GLIMEPIRIDE SANDOZ 4 mg TABLETS

2. What you need to know before you take Glimepiride Sandoz

Do not take Glimepiride Sandozand talk to your doctor if:

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

Do not take this medication if any of the above situations apply to you. If you are not sure, consult your doctor or pharmacist before taking Glimepiride Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Glimepiride Sandoz if:

• you are recovering from an injury, surgery, infection with fever, or other forms of stress. Inform your doctor as it may be necessary to make some changes in your treatment,
• you suffer from severe liver or kidney disorders.

If you are not sure if any of the above situations apply to you, consult your doctor or pharmacist before starting to take Glimepiride Sandoz.

In patients who lack an enzyme called glucose-6-phosphate dehydrogenase, it may happen that hemoglobin levels decrease and red blood cells break down (hemolytic anemia).

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

Important information about hypoglycemia (low blood sugar)

If you are taking glimepiride, you may experience hypoglycemia (low blood sugar). Below, you will find more information about hypoglycemia, its signs, and treatment.

The following factors can increase the risk of hypoglycemia:

• malnutrition, irregular meals, skipping or delaying meals or fasting periods,
• changes in your diet,
• if you take more glimepiride than you need,
• if you have decreased kidney function,
• if you have severe liver disease,
• if you suffer from any other hormonal disorder (such as thyroid, pituitary, or adrenal gland problems),
• if you drink alcohol (especially if you skip a meal),
• if you take certain medications (see "Taking Glimepiride Sandoz with other medications"),
• if you increase your physical exercise and do not eat enough or take foods with fewer carbohydrates than usual.

Signs of hypoglycemia include:

• feeling of empty stomach, headache, nausea, vomiting, drowsiness, sleepiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, feeling of helplessness,
• the following symptoms may also occur: sweating, moist skin, anxiety, rapid heart rate, high blood pressure, palpitations, sudden chest pain that may radiate to neighboring areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), have seizures, lose self-control, have shallow breathing, and a slow heart rate, and you may become unconscious. The clinical picture of a severe drop in blood sugar is similar to a stroke.

Treatment of hypoglycemia

In most cases, symptoms of low blood sugar disappear very quickly when you take something sweet, such as sugar cubes, sweet juices, or sugary tea.

Therefore, you should always carry something sweet with you (e.g., sugar cubes). Remember that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if taking sugar does not help you recover or if symptoms recur.

Blood tests

Your blood sugar and urine levels should be regularly monitored. Your doctor may also ask for blood tests to check your blood cell count and liver function.

Children and adolescents

Glimepiride is not recommended for use in children under 18 years of age.

Taking Glimepiride Sandoz with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Your doctor may want to change your dose of glimepiride if you are taking other medications that may increase or decrease the effect of glimepiride on your blood sugar levels.

The following medications may increase the blood sugar-lowering effect of glimepiride. This may lead to a risk of hypoglycemia (low blood sugar):

• other medications for treating diabetes mellitus(such as insulin or metformin),
• medications for treating pain and inflammation(phenylbutazone, azapropazone, oxyphenbutazone; and acetylsalicylic acid derivatives),
• medications for treating urinary tract infections(such as some long-acting sulfonamides),
• medications for treating fungal and bacterial infections(tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
• medications blood thinners(coumarin derivatives such as warfarin),
• medications for increasing muscle mass(anabolic agents),
• medications used in hormone replacement therapy in men,
• medications for treating depression(fluoxetine, MAO inhibitors),
• medications for reducing high cholesterol levels(fibrates),
• medications for reducing high blood pressure(ACE inhibitors),
• medications called antiarrhythmicsused for controlling abnormal heart rhythms (disopyramide),
• medications for treating gout(allopurinol, probenecid, and sulfinpyrazone),
• medications for treating cancer(cyclophosphamide, ifosfamide, and trofosfamide),
• medications used for weight loss(fenfluramine),
• medications for improving circulationwhen administered in high doses by intravenous infusion (pentoxifylline),

• medications for treating nasal allergiessuch as hay fever (tritoqualine),
• medications called sympatholyticsfor treating high blood pressure, heart failure, or prostate symptoms.

