Package Leaflet: Information for the User

Glimepiride STADA 4 mgTablets EFG

Read this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Glimepirida is an oral medication used to reduce blood sugar levels. This medication belongs to a group of medications for reducing blood sugar levels known as sulfonylureas. Glimepirida acts by increasing the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What Glimepirida is used for:

•Glimepirida is used for the treatment of a certain type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction alone are not sufficient to control blood sugar levels.

Do not take glimepiride:

• if you are allergic to glimepiride, other sulfonylureas (medications used to reduce blood sugar, such as glibenclamide) or sulfonamides (medications used in bacterial infections, such as sulfamethoxazole) or any of the other components of this medication (listed in Section 6)
• if you have insulin-dependent diabetes (type 1 diabetes)
• if you have ketoacidosis (a complication of diabetes with any of the following symptoms: fatigue, nausea, frequent urination, and muscle stiffness)
• if you have diabetic coma
• if you have severe kidney damage
• if you have severe liver damage

Do not take this medication if you have any of the conditions described above. If you are unsure, consult your doctor or pharmacist before taking glimepiride.

Warnings and precautions

Consult your doctor or pharmacist before starting to take glimepiride:

• if you are recovering from any injury, surgery, infection with fever, or other forms of stress, inform your doctor as it may be necessary to temporarily change your treatment.
• if you have severe liver or kidney damage.

If you are unsure whether you have any of these conditions, consult your doctor or pharmacist before taking glimepiride.

A reduction in hemoglobin levels and red blood cell rupture (hemolytic anemia) may occur in patients with glucose-6-phosphate dehydrogenase deficiency.

Children and adolescents

The available information on the use of glimepiride in patients under 18 years is limited. Therefore, its use in these patients is not recommended.

Important information about hypoglycemia (low blood sugar)

When taking glimepiride, you may experience hypoglycemia (low blood sugar). See below for additional information on hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• malnutrition, irregular meal times, not eating or delaying a meal or fasting periods
• changes in diet
• taking too much glimepiride
• reduced liver function
• severe liver damage
• hormone-induced alterations (thyroid, pituitary, or adrenal cortex)
• drinking alcohol (especially skipping a meal)
• taking certain medications (see "Glimepiride with other medications")
• exercising more and not eating enough or consuming fewer carbohydrates than normal

Symptoms of hypoglycemia include:

• hunger, headache, nausea, vomiting, inactivity, numbness, sleep disturbances, fatigue, irritability, decreased concentration. Reduced alertness and reaction time, depression, confusion, visual and speech disturbances, difficulty speaking, agitation, partial paralysis, sensory disturbances, dizziness, feeling of uselessness.
• The following symptoms may also occur: sweating, cold and moist skin, anxiety, rapid heartbeat, elevated blood pressure, palpitations, severe chest pain that may radiate to nearby areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to drop, you may experience significant confusion (delirium), develop seizures, lose control, have shallow breathing, and slower heart rate, potentially leading to unconsciousness. The clinical picture of severe blood sugar reduction may resemble a stroke.

Treatment of hypoglycemia:

In most cases, hypoglycemia symptoms disappear quickly after consuming any type of sugar, e.g., sugar cubes, juices, tea with sugar.

You should carry any type of sugar (e.g., sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or go to the hospital if taking sugar does not help or if symptoms recur.

Laboratory tests

Blood sugar levels and urine should be regularly monitored. Your doctor will also perform blood tests to check your blood cell counts and liver function.

Glimepiride with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may modify your glimepiride dose if you take other medications, which may weaken or enhance glimepiride's effect on blood sugar levels.

