AMARYL 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amaryl 4 mg Tablets

Glimepiride

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 Package Leaflet

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

1. What is Amaryl and what is it used for

Amaryl 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. Amaryl produces an increase in the amount of insulin released by your pancreas. Insulin lowers your blood sugar levels.

What Amaryl is used for:

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

2. What you need to know before you take Amaryl

Do not take Amaryl and tell your doctor 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).
• You have type 1 diabetes mellitus.
• 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 are in a diabetic coma.
• You have severe kidney disease.
• You have severe liver disease.

Do not take this medicine if any of the above conditions apply to you. If you are not sure, consult your doctor or pharmacist before taking Amaryl.

Warnings and precautions

Tell your doctor or pharmacist before you start taking your medicine if:

• You are recovering from any illness, operation, infection with fever, or other forms of stress. Inform your doctor as you may need to adjust your treatment.
• You have severe liver or kidney problems.

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

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

Information on the use of Amaryl 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 Amaryl, 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, skipping meals or delaying meals, or periods of fasting
• Changes in your diet
• Taking more Amaryl than you need
• Having reduced kidney function
• Having severe liver disease
• Having other hormonal disorders (such as thyroid, pituitary, or adrenal gland problems)
• Taking alcohol (especially if you skip a meal)
• Taking certain medicines (see "Taking Amaryl with other medicines")
• Increasing your physical exercise and not eating enough or taking foods with fewer carbohydrates than usual.

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, slurred speech, tremors, partial paralysis, sensory disturbances, dizziness, feeling of helplessness.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, severe and 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 severe confusion (delirium), have convulsions, lose control, have shallow breathing, and a slower heart rate, 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

Amaryl is not recommended for use in children under 18 years of age.

Taking Amaryl with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may want to change your dose of Amaryl if you are taking other medicines that may increase or decrease the effect of Amaryl on your blood sugar levels.

The following medicines may increase the hypoglycemic effect of Amaryl. 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 lowering high cholesterol levels (fibrates)
• Medicines for lowering high blood pressure (ACE inhibitors)
• Medicines called anti-arrhythmics used to control abnormal heart rhythm (disopyramide)
• Medicines for treating gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines for treating cancer (cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used for weight loss (fenfluramine)
• Medicines for improving circulation when administered at high doses in 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 Amaryl. This may lead to a risk of hyperglycemia (high blood sugar):

• 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 treating high cholesterol levels (nicotinic acid)
• Medicines for treating constipation when used for a long time (laxatives)
• Medicines for treating seizures (phenytoin)
• Medicines for treating nervousness and sleep problems (barbiturates)
• Medicines for treating increased pressure in the eye (acetazolamide)
• Medicines for treating high blood pressure or low blood sugar (diazoxide)
• Medicines for treating infections, tuberculosis (rifampicin)
• Medicines for treating severe low blood sugar (glucagon)

The following medicines may increase or decrease the hypoglycemic effect of Amaryl:

• 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.

Amaryl 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 lower cholesterol, affects the absorption of Amaryl. To avoid this effect, it is recommended to take Amaryl at least 4 hours before colesevelam.

Taking Amaryl with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Amaryl 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

Amaryl may pass into breast milk. Amaryl 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 as a result of these conditions. Keep in mind that this puts 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 few or no warning signs of hypoglycemia.

Amaryl contains lactose

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

Amaryl contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to take Amaryl

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist.

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, take the medicine as your doctor has told you. It is important not to skip any meals when taking Amaryl.
• Swallow the tablet with at least half a glass of water. Do not break or chew the tablets.
• The tablet can be divided into equal doses.

How much to take

The dose of Amaryl 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 usual initial dose is one 1 mg tablet of Amaryl once a 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 Amaryl per day.
• You may start with a combination treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will indicate the appropriate doses of glimepiride, metformin, and insulin for you individually.
• If your weight changes or if you change your lifestyle, or if you are under stress, you may need to change the doses of Amaryl, so you should inform your doctor.
• If you think the effect of Amaryl is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take more Amaryl than you should

If you take too much Amaryl, or an extra dose, there is a risk of hypoglycemia (for symptoms of hypoglycemia, see section 2), and 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 patients should not take 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 also be necessary as a precautionary measure to be hospitalized. 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 a doctor in case of an emergency.

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

If you forget to take Amaryl

If you forget a dose, do not take a double dose to make up for the forgotten doses.

If you stop taking Amaryl

If you stop or discontinue treatment, keep in mind that the desired effect of lowering blood sugar will not be achieved, or the disease may worsen again. Continue taking Amaryl until your doctor tells you to stop.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult your doctor immediately if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often 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, including loss of consciousness, convulsions, or coma.

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

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

?Blood sugar levels lower than normal (hypoglycemia) (see section 2).

?Reduction in the number of blood cells:

oPlatelets (which increases the risk of bleeding or bruising).

oWhite blood cells (which makes infections more frequent).

oRed blood cells (which can make your skin pale and cause weakness or difficulty breathing).

These changes usually disappear when treatment with Amaryl is stopped.

?Weight gain.

?Hair loss.

Change in your sense of taste.

Very rare adverse effects(may affect up to 1 in 10,000 people)

• Allergic reactions (including inflammation of blood vessels, often with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes lead 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 (hepatitis), 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 sodium levels in the blood (visible in blood tests).

Frequency not known, cannot be estimated from available data:

• Allergy (hypersensitivity) on the skin, such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe with swallowing or breathing problems, swelling of the lips, throat, or tongue. Therefore, if you have one 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 Amaryl. 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 of 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 https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amaryl

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Amaryl

• The active ingredient is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components are: lactose monohydrate, sodium glycolate starch (type A), magnesium stearate, microcrystalline cellulose, and povidone 25000.
• In addition, the tablets contain colorants: 4 mg tablets contain aluminum indigo lake (E132).

Appearance of the product and package contents

Each Amaryl tablet is oblong and marked on both sides. Each tablet can be divided into equal doses.

The 4 mg tablets are light blue.

They are marketed in blister packs of 14, 20, 28, 30, 50, 60, 90, 112, 120, 280, and 300 tablets. Only some package sizes and doses may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

• Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France.
• Sanofi S.r.l, Strada Statale 17, Km 22, 67019 Scoppito (L'Aquila), Italy.
• Sanofi-Aventis Deutschland GmbH, Industriepark Höchst-Brüningstraße 50, 65926 Frankfurt am Main, Germany.

This medication is authorized in the member statesof the European Economic Areaand in the United Kingdom (Northern Ireland) with the following names:

• Amaryl: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Romania, Slovakia, Spain, Sweden, United Kingdom
• Amaryl Tablete: Slovenia
• Amaryl Tabletes: Latvia
• Amaryl Tabletès: Lithuania
• Amarylle: Belgium, Luxembourg
• Amarel: France
• Solosa: Greece

Date of the last revision of this prospectus: September 2022

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