Leaflet: information for the user

Glimepiride Teva 4 mg tablets EFG

glimepiride

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others,

even if they have the same symptoms as you, 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.

1. What is Glimepiride Teva 4 mg tablets and what it is used for

2. What you need to know before you start taking Glimepiride Teva 4 mg tablets

3. How to take Glimepiride Teva 4 mg tablets

4. Possible side effects

5. Storage of Glimepiride Teva 4 mg tablets

6. Contents of the pack and additional information

Glimepirida Teva is a medication that lowers blood sugar levels, taken orally. This medication belongs to a group of medications that lower blood sugar levels called sulfonylureas. Glimepirida Teva increases the amount of insulin released by your pancreas. Insulin lowers your blood sugar levels.

What Glimepirida Teva 4 mg tablets are used for:

- Glimepirida Teva is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction have not been able to control your blood sugar levels.

Do not take Glimepiride Teva 4 mg tablets

• You are allergic to Glimepiride or other sulfonylureas (medicines used to lower your blood sugar levels such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or to any of the other components of this medicine (listed in section 6).
• You have diabetes mellitus type 1.
• You have diabetic ketoacidosis (a complication of diabetes when your body's acid levels rise and you may have some of the following symptoms: fatigue, dizziness, frequent urination, and muscle stiffness).You are experiencing a diabetic coma.
• You have a severe kidney disease.
• You have a severe liver disease.

Do not take this medicine if any of the above circumstances affect you. If you are unsure, consult your doctor or pharmacist before taking Glimepiride Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glimepiride Teva if:

- You are recovering from an illness, operation, infection with fever, or other forms of stress. Inform your doctor as it may be necessary to make some changes to your treatment.

- You have a severe alteration in the liver or kidneys.

If you are unsure if anything mentioned above affects you, consult your doctor or pharmacist before taking Glimepiride Teva.

You may experience a decrease in hemoglobin levels and a rupture of red blood cells (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphatase.

Important information about hypoglycemia (low blood sugar)

If you are taking Glimepiride Teva, you may have hypoglycemia (low blood sugar). Please see below for more information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of you suffering hypoglycemia:

• Malnutrition, irregular meal times, omission or delay of meals, or fasting periods
• Changes in your diet
• You take more Glimepiride Teva than you need
• You have decreased renal function
• You have severe liver disease
• You have any other hormonal disease (such as thyroid problems, pituitary gland problems, or adrenal cortex problems)
• You consume alcohol (especially if you skip a meal)
• You take certain medications (see 'Taking Glimepiride Teva with other medicines')
• You increase your physical exercise and do not eat enough or take foods with fewer carbohydrates than normal.

The symptoms of hypoglycemia include:

• Empty stomach sensation, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness, and altered reaction time, depression, confusion, speech disturbances, and visual disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, feeling of abandonment.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heart rate, high blood pressure, palpitations, sudden chest pain that may radiate to adjacent areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to fall, you may experience severe confusion (delirium), seizures, loss of self-control, rapid breathing, and decreased heart rate, leading to unconsciousness. The clinical picture of excessive blood sugar lowering may resemble a stroke.

Treatment of hypoglycemia:

In most cases, the symptoms of low blood sugar disappear quickly after consuming sugar, e.g. sugar cubes, sugary drinks, or sweet tea.

You should always carry a small amount of sugar (e.g. sugar cubes) with you. Remember that artificial sweeteners are not effective. If sugar intake does not help or symptoms recur, contact your doctor or the nearest hospital.

Blood tests

Your blood sugar and urine levels should be regularly monitored. Your doctor may ask you to have blood tests to check the number of blood cells and see how your liver is functioning.

Children and adolescents

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

Other medicines and Glimepiride Teva 4 mg

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Your doctor may wish to change your Glimepiride Teva dose if you are taking other medicines, which may increase or decrease the effect of Glimepiride Teva on your blood sugar levels.

