GLIMEPIRIDA CINFA 2 mg TABLETS

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 applies 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 changes in your treatment.
• If you have severe liver or kidney problems.

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.

Information available on the use of glimepiride in children 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). 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 have 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 "Other medications and Glimepiride Cinfa").

? 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, 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, have shallow breathing and a slower heart rate, and 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 you do not recover after taking sugar 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 your blood cell count and see how your liver is working.

Children and adolescents

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

Other medications and Glimepiride Cinfa

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 hypoglycemic 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 aspirin 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 for thinning the blood (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 lowering high cholesterol levels (fibrates).
• Medications for lowering high blood pressure (ACE inhibitors).
• Medications called antiarrhythmics used to control abnormal heart rhythms (disopyramide).
• Medications for treating gout (allopurinol, sulfinpyrazone, and probenecid).
• Medications for treating cancer (cyclophosphamide, ifosfamide, and trofosfamide).
• Medications used for weight loss (fenfluramine).
• Medications for improving circulation when administered at high doses by intravenous infusion (pentoxifylline).
• Medications for treating nasal allergies such as hay fever (tritoqualine).
• Medications called sympatholytics for treating high blood pressure, heart failure, or prostate symptoms.

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

• Medications containing female sex hormones (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 asthma or nasal congestion, cough, and colds, or used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medications for lowering high cholesterol levels (nicotinic acid).
• Medications for treating constipation when used for a prolonged period (laxatives).
• Medications for treating convulsions (phenytoin).
• Medications for treating nervousness and sleep problems (barbiturics).
• Medications for increasing eye pressure (acetazolamide).
• Medications for treating high blood pressure or low blood sugar (diazoxide).
• Medications for treating infections, tuberculosis (rifampicin).
• Medications for treating severe low blood sugar (glucagon).

The following medications may increase or decrease the hypoglycemic effect of glimepiride:

• Medications for treating stomach ulcers (called H2 antagonists).
• Medications 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 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, 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, 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 using machines

Your ability to concentrate and react may be impaired due to the symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. 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 for 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.
• 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 section 2 for symptoms of hypoglycemia), 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 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. You should ensure that there is always someone informed 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, you should consider that the desired effect of lowering 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 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 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 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 experienced 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).
• Decrease 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, low 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.
• Nausea, vomiting, diarrhea, feeling of heaviness in the stomach or bloating, and stomach pain.
• Decrease in blood sodium levels (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, with problems swallowing or breathing, 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 or severe bleeding or bruising under the skin.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. 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. Storage of Glimepiride Cinfa

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glimepiride Cinfa

The active ingredient is glimepiride. Each tablet contains 2 mg of glimepiride.

The other ingredients are: microcrystalline cellulose (E-460), povidone (E-1201), sodium carboxymethyl starch (type A) (from potato), lactose, magnesium stearate (E-470b), carmine indigo (E-132), and quinoline yellow (E-104).

Appearance of the Product and Package Contents

Green, cylindrical, biconvex tablets, scored on one side and marked with the code "G2" 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 Leaflet: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 leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67512/P_67512.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67512/P_67512.html