Summary of Product Characteristics: Information for the User

Glimepiride Cinfa 4 mg Tablets EFG

Read this leaflet carefully before you start taking 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, 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.

Contents of the pack and additional information

glimepiride cinfais a medication that decreases blood sugar levels, active via oral administration. This medication belongs to a group of medications that decrease blood sugar levels called sulfonylureas.

glimepiride cinfa produces an increase in the amount of insulin released by the pancreas. Insulin decreases blood sugar levels.

glimepiride cinfa 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 takeglimepiride cinfa

• If you are allergic to glimepiride or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonylureas (medicines used to lower your blood sugar levels such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole).
• If you have type 1 diabetes mellitus.
• If 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).
• If you are in a diabetic coma.
• If you have severe kidney disease.
• If you have 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take glimepiride cinfa.

-If you are recovering from any 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.

-If you have severe liver or kidney disease.

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

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 dehydrogenase.

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 experience hypoglycemia (low blood sugar). See below for more information about hypoglycemia, its symptoms, and treatment.

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

?Malnutrition, irregular meal times, skipping or delaying meals, or periods of fasting.

?Changes in your diet.

?Taking more glimepiride than you need.

?Having reduced kidney function.

?Having severe liver disease.

?Having other hormonal disorders (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).

?Drinking alcohol (especially if you skip a meal).

?Taking certain medications (see "Other medicines and glimepiride cinfa").

?Increasing your physical activity and not eating enough or eating foods with fewer carbohydrates than usual.

The symptoms of hypoglycemia include:

?Feeling of an empty stomach, headache, nausea, vomiting, drowsiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech disturbances, and vision disturbances.

?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 drop, you may experience significant confusion (delirium), seizures, loss of self-control, shallow breathing, and a slower 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 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. Remember that artificial sweeteners are not effective. 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 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 well your liver is working.

Children and adolescents

The use of glimepiride in children under 18 years is not recommended.

Other medicines and glimepiride cinfa

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 hypoglycemic effect of glimepiride. This may increase the 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 to control 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. This may increase the risk of hyperglycemia (high blood sugar):

-Medicines containing female sex hormones (estrogens, progestogens).

-Diuretics (thiazides).

-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, coughs, and colds, or used for weight loss, or used in life-threatening emergencies (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:

-Medicines for treating stomach ulcers (H2 antagonists).

-Medicines for treating high blood pressure or heart failure (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 blood clotting (cumarin 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 glimepiride cinfa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

Glimepiride should not be taken during pregnancy.

Breastfeeding

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

Driving and operating machines

Your ability to concentrate and react may be affected due to the symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This may be hazardous in situations where these skills are important (such as driving or operating machines). Therefore, consult your doctor if it is recommended to drive or operate machines if:

Glimepiride cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Glimepiride cinfa contains sodium

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

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

How to take 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.
• 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 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 tablet of 1 mg of glimepiride 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 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.
• If your weight changes or if you change your lifestyle, or if you are under stress, you may need to change the doses of glimepiride, so inform your doctor.
• If you estimate that the action of glimepiride is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take moreglimepiride cinfathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have taken too much glimepiride, or a higher dose, there is a risk of hypoglycemia (see section 2 for hypoglycemia symptoms), and therefore, you must consume immediately sufficient sugar (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 last 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 he or she 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 hospitalization. You should ensure that there is always someone informed who can call a doctor in case of an emergency.

If you forgot to takeglimepiride cinfa

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

If you interrupt the treatment with glimepiride cinfa

If you interrupt or stop treatment, keep in mind that the desired effect of reducing blood sugar will not be achieved or that the disease will worsen again. Continue taking glimepiride 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 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 inflammation of blood vessels, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• 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 people)

• Low blood sugar levels (hypoglycemia) (see section 2).
• Reduction in the number of blood cells:

orPlatelets (which increases the risk of bleeding or bruising).

orWhite blood cells (which makes infections more frequent).

orRed blood cells (which can cause pale skin tone and difficulty breathing).

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

These changes usually disappear when treatment with glimepiride is stopped.

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

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock. If you experience any of these symptoms, inform your doctor immediately.
• Abnormal 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, vomiting, diarrhea, feeling of fullness in the stomach or bloating, and stomach pain.
• Decreased sodium levels in the blood (visible in blood tests).

Frequency not known (cannot be estimated from available data):

• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions can become severe reactions with difficulty swallowing or breathing, swelling of the lips, throat, or tongue. Therefore, if you experience any of these side effects, inform your doctor immediately.
• Allergic reactions with sulfonilureas, sulfonamides, or related medications.
• You may experience vision difficulties when starting treatment with glimepiride. This is due to changes in blood sugar levels and should improve soon.
• Increased liver enzymes.
• Unusual intense bleeding or purpura 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 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 store at a temperature above 25°C.

Do not usethis medicationafter the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of glimepiride cinfa

The active ingredient is glimepiride. Each tablet contains 4 mg of glimepiride.

The other components are: microcrystalline cellulose (E-460), povidone (E-1201), sodium carboxymethyl starch (type A) (from potato), lactose, magnesium stearate (E-470b) and indigo carmine (E-132).

Appearance of the product and contents of the packaging

CBlue, cylindrical, biconvex, scored on one side and marked with the code “G4” on the other.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 30 or 120 tablets.

Holder of the marketing authorization and responsible for manufacturing

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:September 2021

The detailed information of this medication 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 medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67511/P_67511.html

QR code to:https://cima.aemps.es/cima/dochtml/p/67511/P_67511.html