Amaryl

Package leaflet: Information for the user

AMARYL 2 mg, 3 mg and 4 mg tablets

glimepiride
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What Amaryl is and what it is used for

Amaryl is an oral antidiabetic medication that lowers blood sugar levels. This medicine
belongs to a group of medicines that lower blood sugar levels known as sulfonylureas.
Amaryl works by increasing the amount of insulin released by the pancreas. Insulin then lowers
blood sugar levels.
What Amaryl is used for:

• Amaryl is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, exercise, and weight reduction alone are not sufficient to control blood sugar levels.

2. What you need to know before taking Amaryl

Do not take Amaryl and inform your doctor if:

• You are allergic to: glimepiride or other sulfonylureas (medicines used to lower blood sugar levels such as glibenclamide), or sulfonamides (medicines for bacterial infections such as sulfamethoxazole), or any of the other ingredients of this medicine (listed in section 6)
• You have type 1 diabetes mellitus
• You have diabetic ketoacidosis (a complication of diabetes in which acid levels in the body are increased and you may experience some of the following signs: fatigue, nausea, frequent need to urinate, and muscle aches)
• You are in diabetic coma
• You suffer from severe kidney disease
• You suffer from severe liver disease

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amaryl.
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Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

• You are recovering from injury, surgery, an infection with fever, or other forms of stress; inform your doctor as your treatment may need to be temporarily adjusted
• You suffer from severe liver or kidney disease

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Amaryl.
In patients lacking the enzyme glucose-6-phosphate dehydrogenase, a reduction in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.
Available information on the use of Amaryl in individuals under 18 years of age is limited.
Therefore, use in these patients is not recommended.
Important information about hypoglycemia (low blood sugar levels)
When taking Amaryl, you may experience hypoglycemia (low blood sugar levels). Read below for further information on hypoglycemia, its symptoms, and treatment.
The following factors may increase the risk of hypoglycemia:

• Not eating enough, eating at irregular times, skipping or delaying meals, or fasting
• You have changed your diet
• You have taken more Amaryl than prescribed
• You have reduced kidney function
• You suffer from severe liver disease
• You suffer from certain hormone-related disorders (thyroid, pituitary, or adrenal cortex disorders)
• You consume alcoholic beverages (especially if you skip a meal)
• You are taking certain other medicines (see below 'Other medicines and Amaryl')
• You are doing more physical exercise and not eating enough or eating foods containing fewer carbohydrates than usual

Warning symptoms of hypoglycemia include:

• Hunger pangs, headache, nausea, vomiting, sluggishness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness, reduced reaction ability, depression, confusion, speech and vision disturbances, difficulty speaking, tremor, partial paralysis, sensory disturbances, dizziness, weakness
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, hypertension, palpitations, sudden chest pain that may spread to nearby areas (angina pectoris and cardiac arrhythmias). If blood sugar levels continue to drop, you may experience marked confusion (delirium), seizures, loss of self-control, breathing may become weak, heart rate may slow down, and you may lose consciousness. The clinical picture of very low blood sugar levels may resemble that of a stroke.

Treatment of hypoglycemia:
In many cases, symptoms of low blood sugar disappear very quickly if you consume sugar, such as sugar cubes, sugar-sweetened drinks, or sweetened tea.
Therefore, always carry sugar with you (e.g., sugar cubes).
Remember that artificial sweeteners are not effective. Contact your doctor or go to a hospital if you notice that taking sugar does not help or if symptoms recur.
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Laboratory tests
You should regularly monitor your blood or urine sugar levels. Your doctor may also prescribe blood tests to monitor blood cell levels and liver function.
Children and adolescents
The use of Amaryl in children under 18 years of age is not recommended.
Other medicines and Amaryl
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may adjust your Amaryl dose if you are taking other medicines that can decrease or increase the blood sugar-lowering effects of Amaryl.
The following medicines may enhance the blood sugar-lowering effect of Amaryl. This may lead to a risk of hypoglycemia (low blood sugar levels):