The following medications may decrease the blood sugar-lowering effect of glimepiride. This may lead to a risk of hyperglycemia (high blood sugar):

• medications containing female sex hormones(estrogens, progestogens),

(estrogens, progestogens),

• medications for increasing urine production(thiazide diuretics),
• medications used to stimulate the thyroid gland(such as levothyroxine),
• medications for treating allergies and inflammation(glucocorticoids),
• medications for treating severe mental disorders(chlorpromazine and other phenothiazine derivatives),
• medications for increasing heart rate, for treating asthmaor nasal congestion, cough and colds, or used for weight loss, or used in life-threatening emergencies (adrenaline and sympathomimetics),
• medications for treating high cholesterol levels(nicotinic acid),
• medications for treating constipationwhen used for a prolonged period (laxatives),
• medications for treating seizures(phenytoin),
• medications for treating nervousness and sleep problems(barbiturates),
• medications for treating increased eye pressure(acetazolamide),
• medications for treating high blood pressureor low blood sugar levels (diazoxide),
• medications for treating infections, tuberculosis(rifampicin),
• medications for treating severe low blood sugar levels(glucagon).

The following medications may increase or decrease blood sugar levels by reducing the effect of glimepiride:

• medications for treating stomach ulcers(called H2 antagonists),
• medications for treating high blood pressure or heart failuresuch as beta-blockers, clonidine, guanethidine, and reserpine. These may even hide the signs of hypoglycemia, so special care is needed when taking these medications.

Glimepiride may also increase or decrease the effects of the following medications:

• medications that inhibit blood clotting(coumarin derivatives such as warfarin).

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

Taking Glimepiride Sandoz with alcohol

Consuming alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable way.

Pregnancy and breastfeeding

Pregnancy

Glimepiride should not be taken during pregnancy.

Breastfeeding

Glimepiride may pass into breast milk. Glimepiride should not be used during the breastfeeding period.

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.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia) or if you experience vision problems as a result of these conditions. Keep in mind that this puts you and others at risk (e.g., when driving or operating machinery). Please ask your doctor if you can drive if:

• you have frequent episodes of hypoglycemia,
• you have fever or do not have warning signs of hypoglycemia.

Glimepiride Sandoz contains lactose and sodium

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

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

3. How to take Glimepiride Sandoz

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

Taking this medication

• take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not have breakfast, you should take the medication as your doctor has told you,
• it is important not to skip any meals when taking glimepiride,
• The tablet can be divided into equal doses. Swallow the tablet with at least half a glass of water. Do not break or chew the tablet.

How much to take

The dose of glimepiride depends on your needs, condition, and results of your blood sugar and urine tests, and will be determined by your doctor. Do not take more tablets than your doctor has prescribed.

• The initial dose is 1 mg of glimepiride once a day.
• If necessary, your doctor will gradually increase the dose after 1 to 2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• You may start with a combination treatment of glimepiride plus metformin or glimepiride plus insulin. In these cases, your doctor will indicate the appropriate doses of glimepiride, metformin, and insulin for you individually.
• Tell your doctor if your weight changes or if you change your lifestyle, or if you are under stress, as you may need to change the doses of glimepiride.
• If you think the effect of the medication is too strong or too weak, do not change the dose yourself, and inform your doctor or pharmacist.

If you take more Glimepiride Sandoz than you should

If you have taken too much glimepiride or a higher dose, there is a risk of hypoglycemia (see symptoms of hypoglycemia in section 2), and therefore, you should immediately consume enough sugar (e.g., sugar cubes, sweet juices, sugary tea) and inform your doctor immediately). When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered should be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. Unconscious persons should not be given food or drink.

As hypoglycemia may continue for some time, it is very important that the patient is carefully monitored until there is no more danger. It may be necessary to take safety measures, such as hospitalization. Show the package or remaining tablets to the doctor so they can see what you have taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological failure are medical emergencies that require immediate medical treatment and hospital admission. It should be ensured that there is always an informed person who can call a doctor in case of an emergency.

