PROSPECTO: INFORMATION FOR THE USER

Glimepiride Kern Pharma 4 mg tablets EFG

Read this prospect carefully before starting to take the medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you, and you must 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 not listed in this prospect. See section 4.

Glimepirida belongs to a group of medications known as oral antidiabetics, which reduce blood glucose to normal levels in adult patients with diabetes (type 2 diabetes).

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

Do not take Glimepirida Kern Pharma

• if you are allergic (hypersensitive) to glimepiride, other sulfonylureas or sulfonamides or to any of the components of Glimepirida 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 experiencing diabetic coma (decreased level of consciousness due to ketoacidosis),
• if you are experiencing ketoacidosis (metabolic disorder with increased blood acidity due to accumulation of ketone bodies),
• if you have severe kidney or liver dysfunction. 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 a regularity in meals, as the 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 seek medical attention immediately,
• if you have any kidney or liver dysfunction, as this may favor the appearance of hypoglycemia. Your doctor will recommend routine monitoring 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 to undergo surgery, as your doctor may temporarily suspend treatment and replace it with insulin,
• if you have an accident or any infection with fever. Your doctor may prescribe a temporary change in treatment to insulin,
• if you take glimepiride with insulin or other antidiabetic drugs, as hypoglycemia may appear (see "Use of other medications").

Hypoglycemia may occur in patients who lack an enzyme called glucose-6-phosphate dehydrogenase, leading to hemolytic anemia.

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 symptoms, and treatment.

Factors that may increase the risk of hypoglycemia:

• Malnutrition, irregular meal times, skipping or delaying meals, fasting periods.
• Changes in your diet.
• Taking more glimepiride than needed.
• Having reduced kidney function.
• Having severe liver disease.
• Having any other hormonal disorder (such as thyroid, pituitary, or adrenal gland disorders).
• Consuming alcohol (especially if you skip a meal).
• Taking certain medications (see "Use of other medications").
• Increasing physical activity and not eating enough or consuming foods with fewer carbohydrates than usual.

Symptoms of hypoglycemia:

• Empty stomach sensation, 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 heart rate, 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), seizures, loss of control, shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of severe hypoglycemia resembles a stroke.

Treatment of hypoglycemia

In most cases, hypoglycemia symptoms disappear quickly when you consume sugar, 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 seek hospital attention if, after consuming sugar, you do not recover or if symptoms recur.

Blood tests

Your blood sugar and urine levels should be regularly monitored. Your doctor may request blood tests to check the number of blood cells and how well your liver is functioning.

Use of other medications

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

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

• other medications for treating diabetes mellitus (such as insulin or metformin),
• medications for treating pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone; and aspirin derivatives),
• medications for treating urinary tract infections (such as some sulfonamides with prolonged action),
• medications for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
• medications for diluting blood (cumarinic derivatives such as warfarin),
• anabolic steroids used to increase muscle mass,
• medications used in hormone replacement therapy in men,
• medications for treating depression (fluoxetine, MAO inhibitors),
• medications for lowering high cholesterol levels (fibrates),
• medications for lowering high blood pressure (ACE inhibitors),
• medications called antiarrhythmics used to control abnormal heart rhythm (disopyramide),
• medications for treating gout (allopurinol, sulfinpyrazone, and probenecid),
• medications for treating cancer (cyclophosphamide, ifosfamide, and trophosphamide),
• medications used to lose weight (fenfluramine),
• medications for increasing circulation when administered at high doses in intravenous infusion (pentoxifylline),
• medications for treating allergic rhinitis such as hay fever (tritoqualine),
• medications called sympatholytics for treating high blood pressure, heart failure, or prostatic symptoms.