• Other medicines used to treat diabetes mellitus (such as insulin or metformin)
• Medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like drugs)
• Medicines used to treat urinary tract infections (such as certain long-acting sulfonamides)
• Medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• Medicines used to inhibit blood clotting (coumarin derivatives such as warfarin)
• Medicines used to strengthen muscles (anabolic agents)
• Medicines used for male hormone 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)
• Medicines called antiarrhythmic agents used to control abnormal heartbeats (disopyramide)
• Medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used for weight reduction (fenfluramine)
• Medicines used to improve circulation when given as high-dose intravenous infusions (pentoxifylline)
• Medicines used to treat nasal allergies, such as hay fever (tritoqualine)
• Medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may reduce the blood sugar-lowering effect of Amaryl. This may lead to a risk of hyperglycemia (high blood sugar levels):

• Medicines containing female sex hormones (estrogens, progestogens)
• Medicines used to promote urine production (thiazide diuretics)
• Medicines used to stimulate the thyroid (such as levothyroxine)
• Medicines used to treat allergies and inflammation (glucocorticoids)
• Medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives)
• Medicines used to increase heart rate, treat asthma or nasal congestion, cough and cold, used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics)
• Medicines used to treat high cholesterol (nicotinic acid)
• Medicines used to treat constipation if used long-term (laxatives)
• Medicines used to treat seizures (phenytoin)
• Medicines used to treat nervousness and sleep disorders (barbiturates)

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• Medicines used to treat increased eye pressure (acetazolamide)
• Medicines used to treat high blood pressure or low blood sugar (diazoxide)
• Medicines used to treat infections and tuberculosis (rifampicin)
• Medicines used to treat very low blood sugar levels (glucagon)

The following medicines may increase or decrease the blood sugar-lowering effect of Amaryl:

• Medicines used to treat stomach ulcers (called H2 antagonists)
• Medicines used to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask the symptoms of hypoglycemia; therefore, particular caution is required when taking these medicines.

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

• Medicines used to inhibit blood clotting (coumarin derivatives such as warfarin)

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Amaryl. To avoid this interaction, you are advised to take Amaryl at least 4 hours before colesevelam.
Amaryl with food, drinks, and alcohol
Drinking alcoholic beverages may unpredictably increase or decrease the blood sugar-lowering effect of Amaryl.
Pregnancy and breastfeeding
Pregnancy
Amaryl must not be taken during pregnancy. Inform your doctor if you are planning a pregnancy, are already pregnant, or think you may be pregnant.
Breastfeeding
Amaryl may pass into breast milk. Amaryl must not be taken if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar levels are low (hypoglycemia) or high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may pose a risk to yourself and others (e.g., when driving a car or operating machinery). Consult your doctor for advice on whether it is appropriate for you to drive if:

• You have frequent hypoglycemic episodes,
• You have few or no warning symptoms of hypoglycemia.

Amaryl contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Amaryl contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.
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3. How to take Amaryl

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How to take this medicine

• Take this medicine by mouth, just before or during your first main meal of the day (usually breakfast). If you do not eat breakfast, take the medicine at the time prescribed by your doctor. It is important not to skip any meals while taking Amaryl.
• Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.
• Each tablet may be divided into equal doses.