If you have taken more Glimepiride Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Glimepiride Sandoz

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

If you stop taking Glimepiride Sandoz

If you stop or abandon treatment, keep in mind that the desired effect of lowering blood sugar will not be achieved, or the disease will worsen again. Continue taking glimepiride until your doctor tells you to stop.

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

4. Possible Adverse Effects

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

Consult your doctor immediately if you suffer from any of the following symptoms:

• allergic reactions (including inflammation of blood vessels, often with skin itching) that can trigger severe reactions with difficulty breathing, drops in blood pressure, and sometimes ending in shock,
• altered liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation, or liver failure,
• allergy (hypersensitivity) of the skin such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe,
• severe hypoglycemia including loss of consciousness, seizures, or coma.

Some patients have suffered the following adverse effects when taking glimepiride:

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

• blood sugar levels below normal (hypoglycemia) (see section 2),
• reduction in the number of cells in the blood:
• • platelets (which increases the risk of bleeding or bruising),
  • white blood cells (which makes infections more frequent),
  • red blood cells (which can make the skin pale or cause weakness or difficulty breathing).

Generally, these alterations disappear when treatment with glimepiride is interrupted.

• changes in the sense of taste,
• hair loss,
• weight gain.

Very Rare Adverse Effects(may affect up to 1 in 10,000 patients)

• allergic reactions (including inflammation of blood vessels, often with skin itching) that can trigger severe reactions with difficulty breathing, drops in blood pressure, and sometimes ending in shock. If you experience any of these symptoms, inform your doctor immediately,
• altered liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, inform your doctor immediately,
• feeling of nausea and vomiting, diarrhea, feeling of heaviness in the stomach or bloating, and stomach pain,
• decrease in sodium levels in your blood (demonstrated in your blood tests).

Adverse Effects of Unknown Frequency (cannot be estimated from available data)

• allergy (hypersensitivity) in the skin such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe with problems swallowing or breathing, swelling of your lips, throat, or tongue. Therefore, if you have one of these adverse effects, inform your doctor immediately,
• allergic reactions to sulfonylureas, sulfonamides, or related medications,
• you may experience difficulties in vision when starting treatment with glimepiride. This is due to changes in blood sugar levels and will improve soon,
• increase in liver enzymes,
• severe 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 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 medicine.

5. Conservation of Glimepirida Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister, bottle, and cardboard box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Glimepirida Sandoz

The active ingredient is glimepiride.

Glimepirida Sandoz 2 mg: each tablet contains 2 mg of glimepiride.

Glimepirida Sandoz 4 mg: each tablet contains 4 mg of glimepiride.

The other components are:

Glimepirida Sandoz 2 mg: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, yellow iron oxide (E172), indigo carmine (E132), microcrystalline cellulose, and magnesium stearate.

Glimepirida Sandoz 4 mg: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K30, indigo carmine (E132), microcrystalline cellulose, and magnesium stearate.

Appearance of the Product and Package Contents

Glimepirida Sandoz 2 mg: green, slightly speckled, oblong, flat tablet with beveled edges, with a notch on both sides and with the mark 'G2' on one of them.

Glimepirida Sandoz 4 mg: blue, slightly speckled, oblong, flat tablet with beveled edges, with a notch on both sides and with the mark 'G4' on one of them.

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters or in PP bottles with LDPE or MDPE caps inside a cardboard box, or in PP containers with LDPE or MDPE caps.

Package sizes:

Blister: 7, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100, 120, and 100x1 tablets.

Bottle: 100 and 250 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Podlipie 16, 95-010 Stryków

Poland

or

LEK S.A.

ul. Domaniewska 50 C, 02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto von Guericke Allee 1, 39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria: Glimepirid Sandoz 2 mg – Tabletten

Czech Republic: Glimepirid Sandoz

Denmark: Glimepirid Sandoz

Finland: Glimepirid Sandoz 2mg tablet

Glimepirid Sandoz 4mg tablet

Slovenia: Glimepirid LEK 2 mg tablets

Glimepirid LEK 4 mg tablets

Slovakia: Glimepirid Sandoz 2 mg

Glimepirid Sandoz 4 mg

Date of the last revision of this prospectus: February 2020.

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/