GLIMEPIRIDE 2 mg Coated Tablet

Содержание инструкции

1. Glimepiride Aurobindo 2 mg tablets, 3 mg tablets, 4 mg tablets
   1. What is Glimepiride Aurobindo and what is it used for
   2. What you need to know before taking Glimepiride Aurobindo
   3. How to take Glimepiride Aurobindo
   4. Possible side effects
   5. How to store Glimepiride Aurobindo
   6. Package contents and other information

Glimepiride Aurobindo 2 mg tablets, 3 mg tablets, 4 mg tablets

Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Glimepiride Aurobindo is an orally active medicine that lowers blood sugar levels. This
medicine belongs to a group of medicines that lower blood sugar levels called
sulfonylureas. Glimepiride Aurobindo works by increasing the amount of insulin released by the pancreas.
Insulin in turn reduces blood sugar levels.

What is Glimepiride Aurobindo used for:

• Glimepiride Aurobindo is used to treat a form of diabetes (type 2 diabetes mellitus) when diet, exercise and weight reduction alone are not sufficient to control blood sugar levels.

2. What you need to know before taking Glimepiride Aurobindo

Do not take Glimepiride Aurobindo and tell your doctor if:

• you are allergic to glimepiride or other sulfonylureas (medicines used to lower blood sugar levels such as glibenclamide) or to sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6);
• you have insulin-dependent diabetes (type 1 diabetes mellitus);
• you have diabetic ketoacidosis (a complication of diabetes in which the level of acid in the body is increased and you may experience some of the following signs: fatigue, feeling unwell (nausea), frequent need to urinate and muscle stiffness);
• you are in a diabetic coma;
• you suffer from a severe kidney disease;
• you suffer from a severe liver disease.

Do not take this medicine if any of these conditions apply to you. If you are unsure, ask your doctor or pharmacist
before taking Glimepiride Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Glimepiride Aurobindo if:

• you are recovering from any trauma, surgery, infection with fever, or other forms of stress; inform your doctor because it may be necessary to temporarily adjust the treatment;
• you suffer from a severe liver or kidney disease.

If you are not sure whether any of these conditions apply to you, ask your doctor or pharmacist before taking
Glimepiride Aurobindo.
In patients who lack the glucose-6-phosphate dehydrogenase enzyme, a decrease in
hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur.
Limited information is available on the use of Glimepiride Aurobindo in people under 18 years of age.
Therefore, use in these patients is not recommended.

Important information about hypoglycemia (low blood sugar levels)
When you take Glimepiride Aurobindo, you may experience hypoglycemia (low blood sugar levels). Read below
for more information about hypoglycemia, its symptoms and its treatment.

The following factors can increase the risk of hypoglycemia:

• you are not eating enough, eating at irregular times, skipping or delaying meals, or are on a period of fasting;
• you have changed your diet;
• you have taken more Glimepiride Aurobindo than necessary;
• you have decreased kidney function;
• you suffer from a severe liver disease;
• you suffer from particular hormone-induced disorders (thyroid, pituitary or adrenal cortex disorders);
• you drink alcohol (especially if you skip a meal);
• you are taking certain other medicines (see “Other medicines and Glimepiride Aurobindo”);
• if you are doing more exercise and not eating enough or eating foods that contain less carbohydrates than usual.

The signs of hypoglycemia include:

• hunger, headache, nausea, vomiting, weakness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disorders, slurred speech, tremor, partial paralysis, sensory disturbances, dizziness, weakness;
• you may also experience the following signs: sweating, clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to surrounding areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to fall, you may experience significant confusion (delirium), develop
convulsions, loss of self-control, breathing may become shallow and the heartbeat slowed, and you may
lose consciousness. The clinical course of a very low blood sugar level can resemble
that of a stroke.

Treatment of hypoglycemia
In many cases, the signs of low blood sugar levels disappear quickly when you
consume some forms of sugar, such as sugar cubes, fruit juices and sweetened tea.
Therefore, always carry some form of sugar with you (e.g. sugar cubes). Remember that
artificial sweeteners are not effective. Contact your doctor or go to hospital if taking sugar does not
help you or if the symptoms return.

Laboratory tests
You should regularly check your blood sugar or urine levels. Your doctor may also
prescribe blood tests to check blood cell levels and liver function.

Children and adolescents
The use of Glimepiride Aurobindo in children under 18 years of age is not recommended.

