercise, and weight reduction alone.

2. Important information before using Symglic

When not to use 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 sulfonylurea drugs (medicines used to lower blood sugar levels, e.g. glibenclamide) or sulfonamides (medicines used for bacterial infections, e.g. sulfamethoxazole);
• if the patient has insulin-dependent diabetes (type 1 diabetes);
• if the patient has ketoacidosis (a complication of diabetes in which acid levels in the body rise 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 use Symglic if any of the above conditions apply.
If in doubt, consult your doctor or pharmacist before using Symglic.
Warnings and precautions
Consult your doctor before starting treatment with Symglic if:

• the patient has experienced trauma, surgery, infection with fever, or any other stress-related condition; inform the doctor, as temporary changes in treatment may be necessary;
• the patient has severe liver or kidney dysfunction. If the patient is unsure whether any of the above points apply, they should consult their doctor or pharmacist before using Symglic.

Patients with glucose-6-phosphate dehydrogenase deficiency may develop reduced haemoglobin levels and breakdown of red blood cells (haemolytic anaemia).
Children and adolescents
Data on the use of Symglic in patients under 18 years of age are limited. Therefore, use of this medicine is not recommended in this patient group.
Important information about hypoglycaemia (low blood sugar)
Hypoglycaemia (low blood sugar) may occur during treatment with Symglic.
Below are additional details regarding hypoglycaemia, its symptoms, and treatment.
The following factors may increase the risk of hypoglycaemia:

• malnutrition, irregular meal intake, skipping or delaying meals, vomiting;
• changes in diet;
• taking a higher dose of Symglic than required;
• kidney dysfunction;
• severe liver dysfunction;
• certain specific conditions caused by hormonal disorders (e.g. thyroid dysfunction, anterior pituitary dysfunction, or adrenal insufficiency);
• alcohol consumption, especially when combined with skipped meals;
• taking certain medications (see section "Symglic with other medicines" below);
• engaging in more physical activity than usual, especially if meals are insufficient or contain fewer carbohydrates than usual.

Symptoms of hypoglycaemia include:

• uncontrollable hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, impaired alertness and reaction time, depression, disorientation, speech and vision disturbances, difficulty speaking, tremor, partial paralysis, sensory disturbances, dizziness, and feelings of helplessness;
• additionally, the following symptoms may occur: sweating, clammy skin, anxiety, rapid heartbeat, elevated blood pressure, palpitations, sudden, severe chest pain radiating to adjacent body parts (angina pectoris and cardiac arrhythmias).

If blood sugar continues to drop, significant disorientation (delirium), seizures, shallow breathing, reduced heart rate, and loss of consciousness may occur.
The clinical picture of hypoglycaemic shock may resemble a stroke.
Treatment of hypoglycaemia:
In most cases, symptoms of low blood sugar resolve quickly after consuming sugar in any form, e.g. sugar cubes, sweet juice, or sweetened tea.
Therefore, always carry a source of sugar (e.g. sugar cubes). Remember that consuming artificial sweeteners is ineffective.
Contact a doctor or go to a hospital if symptoms do not improve after consuming sugar or if symptoms recur.
Laboratory tests
Blood sugar levels or urine glucose should be monitored regularly. Your doctor may also perform regular blood tests to assess liver function and blood cell counts.
Symglic with other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Your doctor may decide to adjust 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 enhance the blood sugar-lowering effect of Symglic, potentially leading to hypoglycaemia (low blood sugar):

• other antidiabetic medicines (e.g. insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, drugs with effects similar 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);
• anticoagulants (coumarin derivatives, e.g. warfarin);
• anabolic steroids used to promote muscle growth;
• medicines used in male hormone replacement therapy;
• antidepressants (fluoxetine, monoamine oxidase inhibitors);
• cholesterol-lowering medicines (fibrates);
• medicines used to treat high blood pressure (angiotensin-converting enzyme inhibitors);
• antiarrhythmic medicines used to prevent cardiac rhythm disturbances (disopyramide);
• medicines used to treat gout (e.g. allopurinol, probenecid, sulfinpyrazone);
• anticancer medicines (cyclophosphamide, ifosfamide, trofosfamide);
• weight-loss medicines (fenfluramine);
• medicines used to increase blood flow through blood vessels, administered intravenously in high doses (pentoxifylline);
• medicines used to treat allergic rhinitis such as hay fever (tryquicylamine);
• medicines known as sympatholytics, used in hypertension, heart failure, or symptoms of prostate disease.

The following medicines may reduce the blood sugar-lowering effect of Symglic, potentially leading to hyperglycaemia (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 psychiatric disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to increase heart rate, treat asthma or nasal congestion, cough and colds, used to reduce body weight, or in life-threatening conditions (adrenaline and sympathomimetics);
• medicines used to treat high blood cholesterol (nicotinic acid);
• long-term use of laxatives used to treat constipation;
• antiepileptic medicines (phenytoin);
• medicines used to treat anxiety and sleep disorders (barbiturates);
• medicines used to treat elevated intraocular pressure (acetazolamide);
• medicines used to treat high blood pressure or lower blood sugar (diazoxide);
• medicines used to treat infections, tuberculosis (rifampicin);
• medicines used to treat life-threatening, very low blood sugar (glucagon).

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

• medicines used to treat stomach ulcers (H-\receptor antagonists);
• medicines used to treat high blood pressure or heart failure, such as β-blockers, clonidine, guanethidine, and reserpine. These may also mask symptoms of hypoglycaemia; therefore, extra caution is required when using these medicines.

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

• anticoagulants (coumarin derivatives, e.g. warfarin).

