Amaril 1

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 you need to.
• If you have 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. The action of Amaryl is to increase the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What is Amaryl used for:

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

2. Important information before taking Amaryl

When not to take Amaryl:

• if you are 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 you have insulin-dependent diabetes (type 1 diabetes),
• if you have 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 you have diabetic coma,
• if you have severe kidney dysfunction,
• if you have severe liver dysfunction.

You should not take this medicine if you have any of the above conditions. If you have any doubts, you should consult a doctor or pharmacist before taking Amaryl.

Warnings and precautions

You should discuss the use of Amaryl with your doctor or pharmacist before starting treatment.

You should consult a doctor or pharmacist before taking Amaryl if:

• you have had an injury, surgery, infection with fever, or other stressful situation; you should inform your doctor, as a temporary change in treatment may be necessary
• you have liver or kidney dysfunction.

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

Important information about hypoglycemia (low blood sugar)

While taking Amaryl, you 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:

• disability (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 dysfunction,
• severe liver dysfunction,
• certain hormonal disorders (e.g. thyroid, pituitary, or adrenal 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 large or the food contained less carbohydrates than usual,
• taking Amaryl without any indications for its use.

The symptoms of hypoglycemia include:

• uncontrolled hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, concentration and attention disorders, depression, disorientation, speech and vision disorders, aphasia (speech disorders), tremors, weakness, sensation disorders, dizziness, feeling of helplessness.
• the following may also occur: 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 following may occur: confusion (delirium), seizures, loss of self-control, shallow breathing, and slow heart rate, and may lead to loss of consciousness, including coma.

Low blood sugar may cause symptoms similar to those of a stroke.

Treatment of hypoglycemia:

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

Laboratory tests

You should regularly check your blood or urine sugar levels. Your doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Amaryl and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your 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 hormonal disorders,
• 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 the symptoms of hypoglycemia, so caution is advised when taking them.

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

• medicines that prevent blood clotting (coumarin derivatives, e.g. warfarin).

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

Your ability to concentrate or react quickly may be impaired due to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). You should be aware that you may pose a risk to yourself or others (e.g. when driving or operating machinery). Patients should consult their doctor whether they can drive or operate machinery if:

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

Amaryl contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult a doctor before taking this 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

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, you should consult a doctor or pharmacist.

Administration

The medicine should be taken orally, immediately before or during the first meal of the day (usually breakfast) or another main meal. The medicine should be taken as directed by your doctor. If you are taking Amaryl, you should follow the recommended diet. The tablet should be swallowed without chewing or crushing, with a liquid.

Recommended dose

The dose of Amaryl depends on your condition and the results of your blood and urine sugar tests, and is determined by your doctor. You should not take more tablets than recommended by your doctor.

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

Taking a higher dose of Amaryl than recommended

Taking too many Amaryl tablets or taking an additional dose is dangerous for you, as there is a risk of hypoglycemia (symptoms of hypoglycemia see section 2. Warnings and precautions). In this case, you should 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, the amount of sugar given to them must be controlled to avoid the risk of hyperglycemia. Unconscious patients should not be given food or drink. In case of prolonged hypoglycemia, it is very important that the patient is under medical supervision until the danger has passed. It may be necessary to hospitalize the patient as a precaution. You should show your 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. You should 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

You should not take a double dose to make up for a missed dose.

Stopping treatment with Amaryl

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

4. Possible side effects

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

You should 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 dysfunction, 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 may develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• Severe hypoglycemia, loss of consciousness, seizures, or coma.

In some patients taking Amaryl, the following side effects have occurred:
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 may cause pale skin and weakness or shortness of breath (erythropenia, hemolytic anemia),
• platelets, white and red blood cells, which may cause a deficiency of these blood elements (pancytopenia). These disorders usually disappear after stopping treatment with 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 dysfunction, 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 the 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 the 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 may 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, you should 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:
Jerozolimskie Avenue 181 C, 02-222 Warsaw.
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Amaryl

The medicine should be stored out of sight and reach of children.
You should not take 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.
You should not store the medicine at a temperature above 30°C.
You should not take Amaryl if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. You should 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 of Amaryl 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

Amaryl tablets of all strengths 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

For more information, please contact the representative of the marketing authorization holder in Poland:

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

Date of last revision of the leaflet: