GLIMEPIRIDE KERN PHARMA 4 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glimepiride Kern Pharma 4 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 pack:

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

1. What is Glimepiride Kern Pharma and what is it used for

Glimepiride belongs to a group of medicines called oral antidiabetics, which reduce blood sugar levels to normal levels in patients with adult diabetes (type 2 diabetes).

This medicine is prescribed to treat adult diabetes (type 2 diabetes) when diet, physical exercise, and weight reduction alone are not adequate.

2. What you need to know before you take Glimepiride Kern Pharma

Do not take Glimepiride Kern Pharma

• if you are allergic (hypersensitive) to glimepiride, other sulfonylureas or sulfonamides or to any of the other ingredients of Glimepiride Kern Pharma (listed in section 6),
• if you have type 1 diabetes (juvenile diabetes, which corresponds to a defect in insulin production by the pancreas),
• if you are in a diabetic coma (decreased level of consciousness due to ketoacidosis),
• if you have ketoacidosis (metabolic disorder with increased acidity in the blood due to accumulation of ketone bodies),
• if you have severe kidney or liver disorders. In these cases, a change to insulin is required.

Warnings and precautions

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

• if you do not maintain regularity in meals, because treatment may decrease blood sugar levels too much (hypoglycemia),
• if you cannot take glimepiride regularly, as this may favor the appearance of hypoglycemia,
• if you experience symptoms of hypoglycemia (see "Important information about hypoglycemia (low blood sugar)") despite having ingested sugar. If these symptoms are severe or prolonged, you should go to the doctor immediately,
• if you have any kidney or liver disorder, as this may favor the appearance of hypoglycemia. Your doctor will recommend routine checks of renal and hepatic function,
• if you have any metabolic disorder (thyroid, parathyroid, or steroid hormone disorders), as this may favor the appearance of hypoglycemia,
• if you are going to undergo surgery, as your doctor may temporarily suspend treatment and replace it with insulin,
• if you have an accident or infection with fever. It is possible that your doctor will prescribe a temporary change in treatment to insulin,
• if you take glimepiride with insulin or other antidiabetics, as hypoglycemia may appear (see "Use of other medicines").

It may happen that hemoglobin levels decrease and hemolytic anemia (breakdown of red blood cells) occurs in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

Important information about hypoglycemia (low blood sugar)

If you are taking glimepiride, you may experience 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, elimination or delay of meals, periods of fasting.
• Changes in your diet.
• If you take more glimepiride than you need.
• If you have decreased renal function.
• If you have severe liver disease.
• If you have any other hormonal disorder (such as thyroid, pituitary, or adrenal gland problems).
• If you consume alcohol (especially if you skip a meal).
• If you take certain medications (see "Use of 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 heart rate, 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, 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, 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 sugar and urine levels should be regularly checked. Your doctor may ask for blood tests to check the number of blood cells and how your liver is working.

Use of 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.

If you take glimepiride with the following compounds, hypoglycemia (low blood sugar) may occur:

• 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 used 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.

If you take glimepiride with the following compounds, hyperglycemia (high blood sugar) may occur:

• 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 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 (barbiturates),
• medicines for increasing eye pressure (acetazolamide),
• medicines used to treat high blood pressure or low blood sugar (diazoxide),
• medicines for treating infections, tuberculosis (rifampicin),
• medicines for treating severe low blood sugar (glucagon).

If you take glimepiride with the following compounds, both hypoglycemia and hyperglycemia may occur:

• 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 may also increase or decrease the effects of the following medicines:

• medicines that inhibit coagulation (coumarin derivatives such as warfarin).

Taking Glimepiride Kern Pharma with food and drinks

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

Glimepiride should be taken shortly before or during a meal.

Pregnancy and breastfeeding

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 should not be used during breastfeeding.

Driving and using machines:

Consult your doctor or pharmacist before using any medicine.

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 Kern Pharma

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 Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

The basis of satisfactory treatment of diabetes is a good diet, regular physical activity, and regular checks of blood and urine. The negative effects that result from not maintaining the diet cannot be compensated for with tablets or insulin.

The dosage is based on the results of the metabolic examination (determinations of glucose in blood and urine).

The initial dose is 1 mg of glimepiride per day orally. In case of good regulation, this same dose may be used as maintenance treatment.

If the regulation is not satisfactory, your doctor will indicate a gradual increase in the dose up to 2, 3, or 4 mg of glimepiride per day.

Only in exceptional cases is it recommended to take more than 4 mg of glimepiride per day, with a maximum recommended dose of 6 mg of glimepiride per day.

If you experience a hypoglycemic reaction after taking a single dose of 1 mg of glimepiride, inform your doctor, as you may probably be regulated only with diet.

During treatment with glimepiride, it is possible that the dose you need may decrease. Therefore, your doctor may need to adjust the daily dose according to your needs and even interrupt treatment.

If you are being treated with metformin and do not achieve adequate metabolic control, your doctor may complement treatment with glimepiride. To do this, they will indicate the necessary dose of glimepiride to use with metformin.

Your doctor will decide if you need to complement glimepiride treatment with insulin. In this case, they will indicate the dose of insulin you should use with glimepiride tablets.

If you think the effect of glimepiride is too strong or too weak, tell your doctor or pharmacist.

The glimepiride tablets should be swallowed without chewing, with a little liquid.

Normally, a single daily dose of glimepiride is sufficient. It is recommended that you take this dose shortly before or during a large breakfast or, if you do not have breakfast, shortly before or during the first meal.

Your doctor will indicate the duration of your treatment with Glimepiride Kern Pharma. Do not stop your treatment before this, as your blood sugar level may become unbalanced again.

Use in children

Glimepiride Kern Pharma has not been studied in children.

Elderly people

No specific studies have been conducted in elderly people.

Due to the fact that biological functions may be decreased, your doctor will adjust the dose with greater caution and more intense monitoring will be necessary.

If you take more Glimepiride Kern Pharma than you should

You may experience an excessive reduction in blood sugar (see "Warnings and precautions") that can last from 12 to 72 hours and may even recur after an initial recovery. The symptoms may appear even 24 hours after ingestion. If this happens, go to the doctor or the emergency department of the nearest hospital, taking this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Glimepiride Kern Pharma

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

If you stop taking Glimepiride Kern Pharma

If you stop or interrupt treatment, you should keep in mind 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 questions about the use of this product, 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).
• 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 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.
• Decrease in blood sodium levels (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 intense 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 Kern Pharma

No special storage conditions are required.

Keep this medicine 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 unused medicines at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Glimepirida Kern Pharma

• The active ingredient is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch type A (potato), povidone, magnesium stearate, and aluminum indigo lacquer (E132).

Appearance of the Product and Packaging Content

Glimepirida Kern Pharma 4 mg is presented in the form of oblong tablets, blue in color, and scored on both sides. Each package contains 30 or 120 tablets (standard package), or 500 tablets (clinical package).

Other presentations:

Glimepirida Kern Pharma 2 mg tablets EFG. Standard packages of 30 or 120 tablets, or clinical package of 500 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Manufacturer

Edmond Pharma S.R.L.

Strada Statale dei Giovi No. 131

20037 Paderno Dugnano

Milan (Italy)

or

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: June 2015

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/.