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

• medications containing female sex hormones (estrogens, progestogens),
• medications for increasing urine production (thiazide diuretics),
• medications used to stimulate the thyroid gland (such as levothyroxine),
• medications for treating allergies and inflammation (glucocorticoids),
• medications for treating severe mental disorders (chlorpromazine and other phenothiazine derivatives),
• medications for increasing heart rate, treating asthma or congestion, coughs, and colds, or used in emergency situations threatening life (adrenaline and sympathomimetics),
• medications for lowering high cholesterol levels (nicotinic acid),
• medications for treating constipation when used for a prolonged period (laxatives),
• medications for treating seizures (phenytoin),
• medications for treating anxiety and sleep disorders (barbiturates),
• medications for increasing intraocular pressure (acetazolamide),
• medications used to treat high blood pressure or low blood sugar (diazoxide),
• medications for treating infections, tuberculosis (rifampicin),
• medications for treating severe low blood sugar (glucagon).

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

• medications for treating stomach ulcers (called H2 antagonists),
• medications for treating high blood pressure or heart failure as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the symptoms of hypoglycemia, so special care is needed when taking these medications.

Glimepiride may also increase or decrease the effects of the following medications:

• medications that inhibit blood coagulation (cumarinic derivatives such as warfarin).

Taking Glimepirida Kern Pharma with food and drinks

Consuming alcohol may unpredictably increase or decrease the hypoglycemic effect of this medication.

Glimepiride should be taken shortly before or during a meal.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

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.

Lactation

Glimepiride may pass into breast milk. Glimepiride should not be used during lactation.

Driving and operating machinery:

Consult your doctor or pharmacist before using any medication.

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as visual disturbances.

This may be hazardous in situations where these skills are essential (e.g., driving or operating machinery). Therefore, consult your doctor if it is recommended to drive or operate machinery.

Important information about some components of Glimepirida Kern Pharma

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

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

Remember to take your medication.

The basis of satisfactory diabetes treatment lies in a good diet, regular physical activity, and regular blood and urine tests. The negative effects resulting from not maintaining the diet cannot be compensated by tablets or insulin.

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

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

If 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, it is recommended to take more than 4 mg of glimepiride per day, with the maximum recommended dose being 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 be regulated solely by 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 discontinue treatment.

If you are being treated with metformin and do not achieve adequate metabolic control, your doctor may complement the treatment with glimepiride. In this case, he will indicate the necessary dose of glimepiride to be used in conjunction with metformin.

Your doctor will decide if you need to complement glimepiride treatment with insulin. In that case, he will indicate the dose of insulin you will need to take in conjunction with glimepiride tablets.

If you estimate that the action of glimepiride is too strong or too weak, inform your doctor or pharmacist.

Glimepiride tablets should be swallowed without chewing, accompanied by a small amount of liquid.

Normally, a daily dose of glimepiride is sufficient. It is recommended that you take this dose a little before or during a generous breakfast or, if you do not take it, a little before or during the first meal.

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

Use in children

Glimepirida Kern Pharma has not been studied in children.

Older adults

No specific studies have been conducted in older adults.

Since biological functions may be decreased, your doctor will adjust the dose with greater caution and close monitoring will be necessary.

If you take more Glimepirida Kern Pharma than you should

You may cause an excessive reduction in blood sugar (see "Warnings and precautions") that may last from 12 to 72 hours and even recur after initial recovery. Symptoms may appear even 24 hours after ingestion. If this occurs, visit your doctor or the nearest hospital emergency service, bringing 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 medication and the amount ingested.

If you forgot to take Glimepirida Kern Pharma

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

If you interrupt treatment with Glimepirida Kern Pharma

If you interrupt or discontinue 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 product, 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 can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock.
• Abnormal liver function, including yellowing of 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 can 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 can 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 can 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 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 can 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 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 for 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 special storage conditions are required.

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications you no longer need. By doing so, you will help protect the environment.

Composition of Glimepiride Kern Pharma

• The active ingredient is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (from potato), povidone, magnesium stearate, and aluminum indigotin lake (E132).

Appearance of the product and content of the packaging

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

Other presentations:

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

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Responsible for manufacturing

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

Last review date of this leaflet: June 2015

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