GLIMEPIRIDE NORMON 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Glimepiride Normon 2 mg Tablets EFG

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• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Normon and what is it used for
2. What you need to know before taking Glimepiride Normon
3. How to take Glimepiride Normon
4. Possible side effects
5. Storage of Glimepiride Normon

1. Contents of the pack and further information

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

Glimepiride is a medicine that lowers blood sugar levels, taken orally. This medicine belongs to a group of medicines that lower blood sugar levels called sulfonylureas. Glimepiride causes an increase in the amount of insulin released by your pancreas. Insulin lowers your blood sugar levels.

What Glimepiride Normon is used for:

This medicine is used to treat a type of diabetes (type 2 diabetes mellitus), when diet, physical exercise, and weight loss have not been able to control your blood sugar levels.

2. What you need to know before taking Glimepiride Normon

Do not take Glimepiride Normon

• If you are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar levels, such as glibenclamide) or sulfonamides (medicines for bacterial infections, such as sulfamethoxazole) or to any of the other ingredients of this medicine (listed in section 6).
• 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine 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.
• 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 people 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 have hypoglycemia (low blood sugar). Please see below for more information about hypoglycemia, its signs, and treatment.

The following factors can increase the risk of you experiencing 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 decreased 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 medicines (see 'Taking Glimepiride Normon with other medicines').
• 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, slurred speech, tremors, 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, severe and 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, 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. Please 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 monitored. Your doctor may ask for blood tests to monitor your blood cell count and check how your liver is working.

Children and adolescents

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

Taking Glimepiride Normon with other medicines

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 Normon if you are taking other medicines that may increase or decrease the effect of glimepiride on your blood sugar levels.

The following medicines may increase the hypoglycemic effect of Glimepiride Normon. This may lead to a 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, 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 used to lower 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, sulfinpyrazone)
• Medicines for treating cancer (cyclophosphamide, ifosfamide, trofosfamide).
• Medicines used for weight loss (fenfluramine)
• Medicines for improving circulation when administered at high doses in intravenous infusion (pentoxifylline).
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• 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 Normon. This may lead to a risk of hyperglycemia (high blood sugar):

• 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 those used for weight loss, or those 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 (barbiturics).
• Medicines for treating increased pressure in the eye (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 hypoglycemic effect of Glimepiride Normon:

• 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 Normon 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 Normon at least 4 hours before colesevelam.

Taking Glimepiride Normon with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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. Consult your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels are low (hypoglycemia) or high (hyperglycemia) or if you have vision problems due to these conditions. Keep in mind that this puts you and others at risk (e.g., when driving or operating machinery). Please consult your doctor if you can drive if:

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

Glimepiride Normon 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 Normon contains sodium

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

Glimepiride Normon contains azo colorants

This medicine may cause allergic reactions because it contains tartrazine (E-102) and orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Glimepiride Normon

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

Taking this medicine

• Take this medicine orally, just before or with the first meal of the day (usually breakfast). If you do not have breakfast, you should take the medicine 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 Normon 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 usual initial dose is one 1 mg Glimepiride Normon tablet once a 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 Normon 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 your lifestyle changes, or you are under stress, you may need to change the doses of Glimepiride Normon, so you should inform your doctor.
• If you think the effect of Glimepiride Normon is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take more Glimepiride Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If you have taken too much glimepiride, or an extra dose, there is a risk of hypoglycemia (for symptoms of hypoglycemia, see 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 also 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 Normon

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

If you stop taking Glimepiride Normon

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 Normon 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, 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 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).
• 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).

These alterations usually disappear when treatment with glimepiride is interrupted.

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

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 (hepatitis), 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 with swallowing or breathing problems, 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 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.
• Severe unusual bleeding or bruising under the skin.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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. Storage of Glimepirida Normon

Keep out of sight and reach of children.

Store below 30 ºC.

Do not use Glimepirida Normon after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE point at 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 Glimepirida Normon

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

The other components are: lactose monohydrate, sodium carboxymethyl starch type A (from potato), magnesium stearate, microcrystalline cellulose, povidone K 29-32, yellow iron oxide (E-172), orange yellow S (E-110), tartrazine (E-102), and brilliant blue FCF (E-133).

Appearance of the Product and Package Contents

Glimepirida Normon is presented in tablet form. Each package contains 30 and 120 tablets. The tablets are green, flat, oblong, beveled, and have a break line on one face and are serigraphed with "G" on the other.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other Presentations

Glimepirida Normon 4 mg EFG tablets

Date of the Last Revision of this Prospectus:October 2024

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