PATIENT INFORMATION LEAFLET

Glimepiride Pensa 4 mg Tablets EFG

Glimepirida Pensa is a medication that lowers blood sugar levels, taken orally. This medication belongs to a group of medications that lower blood sugar levels called sulfonylureas. Glimepirida Pensa increases the amount of insulin released by the pancreas. Insulin lowers blood sugar levels.

What is Glimepirida Pensa used for:

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

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 to any of the other components of this medicine (listed in section 6).
• You have type 1 diabetes (insulin-dependent diabetes mellitus).
• You are experiencing diabetic coma (decreased level of consciousness due to ketoacidosis).
• You have diabetic ketoacidosis (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).
• You have severe kidney disease.
• 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 glimepiride.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glimepiride Pensa:

• If you are recovering from any 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.
• If you have any severe liver or kidney impairment.

If you are unsure whether anything mentioned above affects you, consult your doctor or pharmacist before taking this medicine.

It may occur that your haemoglobin levels decrease and you may experience a rupture of red blood cells (haemolytic anaemia) 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 hypoglycaemia (low blood sugar)

If you are taking glimepiride, you may experience hypoglycaemia (low blood sugar). Please see below for more information about hypoglycaemia, its symptoms, and treatment.

The following factors may increase the risk of you experiencing hypoglycaemia:

• Malnutrition, irregular meal times, omission or delay of meals, fasting periods.
• Changes in your diet.
• Taking more glimepiride than you need.
• Having reduced renal function.
• Having severe liver disease.
• Having any other hormonal disorder (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).
• Consuming alcohol (especially if you miss a meal).
• Taking certain medicines (see "Taking Glimepiride Pensa with other medicines").
• Increasing your physical exercise and not eating enough or consuming foods with fewer carbohydrates than usual.

The symptoms of hypoglycaemia include:

• Feeling of empty stomach, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, feeling of abandonment.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, 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), convulsions, loss of self-control, shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of severe hypoglycaemia resembles a stroke.

Treatment of hypoglycaemia

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 with you (e.g. sugar cubes). 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 levels and urine sugar levels should be regularly monitored. Your doctor may ask you to have blood tests to check your blood cell count and see how well your liver is functioning.

Children and adolescents

Glimepiride Pensa is not recommended for use in children under 18 years.

Taking Glimepiride Pensa with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those purchased 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 hypoglycaemic effect of Glimepiride Pensa, which may lead to a risk of hypoglycaemia (low blood sugar):

• Other medicines for treating diabetes mellitus (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 diluting 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 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 trophosphamide)
• Medicines for weight loss (fenfluramine)
• Medicines for increasing circulation when administered at high doses in intravenous infusion (pentoxifylline)
• 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 hypoglycaemic effect of Glimepiride Pensa, which may lead to a risk of hyperglycaemia (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 congestion, coughs, and colds, or used in emergency life-threatening situations (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 convulsions (phenytoin)
• Medicines for treating nervousness and sleep disorders (barbiturates)
• Medicines for increasing intraocular pressure (acetazolamide)
• Medicines for treating high blood pressure or low blood sugar levels (diazoxide)
• Medicines for treating infections, tuberculosis (rifampicin)
• Medicines for treating severe low blood sugar levels (glucagon)
• The following medicines may increase or decrease the hypoglycaemic 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 mask the symptoms of hypoglycaemia, 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 coagulation (coumarin derivatives such as warfarin).
• Colesevelam, a medicine used to reduce cholesterol, affects 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

The consumption of alcohol may increase or decrease the hypoglycaemic effect of Glimepiride Pensa in an unpredictable manner.

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 operating machinery

Your ability to concentrate and react may be affected due to the symptoms caused by hypoglycaemia or hyperglycaemia, such as visual disturbances. This may be hazardous in situations where these skills are important (e.g. driving or operating machinery). Therefore, consult your doctor if it is recommended to drive or operate machinery.

Important information about some of the components of Glimepiride Pensa

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

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

Glimepiride Dosage

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not take breakfast, take the product 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 groove on the tablet is only for breaking the tablet if it is difficult to swallow it whole.

How much to take

The dose of glimepiride depends on your needs, condition, and results of your blood sugar analysis and will be established 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 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 dose of glimepiride, so inform your doctor.
• If you estimate that the action 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 a higher dose, there is a risk of hypoglycemia (see section 2 for hypoglycemia symptoms), and therefore, you must 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 must be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. People in a coma should not take any 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 be necessary as a safety measure to be admitted to the hospital. Show the packaging or remaining tablets to your doctor so that they 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 hospital admission. 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 nearest hospital emergency department accompanied by this leaflet, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested or administered.

If you forgot to take Glimepiride Pensa

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

If you interrupt the treatment with Glimepiride Pensa

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 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 insufficiency.
• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may become severe.
• Severe hypoglycemia (reduction of blood sugar levels) including loss of consciousness, seizures, or coma.

Some patients have experienced the following side effects while taking glimepiride:

Rare side effects(affect up to 1 in 1,000 people)

• Low blood sugar levels (hypoglycemia) (see section 2).
• Reduction in the 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 may cause pale skin tone and difficulty breathing).

These changes usually disappear when treatment with glimepiride is discontinued.

Very rare side effects(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, or liver insufficiency. 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).

Other side effects include:

• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may become severe reactions with difficulty swallowing or breathing, 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 bruising 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No requires special conditions for conservation.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears after “CAD” on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the 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 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 potato starch, polyvidone K-30, and magnesium stearate (E-572).

Appearance of the product and content of the packaging

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

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Last review date of this leaflet: July 2018

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