Glimepiride Cinfa 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

glimepiride cinfa 2 mg tablets EFG

Read the entire 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, 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What glimepiride cinfa is and what it is used for

Glimepiride cinfa is a medicine that lowers blood sugar levels and is active when taken orally. This medicine belongs to a group of blood sugar-lowering medicines called sulfonylureas.

Glimepiride cinfa increases the amount of insulin released by your pancreas. Insulin reduces 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 sufficient to control your blood sugar levels.

2. What you need to know before starting to take glimepiride cinfa

Do not take glimepiride cinfa

• If you are allergic to glimepiride or to 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 in which acid levels in your body rise and you may experience symptoms such as fatigue, dizziness (nausea), frequent urge to urinate, 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 conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking glimepiride.

Warnings and precautions

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

• If you are recovering from an illness, surgery, infection with fever, or other forms of stress. Inform your doctor, as adjustments to your treatment may be necessary.
• If you have severe liver or kidney impairment.

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

A decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

Available information on the use of glimepiride in individuals under 18 years of age 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 signs, and treatment.

The following factors may increase your risk of hypoglycemia:

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

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

? If you consume alcohol (especially if you skip a meal).

? If you take certain medicines (see “Other medicines and glimepiride cinfa”).

? 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, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, and feelings of helplessness.

? 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 experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, slowed heart rate, and may lose consciousness. The clinical picture of severe hypoglycemia resembles 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 juices, 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. Consult your doctor or go to the hospital if your symptoms do not improve after taking sugar or if symptoms recur.

Blood tests

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

Children and adolescents

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

Other medicines and glimepiride cinfa

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 effect of glimepiride on blood sugar levels.

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

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone; and aspirin derivatives).
• Medicines for urinary tract infections (such as some long-acting sulfonamides).
• Medicines for fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines to thin the blood (coumarin derivatives such as warfarin).
• Medicines to increase muscle mass (anabolic agents).
• Medicines used in male hormone replacement therapy.
• Medicines for depression (fluoxetine, MAO inhibitors).
• Medicines to lower high cholesterol levels (fibrates).
• Medicines to lower high blood pressure (ACE inhibitors).
• Medicines called antiarrhythmics used to control abnormal heart rhythms (disopyramide).
• Medicines for gout (allopurinol, sulfinpyrazone, and probenecid).
• Medicines for cancer (cyclophosphamide, ifosfamide, and trofosfamide).
• Medicines used for weight loss (fenfluramine).
• Medicines to improve circulation when administered at high doses by intravenous infusion (pentoxifylline).
• Medicines for 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 decrease the hypoglycemic effect of glimepiride. This may lead to a risk of hyperglycemia (high blood sugar):

• Medicines containing female sex hormones (estrogens, progestogens).
• Medicines to increase urine production (thiazide diuretics).
• Medicines used to stimulate the thyroid gland (such as levothyroxine).
• Medicines for allergies and inflammation (glucocorticoids).
• Medicines for severe mental disorders (chlorpromazine and other phenothiazine derivatives).
• Medicines to increase heart rate, treat asthma or nasal congestion, cough and colds, or used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medicines for high cholesterol (nicotinic acid).
• Medicines for constipation when used long-term (laxatives).
• Medicines for seizures (phenytoin).
• Medicines for nervousness and sleep problems (barbiturates).
• Medicines to increase eye pressure (acetazolamide).
• Medicines for high blood pressure or low blood sugar (diazoxide).
• Medicines for infections, tuberculosis (rifampicin).
• Medicines for severe low blood sugar (glucagon).

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

• Medicines for stomach ulcers (called H2 antagonists).
• Medicines for high heart pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special caution 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, affects the absorption of glimepiride. To avoid this interaction, it is recommended to take glimepiride at least 4 hours before colesevelam.

Taking glimepiride cinfa with food, drinks, and alcohol

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

Pregnancy and 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.

Pregnancy

Glimepiride must not be taken during pregnancy.

Breastfeeding

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

Driving and using machines

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

• you have frequent episodes of hypoglycemia,
• you have absent or few warning signs of hypoglycemia.

glimepiride cinfa contains lactose

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

glimepiride cinfa contains sodium

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

3. How to take glimepiride cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine orally, just before or with your first meal of the day (usually breakfast). If you do not eat breakfast, you should take the product as directed by your doctor. It is important not to skip any meals while taking glimepiride.
• Swallow the tablet with at least half a glass of water. Do not split or chew the tablets.
• The tablet may be divided into equal doses.

How much to take

The dose of glimepiride depends on your individual needs, condition, and blood and urine sugar test results, and will be determined by your doctor. Do not take more tablets than prescribed by your doctor.

• The initial dose is one 1 mg glimepiride tablet per day.
• If necessary, your doctor will instruct you to gradually increase the dose after 1–2 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.
• If your weight changes, if you change your lifestyle, or if you are under stress, you may need to adjust your glimepiride dose; therefore, inform your doctor.
• If you feel that the effect of glimepiride is too strong or too weak, do not adjust the dose yourself; inform your doctor or pharmacist.

If you take more glimepiride cinfa than you should

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

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

Since hypoglycemia can last for some time, careful monitoring of the patient is very important 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 you have taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and serious neurological impairment are medical emergencies requiring immediate medical treatment and hospitalization. Ensure that someone informed is always available to call a doctor in an emergency.

If you forget to take glimepiride cinfa

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

If you stop treatment with glimepiride cinfa

If you interrupt or stop treatment, bear in mind that the desired effect of lowering blood sugar will not be achieved, or 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, frequently with skin rash), which may lead to severe reactions with difficulty breathing, low blood pressure, and sometimes resulting in shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure.
• Skin allergy (hypersensitivity), such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may progress to 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 people)

• Blood sugar levels lower than normal (hypoglycaemia) (see section 2).

• Reduction in blood cells:

  o Platelets (increasing the risk of bleeding or bruising).

  o White blood cells (making infections more likely).

  o Red blood cells (which may cause paleness of the skin and lead to weakness or difficulty breathing).

• Weight gain.

• Hair loss.

• Change in taste sensation.

In general, these disturbances disappear when treatment with glimepiride is stopped.

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

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash), which may trigger severe reactions with difficulty breathing, low blood pressure, and sometimes result 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), inflammation of the liver, or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Nausea, vomiting, diarrhoea, feeling of heaviness or bloating in the stomach, and stomach pain.
• Decreased levels of sodium in the blood (detected 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 may progress to severe reactions with difficulty swallowing or breathing, or swelling of the 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 should improve quickly.
• Increased liver enzymes.
• Unusual severe bleeding or bruising under the skin.

Reporting of adverse effects

If you experience any 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 cinfa

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of glimepiride cinfa

The active substance is glimepiride. Each tablet contains 2 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), indigo carmine (E-132) and quinoline yellow (E-104).

Appearance of the product and contents of the pack

Green, cylindrical, biconvex tablets, scored on one side and marked with the code “G2” on the other.

The product is presented in PVC-PVDC/Aluminum blisters. Each pack 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 most recent revision of this leaflet: September 2021

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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