Glimepiride Sandoz 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Glimepiride Sandoz 2 mg tablets EFG

Glimepiride Sandoz 4 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Glimepirida Sandoz is and what it is used for

Glimepiride is an orally active medication that lowers blood sugar levels. This medicine belongs to a group of blood glucose-lowering drugs called sulfonylureas. Glimepiride increases the amount of insulin released by the pancreas. Insulin then lowers your blood sugar levels.

What Glimepirida Sandoz is used for:

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

2. What you need to know before taking Glimepiride Sandoz

Do not take Glimepiride Sandoz and talk to your doctor if:

• you are allergic to glimepiride or other sulfonylureas (medicines used to lower blood sugar levels such as glibenclamide) or sulfonamides (medicines used to treat bacterial infections such as sulfamethoxazole), or to any of the other ingredients of this medicine (listed in section 6),
• you have diabetes mellitus type 1,
• you have diabetic ketoacidosis (a complication of diabetes when acid levels in your body rise, and you may experience symptoms such as fatigue, dizziness (nausea), 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 medicine if any of the conditions listed above apply to you. If you are unsure, consult your doctor or pharmacist before taking Glimepiride Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before taking Glimepiride Sandoz if:

• you are recovering from an injury, surgery, infection with fever, or other forms of stress. Inform your doctor, as your treatment may need to be adjusted,
• you have severe impairment of liver or kidney function.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Glimepiride Sandoz.

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

Available data on the use of glimepiride in individuals under 18 years of age are 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 level). Below is further information about hypoglycemia, its signs, and treatment.

The following factors may increase your risk of hypoglycemia:

• malnutrition, irregular meals, skipping or delaying meals, or fasting,
• changes in your diet,
• if you take more glimepiride than needed,
• if you have reduced kidney function,
• if you have severe liver disease,
• if you have another hormonal disorder (such as thyroid, pituitary, or adrenal cortex gland problems),
• if you consume alcohol (especially if you skip a meal),
• if you take certain medicines (see "Taking Glimepiride Sandoz with other medicines"),
• if you increase your physical activity without eating enough or consuming fewer carbohydrates than usual.

Signs of hypoglycemia include:

• feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, aggressiveness, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, feeling helpless,
• the following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to nearby areas (angina pectoris and cardiac arrhythmias).

If your blood sugar continues to drop, you may develop severe confusion (delirium), seizures, loss of consciousness, shallow breathing, and slowed heart rate. The clinical picture of severe hypoglycemia may resemble that of a stroke.

Treatment of hypoglycemia

In most cases, symptoms of low blood sugar disappear quickly after consuming sugar, such as sugar lumps, sweet fruit juice, or sugared tea.

Therefore, you should always carry a source of sugar with you (e.g., sugar lumps). Remember that artificial sweeteners are not effective. Please consult your doctor or go to hospital if your symptoms do not improve after taking sugar or if they recur.

Blood tests

Your blood and urine sugar levels should be monitored regularly. Your doctor may also request blood tests to monitor your blood cell counts and liver function.

Children and adolescents

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

Taking Glimepiride Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your glimepiride dose if you are taking other medicines that may increase or decrease the blood sugar-lowering effect of glimepiride.

The following medicines may enhance the blood sugar-lowering effect of glimepiride. This may lead to an increased 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, oxyphenbutazone; and acetylsalicylic acid derivatives),
• medicines for treating urinary tract infections (such as certain long-acting sulfonamides),
• medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
• anticoagulant medicines (coumarin derivatives such as warfarin),
• medicines for increasing muscle mass (anabolic agents),
• 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),
• antiarrhythmic medicines used to control abnormal heart rhythm (disopyramide),
• medicines for treating gout (allopurinol, probenecid, sulfinpyrazone),
• medicines for treating cancer (cyclophosphamide, ifosfamide, trofosfamide),
• medicines used for weight loss (fenfluramine),
• medicines used to improve circulation when administered at high doses by intravenous infusion (pentoxifylline),
• medicines for treating nasal allergies such as hay fever (tritoqualine),
• medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms.

The following medicines may reduce the blood sugar-lowering effect of glimepiride. This may lead to an increased risk of hyperglycemia (high blood sugar):

• medicines containing female sex hormones (estrogens, progestogens),
• medicines used to increase 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 to increase heart rate, for treating asthma or nasal congestion, cough and colds, or used for weight loss, or used in life-threatening emergencies (adrenaline and sympathomimetics),
• medicines for treating high cholesterol levels (nicotinic acid),
• medicines for treating constipation with prolonged use (laxatives),
• medicines for treating seizures (phenytoin),
• medicines for treating nervousness and sleep disorders (barbiturates),
• medicines for treating increased eye pressure (acetazolamide),
• medicines for treating high blood pressure or severe low blood sugar (diazoxide),
• medicines for treating infections, tuberculosis (rifampicin),
• medicines for treating severe low blood sugar (glucagon).

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

• medicines for treating stomach ulcers (H2-receptor antagonists),
• medicines for treating high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special caution is required when taking these medicines.

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

• medicines that inhibit blood coagulation (coumarin derivatives such as warfarin).

