GLIMEPIRIDA STADA 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Glimepiride STADA 4 mgEFG Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Glimepiride Stada and what is it used for
2. What you need to know before taking Glimepiride Stada
3. How to take Glimepiride Stada
4. Possible side effects
5. Storage of Glimepiride Stada
6. Package Contents and Additional Information

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

Glimepiride is an orally administered medication used to reduce blood sugar levels. This medication belongs to a group of medications for reducing blood sugar levels called sulfonylureas. Glimepiride works by increasing the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What glimepiride is used for:

• Glimepiride is used to treat 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.

2. What you need to know before taking Glimepiride Stada

Do not take glimepiride:

• if you are allergic to glimepiride, other sulfonylureas (medications used to reduce blood sugar levels, 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 mellitus)
• if you suffer from ketoacidosis (a complication of diabetes with some of the following symptoms: 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 medication if you have any of the above conditions. 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 an injury, surgery, infection with fever, or other forms of stress, inform your doctor, as a temporary change in treatment may be necessary.
• if you have severe liver or kidney problems.

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 rupture of red blood cells (hemolytic anemia) may occur in patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Children and Adolescents

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

Important Information on Hypoglycemia (Low Blood Sugar Levels)

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

The following factors can increase the risk of hypoglycemia:

• malnutrition, irregular meal schedule, skipping meals or delaying a meal, or periods of fasting
• changes in diet
• taking more glimepiride than necessary
• having reduced liver function
• having severe liver problems
• suffering from hormone-induced disorders (thyroid, pituitary, or adrenal cortex disorders)
• consuming alcohol (especially when skipping a meal)
• taking certain medications (see "Taking glimepiride with other medications")
• if you engage in more exercise and do not eat enough or consume foods with fewer carbohydrates than usual

Signs of hypoglycemia include:

• feeling hungry, headache, nausea, vomiting, inactivity, numbness, sleep disturbances, fatigue, aggression, 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 signs may also appear: sweating, cold and moist skin, anxiety, rapid heart palpitations, high blood pressure, palpitations, severe chest pain that may radiate to nearby areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to decrease, you may experience significant confusion (delirium), develop convulsions, loss of control, shallow breathing, and slower heartbeats, potentially leading to unconsciousness. The clinical picture of a severe reduction in blood sugar levels may resemble a stroke.

Treatment of Hypoglycemia:

In most cases, the signs of low blood sugar disappear quickly after consuming any type of sugar, e.g., sugar cubes, juice, tea with sugar.

You should, therefore, always carry some 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 or urine levels should be regularly monitored. Your doctor will also perform blood tests to monitor your blood cell counts and liver function.

Taking Glimepiride with Other Medications

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

Your doctor may adjust your glimepiride dose if you are taking other medications, which may weaken or increase the effect of glimepiride on blood sugar levels.

The following medications may increase the blood sugar-reducing effect of glimepiride. This may cause a risk of hypoglycemia (low blood sugar levels):

• other medications for the treatment of diabetes mellitus (such as insulin or metformin)
• medications for the treatment of pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, and medications similar to aspirin)
• medications for the treatment of urinary tract infections (such as some long-acting sulfonamides)
• medications for the treatment of fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• medications to prevent blood clots (coumarin derivatives such as warfarin)
• medications to increase muscle mass (anabolic agents)
• medications used as hormone replacement therapy for male sex hormones
• medications for the treatment of depression (fluoxetine, MAO inhibitors)
• medications to reduce high cholesterol levels (fibrates)
• medications to reduce high blood pressure (ACE inhibitors)
• medications called antiarrhythmics used to control abnormal heart rhythm (disopyramide)
• medications for the treatment of gout (allopurinol, probenecid, sulfinpyrazone)
• medications for the treatment of cancer (cyclophosphamide, ifosfamide, trofosfamide)
• medications for weight loss (fenfluramine)
• medications to improve circulation when administered at high doses by intravenous infusion (pentoxifylline)
• medications for the treatment of nasal allergies such as hay fever (tritoqualine)
• medications called sympatholytics for the treatment of high blood pressure, heart failure, or prostate symptoms

The following medications may reduce the blood sugar-reducing effect of glimepiride. This may cause a risk of hyperglycemia (high blood sugar levels):

• medications containing female sex hormones (estrogens and progestogens)
• medications to facilitate urine production (thiazide diuretics)
• medications used to stimulate the thyroid gland (such as levothyroxine)
• medications for the treatment of allergies and inflammation (glucocorticoids)
• medications for the treatment of severe mental disorders (chlorpromazine and other phenothiazine derivatives)
• medications to increase heart rate, for the treatment of asthma or nasal congestion, cough, and colds, used for weight loss, or in life-threatening emergencies (adrenaline and sympathomimetics)
• medications to reduce high cholesterol levels (nicotinic acid)
• medications for the treatment of constipation when used long-term (laxatives)
• medications for the treatment of seizures (phenytoin)
• medications for the treatment of nervousness and sleep problems (barbiturates)
• medications for the treatment of high eye pressure (acetazolamide)
• medications for the treatment of high blood pressure or to reduce blood sugar levels (diazoxide)
• medications for the treatment of infections, tuberculosis (rifampicin)
• medications for the treatment of severe low blood sugar levels (glucagon)

The following medications may increase or reduce the blood sugar-reducing effect of glimepiride:

• medications for the treatment of stomach ulcers (called H2 antagonists)
• medications for the treatment of high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These medications may also mask the symptoms of hypoglycemia, so caution is advised when administering these medications

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

• medications to prevent blood clots (coumarin derivatives such as warfarin).

