Amaryl 2

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is 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 medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Amaryl 2 is an oral antidiabetic medicine. It belongs to a group of blood glucose-lowering agents known as sulfonylurea derivatives. Amaryl 2 works by increasing the amount of insulin released by the pancreas. Insulin reduces blood glucose levels.
What Amaryl 2 is used for:

• Amaryl 2 is used to treat type 2 diabetes when blood glucose levels cannot be controlled by diet, physical exercise, and weight reduction alone.

2. Important information before using Amaryl 2

When not to use Amaryl 2:

• if the patient is allergic to glimepiride or other sulfonylurea drugs (medicines used to reduce blood glucose levels, e.g. glibenclamide) or sulfonamides (medicines used for bacterial infections, e.g. sulfamethoxazole), or to 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 causing increased acid levels in the body; symptoms may include fatigue, nausea, frequent urination and muscle stiffness),
• if the patient has diabetic coma,
• if the patient has severe kidney dysfunction,
• if the patient has severe liver dysfunction.

Do not use Amaryl 2 if any of the above conditions apply.
If in doubt, consult your doctor or pharmacist before taking Amaryl 2.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Amaryl 2.
Consult your doctor or pharmacist before taking Amaryl 2 if:

• the patient has experienced trauma, surgery, infection with fever, or any other stress-related condition; inform your doctor, as temporary changes in treatment may be necessary,
• the patient has liver or kidney dysfunction.

If in doubt, consult your doctor or pharmacist before taking Amaryl 2.
In patients with glucose-6-phosphate dehydrogenase deficiency, haemoglobin levels may decrease and red blood cells may break down (haemolytic anaemia).
Information on the use of Amaryl 2 in patients under 18 years of age is limited. Use in this patient group is not recommended.
Important information about hypoglycaemia (low blood sugar)
Treatment with Amaryl 2 may cause hypoglycaemia (low blood sugar). Below are additional details regarding hypoglycaemia, its symptoms and treatment.
The following factors may increase the risk of hypoglycaemia:

• reluctance (more common in elderly patients) or inability to cooperate,
• malnutrition, irregular meals or skipped meals,
• changes in diet,
• taking a higher dose of Amaryl 2 than necessary (overdose),
• kidney dysfunction,
• severe liver dysfunction,
• certain conditions caused by hormonal disorders (e.g. thyroid, pituitary or adrenal cortex dysfunction),
• alcohol consumption, especially when meals are skipped,
• concomitant use of certain other medicines (see “Amaryl 2 and other medicines”),
• unusually high physical exertion, especially if meals are insufficient or contain fewer carbohydrates than usual,
• treatment with Amaryl 2 without any medical indication.

Symptoms of hypoglycaemia include:

• uncontrollable hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, impaired alertness and reaction time, depression, disorientation, speech and vision disturbances, aphasia (speech impairment), tremor, weakness, sensory disturbances, dizziness, feeling of helplessness,
• also possible: sweating, moist skin, anxiety, rapid heartbeat, increased blood pressure, palpitations, sudden severe chest pain radiating to adjacent body parts (angina pectoris or irregular heartbeat).

If blood glucose levels continue to fall, symptoms may progress to confusion (delirium), seizures, loss of self-control, shallow breathing, slowed heart rate, and may lead to loss of consciousness or coma.
Low blood sugar may produce symptoms similar to stroke.
Treatment of hypoglycaemia
In many cases, symptoms of low blood glucose resolve quickly after consuming certain types of sugar, such as sugar cubes, sweet juice, or sweetened tea.
Always carry a source of sugar (e.g. sugar cubes).
Note that artificial sweeteners are ineffective in treating hypoglycaemia (low blood sugar). Contact your doctor or go to hospital if symptoms do not improve after consuming sugar.
Laboratory tests
Regularly monitor blood or urine glucose levels. Your doctor may also perform regular blood tests. These are necessary to check liver function and blood cell counts.
Amaryl 2 and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Your doctor may adjust the dose of Amaryl 2 if you are taking other medicines that may weaken or enhance its effect on blood glucose levels.
The following medicines may enhance the effect of Amaryl 2 on blood glucose, potentially leading to hypoglycaemia (low blood sugar):