Other medicines and Glimepiride Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Your doctor may want to change your dose of Glimepiride Aurobindo if you are taking other medicines that
can decrease or increase the effects of Glimepiride Aurobindo on blood sugar levels.
The following medicines can increase the blood sugar-lowering effect of Glimepiride
Aurobindo. This can lead to a risk of hypoglycemia (low blood sugar level):

• other medicines used to treat diabetes mellitus (such as insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like drugs);
• medicines used to treat urinary tract infections (such as some long-acting sulfonamides);
• medicines used to treat infections caused by bacteria and fungi (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin);
• medicines used to inhibit blood clotting (coumarin derivatives such as warfarin);
• medicines used to promote muscle growth (anabolics);
• medicines used for hormone replacement therapy in men;
• medicines to treat depression (fluoxetine, MAO inhibitors);
• medicines that reduce high cholesterol levels (fibrates);
• medicines that reduce high blood pressure (ACE inhibitors);
• medicines called antiarrhythmic agents used to control irregular heartbeats (disopyramide);
• medicines to treat gout (allopurinol, probenecid, sulfinpyrazone);
• medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide);
• medicines used to reduce weight (fenfluramine);
• medicines to increase circulation when administered intravenously in high doses (pentoxifylline);
• medicines to treat nose allergies, such as hay fever (tritoqualine);
• medicines called sympatholytics used to treat high blood pressure, heart failure or prostate symptoms.

The following medicines can decrease the blood sugar-lowering effects of
Glimepiride Aurobindo. This can lead to a risk of hyperglycemia (high blood sugar levels):

• medicines that contain female sex hormones (estrogens, progestins);
• medicines used to help produce urine (thiazide diuretics);
• medicines used to stimulate the thyroid (such as levothyroxine);
• medicines used to treat allergies and inflammation (glucocorticoids);
• medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to increase the heartbeat, to treat asthma or nasal congestion, cough and cold, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics);
• medicines used to treat high cholesterol (nicotinic acid);
• medicines used to treat constipation if used for a long time (laxatives);
• medicines used to treat seizures (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 or low blood sugar (diazoxide);
• medicines used to treat infections and tuberculosis (rifampicin);
• medicines used to treat very low blood sugar levels (glucagon).

The following medicines can increase or decrease the blood sugar-lowering effects of
Glimepiride Aurobindo:

• medicines used to treat stomach ulcers (so-called anti-H2);
• medicines used to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanitidine and reserpine. These can also mask the symptoms of hypoglycemia, so particular attention is required when taking these medicines.

Glimepiride Aurobindo can increase or decrease the effects of the following medicines:

• medicines used to inhibit blood clotting (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Glimepiride
Aurobindo. To avoid this effect, it is recommended to take Glimepiride Aurobindo at least 4 hours before
colesevelam.

Glimepiride Aurobindo with food, drinks and alcohol
Drinking alcohol can increase or decrease the blood sugar-lowering effects of
Glimepiride Aurobindo in an unpredictable way.

Pregnancy, breastfeeding and fertility
Pregnancy
Glimepiride Aurobindo should not be taken during pregnancy. If you are pregnant, suspect
you may be pregnant, or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Breastfeeding
Glimepiride Aurobindo can pass into breast milk. Glimepiride Aurobindo should not be taken if you are
breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Your ability to concentrate or react may be impaired if your blood sugar levels
are low (hypoglycemia) or high (hyperglycemia), or if you develop vision problems as a result of these
conditions. Keep in mind that you may pose a risk to yourself and others (e.g.
driving vehicles or using machinery). Ask your doctor if you can drive if:

• you have frequent attacks of hypoglycemia,
• you have few or no warning signs of hypoglycemia.

Glimepiride Aurobindo contains lactose. If you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Glimepiride Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.

How to take this medicine

• Take this medicine by mouth, immediately before or during the first main meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine at the time prescribed by your doctor. It is important not to skip any meals when taking Glimepiride Aurobindo.
• Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.

Each tablet can be divided into equal doses.

How much medicine to take
The dose of Glimepiride Aurobindo depends on your needs, condition and results of blood and urine sugar
tests and is established by the doctor. Do not take more tablets than those prescribed by your doctor.

• The recommended initial dose of Glimepiride Aurobindo is one 1 mg tablet once a day.
• If necessary, your doctor may increase the dose after each 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of Glimepiride Aurobindo per day.
• A combination therapy of glimepiride and metformin or glimepiride and insulin may be started. In this case, the doctor will establish the appropriate dose of glimepiride, metformin or insulin specific for you.
• If your weight changes or you modify your lifestyle, or are in a stressful situation, a change in the doses of Glimepiride Aurobindo may be necessary, so inform your doctor.
• If you feel that the effects of the medicine are too weak or too strong, do not change the dose yourself, but consult your doctor.