Taking Glimepiride with Food, Drinks, and Alcohol

Consuming alcohol may increase or reduce the blood sugar-reducing effect of glimepiride in an unpredictable manner.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 Using Machines

You should be aware that your alertness and reaction time may be impaired due to hypoglycemia or hyperglycemia (decrease or increase in blood sugar levels) or if you experience visual disturbances as a result of these conditions. Be aware that you may put yourself or others at risk (e.g., when driving or using machines). Consult your doctor if you can drive in case of:

• Frequent episodes of hypoglycemia.
• Having a fever or not having warning signs in case of hypoglycemia.

Glimepiride Stada 4 mg contains lactose and sodium

If your doctor has told you 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; this is essentially "sodium-free".

3. How to Take Glimepiride Stada

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 determined 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.
• If necessary, your doctor may increase the dose every 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• Combination therapy with glimepiride and metformin or glimepiride and insulin may be initiated. In this case, your doctor will determine the appropriate dose of glimepiride, metformin, or insulin for you individually.
• If you change your weight or lifestyle, or if you are under stress, it may be necessary to adjust the dose of glimepiride. In this case, inform your doctor.

Method of Administration

• Take this medication orally, immediately before or with the first main meal of the day (usually breakfast). If you do not eat breakfast, take the medication at the same time every day, as indicated by your doctor. It is essential not to skip any meals when 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 symptoms of hypoglycemia) and you should take sugar immediately (e.g., a sugar cube, juice, tea with sugar) and inform your doctor immediately. When treating accidental ingestion in children, the amount of sugar administered should be carefully controlled to avoid the possibility of causing dangerous hyperglycemia. Do not give food or drinks to unconscious persons.

Since the state of hypoglycemia can last for some time, it is very important that the patient is carefully monitored until there is no danger. Hospitalization may be necessary as a precaution. Show the doctor the package or remaining tablets, so they know what the patient has ingested.

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

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

If you forget to take glimepiride

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with glimepiride

If you interrupt treatment, the desired blood sugar-reducing effect will not be achieved, or your condition may worsen again. Continue taking glimepiride until your doctor tells you that you can stop.

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

4. Possible Adverse Effects

Like all medicines, glimepiride can cause adverse effects, although not all people suffer from them.

Tell 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, drop in blood pressure, and occasionally shock.
• Abnormal liver function, including yellowish skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• Skin allergy (hypersensitivity) such as itching, rash, hives, 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 makes infections easier).
  • Red blood cells (which can cause pale skin and weakness or shortness of breath).

These reactions usually 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, drop in blood pressure, and occasionally shock. If you experience any of these symptoms, tell your doctor immediately
• Abnormal liver function, including yellowish skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms, tell your doctor immediately
• Nausea, diarrhea, feeling bloated, and abdominal pain
• Decrease in blood sodium levels (appreciable in blood tests)

Frequency Not Known(cannot be estimated from available data)

• Skin allergy (hypersensitivity) such as itching, rash, hives, and increased sensitivity to the sun. Some mild allergic reactions can evolve into severe reactions with difficulty swallowing or breathing, swelling of the lips, throat, or tongue. If you experience any of these adverse reactions, tell your doctor immediately
• May appear allergic reactions to sulfonylureas, 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 blood platelets and abnormal bleeding or bruising under the skin.

Reporting 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Glimepirida Stada

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medicine 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 thrown down the drain or into the trash. Deposit the packaging and unused medicines at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Glimepirida 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, carmine indigo (E-132).

Appearance of the Product and Package Contents

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

In case 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.

Glimepirida Stada is presented in PVC/Al blisters.

The packaging of Glimepirida Stada 4 mg tablets contains 10, 20, 30, 50, 60, 90, 118, 120, 180, and 195 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

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:

Denmark Glimepirid Stada 1mg/2mg/3mg/4mg tablets

Spain Glimepirida STADA 2 mg/4 mg EFG tablets

Germany Glimepirid STADA 1mg/2mg/3mg/4mg/6mg tablets

Sweden Glimepirid Stada 1mg/2mg/3mg/4mg tablets

France Glimepirid EG 1mg/2mg/3mg/4mg/6mg tablets

Date of the Last Revision of this Prospectus:August 2019

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