Amaril 2

Leaflet accompanying the packaging: patient information

AMARYL 1, 1 mg, tablets

AMARYL 2, 2 mg, tablets

AMARYL 3, 3 mg, tablets

AMARYL 4, 4 mg, tablets

Glimepiride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Amaryl and what is it used for
• 2. Important information before taking Amaryl
• 3. How to take Amaryl
• 4. Possible side effects
• 5. How to store Amaryl
• 6. Contents of the packaging and other information

1. What is Amaryl and what is it used for

Amaryl is an oral medicine that reduces blood sugar levels. It belongs to a group of medicines that reduce blood sugar levels called sulfonylureas. Amaryl works by increasing the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What Amaryl is used for:

• Amaryl is used to treat type 2 diabetes, when diet, exercise, and weight loss alone cannot control blood sugar levels.

2. Important information before taking Amaryl

When not to take Amaryl:

• if the patient is allergic to glimepiride or other sulfonylureas (medicines used to reduce blood sugar levels, e.g., glibenclamide) or sulfonamides (medicines used to treat bacterial infections, e.g., sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6),
• if the patient has insulin-dependent diabetes (type 1 diabetes),
• if the patient has diabetic ketoacidosis (a complication of diabetes that causes an increase in acid levels in the body; symptoms may include fatigue, nausea, frequent urination, and muscle stiffness),
• if the patient has a diabetic coma,
• if the patient has severe kidney problems,
• if the patient has severe liver problems.

Do not take the medicine if any of the above conditions occur. In case of any doubts, consult a doctor or pharmacist before taking Amaryl.

Warnings and precautions

Before starting Amaryl, discuss it with your doctor or pharmacist.

Consult a doctor or pharmacist before taking Amaryl if:

• the patient has had an injury, surgery, infection with fever, or other stressful situation; inform your doctor, as a temporary change in treatment may be necessary
• the patient has liver or kidney problems.

In case of any doubts, consult a doctor or pharmacist before taking Amaryl. Patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). Information on the use of Amaryl in patients under 18 years of age is limited. The use of the medicine is not recommended in this patient group.

Important information about hypoglycemia (low blood sugar)

While taking Amaryl, the patient may experience hypoglycemia (low blood sugar). Below are additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• neglect (more common in elderly patients) or inability to cooperate,
• malnutrition, irregular meals, or skipping meals,
• change in diet,
• taking a higher dose of Amaryl than necessary (overdose),
• kidney problems,
• severe liver problems,
• certain hormonal disorders (e.g., thyroid, pituitary, or adrenal gland disorders),
• alcohol consumption, especially with skipped meals,
• concomitant use of certain other medicines (see Amaryl and other medicines),
• performing more physical activity than usual, if the meal was not sufficiently filling or contained less carbohydrates than usual,
• taking Amaryl without any indications.

Hypoglycemia symptoms include:

• uncontrolled hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, concentration, attention, and reaction time disorders, depression, disorientation, speech and vision disorders, aphasia (speech disorders), tremors, weakness, sensation disorders, dizziness, feeling of helplessness.
• other symptoms may include: sweating, moist skin, restlessness, rapid heartbeat, increased blood pressure, palpitations, sudden severe chest pain that may radiate to adjacent parts of the body (angina pectoris or irregular heartbeat).

If blood sugar levels continue to decrease, the patient may experience: confusion (delirium), seizures, loss of self-control, shallow breathing, and slow heart rate, and may even lose consciousness, including coma. Low blood sugar can cause symptoms similar to a stroke.

Treating hypoglycemia:

In many cases, low blood sugar symptoms disappear quickly after consuming some types of sugar, such as sugar cubes, sweet juice, or sweetened tea. Always carry sugar with you (e.g., sugar cubes). Remember that artificial sweeteners are not effective in treating hypoglycemia. Consult a doctor or go to the hospital if sugar consumption does not relieve hypoglycemia symptoms.

Lab tests

Regularly check blood or urine sugar levels. The doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Amaryl and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. The doctor may decide to change the dose of Amaryl if you are taking other medicines that may weaken or enhance the effect of Amaryl on blood sugar levels. The following medicines may increase the effect of Amaryl on blood sugar levels, which may lead to hypoglycemia (low blood sugar):

• other diabetes medicines (e.g., insulin or metformin),
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines with a similar effect to acetylsalicylic acid),
• medicines used to treat urinary tract infections (including some long-acting sulfonamides),
• medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolone antibiotics, clarithromycin),
• anticoagulant medicines (coumarin derivatives, e.g., warfarin),
• medicines that promote muscle growth (anabolic steroids),
• medicines used to treat male hormone deficiencies,
• medicines used to treat depression (fluoxetine, MAO inhibitors),
• medicines used to lower high cholesterol levels (fibrates),
• medicines used to lower high blood pressure (ACE inhibitors),
• antiarrhythmic medicines used to prevent heart rhythm disorders (disopyramide),
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone),
• medicines used to treat cancer (cyclophosphamides, ifosfamides, trofosfamides),
• medicines used to reduce weight (fenfluramine),
• medicines used to improve circulation, administered intravenously in high doses (pentoxifylline),
• medicines used to treat nasal allergies, e.g., hay fever (tritoqualine),
• medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms,
• phenyramidol,
• guanethidine.

