Amaril 3

Leaflet accompanying the packaging: patient information

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

Amaryl 3, 3 mg, tablets

Glimepiride

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Amaryl 3 and what is it used for

Amaryl 3 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 3 is to increase the amount of insulin released by the pancreas. Insulin reduces blood sugar levels.

What is Amaryl 3 used for:

• Amaryl 3 is used to treat type 2 diabetes when diet, physical exercise, and weight loss cannot control blood sugar levels.

2. Important information before taking Amaryl 3

When not to take Amaryl 3:

• if the patient is allergic to glimepiride or other sulfonylurea medicines (used to reduce blood sugar levels, e.g., glibenclamide) or sulfonamides (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.

Amaryl 3 should not be taken if any of the above conditions occur. In case of any doubts, the patient should consult a doctor or pharmacist before taking Amaryl 3.

Warnings and precautions

Before starting Amaryl 3, the patient should discuss it with their doctor or pharmacist.

The patient should consult a doctor or pharmacist before taking Amaryl 3 if:

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

In case of any doubts, the patient should consult a doctor or pharmacist before taking Amaryl 3. 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 3 in patients under 18 years of age is limited. The use of this medicine is not recommended in this patient group.

Important information about hypoglycemia (low blood sugar)

During treatment with Amaryl 3, 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:

• 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 3 than necessary (overdose),
• kidney problems,
• severe liver problems,
• certain hormonal disorders (e.g., thyroid, pituitary, or adrenal gland disorders),
• consumption of alcohol, especially with skipped meals,
• concomitant use of certain other medicines (see "Amaryl 3 and other medicines"),
• performing more physical exercise than usual, if the meal was not sufficiently filling or the food contained less carbohydrates than usual,
• treatment with Amaryl 3 without any indications.

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,
• 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 patient may experience: confusion (delirium), seizures, loss of self-control, shallow breathing, and slow heart rate, and may even lead to loss of consciousness, including coma. Low blood sugar can cause symptoms similar to 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. The patient should always carry sugar (e.g., sugar cubes). It should be remembered that artificial sweeteners are not effective in treating hypoglycemia (low blood sugar). The patient should consult a doctor or go to the hospital if sugar consumption does not cause the symptoms of hypoglycemia to disappear.

Laboratory tests

Blood sugar or urine levels should be regularly monitored. The doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Amaryl 3 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may decide to change the dose of Amaryl 3 if the patient is taking other medicines that may weaken or enhance the effect of Amaryl 3 on blood sugar levels. The following medicines may increase the effect of Amaryl 3 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 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 decrease the effect of Amaryl 3 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 inflammatory conditions (glucocorticoids),
• 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 (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 3 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 should be exercised when taking them.

Amaryl 3 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 3 and reduces its absorption from the gastrointestinal tract. This interaction has not been observed when Amaryl 3 is administered at least 4 hours before colesevelam. Therefore, Amaryl 3 should be administered at least 4 hours before colesevelam.

Amaryl 3 with food, drink, and alcohol

Consumption of alcohol may enhance or weaken the effect of Amaryl 3 in an unpredictable way.

Pregnancy, breastfeeding, and fertility

Amaryl 3 should not be taken during pregnancy and breastfeeding. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Amaryl 3 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). The patient should be aware that they may pose a risk to themselves or others (e.g., when driving or operating machines). Patients should consult their doctor if they can drive or operate machines if:

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

Amaryl 3 contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Amaryl 3.

Amaryl 3 contains sodium

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

3. How to take Amaryl 3

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

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 directed by the doctor. When taking Amaryl 3, the patient should follow the recommended diet. The tablet should be swallowed without chewing or crushing, with a drink.

Recommended dose

The dose of Amaryl 3 depends on the patient's condition and the results of blood sugar and urine tests, and is determined by the doctor. The patient should not take more tablets than recommended by the 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 such cases, the doctor will recommend the appropriate, individually determined doses of glimepiride with metformin or insulin.
• If the patient's weight, lifestyle, or stress levels change, they should inform their doctor so that the dose of the medicine can be adjusted if necessary.
• If the patient thinks the effect of the medicine is too weak or too strong, they should not change the dose themselves, but consult their doctor.

Taking a higher dose of Amaryl 3 than recommended

Taking too many Amaryl 3 tablets or taking an additional dose is dangerous for the patient, as there is a risk of hypoglycemia (hypoglycemia symptoms, see section 2, "Warnings and precautions"). In such cases, the patient should immediately consume a sufficient amount of sugar (e.g., sugar cubes, sweet juice, sweetened tea) and inform their 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. The patient should show their 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. The patient should ensure that someone is always nearby who can call a doctor in case of an emergency.

Missing a dose of Amaryl 3

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

Stopping Amaryl 3 treatment

After stopping treatment with Amaryl 3, the achieved reduction in blood sugar levels will not be maintained, and the disease may worsen. The patient should take Amaryl 3 for as long as their doctor recommends. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amaryl 3 can cause side effects, although not everybody gets them.

The patient should immediately consult their doctor if they experience the following symptoms:

• Allergic reactions (including vasculitis, often with rash), which can develop into severe reactions with difficulty breathing, low 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 3 have experienced the following side effects: Rare(may occur in up to 1 in 100 patients)

• Low blood sugar levels (hypoglycemia, see section 2, "Important information before taking Amaryl 3", 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 likelihood 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 deficiency of these blood elements (pancytopenia). These disorders usually disappear after stopping Amaryl 3 treatment.

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, low 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 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 these symptoms should disappear quickly.
• Increased liver enzyme activity (in blood tests).
• Allergic reactions to sulfonylurea medicines, 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 3, 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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: 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Amaryl 3

The medicine should be stored out of sight and reach of children. The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. The medicine should be stored at a temperature below 30°C. The medicine should be stored in its original packaging to protect it from moisture. The medicine should not be taken if signs of spoilage are visible. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 3 contains

• The active substance of Amaryl 3 is glimepiride. Each tablet contains 3 mg of glimepiride.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose, povidone 25,000.
• The tablets also contain the dye iron oxide yellow (E 172).

What Amaryl 3 looks like and what the packaging contains

Amaryl 3 tablets are oblong and scored on both sides. The tablets can be divided into two equal doses along the score line. Amaryl 3 tablets are light yellow. The packaging contains 30 tablets in blisters, placed in a cardboard box. For more detailed information, the patient should contact 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.p.A. 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 utca1. 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 Number of the marketing authorization in the Czech Republic, the country of export: 18/234/97-C

Number of the parallel import authorization: 73/22 Date of approval of the leaflet: 08.02.2022

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