The following medicines may increase the hypoglycemic effect of Glimepiride Teva. This may lead to a risk of hypoglycemia (low blood sugar):

- Other medicines for treating diabetes mellitus (such as insulin or metformin)

- Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone; and aspirin derivatives)

- Medicines for treating urinary tract infections (such as some sulfonamides with prolonged action)

- Medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)

- Medicines for diluting the blood (cumarin derivatives such as warfarin)

- Medicines for increasing muscle mass (anabolic steroids)

- Medicines used in hormone replacement therapy in men

- Medicines for treating depression (fluoxetine, MAO inhibitors)

- Medicines for lowering high cholesterol levels (fibrates)

- Medicines for lowering high blood pressure (ACE inhibitors)

- Medicines called antiarrhythmics used for controlling abnormal heart rhythm (disopyramide)

- Medicines for treating gout (allopurinol, sulfinpyrazone, and probenecid)

- Medicines for treating cancer (cyclophosphamide, ifosfamide, and trophosphamide)

- Medicines used for weight loss (fenfluramine)

- Medicines for increasing circulation when administered at high doses in intravenous infusion (pentoxifylline)

- Medicines for treating allergic rhinitis such as hay fever (tritoqualine)

- Medicines called sympatholytics for treating high blood pressure, heart failure, or prostatic symptoms.

The following medicines may decrease the hypoglycemic effect of Glimepiride Teva. This may lead to a risk of hyperglycemia (high blood sugar):

- Medicines containing female sex hormones (estrogens, progestogens)

- Medicines for increasing urine production (thiazide diuretics)

- Medicines used to stimulate the thyroid gland (such as levothyroxine)

- Medicines for treating allergies and inflammation (glucocorticoids)

- Medicines for treating severe mental disorders (chlorpromazine and other phenothiazine derivatives)

- Medicines for increasing heart rate, for treating asthma or congestion, cough, and cold, or used in emergency life-threatening situations (adrenaline and sympathomimetics)

- Medicines for lowering high cholesterol levels (nicotinic acid)

- Medicines for treating constipation when used for a prolonged period (laxatives)

- Medicines for treating seizures (phenytoin)

- Medicines for treating anxiety and sleep disorders (barbiturates)

- Medicines for increasing intraocular pressure (acetazolamide).

- Medicines for treating high blood pressure or low blood sugar levels (diazoxide)

- Medicines for treating infections, tuberculosis (rifampicin)

- Medicines for treating severe low blood sugar levels (glucagon)

The following medicines may increase or decrease the hypoglycemic effect of Glimepiride Teva:

- Medicines for treating stomach ulcers (called H2 antagonists).

- Medicines for treating high blood pressure or heart failure as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the symptoms of hypoglycemia, so special care is needed when taking these medicines.

Glimepiride Teva may also increase or decrease the effects of the following medicines:

- Medicines that inhibit coagulation (cumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Glimepiride Teva. To avoid this effect, it is recommended to take Glimepiride Teva at least 4 hours before colesevelam.

Taking Glimepiride Teva 4 mg tablets with alcohol

The consumption of alcohol may unpredictably increase or decrease the hypoglycemic effect of Glimepiride Teva.

Pregnancy and lactation

Pregnancy:

Glimepiride Teva should not be taken during pregnancy. If you think you may become pregnant, you should consult your doctor about treatment. Inform your doctor immediately if you become pregnant during treatment with glimepiride.

Lactation:

Glimepiride passes into breast milk.Glimepiride Tevashould not be used during lactation.

Driving and operating machinery

If you decrease your blood sugar levels (hypoglycemia), increase (hyperglycemia), or experience visual problems due to these conditions, your ability to concentrate or react may be affected. Please note that you may put yourself or others at risk (e.g. while driving or operating machinery). Please ask your doctor if you can drive if:

- You have frequent episodes of hypoglycemia

- You do not have symptoms of hypoglycemia or they are mild

Glimepiride Teva 4 mg tablets contain lactose:

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Glimepiride Teva 4 mg tablets contain sodium:

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

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

Administration of this medication

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not take breakfast, take the product as your doctor has told you. It is essential not to skip any meals while taking Glimepiride Teva.
• Swallow the tablet with at least half a glass of water. Do not break or chew the tablets.
• The tablet can be divided into equal doses.

How much to take

The dose of Glimepiride Teva depends on your needs, condition, and results of your blood sugar and urine analysis, and will be established by your doctor. Do not take more tablets than your doctor has told you.

