Glimepiride Normon 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Patient Information Leaflet

Glimepiride Normon 2 mg tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may 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.

Package leaflet

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

2. What you need to know before taking Glimepiride Normon

3. How to take Glimepiride Normon

4. Possible side effects

5. How to store Glimepiride Normon

6. Contents of the pack and other information

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

Glimepirida is a medication that lowers blood sugar levels and is active when taken orally. This medicine belongs to a group of blood sugar-lowering medications called sulfonylureas. Glimepirida increases the amount of insulin released by your pancreas. Insulin reduces the levels of sugar in your blood.

What Glimepirida Normon is used for:

This medicine 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 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 in which acid levels in your body rise and you may experience symptoms such as 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 conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine 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.
• You have severe impairment of liver or kidney function.

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

Decreased 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). Please see below for further 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.
• Taking more glimepiride than you need.
• Impaired kidney function.
• Severe liver disease.
• Other hormonal disorders (such as thyroid, pituitary, or adrenal gland problems).
• Consuming alcohol (especially if skipping a meal).
• Taking certain medications (see ‘Taking Glimepiride Normon with other medicines’).
• Increasing physical exercise without adequate food intake or consuming fewer carbohydrates than usual.

Signs of hypoglycemia include:

• Feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, 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, and feelings of helplessness.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden and severe chest pain radiating to adjacent 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 unconsciousness. The clinical picture of severe hypoglycemia may resemble a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, such as sugar lumps, sweet fruit juice, or sugared tea.

Therefore, you should always carry a source of sugar with you (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. Please consult your doctor or go to the hospital if symptoms do not improve after taking sugar or if they 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.

Taking Glimepiride Normon with other medicines

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 dose of Glimepiride Normon 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 Normon. This may lead to a risk of hypoglycemia (low blood sugar):

• Other medicines for 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 certain long-acting sulfonamides)
• Medicines for fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• Medicines used as blood thinners (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 used to lower high cholesterol levels (fibrates)
• Medicines to lower high blood pressure (ACE inhibitors)
• Antiarrhythmic medicines used to control abnormal heart rhythms (disopyramide)
• Medicines for gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines for cancer (cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used for weight loss (fenfluramine)
• Medicines to improve circulation when administered at high doses via intravenous infusion (pentoxifylline)
• Medicines for depression (fluoxetine, MAO inhibitors)
• 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 reduce 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 that 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 anxiety and sleep problems (barbiturates)
• Medicines for increased eye pressure (acetazolamide)
• Medicines for high blood pressure or severe 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 Normon:

• Medicines for stomach ulcers (H2 antagonists)
• Medicines for high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special caution is required when taking these medicines.

Glimepiride Normon may also increase or decrease the effects of the following medicines:

• Medicines that inhibit blood coagulation (coumarin derivatives such as warfarin)
• Colesevelam, a medicine used to reduce cholesterol, affects the absorption of glimepiride. To avoid this interaction, it is recommended to take Glimepiride Normon at least 4 hours before colesevelam.

Taking Glimepiride Normon with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan 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 a pregnancy.

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 drop (hypoglycemia) or rise (hyperglycemia), or if you experience vision problems due to these conditions. Be aware that this may put 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 absent or few warning signs of hypoglycemia.

Glimepiride Normon contains lactose

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

Glimepiride Normon contains sodium

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

Glimepiride Normon contains azo dyes

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

3. How to take Glimepirida Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, 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 eat breakfast, you should take the medicine 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 Glimepirida Normon 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 usual starting dose is one 1 mg Glimepirida Normon tablet once daily.
• If necessary, your doctor may gradually increase your dose after 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of Glimepirida Normon 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 Glimepirida Normon dose; therefore, inform your doctor.
• If you feel that the effect of Glimepirida Normon is too strong or too weak, do not adjust the dose yourself; inform your doctor or pharmacist.

If you take more Glimepirida Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, stating 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). In this case, you should immediately consume sufficient sugar (for example, sugar lumps, sweet fruit juice, sugary 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 should not be given food or drink.

Since hypoglycemia may last for some time, it is very important that the patient be carefully monitored until the danger has passed. As a precaution, hospitalization may also 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. Make sure there is always someone informed and ready to call a doctor in case of emergency.

If you forget to take Glimepirida Normon

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

If you stop taking Glimepirida Normon

If you interrupt or stop treatment, keep in mind that the desired effect of lowering blood sugar will not be achieved, or your condition may worsen again. Continue taking Glimepirida Normon 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.

Contact 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 breathing difficulties, 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, rash, hives, and sensitivity to light. 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:

Uncommon adverse effects (may affect up to 1 in 1,000 people)

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

• Reduction in blood cell counts:

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

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

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

In general, these abnormalities resolve when treatment with glimepiride is stopped.

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

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 lead to severe reactions with breathing difficulties, low blood pressure, and sometimes resulting in shock. If you experience any of these symptoms, contact your doctor immediately.

• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure. If you experience any of these symptoms, contact your doctor immediately.

• Nausea, vomiting, diarrhoea, feeling of heaviness or bloating in the stomach, and stomach pain.

• Decreased levels of sodium in the blood (detectable in blood tests).

Frequency not known, cannot be estimated from available data:

• Skin allergy (hypersensitivity) such as itching, rash, hives, and sensitivity to light. 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, contact 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glimepiride Normon

Keep out of sight and reach of children.

Store below 30 °C.

Do not use Glimepiride Normon after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Glimepirida Normon

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

The other components are: monohydrate lactose, sodium carboxymethylstarch 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 contents of the container

Glimepirida Normon is presented as tablets. Each package contains 30 or 120 tablets. The tablets are green, flat, oblong, bevelled, and have a break line on one side and are printed 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 tablets EFG

Date of the most recent review of this leaflet: October 2024

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