The following medications may increase glimepiride's blood sugar-lowering effect, potentially leading to hypoglycemia (low blood sugar):

• other diabetes medications (such as insulin or metformin)
• medications for pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone, and similar medications to aspirin)
• medications for urinary tract infections (such as some long-acting sulfonamides)
• medications for fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• medications to prevent blood clotting (cumarinic derivatives such as warfarin)
• anabolic steroids
• medications used as hormone replacement therapy
• medications for depression (fluoxetine, MAO inhibitors)
• medications to lower elevated cholesterol levels (fibrates)
• medications to lower high blood pressure (ACE inhibitors)
• medications called antiarrhythmics used to control abnormal heart rhythm (disopyramide)
• medications for gout treatment (allopurinol, probenecid, sulfinpyrazone)
• medications for cancer treatment (cyclophosphamide, ifosfamide, trophosphamide)
• medications for weight loss (fenfluramine)
• medications to increase circulation when administered at high doses by intravenous infusion (pentoxifylline)
• medications for allergic rhinitis such as hay fever (tritoqualine)
• medications called sympatholytics for high blood pressure, heart failure, or prostatic symptoms

The following medications may reduce glimepiride's blood sugar-lowering effect, potentially leading to hyperglycemia (high blood sugar):

• medications containing female sex hormones (estrogens and progestogens)
• diuretics (thiazides)
• medications used to stimulate the thyroid gland (such as levothyroxine)
• glucocorticoids
• medications for severe mental disorders (chlorpromazine and other phenothiazine derivatives)
• medications to increase heart rate, for asthma or congestion, cough, and chills, used for weight loss, or in emergency situations that put the patient's life at risk (adrenaline and sympathomimetics)
• medications to lower elevated cholesterol levels (nicotinic acid)
• medications for constipation when used long-term (laxatives)
• medications for seizures (phenytoin)
• medications for nervousness and sleep disorders (barbiturates)
• medications for high eye pressure (acetazolamide)
• medications for high blood pressure or to lower blood sugar levels (diazoxide)
• medications for infections, tuberculosis (rifampicin)
• medications to lower severe blood sugar levels (glucagon)

The following medications may increase or decrease glimepiride's blood sugar-lowering effect:

• medications for stomach ulcers (H2 antagonists)
• medications for high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. They may also mask hypoglycemia symptoms, so special care should be taken when administering these medications

Glimepiride may increase or decrease the effect of the following medications:

• medications to prevent blood clotting (cumarinic derivatives such as warfarin)

Glimepiride with food, drinks, and alcohol

Consuming alcohol may unpredictably increase or decrease glimepiride's blood sugar-lowering effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take glimepiride during pregnancy. Inform your doctor if you are or may be pregnant, or if you plan to become pregnant.

Breastfeeding

Glimepiride may pass into breast milk. Do not take glimepiride during breastfeeding.

Driving and operating machinery

You should be aware that your alertness and reaction time may be impaired due to hypoglycemia or hyperglycemia (low or high blood sugar) or if you experience visual disturbances as a result of these states. Be aware that you may put yourself or others at risk (e.g., while driving or operating machinery). Consult your doctor if you can drive in cases of:

• having frequent episodes of hypoglycemia.
• having fever or no warning signs of hypoglycemia.

Glimepiride Stada 4 mg contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

The dose of glimepiride depends on your needs, condition, and blood and urine test results, and is established by your doctor. Do not take more tablets than your doctor has indicated:

• The initial recommended dose is 1 mg of glimepiride per day orally.
• Your doctor may increase the dose as needed, every 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• A combined therapy of glimepiride and metformin or glimepiride and insulin may be initiated. In this case, your doctor will determine the individualized dose of glimepiride, metformin, or insulin for you.
• If you change your weight or lifestyle, or if you are under stress, it may be necessary to adjust the dose of glimepiride. Inform your doctor in this case.

Administration form

• Take this medication orally, just before or with the first main meal of the day (usually breakfast). If you do not take breakfast, take the medication at the same time every day as indicated by your doctor. It is essential not to skip any meals while taking glimepiride.
• Swallow the tablets whole with at least half a glass of water. Do not crush or chew the tablets.

If you take more glimepiride than you should

If you take too much glimepiride or an additional dose, there is a risk of hypoglycemia (see section 2 for hypoglycemia symptoms) and you should take immediately sufficient sugar (e.g., a sugar cube, juice, tea with sugar) and inform your doctor immediately. When treating accidental hypoglycemia in children, the amount of sugar administered must be carefully controlled to avoid the risk of causing a potentially dangerous hyperglycemia. Do not administer food or drinks to people who are unconscious.

Since hypoglycemia can last for some time, it is very important that the patient be carefully monitored until there is no longer a risk. Hospitalization may be necessary as a precaution. Show the doctor the packaging or remaining tablets so that he knows what the patient has ingested.

Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological insufficiency are emergency cases that require immediate medical treatment and hospitalization. Ensure that there are always informed people who can call a doctor in case of an emergency.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take glimepiride

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with glimepiride

If you interrupt the treatment, you will not achieve the desired effect of reducing blood sugar or your disease will worsen again. Continue taking glimepiride until your doctor tells you to stop.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,glimepiridemay cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following symptoms:

• allergic reactions (including inflammation of blood vessels, often with skin rash) that can transform into severe reactions with difficulty breathing, low blood pressure, and in some cases, shock.
• abnormal liver function, including yellow skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• skin allergy (hypersensitivity) such as itching, rash, urticaria, and increased sensitivity to the sun. Some mild allergic reactions can evolve into severe reactions.
• severe hypoglycemia, including loss of consciousness, seizures, or coma.

Some patients experience the following adverse reactions when taking glimepiride:

Rare(may affect up to 1 in 1,000 patients)

• blood sugar levels below normal (hypoglycemia) (see section 2 “Warnings and precautions”)
• decrease in the number of blood cells:
• • platelets (which increases the risk of bleeding or bruising).
  • white blood cells (which facilitates infections).
  • red blood cells (which may cause pale skin and weakness or shortness of breath).

These reactions generally disappear when treatment with glimepiride is discontinued.

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

• allergic reactions (including inflammation of blood vessels, often with skin rash) that can transform into severe reactions with difficulty breathing, low blood pressure, and in some cases, shock. If you experience any of these symptoms,inform your doctor immediately
• abnormal liver function, including yellow skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms,inform your doctor immediately
• nausea, diarrhea, feeling bloated, and abdominal pain
• reduction in sodium levels in the blood (detectable in blood tests)

Frequency not known(cannot be estimated from available data)

• skin allergy (hypersensitivity) such as itching, rash, urticaria, and increased sensitivity to the sun. Some mild allergic reactions can evolve into severe reactions with difficulty swallowing or breathing, swelling in the lips, throat, or tongue. In case of any of these adverse reactions,inform your doctor immediately
• may experience allergic reactions with sulfonilureas, sulfonamides, or related medications
• may experience vision problems when starting treatment with glimepiride. This is due to changes in blood sugar levels and should improve quickly
• increased liver enzymes
• severe decrease in platelets in the blood and abnormal bleeding or bruising under the skin.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30.ºC.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment

Composition of Glimepiride Stada 4 mg

The active ingredient is glimepiride.

Each tablet contains 4 mg of glimepiride.

The other components are lactose monohydrate, sodium glycolate starch type A, magnesium stearate, microcrystalline cellulose, povidone K 29-32, indigo carmine (E-132).

Appearance of the product and contents of the package

Glimepiride Stada 4 mg tablets are blue, flat, oval, 10x5 mm tablets with beveled edges, scored on one side and with a "G" engraved on the other.

If you need a dose corresponding to half a tablet, it can be split on a hard surface with the score facing up. Apply pressure from above with your thumb and with a small spatula divide it into two equal halves.

Glimepiride Stada is presented in PVC/Al blisters.

The packages of Glimepiride Stada 4 mg tablets contain 10, 20, 30, 50, 60, 90, 118, 120, 180, and 195 tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastr. 2 – 18

61118 Bad Vilbel (Germany)

or

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

or

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

or

KeVaRo Group EOOD

9 Tsaritsa Eleonora Str., Office #23

Krasno Selo Administrative District

1618 Sofia

Bulgaria

This medicine is authorized in the member states of the European Economic Area with the following names:

DenmarkGlimepirid Stada 1mg/2mg/3mg/4mg tablets

SpainGlimepiride STADA 2 mg/4 mg tablets EFG

GermanyGlimepirid STADA 1mg/2mg/3mg/4mg/6mg Tablets

SwedenGlimepirid Stada 1mg/2mg/3mg/4mg tablets

FranceGlimepirid EG 1mg/2mg/3mg/4mg/6mg tablet

Last review date of this leaflet:August 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/