• other antidiabetic medicines (e.g. insulin or metformin),
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines with acetylsalicylic acid-like action),
• medicines used to treat urinary tract infections (including certain 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),
• anabolic steroids (medicines supporting muscle mass increase),
• medicines used in male hormone replacement therapy,
• antidepressants (fluoxetine, MAO inhibitors),
• cholesterol-lowering medicines (fibrates),
• medicines lowering high blood pressure (ACE inhibitors),
• antiarrhythmic medicines used to prevent heart rhythm disorders (disopyramide),
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone),
• anticancer medicines (cyclophosphamide, ifosfamide, trofosfamide),
• weight-loss medicines (fenfluramine),
• medicines used to improve circulation, administered intravenously in high doses (pentoxifylline),
• medicines used to treat nasal allergies, e.g. hay fever (tritoqualine),
• medicines known as sympatholytics, used to treat high blood pressure, heart failure or symptoms of prostate disease,
• fenyramidol,
• guanethidine.

The following medicines may reduce the effect of Amaryl 2 on blood glucose, potentially leading to hyperglycaemia (high blood sugar):

• medicines containing female sex hormones (oestrogens, progestogens),
• medicines promoting urine production (diuretics), saluretics,
• thyroid-stimulating medicines (e.g. levothyroxine),
• medicines used to treat allergies and inflammation (glucocorticosteroids),
• medicines used to treat severe mental disorders (chlorpromazine and phenothiazine derivatives),
• medicines stimulating the heart, used in tachycardia, asthma, nasal congestion, cough, colds, weight loss, or in life-threatening emergencies (adrenaline and sympathomimetics),
• cholesterol-lowering medicines (nicotinic acid and its derivatives),
• long-term use of laxatives for constipation,
• antiepileptic medicines (phenytoin),
• medicines used to treat anxiety and sleep disorders (barbiturates),
• medicines used to treat increased intraocular 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 very low blood sugar (glucagon).

The following medicines may either increase or decrease the effect of Amaryl 2 on blood glucose:

• medicines used to treat stomach ulcers (known as H\ receptor antagonists),
• medicines used to treat high blood pressure or heart failure, e.g. beta-blockers, clonidine and reserpine. These medicines may also mask hypoglycaemia symptoms, so caution is advised when using them.

Amaryl 2 may increase or decrease the effect of the following medicines:

• anticoagulant medicines (coumarin derivatives, e.g. warfarin).

Colesevelam (a bile acid sequestrant) binds to Amaryl 2 and reduces its gastrointestinal absorption. This interaction has not been observed when Amaryl 2 is taken at least 4 hours before colesevelam. Therefore, Amaryl 2 should be taken at least 4 hours before colesevelam.
Amaryl 2 with food, drink and alcohol
Alcohol consumption may unpredictably enhance or weaken the effect of Amaryl 2.
Pregnancy, breastfeeding and fertility
Do not use Amaryl 2 during pregnancy or breastfeeding. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Amaryl 2 may pass into breast milk.
There is no data on effects on fertility.
Driving and operating machinery
The ability to concentrate or react quickly may be impaired due to low blood glucose (hypoglycaemia) or high blood glucose (hyperglycaemia). Be aware that this 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 frequently experience hypoglycaemia,
• warning symptoms of hypoglycaemia are weakened or absent.

Amaryl 2 contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Amaryl 2 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Amaryl 2

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The following products are available on the market: Amaryl 1 (1 mg), Amaryl 2 (2 mg), Amaryl 3 (3 mg), Amaryl 4 (4 mg).
Administration
The medicine should be taken orally, just 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. If Amaryl 2 is being used, the recommended diet should be followed.
The tablet should be swallowed whole, 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 glucose tests, and is determined by the doctor. Do not take more tablets than recommended by the doctor.

• The initial dose is one tablet of Amaryl - 1 mg once daily.
• The doctor may increase the dose after 1-2 weeks of treatment, if necessary.
• The maximum recommended dose is 6 mg of Amaryl per day.
• The doctor may recommend concomitant use of glimepiride with metformin or glimepiride with insulin. In such cases, the doctor will prescribe appropriate, individually adjusted doses of glimepiride with metformin or insulin.
• If there are changes in body weight, lifestyle, or if the patient is under stress, the doctor should be informed so that the dose of the medicine can be adjusted if necessary.
• If the patient feels that the effect of the medicine is too weak or too strong, the dose should not be changed without consulting the doctor; contact your doctor instead.

Taking more than the recommended dose of Amaryl 2
Taking too many Amaryl 2 tablets or an additional dose is dangerous for the patient, as there is a risk of hypoglycaemia (symptoms of hypoglycaemia, see section 2. "Warnings and precautions"). In such a case, consume an adequate amount of sugar immediately (e.g. sugar cubes, sweet juice, sweetened tea) and contact a doctor as soon as possible. In treating hypoglycaemia in children who have accidentally taken the medicine, the amount of sugar given must be controlled to avoid the risk of hyperglycaemia. Food and drinks must not be given to unconscious persons.
In cases of prolonged hypoglycaemia, it is very important that the patient remains under medical supervision until the danger has passed. Hospitalisation may be necessary as a precaution. Show the doctor the packaging or remaining tablets so that they know which medicine has been taken.
Severe cases of hypoglycaemia with loss of consciousness and severe neurological disturbances require immediate medical assistance, usually in a hospital. Ensure that a previously informed person is always nearby to call a doctor in an emergency.
Missed dose of Amaryl 2
Do not take a double dose to make up for a missed dose.
Stopping Amaryl 2
After stopping treatment, the achieved reduction in blood glucose concentration will not be maintained and the disease may worsen. Continue taking Amaryl 2 for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact your doctor immediately if any of the following symptoms occur:

• Allergic reactions (including inflammation of blood vessels, often with rash), which may progress to severe reactions with difficulty breathing, low blood pressure, and even shock.
• Liver function disorders, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), liver inflammation or liver failure.
• Skin allergy (hypersensitivity), manifesting as itching, rash, urticaria, or photosensitivity. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• Severe hypoglycaemia, loss of consciousness, seizures, or coma.

In some patients, the following adverse reactions have occurred during treatment with Amaryl 2:
Rare (may occur in up to 1 in 1,000 patients)

• Lower than normal blood glucose levels (hypoglycaemia; see section 2. "Important information before taking Amaryl 2", subsection "Warnings and precautions").
• Decreased numbers of blood cells, such as:
• platelets, increasing the risk of bleeding or bruising (thrombocytopenia),
• white blood cells, increasing the likelihood of infections (leukopenia, granulocytopenia, agranulocytosis),
• red blood cells, which may cause paleness, weakness, or shortness of breath (erythropenia, haemolytic anaemia),
• platelets, white blood cells, and red blood cells, leading to deficiency of these blood components (pancytopenia). These disorders usually resolve after discontinuation of Amaryl 2.

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

• Allergic reactions (including inflammation of blood vessels, often with rash), which may progress to severe reactions with difficulty breathing, low blood pressure, and even shock.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), liver inflammation or liver failure.
• Nausea, vomiting, diarrhoea, bloating, abdominal discomfort, and abdominal pain.

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

• Taste disturbances.
• Hair loss (alopecia).
• Marked decrease in platelet count (below 10,000/microlitre) and cases of thrombotic thrombocytopenic purpura.
• Visual disturbances, particularly at the beginning of treatment. These are caused by changes in blood glucose concentration and should resolve quickly.
• Increased liver enzyme activity (in blood tests).
• Allergic reactions to sulphonylurea derivatives, sulfonamides, or related drugs may occur.
• Skin allergy (hypersensitivity) with itching, rash, urticaria. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue.
• The active substance in Amaryl 2 – glimepiride – like all sulphonylurea derivatives, may cause weight gain and hypersensitivity to sulphonylurea derivatives, sulfonamides, or related drugs.
• Decreased sodium levels in blood (in blood tests), allergic vasculitis, photosensitivity.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Amaryl 2

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Do not use Amaryl 2 if signs of deterioration are visible.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Amaryl 2 contains

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

What Amaryl 2 looks like and contents of the pack
Amaryl 2 tablets are green, elongated and scored on both sides. Tablets may be divided into two equal doses along the break line.
The pack contains 30 or 120 tablets in blister packs.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 18/233/97-C
Parallel import authorisation number: 175/23