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

Taking Glimepiride Sandoz with alcohol

Alcohol consumption may unpredictably increase or decrease the hypoglycemic effect of glimepiride.

Pregnancy and breastfeeding

Pregnancy

Glimepiride must not be taken during pregnancy.

Breastfeeding

Glimepiride may pass into breast milk. Glimepiride must not be used during 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 medicine.

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. Be aware that this may put you and others at risk (e.g., when driving or operating machinery). Please ask your doctor if you may drive if:

• you have frequent episodes of hypoglycemia,
• you have fever or lack warning symptoms of hypoglycemia.

Glimepiride Sandoz contains lactose and sodium

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

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

3. How to take Glimepiride Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, please consult your doctor or pharmacist again.

Taking this medicine

• take this medicine orally, just before or with the first meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine as directed by your doctor;
• it is important not to skip any meals while taking glimepiride;
• the tablet may 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 individual needs, condition, and results of your blood and urine sugar tests, and will be determined by your doctor. Do not take more tablets than prescribed by your doctor.

• The starting dose is 1 mg of glimepiride once daily.
• If necessary, your doctor will gradually increase your dose after 1 to 2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• You may start combination therapy with glimepiride plus metformin or glimepiride plus insulin. In such cases, your doctor will individually determine the appropriate doses of glimepiride, metformin, and insulin for you.
• Inform your doctor if you experience weight changes, changes in lifestyle, or are under stress, as you may need adjustments in your glimepiride dose.
• If you think the effect of the medicine is too strong or too weak, do not change the dose yourself; inform your doctor or pharmacist.

If you take more Glimepiride Sandoz than you should

If you have taken too much glimepiride or an extra dose, there is a risk of hypoglycemia (see section 2 for symptoms of hypoglycemia). In this case, you must immediately consume sufficient sugar (for example, sugar lumps, sweet fruit juices, sugared tea) and contact your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar administered must be carefully controlled to avoid causing dangerous hyperglycemia. Do not give food or drink to unconscious individuals.

Since hypoglycemia may persist for some time, careful monitoring of the patient is essential until the danger has passed. As a precaution, hospital admission may be necessary. Show the packaging or any remaining tablets to the doctor so they can determine what has been taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological impairment are medical emergencies requiring immediate medical treatment and hospital admission. Ensure that there is always an informed person available who can call a doctor in case of emergency.

If you have taken more Glimepiride Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Glimepiride Sandoz

Do not take a double dose to make up for a missed dose.

If you stop taking Glimepiride Sandoz

If you stop or discontinue treatment, bear in mind that the desired effect of lowering blood sugar will no longer be achieved, and your condition may worsen again. Continue taking glimepiride until your doctor tells you to stop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• allergic reactions (including inflammation of blood vessels, often with skin itching), which may lead to severe reactions with breathing difficulties, low blood pressure, and sometimes resulting in shock,
• impaired liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation or liver failure,
• skin allergy (hypersensitivity), such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may progress into severe reactions,
• severe hypoglycaemia, including loss of consciousness, seizures or coma.

Some patients have experienced the following adverse effects while taking glimepiride:

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

• blood sugar levels lower than normal (hypoglycaemia) (see section 2),
• reduction in blood cell counts:
  • platelets (which increases the risk of bleeding or bruising),
  • white blood cells (which increases the likelihood of infections),
  • red blood cells (which may cause paleness of the skin or lead to weakness or difficulty breathing).

In general, these abnormalities resolve upon discontinuation of glimepiride treatment.

• changes in taste sensation,
• 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), which may lead to severe reactions with breathing difficulties, low blood pressure, and sometimes resulting in shock. If you experience any of these symptoms, inform your doctor immediately,
• impaired 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,
• nausea and vomiting, diarrhoea, feeling of stomach heaviness or bloating, and stomach pain,
• decreased levels of sodium in your blood (shown in blood tests).

Adverse effects with unknown frequency (cannot be estimated from available data)

• skin allergy (hypersensitivity), such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may progress into severe reactions with difficulty swallowing or breathing, swelling of lips, throat or tongue. Therefore, if you experience any of these adverse effects, inform your doctor immediately,
• allergic reactions to sulfonylureas, sulfonamides or related medicines,
• you may experience vision disturbances when starting treatment with glimepiride. This is due to changes in blood sugar levels and will improve quickly,
• increased liver enzymes,
• severe bleeding or bruising under the skin.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glimepiride Sandoz

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

Do not use this medicine after the expiry date stated on the blister, bottle, and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glimepiride Sandoz

The active substance is glimepiride.

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

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

The other components are:

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

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

Appearance of the product and contents of the container

Glimepiride Sandoz 2 mg: green, slightly mottled, oblong, flat tablet with bevelled edges, scored on both sides and marked ‘G2’ on one side.

Glimepiride Sandoz 4 mg: blue, slightly mottled, oblong, flat tablet with bevelled edges, scored on both sides and marked ‘G4’ on one side.

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters or in PP bottles with LDPE or MDPE caps, all contained within a cardboard outer packaging, or in PP containers with LDPE or MDPE caps.

Pack sizes:

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

Bottle: 100 and 250 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

Date of the most recent review of this leaflet: July 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/