GLIMEPIRIDE 3 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Glimepiride Aurovitas, 2 mg, tablets
3. Glimepiride Aurovitas, 3 mg, tablets
4. Glimepiride Aurovitas, 4 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the 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, you should discuss it with your doctor or pharmacist if:
   4. Important information about hypoglycemia (low blood sugar)
   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. Administration
   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. You should immediately consult your doctor if you experience any of 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 leaflet: 05/2021

Leaflet accompanying the packaging: information for the user

Glimepiride Aurovitas, 2 mg, tablets

Glimepiride Aurovitas, 3 mg, tablets

Glimepiride Aurovitas, 4 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.
• If you have any further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the 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 reduces blood sugar levels.
It belongs to a group of medicines that reduce blood sugar levels, called sulfonylureas. The action of Glimepiride Aurovitas is to increase the amount of insulin released by the pancreas. Insulin reduces 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 cannot 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 reduce 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 tiredness, 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.

You should not take this medicine if you have any of the above conditions. If you are unsure, you should consult your doctor or pharmacist before taking Glimepiride Aurovitas.

Warnings and precautions

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

• you have had an injury, operation, infection with fever, or other stressful situation; you should inform your doctor, as a temporary change in treatment may be necessary
• you have liver or kidney problems.

If you are unsure, you should consult your doctor or pharmacist before taking Glimepiride Aurovitas.
In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, 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.
The use of this medicine is not recommended in this age group.

Important information about hypoglycemia (low blood sugar)

While taking Glimepiride Aurovitas, 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:

• dislike (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),
• consumption of alcohol, especially when skipping meals,
• concomitant use of 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 disturbances, 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), seizures, loss of self-control, shallow breathing, and slow heart rate, and may lead to loss of consciousness, including coma. Low blood sugar can cause symptoms similar to a stroke.

Treatment of hypoglycemia:

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

Laboratory tests

You should 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

You should tell your doctor or pharmacist about all medicines you are currently 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):

• other diabetes 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 (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 supplement male sex hormones,
• 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 arrhythmias (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):

• medicines containing female sex hormones (estrogens, progestogens),
• diuretic medicines (thiazide diuretics),
• medicines that stimulate the thyroid gland (e.g. levothyroxine),
• medicines used to treat allergies and inflammation (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, reduce weight, or used 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 (diazoxide),
• medicines used to treat infections, tuberculosis (rifampicin),
• medicines used to treat life-threatening low blood sugar (glucagon).

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

• medicines used to treat stomach ulcers (called 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:

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

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

Glimepiride Aurovitas with food, drink, and alcohol

Consuming alcohol may enhance or weaken the effect of Glimepiride Aurovitas in an unpredictable way.

Pregnancy, breastfeeding, and fertility

Pregnancy

Glimepiride Aurovitas should not be taken during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Breastfeeding

Glimepiride Aurovitas may pass into breast milk.
You should consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Your ability to concentrate or react quickly may be impaired due to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). You should be aware that this may put you or others at risk (e.g. when driving or operating machinery). Patients should consult their doctor whether they can drive or operate machinery, if:

• they often experience hypoglycemia,
• the warning symptoms of hypoglycemia are weakened or do not occur.

Glimepiride Aurovitas contains lactose

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

Glimepiride Aurovitas contains sodium

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

3. How to take Glimepiride Aurovitas

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Administration

The medicine should be taken orally, immediately before or during the first meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine as advised by your doctor.
It is important not to skip meals if you are taking Glimepiride Aurovitas.
The tablet should be swallowed without chewing or crushing, washed down 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 tests, and is determined by your doctor. You should not take more tablets than prescribed by your doctor.

• The initial dose is one Glimepiride Aurovitas tablet - 1 mg once a 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 prescribe the appropriate, individually determined doses of glimepiride with metformin or insulin.
• If you experience changes in weight, lifestyle, or are under stress, you should 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, you should not change the dose yourself, you should 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 there is a risk of hypoglycemia (hypoglycemia symptoms see section 2. Warnings and precautions). In this case, you should immediately consume a sufficient amount of sugar (e.g. sugar cubes, sweet juice, sweetened tea) and inform your doctor as soon as possible. If a child has accidentally taken the medicine, the amount of sugar given to them should be controlled to avoid the risk of hyperglycemia. Unconscious persons 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. You should show your doctor the packaging 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. You should make sure that someone who is informed in advance is always nearby, who can call a doctor in emergency situations.

Missing a dose of Glimepiride Aurovitas

You should 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. You should take Glimepiride Aurovitas for as long as your doctor has prescribed.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should immediately consult your doctor if you experience any of 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, manifested by itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions can develop into severe reactions with swallowing or breathing difficulties, and swelling of the lips, throat, or tongue.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

In some patients taking Glimepiride Aurovitas, the following side effects have occurred:
Rare(may occur in up to 1 in 100 patients)

• 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 likelihood 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 occur in up to 1 in 10,000 patients)

• 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, you should immediately consult your doctor.
• Abnormal liver function, manifested by yellowing of the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, you should immediately consult 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 with itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions can develop into severe reactions with swallowing or breathing difficulties, and swelling of the lips, throat, or tongue. If you experience any of these symptoms, you should immediately consult your doctor.
• Allergic reactions to sulfonylureas, sulfonamides, or similar medicines may occur.
• At the beginning of treatment with Glimepiride Aurovitas, vision disturbances may occur. These disturbances 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 any not listed in this leaflet, you should 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glimepiride Aurovitas

The medicine should be stored out of the sight and reach of children.
You should not take 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.
You should not take this medicine if it shows signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Glimepiride Aurovitas contains

• The active substance of the medicine 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 also contain yellow iron oxide (E 172),
• 4 mg 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, with a dividing line. On one side, on both sides of the dividing line, 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, flat, oblong, uncoated, with a dividing line. On one side, on both sides of the dividing line, 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, with a dividing line. On one side, on both sides of the dividing line, 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 Warsaw

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 leaflet: 05/2021