Package Insert: Information for the User

Amaryl 2 mg Tablets

glimepiride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

Package Insert Content

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

Amaryl is a medication that decreases blood sugar levels, taken orally. This medicationbelongs to a group of medicationsthat decrease blood sugar levels calledsulfonilureas. Amaryl increases the amount of insulin released by your pancreas. Insulin decreases your blood sugar levels.

What is Amaryl used for:

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

Do not take Amaryl and talk to 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 components of this medicine (listed in section 6).

-You have diabetes mellitus type 1.

-You have diabetic ketoacidosis (a 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 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 circumstances affect you. If you are unsure,consult your doctor or pharmacist before taking Amaryl.

Warnings and precautions

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

-You have severe liver or kidney dysfunction.

If you are unsure if anything mentioned above affects you, consult your doctor or pharmacist before taking Amaryl.

It may occur that your hemoglobin levels decrease and you develop a red blood cell rupture (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

The available information on the use of Amaryl in people under 18 years 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 have hypoglycemia (low blood sugar). Please see below for more information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of you suffering hypoglycemia:

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

The symptoms of hypoglycemia include:

• 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, slurred speech, tremors, 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, severe and 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 self-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, 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 (such as sugar cubes) with you. 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 and urine levels should be regularly monitored. Your doctor may ask you to have blood tests to check the number of blood cells and see how your liver is functioning.

Children and adolescents

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

Taking Amaryl with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Your doctor may want to change your Amaryl dose if you are taking other medicines that can increase or decrease the effect of Amaryl on your blood sugar levels.

The following medicines may increase the hypoglycemic effect of Amaryl, which may lead to a risk of hypoglycemia:

• 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 lowering high cholesterol levels (fibrates)
• Medicines for lowering high blood pressure (ACE inhibitors)
• Medicines called antiarrhythmics used to control abnormal heart rhythms (disopyramide)
• Medicines for treating gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines for treating cancer (cyclophosphamide, ifosfamide, trophosphamide)
• Medicines used 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 hypoglycemic effect of Amaryl, which may lead to a risk of hyperglycemia:

• Medicines containing female sex hormones (estrogens, progestogens)
• Medicines for treating urinary retention (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, treating asthma or congestion, coughs, and colds, or used in emergency life-threatening situations (adrenaline and sympathomimetics)
• Medicines for lowering high cholesterol levels (nicotinic acid)
• Medicines for treating constipation when used for a prolonged period (laxatives)
• Medicines for treating seizures (phenytoin)
• Medicines for treating nervousness and sleep disorders (barbiturates)
• Medicines for treating increased eye 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 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 mask 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 coagulation (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

The consumption of alcohol may unpredictably increase or decrease the hypoglycemic effect of Amaryl.

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 operating machinery

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 due to these conditions. Please note that this puts you and others at risk (for example, 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 certain sugars, consult him before taking this medicine.

Amaryl contains sodium

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

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

How to take this medication

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not take breakfast, take the medication as your doctor has told you. It is important not to skip any meals while 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 sugar and urine analysis, and will be established by your doctor. Do not take more tablets than your doctor has told you.

• The usual initial dose is one tablet of 1 mg 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 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 doses of Amaryl, so inform your doctor.
• If you estimate that the action 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 have taken too much Amaryl, or an extra dose, there is a risk of hypoglycemia (see section 2), and therefore, you should consume immediately sufficient sugar (for example, sugar cubes, sweet juices, sweet tea), and inform your doctor immediately. When treating a 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. People in a coma should not take or drink anything.

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 also be necessary for safety reasons to be admitted to the hospital. Show the packaging or tablets that are left for your doctor to 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 a doctor in case of an emergency.

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

If you forget to take Amaryl

If you forget a dose, do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Amaryl

If you interrupt or stop treatment, you should be aware that the desired effect of reducing blood sugar will not be achieved or that the disease will worsen again. Continue taking Amaryl 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 can cause side effects, although not everyone will experience them.

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

• Allergic reactions (including blood vessel inflammation, 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 the skin and eyes (jaundice), bile flow problems (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, including loss of consciousness, seizures, 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)

?Low blood sugar levels (hypoglycemia) (see section 2).

?Reduction in the number of blood cells:

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

orWhite blood cells (which makes infections more frequent).

orRed blood cells (which can cause pale skin tone and difficulty breathing).

These changes usually disappear when treatment with Amaryl is stopped.

• Weight gain.
• Hair loss.
• Change in taste.

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

• Allergic reactions (including blood vessel inflammation, 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 the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation (hepatitis), 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).

Frequency not known, cannot be estimated from available data:

• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions can become severe with swallowing or breathing problems, 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 Amaryl. This is due to changes in blood sugar levels and should improve soon.
• Increased liver enzymes.
• Unusual intense bleeding or purpura 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store above 86°F (30°C).

Store in the original packagingto protect it from moisture.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need atthe SIGRE drop-off pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amaryl

Appearance of the product and contents of the package

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

The 2 mg tablets are green.

They are marketed in blister packs of 14, 20, 28, 30, 50, 60, 90, 112, 120, 280, and 300 tablets. Some package sizes and doses may not be available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing:

-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-Brüningstraße50, 65926 Frankfurt

am Main, Germany

• Sanofi-Aventis Private Co.Ltd,Budapest Logistics and Distribution Platform Bdg. DC5, Campona utca1. Budapest, 1225, Hungary

This medicine 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

Last reviewed date of this leaflet: September 2022

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