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 medicinal product.
Please read the following 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 that lowers blood glucose (sugar) levels. It belongs to a group of antidiabetic medicines called sulfonylureas. Amaryl 2 works by increasing the amount of insulin released by the pancreas. Insulin reduces blood glucose levels.

For what purpose is Amaryl 2 used:

• Amaryl 2 is used in the treatment of 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 drugs from the sulfonylurea group (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 function impairment,
• if the patient has severe liver function impairment.

Do not use Amaryl 2 if any of the above conditions apply.
In case of any doubts, contact your doctor or pharmacist before using Amaryl 2.
Warnings and precautions
Before starting treatment with Amaryl 2, discuss it with your doctor or pharmacist.
Consult your doctor or pharmacist before using Amaryl 2 if:

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

In case of any doubts, contact your doctor or pharmacist before using 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 individuals under 18 years of age is limited. Use of the medicine is not recommended in this patient group.
Important information about hypoglycaemia (low blood sugar)
While using Amaryl 2, the patient may experience 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 skipping meals,
• change in diet,
• taking a higher dose of Amaryl 2 than necessary (overdose),
• kidney function disorders,
• severe liver function disorders,
• certain conditions caused by hormonal disorders (e.g. thyroid, pituitary or adrenal cortex dysfunction),
• alcohol consumption, especially when combined with skipped meals,
• concomitant use of certain other medicines (see section: Amaryl 2 and other medicines),
• unusually high physical exertion, especially if the meal was insufficient or contained fewer carbohydrates than usual,
• treatment with Amaryl 2 without any valid 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.
• sweating, clammy skin, anxiety, rapid heartbeat, increased blood pressure, palpitations, sudden severe chest pain radiating to adjacent body parts (angina or irregular heart rhythm) may also occur.

If blood glucose (sugar) levels continue to drop, symptoms may progress to confusion (delirium), seizures, loss of self-control, shallow breathing and slowed heart rate, and may lead to loss of consciousness up to coma.
Low blood sugar may produce symptoms similar to those of 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 sugar (e.g. sugar cubes) with you.
Note that artificial sweeteners are not effective in treating hypoglycaemia (low blood sugar). Contact your doctor or go to hospital if symptoms of hypoglycaemia do not subside after consuming sugar.
Laboratory tests
Blood or urine glucose levels should be monitored regularly. Your doctor may also perform regular blood tests. These are necessary to check liver function and blood cell counts.
Amaryl 2 and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Your doctor may decide to adjust the dose of Amaryl 2 if the patient is taking other medicines that may weaken or enhance the effect of Amaryl 2 on blood glucose levels.
The following medicines may enhance the effect of Amaryl 2 on blood glucose levels, 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, drugs with action similar to acetylsalicylic acid),
• 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 used to increase muscle mass,
• medicines used as testosterone replacement therapy,
• 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),
• anticancer medicines (cyclophosphamide, ifosfamide, trofosfamide),
• medicines used to reduce body 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 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 levels, 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 inflammatory conditions (glucocorticoids),
• medicines used to treat severe psychiatric disorders (chlorpromazine and phenothiazine derivatives),
• medicines used for rapid heartbeat, asthma, nasal congestion, cough and colds, weight reduction, or in life-threatening emergencies (adrenaline and sympathomimetics),
• medicines used to treat high cholesterol levels (nicotinic acid and its derivatives),
• medicines used for constipation when used long-term (laxatives),
• medicines used to treat epileptic seizures (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 increase or decrease the effect of Amaryl 2 on blood glucose levels:

• 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 symptoms of hypoglycaemia; therefore, 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 absorption from the gastrointestinal tract. This interaction has not been observed when Amaryl 2 is administered 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 while breastfeeding. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 available 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amaryl 2

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Administration of 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 in accordance with your doctor's instructions. If you are taking Amaryl 2, you must follow the recommended diet.
The tablet should be swallowed whole, without chewing or crushing, with liquid.
Amaryl is available in the following strengths: 1 mg (Amaryl 1), 2 mg (Amaryl 2), 3 mg (Amaryl 3), 4 mg (Amaryl 4).
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 prescribed by your doctor.

• The initial dose is one tablet of Amaryl – 1 mg once daily.
• 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 concomitant use of glimepiride with metformin or glimepiride with insulin. In such cases, your doctor will prescribe appropriate, individually determined doses of glimepiride with metformin or insulin.
• If there are changes in body weight, lifestyle, or if the patient is under stress, inform your doctor 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, do not change the dose independently; contact your doctor.

Taking more than the recommended dose of Amaryl 2
Taking too many tablets of Amaryl 2 or taking an additional dose is dangerous for the patient, as there is a risk of hypoglycaemia (hypoglycaemia symptoms, 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 your doctor as quickly as possible. In the treatment of hypoglycaemia in children who have accidentally taken the medicine, the amount of sugar administered 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. Hospitalization may be necessary as a precaution. Show the doctor the packaging or remaining tablets so that he or she knows 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 who can call a doctor in case of emergency.
Missed dose of Amaryl 2
Do not take a double dose to make up for a missed dose.
Stopping treatment with Amaryl 2
After discontinuing the medicine, 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 has instructed.
If you have any further doubts regarding 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 everyone experiences them.
You should contact your doctor immediately if any of the following symptoms occur:

• Allergic reactions (including inflammation of blood vessels, often with a rash), which may progress to severe reactions with breathing difficulties, 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, or swelling of the lips, throat, or tongue.
• Severe hypoglycaemia, loss of consciousness, seizures, or coma.

The following adverse reactions have been reported in some patients treated with Amaryl 2:
Uncommon (may occur in no more than 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 number 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 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 no more than 1 in 10,000 patients)

• Allergic reactions (including vasculitis, often with a rash), which may progress to severe reactions with breathing difficulties, low blood pressure, or 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, flatulence, abdominal discomfort, and abdominal pain.

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

• Taste disturbances.
• Hair loss (alopecia).
• Marked decrease in platelet count (below 10,000/microlitre) and cases of thrombocytopenic purpura.
• Visual disturbances, particularly at the beginning of treatment. These are caused by changes in blood glucose levels and should resolve quickly.
• Increased liver enzyme activity (in blood tests).
• Hypersensitivity reactions to sulfonylurea derivatives, sulfonamides, or related drugs may occur.
• Skin allergy (hypersensitivity) with itching, rash, or urticaria. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, or swelling of the lips, throat, or tongue.
• The active substance in Amaryl 2 – glimepiride – like all sulfonylurea derivatives, may cause weight gain and hypersensitivity to sulfonylurea derivatives, sulfonamides, or related drugs.
• Decreased sodium concentration 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging 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 25 000, yellow iron oxide (E 172), indigo carmine lake (E 132).

What Amaryl looks like and contents of the pack
Amaryl 2 tablets are green, elongated, and scored on both sides. The tablets can be divided into two equal doses along the dividing line.
The pack contains 30 or 120 tablets in blisters packed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation 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, Budapest, 1225, Hungary

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 18/233/97-C
Parallel Import Licence Number: 402/22