If you take more Glimepiride Aurobindo than you should
If you happen to have taken an excessive amount of Glimepiride Aurobindo or you have taken an extra dose, there is a
risk of hypoglycemia (for the signs of hypoglycemia see paragraph 2 – Warnings and
precautions) and therefore you should immediately take a sufficient amount of sugar (e.g. a small sugar cube, fruit juice or sweetened tea) and inform your doctor immediately. If you are treating
hypoglycemia due to accidental intake in children, the amount of sugar administered must be
carefully monitored to avoid producing dangerous hyperglycemia. People in a state of
unconsciousness should not be given food or drinks.
Since the state of hypoglycemia can last for a certain period of time, it is very important that the patient
is carefully monitored until there is no longer any danger. Hospitalization may be necessary, even as a precautionary measure. Show your doctor the box or the remaining tablets,
so that the doctor can see what has been taken.
Severe cases of hypoglycemia with loss of consciousness and severe neurological insufficiency are medical emergencies
that require immediate medical treatment and hospitalization. You should ensure that there is always an informed person who can call the doctor in case of emergency.

If you forget to take Glimepiride Aurobindo
If you have forgotten to take a dose, do not take a double dose to make up for the missed dose.

If you stop taking Glimepiride Aurobindo
If you stop or discontinue treatment, you should know that you will not obtain the desired effect of decreasing blood
sugar levels and that the disease will worsen again. Continue taking Glimepiride
Aurobindo until your doctor tells you to stop.
If you have any doubts 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.
manifest.

Immediately inform your doctor if any of the following symptoms occur:

• allergic reactions (including inflammation of the blood vessels, often with skin rash) which can become a serious reaction with difficulty breathing, low blood pressure and sometimes progressing to shock;
• abnormal liver function including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure;
• skin allergy (hypersensitivity) such as itching, rash, hives and increased sensitivity to the sun. Some mild allergic reactions can become serious reactions;
• severe hypoglycemia with loss of consciousness, convulsions or coma.

Some patients have experienced the following adverse events while taking Glimepiride Aurobindo:

Rare undesirable effects(may affect up to 1 in 1,000 people)

• lower than normal blood sugar (hypoglycemia) (see section 2 - Warnings and precautions);
• decreased number of blood cells:
• platelets (which increases the risk of bleeding or bruising),
• white blood cells (which increases the risk of infections),
• red blood cells (which can make the skin pale and cause weakness and shortness of breath). These problems generally improve after stopping Glimepiride Aurobindo;
• weight gain;
• hair loss;
• altered sense of taste.

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

• allergic reactions (including inflammation of the blood vessels, often with skin rash) which can become a serious reaction with difficulty breathing, low blood pressure and sometimes progressing to shock. If any of these symptoms occur, immediately inform your doctor;
• abnormal liver function including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If any of these symptoms occur, immediately inform your doctor;
• nausea or vomiting, diarrhea, feeling of fullness or bloating, and abdominal pain;
• decreased levels of sodium in the blood (highlighted by blood tests).

Undesirable effects with unknown frequency(frequency cannot be estimated on the basis of the available data) :

• skin allergy (hypersensitivity) such as itching, rash, hives and increased sensitivity to the sun. Some mild allergic reactions can become serious with difficulty swallowing or breathing, swelling of the lips, throat or tongue. Therefore, if any of these side effects occur, immediately inform your doctor;
• allergic reactions may occur with sulfonylureas, sulfonamides or related medicines;
• at the beginning of treatment with Glimepiride Aurobindo, vision problems may occur. This is due to the change in blood sugar levels, and should improve shortly;
• increased liver enzymes;
• severe unusual bleeding or bruising under the skin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Glimepiride Aurobindo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, on the carton and on the bottle
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Glimepiride Aurobindo if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Glimepiride Aurobindo contains
The active ingredient is glimepiride. Each tablet contains 2 mg/3 mg/4 mg of glimepiride.

• Other ingredients are: microcrystalline cellulose, lactose monohydrate, povidone (K 25), sodium starch glycolate, magnesium stearate.
• Also, the tablets contain coloring agents:
• 3 mg tablets contain yellow iron oxide (E172)
• 4 mg tablets contain indigo carmine aluminum lake (E132)

Description of the appearance of Glimepiride Aurobindo and package contents
Tablet.
Glimepiride Aurobindo 2 mg tablets:
Tablets from white to almost white, flat, oblong, uncoated with dented sides with a double line
of incision, with “Y” and “32” imprinted on either side of the incision line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo 3 mg tablets:
Light yellow tablets, flat, oblong, uncoated with dented sides with a double line
of incision, with “Y” and “33” imprinted on either side of the incision line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo 4 mg tablets:
Tablets from sky blue to blue, flat, oblong, uncoated with dented sides with a double line
of incision, with “Y” and “34” imprinted on either side of the incision line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo tablets are available in blister packs and in HDPE bottles with a
polypropylene closure.

Packs:

Blister packs: 15, 30, 50, 60, 90 and 120 tablets.

HDPE bottle pack: 500 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia
BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip
HA4 6QD
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
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 comprimidos EFG