GLIMEPIRIDA CINFA 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Glimepiride Cinfa 4 mg Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Glimepiride Cinfa and what is it used for
2. What you need to know before you take Glimepiride Cinfa
3. How to take Glimepiride Cinfa
4. Possible side effects
5. Storage of Glimepiride Cinfa

Contents of the pack and other information

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

Glimepiride Cinfa is a medicine that lowers blood sugar levels, taken by mouth. This medicine belongs to a group of medicines that lower blood sugar levels called sulfonylureas.

Glimepiride Cinfa increases the amount of insulin released by your pancreas. Insulin lowers blood sugar levels.

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

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

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 acid levels rise in your body and you may have some of the following symptoms: fatigue, dizziness (nausea), 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 apply to you. If you are not sure, 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, surgery, infection with fever, or other forms of stress. Inform your doctor as it may be necessary to make some change in your treatment.
• If you have any severe liver or kidney disorder.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking glimepiride.

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

The 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 level)

If you are taking glimepiride, you may have hypoglycemia (low blood sugar level). See below for more information about hypoglycemia, its signs, and treatment.

The following factors can increase the risk of you suffering from hypoglycemia:

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

? Changes in your diet.

? If you take more glimepiride than you need.

? If you have reduced 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 medicines (see "Other medicines and Glimepiride Cinfa").

? If you increase your physical exercise and do not eat enough or take foods with fewer carbohydrates than usual.

The 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, tremors, slurred speech, 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 adjacent areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience considerable confusion (delirium), have convulsions, lose self-control, your breathing may become shallow, and your heart rate may slow down, 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, the symptoms of low blood sugar disappear quickly when you take something sweet, such as sugar cubes, sweet juices, sugary tea.

Therefore, you should always carry something sweet with you (e.g., sugar cubes). 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 and urine sugar levels should be regularly checked. Your doctor may ask for blood tests to check the number of blood cells and see how your liver is working.

Children and adolescents

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

Other medicines and Glimepiride Cinfa

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

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

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone; and aspirin 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).
• Medicines for thinning the blood (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).
• 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 trofosfamide).
• Medicines used for weight loss (fenfluramine).
• Medicines for improving circulation when administered at high doses by intravenous infusion (pentoxifylline).
• Medicines for treating nasal allergies such as hay fever (tritoqualine).
• Medicines called sympatholytics for treating high blood pressure, heart failure, or prostate symptoms.

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

• 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 nasal congestion, cough, 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 convulsions (phenytoin).
• Medicines for treating nervousness and sleep problems (barbiturics).
• Medicines for increasing eye 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 (called H2 antagonists).
• Medicines for treating high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These may even hide the signs 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 (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, has an effect on 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 using machines

Your ability to concentrate and react may be impaired due to the symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines if:

• you have frequent episodes of hypoglycemia,
• you have few or no warning signs of hypoglycemia.

Glimepiride Cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Glimepiride Cinfa contains sodium

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

3. How to take Glimepiride Cinfa

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

Taking this medicine

• Take this medicine by mouth, just before or with the first meal of the day (usually breakfast). If you do not have breakfast, you should take the product as your doctor has told you. It is important not to skip any meals when 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 and urine sugar tests and will be determined by your doctor. Do not take more tablets than your doctor has told you.

• The initial dose is one 1 mg glimepiride 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 6 mg of glimepiride per day.
• You may start with a combination treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will indicate the appropriate doses of glimepiride, metformin, and insulin for you individually.
• 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 you should inform your doctor.
• If you think the effect of glimepiride is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take more Glimepiride Cinfa than you should

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

If it happens that you have taken too much glimepiride, or an extra dose, there is a risk of hypoglycemia (see symptoms of hypoglycemia in section 2), and therefore, you should immediately consume sufficient 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 take any food or drink.

As hypoglycemia can last for a while, 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 hospitalization. It should be ensured that there is always an informed person who can call a doctor in case of an emergency.

If you forget to take Glimepiride Cinfa

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

If you stop taking Glimepiride Cinfa

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

If you have any further questions on 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 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, frequently with skin rash) that can trigger severe reactions with difficulty breathing, drops in blood pressure, and sometimes ending in 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, 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 while taking glimepiride:

Rare Adverse 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:

o Platelets (which increases the risk of bleeding or bruising).

o White blood cells (which makes infections more frequent).

o Red blood cells (which can cause pale skin tone and produce weakness or difficulty breathing).

• Weight gain.
• Hair loss.
• Change in your sense of taste.

These alterations usually disappear when treatment with glimepiride is discontinued.

Very Rare Adverse 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, drops in blood pressure, and sometimes ending in 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.
• Feeling of nausea, vomiting, diarrhea, feeling of heaviness in the stomach or bloating, and stomach pain.
• Decrease in 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, hives, and hypersensitivity to light. Some mild allergic reactions can become severe reactions with swallowing or breathing difficulties, swelling of your lips, throat, or tongue. Therefore, if you experience any of these adverse effects, inform your doctor immediately.
• Allergic reactions to sulfonylureas, 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 bruising under the skin.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed 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 Glimepiride Cinfa

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 carmine indigo (E-132).

Appearance of the Product and Package Contents

Blue, cylindrical, biconvex tablets, scored on one side and marked with the code "G4" on the other.

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

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:September 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). 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