The following medicines may decrease the effect of Amaryl on blood sugar levels, which may lead to hyperglycemia (high blood sugar):

• medicines containing female sex hormones (estrogens, progestogens),
• diuretics, saluretics,
• medicines that stimulate the thyroid gland (e.g., levothyroxine),
• medicines used to treat allergies and inflammation (glucocorticosteroids),
• medicines used to treat severe mental disorders (chlorpromazine and phenothiazine derivatives),
• medicines used to treat rapid heartbeat, asthma, or nasal congestion, cough, and cold, to reduce weight, or used in emergency situations (adrenaline and sympathomimetics),
• medicines used to lower high cholesterol levels (nicotinic acid and its derivatives),
• medicines used to treat constipation, used for a long time (laxatives),
• medicines used to treat epilepsy (phenytoin),
• medicines used to treat nervousness and sleep disorders (barbiturates),
• medicines used to treat increased eye pressure (acetazolamide),
• medicines used to treat high blood pressure and low blood sugar (diazoxide),
• medicines used to treat infections, tuberculosis (rifampicin),
• medicines used to treat life-threatening low blood sugar (glucagon).

The following medicines may increase or decrease the effect of Amaryl on blood sugar levels:

• medicines used to treat stomach ulcers (H2 receptor antagonists),
• medicines used to treat high blood pressure or heart failure, e.g., beta-blockers, clonidine, and reserpine. These medicines may also weaken hypoglycemia symptoms, so caution is advised when taking them.

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

• blood clotting inhibitors (coumarin derivatives, e.g., warfarin).

Colesevelam (a bile acid sequestrant) binds to Amaryl and reduces its absorption from the gastrointestinal tract. This interaction was not observed when Amaryl was administered at least 4 hours before colesevelam. Therefore, Amaryl should be administered at least 4 hours before colesevelam.

Amaryl with food, drink, and alcohol

Alcohol consumption may enhance or weaken the effect of Amaryl in an unpredictable way.

Pregnancy, breastfeeding, and fertility

Amaryl should not be taken during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine. Amaryl may pass into breast milk. There is no data on the effect on fertility.

Driving and using machines

The ability to concentrate or react quickly may be impaired due to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Be aware that you may pose a risk to yourself or others (e.g., when driving or operating machines). Patients should consult a doctor to determine if they can drive or operate machines, especially if:

• they often experience hypoglycemia,
• hypoglycemia warning symptoms are weakened or do not occur.

Amaryl contains lactose

If you have been diagnosed with an intolerance to some sugars, consult a doctor before taking the medicine.

Amaryl contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Amaryl

Always take this medicine exactly as your doctor has told you. If you are not sure, consult a doctor or pharmacist.

How to take the medicine

Take the medicine orally, immediately before or during the first meal of the day (usually breakfast) or another main meal. Take the medicine as recommended by your doctor. If you are taking Amaryl, follow the recommended diet. Swallow the tablet without chewing or crushing, with a drink.

Recommended dose

The dose of Amaryl depends on the patient's condition and blood sugar and urine test results, and is determined by the doctor. Do not take more tablets than recommended by your doctor.

• The initial dose is one 1 mg Amaryl tablet per day.
• The doctor may increase the dose after 1-2 weeks of therapy if necessary.
• The maximum recommended dose is 6 mg of Amaryl per day.
• The doctor may recommend taking glimepiride with metformin or glimepiride with insulin. In this case, the doctor will recommend the appropriate, individually determined doses of glimepiride with metformin or insulin.
• If there are changes in weight, lifestyle, or if the patient is under stress, inform the doctor so that they can adjust the dose if necessary.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself; consult a doctor.

Taking a higher dose of Amaryl than recommended

Taking too many Amaryl tablets or an additional dose is dangerous for the patient, as there is a risk of hypoglycemia (hypoglycemia symptoms, see section 2. Warnings and precautions). In this case, immediately consume a sufficient amount of sugar (e.g., small sugar cubes, sweet juice, sweetened tea) and inform your doctor as soon as possible. Treatment of hypoglycemia in children who have accidentally taken the medicine requires controlled sugar intake to avoid the risk of hyperglycemia. Do not give food or drink to unconscious persons. In case of prolonged hypoglycemia, it is very important for the patient to be under medical supervision until the danger has passed. It may be necessary to hospitalize the patient as a precaution. Show the doctor the packaging or remaining tablets so that they know what medicine was taken. Severe cases of hypoglycemia with loss of consciousness and severe neurological disorders require immediate medical attention, usually in a hospital. Make sure that someone who is aware of the situation is always nearby to call a doctor in case of an emergency.

Missing a dose of Amaryl

Do not take a double dose to make up for a missed dose.

Stopping Amaryl treatment

After stopping Amaryl, the achieved reduction in blood sugar levels will not be maintained, and the disease may worsen. Take Amaryl for as long as your doctor recommends. If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Immediately consult a doctor if you experience the following symptoms:

• Allergic reactions (including vasculitis, often with rash), which can develop into severe reactions with difficulty breathing, decreased blood pressure, and even shock.
• Liver problems, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure.
• Skin allergy (hypersensitivity) with itching, rash, hives, photosensitivity. Some mild allergic reactions can develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• Severe hypoglycemia, loss of consciousness, seizures, or coma.

Some patients taking Amaryl have experienced the following side effects: Rare(may occur in up to 1 in 1000 patients)

• Lower than normal blood sugar levels (hypoglycemia, see section 2. Important information before taking Amaryl, subsection Warnings and precautions).
• Decreased blood cell count, such as:
• platelets, which increases the risk of bleeding or bruising (thrombocytopenia),
• white blood cells, which increases the risk of infection (leukopenia, granulocytopenia, agranulocytosis),
• red blood cells, which can cause pale skin and weakness or shortness of breath (erythropenia, hemolytic anemia),
• platelets, white blood cells, and red blood cells, which can cause a lack of these blood elements (pancytopenia). These disorders usually disappear after stopping Amaryl.

Very rare(may occur in up to 1 in 10,000 patients)

• Allergic reactions (including vasculitis, often with rash), which can develop into severe reactions with difficulty breathing, decreased blood pressure, and even shock.
• Liver problems, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure.
• Nausea, vomiting, diarrhea, bloating, discomfort in the abdominal cavity, and abdominal pain.

Frequency not known(frequency cannot be estimated from available data)

• Taste disorders.
• Hair loss.
• Significant decrease in platelet count (below 10,000/microliter) and cases of thrombocytopenic purpura.
• Visual disturbances, especially at the beginning of treatment. This is due to changes in blood sugar levels, and symptoms should disappear quickly.
• Increased liver enzyme activity (in blood tests).
• Allergic reactions to sulfonylureas, sulfonamides, or related medicines may occur.
• Skin allergy (hypersensitivity) with itching, rash, hives. Some mild allergic reactions can develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• The active substance of Amaryl, glimepiride, like all sulfonylureas, may cause weight gain and hypersensitivity to sulfonylureas, sulfonamides, or related medicines.
• Decreased sodium levels in the blood (in blood tests), allergic vasculitis, photosensitivity.

Reporting side effects If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw. Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amaryl

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "Expiry date (EXP):". The expiry date refers to the last day of the month. Do not store above 30°C. Do not use Amaryl if signs of deterioration are visible. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amaryl contains

• The active substance is glimepiride. Each tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of glimepiride, depending on the dose indicated on the blister and carton.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose, povidone 25,000.
• The tablets also contain dyes:
• 1 mg tablets contain iron oxide red (E172),
• 2 mg tablets contain iron oxide yellow (E172) and indigo carmine lake (E132),
• 3 mg tablets contain iron oxide yellow (E172),
• 4 mg tablets contain indigo carmine lake (E132).

What Amaryl looks like and contents of the packaging

All strengths of Amaryl tablets are oblong and scored on both sides. The tablets can be divided into two equal doses along the score line. The tablets differ in color depending on the dose:

• 1 mg are pink,
• 2 mg are green,
• 3 mg are light yellow,
• 4 mg are light blue.

The packaging contains 30 or 120 tablets in blisters, placed in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65926 Frankfurt am Main Germany

Manufacturer

Sanofi S.r.l., Strada Statale 17 Km 22, 67019 Scoppito (AQ), Italy Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France

To obtain more detailed information, contact the representative of the marketing authorization holder in Poland:

Sanofi Sp. z o.o. ul. Marcina Kasprzaka 6 01-211 Warsaw tel.: +48 22 280 00 00

Date of last revision of the leaflet: