GLIMEPIRIDE PENSA 4 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glimepiride Pensa 4 mg tablets EFG

Contents of the pack:

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

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

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

What Glimepiride Pensa is used for:

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

2. What you need to know before you take Glimepiride Pensa

Do not take Glimepiride Pensa and talk to your doctor if:

• you are allergic (hypersensitive) to glimepiride, other sulfonylureas (medicines used to lower your blood sugar levels, such as glibenclamide), or sulfonamides (medicines for bacterial infections, such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6).
• you have type 1 insulin-dependent diabetes mellitus.
• you have a diabetic coma (reduced level of consciousness due to ketoacidosis).
• 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, frequent urination, and muscle stiffness).
• you have severe kidney disease.
• 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 glimepiride.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Glimepiride Pensa:

• 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 any severe liver or kidney disorder.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

It may happen that your hemoglobin levels decrease and you may experience a rupture of red blood cells (hemolytic anemia) if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.

The information available on the use of glimepiride in children 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 can increase the risk of you experiencing hypoglycemia:

• Malnutrition, irregular meal schedule, skipping or delaying meals, 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 medicines (see "Taking Glimepiride Pensa with other medicines").
• If you increase your physical exercise and do not eat enough or take foods with fewer carbohydrates than usual.

The 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 heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to neighboring 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, your breathing may become shallow, and your heart rate may slow down, and you 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. 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 checked. Your doctor may ask for blood tests to check your blood cell count and to see how your liver is working.

Children and adolescents

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

Taking Glimepiride Pensa with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

The following medicines may increase the hypoglycemic effect of Glimepiride Pensa. 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 for reducing high cholesterol levels (fibrates)
• Medicines for reducing high blood pressure (ACE inhibitors)
• Medicines called antiarrhythmics used to control abnormal heart rhythm (disopyramide)
• Medicines for treating gout (allopurinol, sulfinpyrazone, and probenecid)
• Medicines for treating cancer (cyclophosphamide, ifosfamide, and trofosfamide)
• Medicines for weight loss (fenfluramine)
• Medicines for improving circulation when administered at high doses by intravenous infusion (pentoxifylline)
• 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 Pensa. This may lead to a risk of hyperglycemia (high blood sugar):

• Medicines containing female sex hormones (estrogens and 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 used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics)
• Medicines for reducing high cholesterol levels (nicotinic acid)
• Medicines for treating constipation when used for a prolonged period (laxatives)
• Medicines for treating convulsions (phenytoin)
• Medicines for treating nervousness and sleep problems (barbiturics)
• Medicines for increasing eye pressure (acetazolamide)
• Medicines for treating high blood pressure or low blood sugar (diazoxide)
• Medicines for treating infections, tuberculosis (rifampicin)
• Medicines for treating low blood sugar (glucagon)
• The following medicines may increase or decrease the hypoglycemic effect of Glimepiride Pensa: 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 Pensa 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 reduce cholesterol, has an effect on the absorption of Glimepiride Pensa. To avoid this effect, it is recommended to take Glimepiride Pensa at least 4 hours before colesevelam.

Taking Glimepiride Pensa with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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 should not be used during breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

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 disturbances. 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.

Important information about some of the ingredients of Glimepiride Pensa

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

3. How to take Glimepiride Pensa

Follow exactly the administration instructions of Glimepiride indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 score line on the tablet is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

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 plus metformin or glimepiride plus 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 dose 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 Pensa than you should

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 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 the doctor in case of an emergency.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the emergency department of the nearest hospital with this leaflet, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken or administered.

If you forget to take Glimepiride Pensa

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

If you stop taking Glimepiride Pensa

If you stop or interrupt treatment, you should be aware that the desired effect of lowering blood sugar will not be achieved, or the disease may worsen again. Continue taking glimepiride until your doctor tells you to stop.

If you have any other 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 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 (reduction of blood sugar levels) including loss of consciousness, seizures, or coma.

Some patients have suffered the following adverse effects while taking glimepiride:

Rare Adverse Effects(affect up to 1 in 1,000 people)

• Low blood sugar levels (hypoglycemia) (see section 2).
• Reduced number of blood cells:
• • Platelets (which increases the risk of bleeding or bruising).
  • White blood cells (which makes infections more frequent).
  • Red blood cells (which can cause pale skin tone and produce weakness or difficulty breathing).

These alterations usually disappear when treatment with glimepiride is discontinued.

Very Rare Adverse Effects(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.
• Feeling of nausea, vomiting, diarrhea, feeling of heaviness in the stomach or bloating, and stomach pain.
• Decreased sodium levels in the blood (visible in blood tests).

Other Adverse Effects Include:

• Skin allergy (hypersensitivity) such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe reactions with swallowing or breathing difficulties, 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.
• Unusual heavy bleeding or bruising under the skin.

Reporting 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 http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Glimepirida Pensa

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medicine 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 any unused medicines in the SIGRE Point at the pharmacy. 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 Glimepirida Pensa 4 mg Tablets

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

The other components are: lactose monohydrate, microcrystalline cellulose (E-460), sodium glycolate starch from potato, povidone K-30, and magnesium stearate (E-572).

Appearance of the Product and Package Contents

Glimepirida Pensa 4 mg tablets are presented in the form of white, lens-shaped, and scored tablets on one side. Each package contains 30 or 120 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Date of the last revision of this prospectus: July 2018

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