Symglic with food, drink, and alcohol
Alcohol may unpredictably enhance or weaken the effect of glimepiride.
Pregnancy and breastfeeding
Pregnancy
Glimepiride should not be used during pregnancy. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding
Glimepiride may pass into breast milk; therefore, its use is not recommended during breastfeeding.
Driving and operating machinery
The ability to concentrate or reaction speed may be impaired due to low blood sugar (hypoglycaemia) or high blood sugar (hyperglycaemia), or due to vision disturbances as a symptom of these conditions. Patients should be aware that they may pose a risk to themselves or others (e.g. when driving or operating machinery). Consult a doctor about the ability to drive in the following cases:

• if the patient frequently experiences hypoglycaemia;
• if the patient rarely experiences warning symptoms of hypoglycaemia or has never experienced such symptoms.

Symglic contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Symglic contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Symglic 6 mg contains Sunset Yellow FCF (E110)
Symglic 6 mg contains Sunset Yellow FCF (E110). This medicine may cause allergic reactions.

3. How to take Symglic

The medicine should always be taken exactly as directed by the physician or pharmacist. In case of doubt, consult a physician or pharmacist.
Symglic 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 physician. While taking Symglic, patients should follow the recommended diet.
Tablets should be swallowed whole, with at least half a glass of water. Do not break or chew the tablets.
The dose of Symglic is determined by the physician according to individual needs, the patient's condition, and the results of blood and urine glucose concentration tests. Do not take more tablets than prescribed by the physician.

• The usual starting dose is one 1 mg Symglic tablet once daily.
• If necessary, the physician may increase the dose after 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of Symglic per day.
• The physician may prescribe combination therapy with glimepiride and metformin or glimepiride and insulin. In such cases, the physician will determine the appropriate doses of glimepiride, metformin, and insulin individually for each patient.
• If changes in body weight, lifestyle, or stress occur, inform the physician so that the dose of medicine can be adjusted if necessary.
• If you feel that the effect of Symglic is too strong or too weak, consult your physician. Do not change the dose independently.

Taking more Symglic than prescribed
If an overdose of glimepiride is taken or an extra dose is ingested, there is a risk of hypoglycemia (hypoglycemia symptoms – see section 2. "Warnings and precautions"). Immediately consume an appropriate amount of sugar (e.g. a few sugar cubes, sweet juice, sweetened tea) and contact a physician or pharmacist without delay. In cases of hypoglycemia caused by accidental ingestion of the medicine by a child, the amount of sugar administered must be strictly controlled to avoid inducing dangerous hyperglycemia. Do not give food or drink to unconscious individuals.
Hypoglycemia may last for some time; therefore, it is very important to monitor the patient until the danger has passed. Hospital observation may be necessary as an additional precaution. Bring the medicine packaging or any remaining tablets with you so the physician knows which medicine has been taken.
Severe cases of low blood sugar, with loss of consciousness and serious neurological complications, require immediate treatment and hospitalization. Ensure that people around the patient are aware of the condition and know when to call for medical help.

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

Stopping treatment with Symglic
If the patient stops taking Symglic, they should be aware that the blood glucose-lowering effect will not be maintained and the clinical condition may worsen. Continue taking Symglic for as long as directed by the physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following symptoms occur:

• allergic reactions (including inflammation of blood vessels, often with skin rash), which may develop into severe allergic reactions with difficulty breathing, low blood pressure, sometimes leading to shock;
• liver function disorders including yellowing of the skin and eyes (jaundice), disorders of bile flow (cholestasis), hepatitis or liver failure;
• skin allergy (hypersensitivity), manifesting as itching, rash, urticaria and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, swelling of the lips, throat or tongue;
• severe hypoglycaemia with loss of consciousness, seizures, coma.

The following adverse reactions have also been reported:
Uncommon adverse reactions (may occur in no more than 1 in 1,000 patients):

• lower than normal blood glucose levels (hypoglycaemia) (see section 2. "Warnings and precautions");
• decreased number of blood cells:
  • platelets (increases the risk of bleeding and bruising);
  • white blood cells (increases the likelihood of infections);
  • red blood cells (may cause paleness of the skin, weakness or shortness of breath). These symptoms usually resolve after discontinuation of Symglic.

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):

• allergic reactions (with inflammation of blood vessels, often with skin rash), which may develop into severe allergic reactions with difficulty breathing, low blood pressure, sometimes leading to shock. In the event of any of the above symptoms, seek medical advice immediately;
• liver function disorders with yellowing of the skin and eyes (jaundice), disorders of bile flow (cholestasis), hepatitis or liver failure. In the event of any of the above symptoms, seek medical advice immediately;
• nausea or vomiting, diarrhoea, feeling of fullness or bloating, abdominal pain;
• decreased sodium levels in blood (detected in blood tests).

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

• skin allergy (hypersensitivity) manifesting as itching, rash, urticaria and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, swelling of the lips, throat or tongue. In the event of any of the above symptoms, seek medical advice immediately;
• allergic reactions to drugs of the sulfonylurea derivatives, sulfonamides and related medicines may occur;
• visual disturbances may occur, especially at the beginning of treatment with Symglic. These are caused by changes in blood glucose levels and should resolve shortly;
• increased liver enzyme activity;
• occurrence of severe, unexpected bleeding or subcutaneous petechiae.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the 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 pack after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any visible changes in its appearance.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Symglic contains

• The active substance is glimepiride. Each tablet contains 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg of glimepiride.
• The other ingredients are: monohydrate lactose, sodium carboxymethyl starch (type A), microcrystalline cellulose, povidone K30, magnesium stearate.
• Additionally, the tablets contain colouring agents:
  • 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: sunset yellow (E110).

What Symglic looks like and contents of the pack

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

Clear PVC/Aluminium 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 Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw
Poland

Manufacturer
PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece