Amaril 2

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Amaryl 2 (Amaryl 2 mg)

2 mg, tablets

Glimepiride
Amaryl 2 and Amaryl 2 mg are different trade names for the same drug.

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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Amaryl 2 and what is it used for

Amaryl 2 is an oral anti-diabetic medicine that reduces blood sugar levels. It belongs to a group of anti-diabetic medicines called sulfonylureas. The action of Amaryl 2 is based on increasing the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What is Amaryl 2 used for:

• Amaryl 2 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 2

When not to take Amaryl 2:

• if you are allergic to glimepiride or other sulfonylureas (drugs used to lower blood sugar levels, e.g., glibenclamide) or sulfonamides (drugs 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 tiredness, nausea, frequent urination, and muscle stiffness),
• if you have a diabetic coma,
• if you have severe kidney problems,
• if you have severe liver problems.

Do not take the medicine if you have any of the above conditions. In case of any doubts, consult your doctor or pharmacist before taking Amaryl 2.

Warnings and precautions

Before starting treatment with Amaryl 2, discuss it with your doctor or pharmacist.

Consult your doctor or pharmacist before taking the medicine 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 problems.

In case of any doubts, consult your doctor or pharmacist before taking Amaryl 2.
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 2 in children under 18 years of age is limited. The use of the medicine is not recommended in this age group.

Important information about hypoglycemia (low blood sugar levels)

While taking Amaryl 2, you may experience hypoglycemia (low blood sugar levels). Below are additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• unwillingness (more common in elderly patients) or inability to cooperate,
• malnutrition, irregular meals, or skipping meals,
• change in diet,
• taking a higher dose of Amaryl 2 than necessary (overdose),
• kidney problems,
• severe liver problems,
• certain hormonal disorders (e.g., thyroid, pituitary, or adrenal gland disorders),
• consumption of alcohol, especially when skipping meals,
• taking certain other medicines (see "Amaryl 2 and other medicines"),
• performing more physical exercise than usual, if the meal was not sufficiently filling or the food contained less carbohydrates than usual,
• taking Amaryl 2 without any indications.

The symptoms of hypoglycemia include:

• uncontrollable 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,
• additional 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 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.
A decrease in blood sugar levels may cause symptoms similar to those of a stroke.

Treatment of hypoglycemia

In many cases, the symptoms of low blood sugar levels 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).
Remember that artificial sweeteners are not effective in treating hypoglycemia (low blood sugar levels). You should consult your doctor or go to the hospital if consuming sugar does not relieve the symptoms of hypoglycemia.

Lab 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 2 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor may decide to change the dose of Amaryl 2 if you are taking other medicines that may weaken or enhance the effect of Amaryl 2 on blood sugar levels.
The following medicines may increase the effect of Amaryl 2 on blood sugar levels, which may lead to hypoglycemia (low blood sugar levels):

• other anti-diabetic 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 supplement male sex hormones,
• medicines used to treat depression (fluoxetine, MAO inhibitors),
• medicines that lower high cholesterol levels (fibrates),
• medicines that lower high blood pressure (ACE inhibitors),
• anti-arrhythmic 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 increase circulation, administered intravenously in high doses (pentoxifylline),
• medicines used to treat nasal allergies, e.g., hay fever (tritoqualine),
• medicines called sympathomimetics used to treat high blood pressure, heart failure, or prostate symptoms,
• phenyramidol,
• guanethidine.

The following medicines may reduce the effect of Amaryl 2 on blood sugar levels, which may lead to hyperglycemia (high blood sugar levels):

• 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 treat 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 levels (diazoxide),
• medicines used to treat infections, tuberculosis (rifampicin),
• medicines used to treat life-threatening low blood sugar levels (glucagon).

The following medicines may increase or reduce the effect of Amaryl 2 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 2 may increase or reduce the effect of the following medicines:

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

Colesevelam (a bile acid sequestrant) binds to Amaryl 2 and reduces its absorption from the gastrointestinal tract. This interaction was not observed when Amaryl 2 was administered at least 4 hours before colesevelam. Therefore, Amaryl 2 should be administered at least 4 hours before colesevelam.

Amaryl 2 with food, drink, and alcohol

Consuming alcohol may enhance or weaken the effect of Amaryl 2 in an unpredictable way.

Pregnancy, breastfeeding, and fertility

Amaryl 2 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, ask your doctor or pharmacist for advice before taking this medicine.
Amaryl 2 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 levels (hypoglycemia) or high blood sugar levels (hyperglycemia). You should be aware that you may pose a risk to yourself or others (e.g., when driving a vehicle or operating machinery). Patients should consult their doctor to determine if they can drive a vehicle or operate machinery, especially if:

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

Amaryl 2 contains lactose monohydrate

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

Amaryl 2 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 2

This medicine should always be taken exactly as prescribed by your doctor. In case of doubts, consult your doctor or pharmacist.
Amaryl 1 (1 mg), Amaryl 2 (2 mg), Amaryl 3 (3 mg), and Amaryl 4 (4 mg) are available on the market.

How to take the medicine

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 prescribed by your doctor. If you are taking Amaryl 2, you should follow the recommended diet.
The tablet should be swallowed without chewing or crushing, with a drink.

Recommended dose

The dose of Amaryl 2 depends on the patient's condition and the results of blood and urine sugar level tests, and is determined by the doctor. Do not take more tablets than prescribed by your doctor.

• The initial dose is one 1 mg tablet of Amaryl 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, the doctor will prescribe 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, do not change the dose yourself, consult your doctor.

Taking a higher dose of Amaryl 2 than recommended

Taking too many Amaryl 2 tablets or an additional dose is dangerous for the patient, as there is a risk of hypoglycemia (see hypoglycemia symptoms in section 2, "Warnings and precautions"). In this case, you should immediately consume a sufficient amount of sugar (e.g., 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 administration of sugar to avoid the risk of hyperglycemia. Unconscious patients should not be given food or drink.
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. You should show your doctor the packaging or remaining tablets so that they know which 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 ensure that someone is always nearby who can call a doctor in case of an emergency.

Missing a dose of Amaryl 2

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

Stopping treatment with Amaryl 2

After stopping treatment with Amaryl 2, the achieved reduction in blood sugar levels will not be maintained, and the disease may worsen. You should take Amaryl 2 for as long as your doctor recommends.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amaryl 2 can cause side effects, although not everybody gets them.

You should immediately consult your 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), 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 2 have experienced the following side effects:
Rare(may occur in up to 1 in 1000 patients)

• Low blood sugar levels (hypoglycemia, see section 2, "Important information before taking Amaryl 2", 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 cells (pancytopenia). These disorders usually disappear after stopping treatment with Amaryl 2.

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), 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 can develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• The active substance of Amaryl 2, 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 any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Amaryl 2

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Do not take Amaryl 2 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 2 contains

• The active substance of Amaryl 2 is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose, povidone K 25.
• The tablets also contain dyes: yellow iron oxide (E 172) and indigo carmine, aluminum lake (E 132).

What Amaryl 2 looks like and contents of the packaging

Amaryl 2 tablets are green, oblong, and scored on both sides. The tablets can be divided into two equal doses along the score line.
The packaging contains 30 or 120 tablets in blisters.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

sanofi-aventis, s.r.o., Evropská 846/176a, 160 00 Prague, Czech Republic

Manufacturer:

Sanofi S.r.l., Strada Statale 17, Km 22, 67019 Scoppito (L'Aquila), Italy
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France
Sanofi-Aventis Deutschland GmbH, Industriepark Höchst-Brüningstraße 50, 65926 Frankfurt am Main, Germany
Sanofi-Aventis Private Co. Ltd, Budapest Logistics and Distribution Platform Bdg. DC5, Campona utca 1., 1225 Budapest, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 18/233/97-C

Parallel import authorization number: 175/23

Date of leaflet approval: 28.08.2023

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