GLIMEPIRIDE 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Glimepiride Aurovitas, 2 mg, tablets
3. Glimepiride Aurovitas, 3 mg, tablets
4. Glimepiride Aurovitas, 4 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet:
5. What is Glimepiride Aurovitas and what is it used for
   1. What is Glimepiride Aurovitas used for:
6. Important information before taking Glimepiride Aurovitas
   1. When not to take Glimepiride Aurovitas:
   2. Warnings and precautions
   3. Before taking the medicine, discuss it with your doctor or pharmacist if:
   4. Important information about hypoglycemia (low blood sugar levels)
   5. The following factors may increase the risk of hypoglycemia:
   6. Hypoglycemia symptoms include:
   7. Treatment of hypoglycemia:
   8. Laboratory tests
   9. Children and adolescents
   10. Glimepiride Aurovitas and other medicines
   11. Glimepiride Aurovitas with food, drink, and alcohol
   12. Pregnancy, breastfeeding, and fertility
   13. Pregnancy
   14. Breastfeeding
   15. Driving and using machines
   16. Glimepiride Aurovitas contains lactose
   17. Glimepiride Aurovitas contains sodium
7. How to take Glimepiride Aurovitas
   1. How to take the medicine
   2. Recommended dose
   3. Taking a higher dose of Glimepiride Aurovitas than recommended
   4. Missing a dose of Glimepiride Aurovitas
   5. Stopping treatment with Glimepiride Aurovitas
8. Possible side effects
   1. Immediately consult your doctor if you experience the following symptoms:
   2. Frequency not known, cannot be estimated from available data:
   3. Reporting side effects
9. How to store Glimepiride Aurovitas
10. Contents of the pack and other information
    1. What Glimepiride Aurovitas contains
    2. What Glimepiride Aurovitas looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer/Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the package leaflet: 05/2021

Package Leaflet: Information for the User

Glimepiride Aurovitas, 2 mg, tablets

Glimepiride Aurovitas, 3 mg, tablets

Glimepiride Aurovitas, 4 mg, tablets

Glimepiride

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

• You should 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Glimepiride Aurovitas and what is it used for

Glimepiride Aurovitas is an oral medicine that lowers blood sugar levels (glucose).
It belongs to a group of medicines that lower blood sugar levels, called sulfonylureas. The action of Glimepiride Aurovitas is based on increasing the amount of insulin released by the pancreas. Insulin lowers blood sugar levels.

What is Glimepiride Aurovitas used for:

Glimepiride Aurovitas is used to treat type 2 diabetes, when diet, physical activity, and weight loss alone are not enough to control blood sugar levels.

2. Important information before taking Glimepiride Aurovitas

When not to take Glimepiride Aurovitas:

• if you are allergic to glimepiride or other sulfonylureas (medicines used to lower blood sugar levels, e.g., glibenclamide) or sulfonamides (medicines used to treat bacterial infections, e.g., sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6),
• if you have insulin-dependent diabetes (type 1 diabetes),
• if you have diabetic ketoacidosis (a complication of diabetes that causes an increase in acid levels in the body; symptoms may include fatigue, nausea, frequent urination, and muscle stiffness),
• if you are in a diabetic coma,
• if you have severe kidney problems,
• if you have severe liver problems.

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

Warnings and precautions

Before taking the medicine, discuss it with your doctor or pharmacist if:

• you have had an injury, surgery, infection with fever, or other stress-related condition; you should inform your doctor, as a temporary change in treatment may be necessary
• you have liver or kidney problems.

If in doubt, consult your doctor or pharmacist before taking Glimepiride Aurovitas.
In patients with glucose-6-phosphate dehydrogenase enzyme deficiency, a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur.
Information on the use of Glimepiride Aurovitas in children under 18 years of age is limited.
It is not recommended to use this medicine in this age group.

Important information about hypoglycemia (low blood sugar levels)

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

The following factors may increase the risk of hypoglycemia:

• unwillingness (more common in elderly patients) or inability to cooperate,
• malnutrition, irregular meals, or skipping meals,
• change in diet,
• taking a higher dose of Glimepiride Aurovitas than necessary
• kidney problems,
• severe liver problems,
• certain hormonal disorders (e.g., thyroid, pituitary, or adrenal gland disorders),
• alcohol consumption, especially when skipping meals,
• taking certain other medicines (see below Glimepiride Aurovitas and other medicines),
• performing more physical activity than usual, if the meal was not sufficient or the food contained less carbohydrates than usual.

Hypoglycemia symptoms include:

Hunger attacks, headache, nausea, vomiting, fatigue, drowsiness, sleep disorders, anxiety, aggression, decreased concentration, attention, and reaction time, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, sensory disturbances, dizziness, feeling of helplessness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, increased blood pressure, palpitations, sudden and severe chest pain that may radiate to adjacent areas (angina pectoris and arrhythmias).
If blood sugar levels continue to decrease, the following may occur: confusion (delirium), convulsions, loss of self-control, shallow breathing, and slow heart rate, and may lead to loss of consciousness, including coma. Low blood sugar levels can cause symptoms similar to a stroke.

Treatment of hypoglycemia:

In many cases, the symptoms of low blood sugar levels disappear very quickly after consuming some sugar in certain forms, e.g., sugar cubes, sweet juice, sweetened tea.
Always carry sugar with you (e.g., sugar cubes).
Remember that artificial sweeteners are not effective in treating hypoglycemia. If sugar consumption does not relieve the symptoms of hypoglycemia, consult your doctor or go to the hospital.

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.

Children and adolescents

Glimepiride Aurovitas is not recommended for use in children under 18 years of age.

Glimepiride Aurovitas and other medicines

Tell your doctor or pharmacist 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 Glimepiride Aurovitas if you are taking other medicines that may weaken or enhance the effect of Glimepiride Aurovitas on blood sugar levels.
The following medicines may increase the effect of Glimepiride Aurovitas on blood sugar levels, which may lead to hypoglycemia (low blood sugar levels):

• other diabetes medicines (e.g., insulin or metformin),
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, salicylate-like medicines),
• medicines used to treat urinary tract infections (including some long-acting sulfonamides),
• medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolone antibiotics, clarithromycin),
• anticoagulant medicines (coumarin derivatives, e.g., warfarin),
• medicines that promote muscle growth (anabolic steroids),
• medicines used to treat male hormone deficiencies,
• medicines used to treat depression [fluoxetine, monoamine oxidase inhibitors (MAOIs)],
• medicines used to lower high cholesterol levels (fibrates),
• medicines used to lower high blood pressure [angiotensin-converting enzyme (ACE) inhibitors],
• antiarrhythmic medicines used to prevent heart rhythm disorders (disopyramide),
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone),
• medicines used to treat cancer (cyclophosphamides, ifosfamides, trofosfamides),
• medicines used to reduce weight (fenfluramine),
• medicines used to improve circulation, administered intravenously in high doses (pentoxifylline),
• medicines used to treat nasal allergies, e.g., hay fever (tritoqualine),
• medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms,

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

• medicines containing female sex hormones (estrogens, progestogens),
• diuretics (thiazide diuretics),
• medicines that 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 phenothiazine derivatives),
• medicines used to accelerate heart rate, treat asthma, or relieve nasal congestion, cough, and cold, or used to reduce weight or in emergency situations (adrenaline and sympathomimetics),
• medicines used to lower high cholesterol levels (nicotinic acid and its derivatives),
• 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 increased eye pressure (acetazolamide),
• medicines used to treat high blood pressure and low 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 Glimepiride Aurovitas on blood sugar levels:

• medicines used to treat stomach ulcers (H2 receptor antagonists),
• medicines used to treat high blood pressure or heart failure, e.g., beta-blockers, clonidine, and reserpine. These medicines may also weaken the symptoms of hypoglycemia, so caution is advised when taking them.

Glimepiride Aurovitas may increase or decrease the effect of the following medicines:

• blood clotting inhibitors (coumarin derivatives, e.g., warfarin).

Colesevelam, a medicine used to lower cholesterol levels, affects the absorption of Glimepiride Aurovitas. This interaction was not observed when Glimepiride Aurovitas was administered at least 4 hours before colesevelam. To avoid this effect, Glimepiride Aurovitas should be administered at least 4 hours before colesevelam.

Glimepiride Aurovitas with food, drink, and alcohol

Alcohol consumption may enhance or weaken the effect of Glimepiride Aurovitas in an unpredictable way.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take Glimepiride Aurovitas during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

Glimepiride Aurovitas may pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate or react quickly may be impaired due to low blood sugar levels (hypoglycemia) or high blood sugar levels (hyperglycemia). Be aware that you may pose a risk to yourself or others (e.g., when driving a vehicle or operating machinery). Patients should ask their doctor if they can drive or operate machinery, if:

• they often experience hypoglycemia,
• hypoglycemia warning signs are weakened or do not occur.

Glimepiride Aurovitas contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Glimepiride Aurovitas contains sodium

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

3. How to take Glimepiride Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How to take the medicine

Take the medicine orally, immediately before or during the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine as recommended by your doctor.
It is important not to skip meals when taking Glimepiride Aurovitas.
Swallow the tablet without chewing or crushing, with at least half a glass of water.
Each tablet can be divided into equal doses.

Recommended dose

The dose of Glimepiride Aurovitas depends on your condition and the results of your blood and urine sugar level tests, and is determined by your doctor. Do not take more tablets than recommended by your doctor.

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

Taking a higher dose of Glimepiride Aurovitas than recommended

Taking too many Glimepiride Aurovitas tablets or taking an additional dose is dangerous, as it may cause hypoglycemia (see hypoglycemia symptoms in section 2. Warnings and precautions). In this case, immediately consume a sufficient amount of sugar (e.g., sugar cubes, sweet juice, sweetened tea) and inform your doctor as soon as possible. Treatment of hypoglycemia in children who have accidentally taken the medicine requires controlled sugar intake to avoid the risk of hyperglycemia. Unconscious patients should not be given food or drink.
In case of prolonged hypoglycemia, it is very important that the patient is under close medical supervision until the danger has passed. Hospitalization may be necessary as a precaution. Show your doctor the package or remaining tablets so that they know what medicine has been taken.
Severe cases of hypoglycemia with loss of consciousness and severe neurological impairment require immediate medical attention, usually in a hospital. Make sure that someone who is informed is always nearby and can call a doctor in case of an emergency.

Missing a dose of Glimepiride Aurovitas

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

Stopping treatment with Glimepiride Aurovitas

After stopping treatment with Glimepiride Aurovitas, the achieved reduction in blood sugar levels will not be maintained, and the disease may worsen. Take Glimepiride Aurovitas for as long as your doctor recommends.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glimepiride Aurovitas can cause side effects, although not everybody gets them.

Immediately consult your doctor if you experience the following symptoms:

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

Some patients taking Glimepiride Aurovitas have experienced the following side effects:
Rare(may affect up to 1 in 100 people)

• Low blood sugar levels (hypoglycemia, see section 2. Important information before taking Glimepiride Aurovitas, subsection Warnings and precautions).
• Decreased blood cell count, such as:
• platelets, which increases the risk of bleeding or bruising (thrombocytopenia),
• white blood cells, which increases the risk of infection,
• red blood cells, which can cause pale skin and weakness or shortness of breath,

These disorders usually disappear after stopping treatment with Glimepiride Aurovitas.

• weight gain,
• hair loss,
• taste disorders.

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

• Allergic reaction (including vasculitis, often with skin rash), which can develop into a severe reaction with difficulty breathing, low blood pressure, and sometimes shock. If you experience any of these symptoms, immediately inform your doctor.
• Liver problems, including yellowing of the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, immediately inform your doctor.
• Nausea or vomiting, diarrhea, feeling of fullness in the stomach or bloating, and abdominal pain.
• Decreased sodium levels in the blood (as shown by laboratory tests).

Frequency not known, cannot be estimated from available data:

• Skin allergy (hypersensitivity) with itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions can develop into severe reactions with swelling or difficulty breathing, swelling of the lips, throat, or tongue. If you experience any of these symptoms, immediately inform your doctor.
• Allergic reactions to sulfonylureas, sulfonamides, or similar medicines may occur.
• At the beginning of treatment with Glimepiride Aurovitas, vision disorders may occur. These disorders are caused by changes in blood sugar levels and should quickly disappear.
• Increased liver enzyme activity.
• Severe bleeding or bruising under the skin.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, al. Jerozolimskie 181c, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glimepiride Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage of the medicinal product.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Glimepiride Aurovitas contains

• The active substance is glimepiride. One tablet contains 2 mg, 3 mg, or 4 mg of glimepiride.
• The other ingredients are: microcrystalline cellulose (PH-101), lactose monohydrate, povidone (K 25), sodium carboxymethylcellulose (type A), magnesium stearate.
• In addition, the tablets contain dyes:
• 3 mg tablets also contain yellow iron oxide (E 172),
• 4 mg tablets also contain indigo carmine, aluminum lake (E 132).

What Glimepiride Aurovitas looks like and contents of the pack

Tablet
Glimepiride Aurovitas, 2 mg, tablets:
White or almost white, flat, oblong, uncoated tablets with a dividing line. On one side, with the dividing line on both sides, the marking "Y" and "32" is embossed, the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas, 3 mg, tablets:
Light yellow tablets, flat, oblong, uncoated, with a dividing line. On one side, with the dividing line on both sides, the marking "Y" and "33" is embossed, the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas, 4 mg, tablets:
Light blue or almost blue, flat, oblong, uncoated tablets with a dividing line. On one side, with the dividing line on both sides, the marking "Y" and "34" is embossed, the other side is smooth. Dimensions: 10 mm x 5 mm. The tablet can be divided into equal doses.
Glimepiride Aurovitas tablets are available in PVC/PE/PVDC/Aluminum blisters and HDPE bottles with PP caps, in a cardboard box.
Packaging:
Blister:15, 30, 50, 60, 90, and 120 tablets.
HDPE bottle:500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa

Manufacturer/Importer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Glimepirid Aurovitas
Italy:
GLIMEPIRIDE AUROBINDO
Netherlands:
Glimepiride Aurobindo 1 mg/2 mg /3 mg /4 mg, tablets
Poland:
Glimepiride Aurovitas
Portugal:
Glimepirida Aurovitas
Spain:
GLIMEPIRIDA AUROVITAS 2 mg/ 4 mg tablets EFG

Date of last revision of the package leaflet: 05/2021