• The initial dose is one 1mg Glimepiride Teva tablet per day.
• If necessary, your doctor will indicate a gradual increase in the dose after 1-2 weeks of treatment.
• The maximum recommended dose is 6mg of Glimepiride Teva per day.
• You may start with a combined treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will indicate the individualized doses of glimepiride, metformin, and insulin for you.
• If your weight changes or you change your lifestyle, or you are under stress, you may need to change the doses of Glimepiride Teva, so inform your doctor.
• If you estimate that the action of Glimepiride Teva is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take more Glimepiride Teva 4mg tablets than you should

If you think you have taken too much Glimepiride Teva or an extra dose, there is a risk of hypoglycemia (for signs of hypoglycemia see section 2), so take immediately sufficient sugar (e.g., sugar cubes, sweet juice, sweet tea) and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered must be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. Do not feed or give drinks to people who are unconscious.

As hypoglycemia can last for a while, it is very important that the patient be closely monitored until there is no longer a risk.

As a precaution, it may be necessary to admit the patient to the hospital.

Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological damage are emergency cases that require immediate medical treatment and hospital admission. Ensure that there is always someone informed who can call the doctor in case of an emergency.

If you forgot to take Glimepiride Teva 4mg tablets

If you have forgotten to take a dose, do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Glimepiride Teva 4mg tablets

If you interrupt your treatment, be aware that you will not achieve the blood sugar-lowering effect or that the disease may worsen.Continue taking Glimepiride Teva 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 medicines, this medicine may cause side effects,although not everyone will experience them.

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

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

Allergic reactions (including inflammation of blood vessels, frequently

accompanied by skin rash) that may evolve into serious situations with

difficulty breathing, sudden drop in blood pressure, and in some cases progress to

collapse.

Abnormal liver function, including yellowing of the skin and eyes (jaundice),

problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver

failure.

Unknown frequency (frequency cannot be estimated from available data)

Skin allergy (hypersensitivity), such as itching, redness, hives, and increased

sensitivity to the sun. Some mild allergic reactions may evolve into severe reactions

with difficulty swallowing or breathing, swelling of the lips, throat, or tongue

Severe hypoglycemia, including loss of consciousness, seizures, or coma.

Other possible side effects

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

Low blood sugar (hypoglycemia) (see Section 2 – Warnings and precautions).

Decreased number of blood cells:

Platelets (which increases the risk of bleeding or appearance of hematoma).

White blood cells (which makes it more likely to have infections).

Red blood cells (which causes pale skin and presents weakness or

difficulty breathing).

These problems usually improve once treatment with Glimepririda Teva is discontinued.

• Weight gain.
• Hair loss.
• Change in taste.

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

Nausea, vomiting, diarrhea, feeling full or bloated, and abdominal discomfort or

pain,

Decreased sodium levels in the blood (detected in blood tests).

Unknown frequency(frequency cannot be estimated from available data)

Allergic reactions with sulfonilureas, sulfonamides, or related medications may occur.

Transient visual difficulties, which may occur especially at the start of treatment with

Glimepirida Teva. This is due to changes in blood sugar levels.

Increased levels of liver enzymes.

Unusual intense bleeding or petechiae under the skin

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 25°C.

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 of 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 Teva 4 mg tablets

- The active ingredient is glimepiride, 4 mg.

- The other components are: lactose monohydrate, sodium glycolate starch, povidone K-30, microcrystalline cellulose, magnesium stearate, and aluminum lake of indigo carmine (E132).

Appearance of the product and content of the container

Glimepiride Teva 4 mg are light blue speckled, round, and scored tablets on both faces. One face of the tablet has "9" engraved on one side of the score and "3" on the other side. The other face of the tablet has "72" engraved on one side of the score and "56" on the other.

Glimepiride Teva 4 mg tablets are available in containers of 30, 120, and 200 tablets.

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11,

Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid

Responsible for manufacturing

Pharmachemie B. V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13.

Debrecen H-4042,

Hungary

Or

Merckle GmbH

Ludwig-Merckle-Str. 3,

89143 Blaubeuren,

Germany

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

ES: Glimepiride TEVA 4 mg tablets EFG

FR: Glimepiride TEVA HEALTH 4 mg, tablets

NO: Glimepiride Teva 4 mg, Tablets

UK (NI): Glimepiride 4mg Tablets

Last review date of this leaflet: March 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68780/P_68780.html