Package Leaflet: Information for the User

Glimepiride Normon 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Glimepiride Normon is and what it is used for
2. What you need to know before you start taking Glimepiride Normon
3. How to take Glimepiride Normon
4. Possible side effects
5. Storage of Glimepiride Normon
6. Contents of the pack and additional information

Glimepirida is 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. Glimepirida increases the amount of insulin released by your pancreas. Insulin decreases blood sugar levels.

What is Glimepirida Normon used for:

This medication 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 your blood sugar levels.

Do not take Glimepirida 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 components of this medicine (listed in section 6).
• If you have type 1 diabetes.
• 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 this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine if:

- You are recovering from an 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.

- 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 hemolytic anemia in patients who lack an enzyme called glucose-6-phosphate 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 have hypoglycemia (low blood sugar). Please see below for more information about hypoglycemia, its symptoms, and treatment.

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

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

- Changes in your diet.

- If you take more glimepiride than you need.

- If you have reduced renal function.

- If you have severe liver disease.

- If you have any other hormonal disorders (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).

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

- If you take certain medications (see 'Taking Glimepiride Normon with other medicines').

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

The symptoms of hypoglycemia include:

- Feeling of an empty stomach, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, slurred speech, dizziness, feelings of abandonment.

- The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, 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 significant confusion (delirium), seizures, loss of control, shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of severe low 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, or sweet tea.

Therefore, you should always carry something sweet (such as sugar cubes) with you. Remember that artificial sweeteners are not effective. Please 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 your liver is functioning.

Children and adolescents

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

Taking Glimepiride Normon with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Your doctor may wish to change your dose of Glimepiride Normon if you are taking other medicines, which 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 type 2 diabetes (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 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 steroids).
• Medicines used in hormone replacement therapy in men.
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• Medicines used to lower high cholesterol levels (fibrates).
• Medicines used to lower 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, trophosphamide).
• Medicines used for weight loss (fenfluramine).
• Medicines used to increase circulation when administered at high doses intravenously (pentoxifylline).
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• 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 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 congestion, coughs, and colds, or those 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 treating increased eye pressure (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 (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 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, affects 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

The consumption of alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable manner.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using 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 become pregnant.

Breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia) or if you experience vision problems due to these conditions. Please note that this puts you and others at risk (for example, 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 certain sugars, consult him before taking this medicine.

Glimepiride Normon contains sodium

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

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

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, you should take the medication 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 Normon 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 usual initial dose is one tablet of 1 mg of Glimepiride Normon 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 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 Normon, so you should inform your doctor.
• If you estimate that the action 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 Toxicological Information Service, phone 915 620 420, 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 should 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 should 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 also be necessary for safety reasons to be admitted to the hospital. Show the packaging or remaining tablets so that your doctor 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 take Glimepiride Normon

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

If you interrupt the treatment with Glimepiride Normon

If you interrupt or stop treatment, be aware that the desired effect of reducing blood sugar will not be achieved or that the disease will worsen again. Continue taking Glimepiride Normon 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 may 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 may 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 may 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 may cause pale skin tone and difficulty breathing).

These changes usually disappear when treatment with glimepiride is stopped.

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

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 may 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 (hepatitis), 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 may become severe with swallowing or breathing problems, 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 leaflet. You can also report them directly through the Spanish System for the Vigilance 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 out of the sight and reach of children.

Store below 30 °C.

Do not use Glimepiride Normon after the expiration date indicated on the packaging 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 the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Glimepiride Normon

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

The other components are: lactose monohydrate, carboxymethylstarch sodium type A (from potato), magnesium stearate, microcrystalline cellulose, povidone K 29-32, and indigo carmine (E-132).

Appearance of the product and contents of the packaging

Glimepiride Normon is presented in the form of tablets. Each package contains 30 and 120 tablets. The tablets are blue, flat, oval, beveled, and have a breaking bar on one face and are printed with “G” on the other.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Other presentations

Glimepiride Normon 2 mg tablets EFG

Date of the last review of this leaflet:November 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es