Patient Information Leaflet

Glimepiride Sandoz 2 mg Tablets EFG

Glimepiride Sandoz 4 mg Tablets EFG

Please read this leaflet carefully before you start to take 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 pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Glimepiride Sandoz

3.How to take Glimepiride Sandoz

4.Possible side effects

5.Storage of Glimepiride Sandoz

6.Contents of the pack and additional information

Glimepirida is an orally active medication that decreases blood sugar levels. This medication belongs to a group of medications that decrease blood sugar levels called sulfonylureas. Glimepirida increases the amount of insulin released by the pancreas. Afterward, insulin decreases blood sugar levels.

What is Glimepirida Sandoz used for:

Glimepirida 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 blood sugar levels.

Do not take Glimepirida Sandozand 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 for treating 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 in a diabetic coma,
• You have severe kidney disease,
• You have a severe liver disease.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glimepirida Sandoz if:

• You are recovering from any injury, operation, infection with fever or other forms of stress. Inform your doctor as you may need to make some changes to your treatment,
• You have any severe liver or kidney dysfunction.

If you are unsure if any of the above situations affect you, consult your doctor or pharmacist before starting to take Glimepirida Sandoz.

In patients who lack an enzyme called glucose-6-phosphate dehydrogenase, you may experience a decrease in hemoglobin levels and a rupture of red blood cells (hemolytic anemia).

The available information on the use of glimepiride in people under 18 years 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 have hypoglycemia (low blood sugar). The following information will provide you with more information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• Malnutrition, irregular meals, skipping or delaying meals or fasting periods,
• Changes in your diet,
• Taking more glimepiride than you need,
• Having reduced renal function,
• Having a severe liver disease,
• Having any other hormonal disease (such as thyroid problems, pituitary gland problems, or adrenal cortex problems),
• Consuming alcohol (especially if you skip a meal),
• Taking certain medications (see "Taking Glimepirida Sandoz with other medicines"),
• Increasing your physical exercise and not eating enough or consuming foods with fewer carbohydrates than usual.

The symptoms of hypoglycemia include:

• Empty stomach sensation, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced sense of alertness and reaction time, depression, confusion, speech and vision disturbances, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, feeling of abandonment,
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, 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 drop, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and a decrease in your heart rate, and you may become unconscious. The clinical picture of severe hypoglycemia resembles a stroke.

Treatment of hypoglycemia

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

Therefore, you should always carry something sweet (such as sugar cubes) with you. Please note that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if, after taking sugar, you do not recover or if the symptoms recur.

Blood tests

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

Children and adolescents

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

Taking Glimepirida Sandoz with other medicines

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

The following medicines may increase the effect of glimepiride on lowering blood sugar levels, which may increase the risk of hypoglycemia:

• Other medicines for treating diabetes mellitus (such as insulin or metformin),
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone; and salicylate derivatives),
• Medicines for treating urinary tract infections (such as some long-acting sulfonamides),
• Medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
• Anticoagulant medicines (cumarinic 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 to control abnormal heart rhythm (disopyramide),
• Medicines for treating gout (allopurinol, probenecid, and sulfinpyrazone),
• Medicines for treating cancer (cyclophosphamide, ifosfamide, and trophosphamide),
• Medicines used for weight loss (fenfluramine),
• Medicines for increasing circulation when administered at high doses intravenously (pentoxifylline),

• Medicines for treating allergic rhinitis such as hay fever (tritoqualine),
• Medicines called sympatholytics for treating high blood pressure, heart failure, or prostate symptoms.

The following medicines may decrease the effect of glimepiride on lowering blood sugar levels, which may increase the risk of hyperglycemia:

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

(estrógenos, progestágenos),

• 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 disturbances (chlorpromazine and other phenothiazine derivatives),
• Medicines for increasing heart rate, for treating asthma or congestion, coughs, 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 when used for a prolonged period (laxatives),
• Medicines for treating seizures (phenytoin),
• Medicines for treating nervousness and sleep problems (barbiturates),
• Medicines for treating increased eye pressure (acetazolamide),
• Medicines for treating high blood pressure or 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 the levels of blood sugar by reducing the effect of glimepiride:

• Medicines for treating stomach ulcers (called H2 antagonists),
• Medicines for treating high blood pressure or heart failure (such 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 may also increase or decrease the effects of the following medicines:

• Medicines that inhibit coagulation (cumarinic derivatives such as warfarin).

Colesevelam, a medicine 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 Glimepirida Sandoz with alcohol

The consumption of alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable manner.

Pregnancy and lactation

Pregnancy

Glimepiride should not be taken during pregnancy.

Lactation

Glimepiride may pass into breast milk. Glimepiride should not be used during lactation.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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. Please note that this puts you and others at risk (for example, when driving or operating machinery). Please ask your doctor if you can drive if:

Glimepirida Sandoz contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which 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.

Taking this medication

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medication as your doctor has told you,
• It is important not to skip any meals while 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 analysis, and will be established 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 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.
• Inform 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 estimate that the medication's effect 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 an extra dose, there is a risk of hypoglycemia (see section 2 for hypoglycemia symptoms), and therefore, you should consume enough sugar immediately (e.g., sugar cubes, sweet juices, 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. People in a coma should not take food or drinks.

Since hypoglycemia can continue for a while, it is very important that the patient be closely monitored until there is no longer a risk. It may be necessary to be admitted to the hospital as a precaution. Show the packaging or remaining tablets to your doctor so that they can know 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. You should ensure that there is always someone informed 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 forgot to take Glimepiride Sandoz

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

If you interrupt the treatment with Glimepiride Sandoz

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

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

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

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

• allergic reactions (including blood vessel inflammation, frequently with skin itching) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock,
• altered liver function, including yellow discoloration of skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation, or liver insufficiency,
• skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions can become severe,
• severe hypoglycemia, including loss of consciousness, seizures, or coma.

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

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

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

These changes usually disappear when treatment with glimepiride is discontinued.

• changes in taste,
• hair loss,
• weight gain.

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

Side effects of unknown frequency (cannot be estimated from available data)

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 blister pack, bottle, and carton packaging 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 disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Glimepiride Sandoz

The active ingredient 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: lactose monohydrate, carboxymethylstarch sodium (type A), povidone K30, iron oxide yellow (E172), indigo carmine (E132), microcrystalline cellulose, and magnesium stearate.

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

Appearance of the product and contents of the package

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

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

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

Package sizes:

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

Bottle: 100 and 250 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Sandoz Farmacéutica, S.A.

Corporate Park North

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 tabletti

Glimepirid Sandoz 4mg tabletti

Slovenia:Glimepirid LEK 2 mg tablete

Glimepirid LEK 4 mg tablete

Slovakia:Glimepirid Sandoz 2 mg

Glimepirid Sandoz 4 mg

Last review date of this leaflet: February2020.

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/