How much medicine to take
The dose of Amaryl depends on your individual needs, condition, and blood and urine sugar test results, and is determined by your doctor. Do not take more tablets than prescribed by your doctor.
The usual starting dose of Amaryl is 1 mg once daily.
If necessary, your doctor may increase the dose every 1–2 weeks of treatment.
The maximum recommended dose of Amaryl is 6 mg per day.
Combination therapy with glimepiride + metformin or glimepiride + insulin may be initiated. In such cases, your doctor will determine the appropriate dose of glimepiride, metformin, or insulin specific to you.
If your weight changes, or if you change your lifestyle, or are under stress, your Amaryl dosage may need to be adjusted; therefore, inform your doctor.
If you feel the medicine’s effects are too weak or too strong, do not adjust the dose on your own, but consult your doctor.
If you take more Amaryl than you should
If you have taken too much Amaryl or taken an extra dose, there is a risk of hypoglycaemia (for symptoms of hypoglycaemia, see Section 2). You should immediately consume an adequate amount of sugar (e.g. a small bar of sugar cubes, sugary drinks, or sweetened tea) and contact your doctor immediately. If treating hypoglycaemia due to accidental ingestion in children, the amount of sugar administered must be carefully controlled to avoid dangerous hyperglycaemia. Do not give food or drinks to unconscious individuals.
Since hypoglycaemic conditions may last for some time, it is very important that the patient is closely monitored until the danger has passed. Hospitalization may be necessary, even as a precautionary measure. Show your doctor the packaging or remaining tablets so that the doctor can see what has been taken.
Severe cases of hypoglycaemia with loss of consciousness and severe neurological impairment are medical emergencies requiring immediate medical treatment and hospitalization. Ensure that there is always an informed person available who can call the doctor in an emergency.
If you forget to take Amaryl
If you forget to take a dose, do not take a double dose to make up for the missed dose.
If you stop taking Amaryl
If you interrupt or stop treatment, be aware that you will not achieve the desired blood sugar-lowering effect and your condition may worsen. Continue taking Amaryl until your doctor tells you to stop.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often with a skin rash), which may become severe with difficulty breathing, drop in blood pressure, and sometimes progress to shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• Skin allergy (hypersensitivity), such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may become severe.
• Severe hypoglycaemia with loss of consciousness, seizures, or coma.

Some patients have experienced the following adverse events while taking Amaryl:
Rare side effects (may occur in 1 to 10 out of 10,000 patients)

• Blood sugar levels lower than normal (hypoglycaemia) (See section 2)
• Decrease in blood cell counts:
• Platelets (increasing the risk of bleeding or bruising)
• White blood cells (increasing the risk of infections)
• Red blood cells (which may cause pale skin, weakness, and shortness of breath)
  These problems generally improve when stopping Amaryl
• Weight gain
• Hair loss
• Altered sense of taste

Very rare side effects (may occur in fewer than 1 out of 10,000 patients)

• Allergic reactions (including inflammation of blood vessels, often with a skin rash), which may become severe with difficulty breathing, drop in blood pressure, and sometimes progress to shock. If any of these symptoms occur, contact your doctor immediately
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), liver inflammation (hepatitis), or liver failure. If any of these symptoms occur, contact your doctor immediately
• Nausea or vomiting, diarrhoea, feeling of fullness or bloating, and abdominal pain
• Decreased sodium levels in the blood (detected by blood tests)

Frequency not known, cannot be estimated from available data:

• Skin allergy (hypersensitivity), such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may become severe, causing difficulty swallowing or breathing, or swelling of the lips, throat, or tongue. Therefore, if any of these adverse events occur, contact your doctor immediately
• Allergic reactions may occur with sulphonylureas, sulfonamides, or related drugs
• At the start of treatment with Amaryl, vision problems may occur. These are due to changes in blood sugar levels and should improve quickly
• Increased liver enzymes
• Severe, unusual bleeding or bruising under the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store Amaryl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after Exp. The
expiry date refers to the last day of that month.
Amaryl 2 mg, 3 mg and 4 mg tablets: do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amaryl contains

• The active substance is glimepiride. Each tablet contains 2 mg, 3 mg or 4 mg of glimepiride, according to the dosage indicated on the blister and the packaging.
• The other components are: monohydrate lactose, sodium carboxymethyl starch (type A), magnesium stearate, microcrystalline cellulose, povidone 25000.
• Additionally, the tablets contain colouring agents:
• The 2 mg tablets contain yellow iron oxide (E172) and indigo carmine aluminium lake (E132)
• The 3 mg tablets contain yellow iron oxide (E172)
• The 4 mg tablets contain indigo carmine aluminium lake (E132)

Description of the appearance of Amaryl and the contents of the pack
All Amaryl tablets are oblong and scored on both sides. Each tablet can be divided into two equal doses. They are of different colours:
The 2 mg tablets are green
The 3 mg tablets are pale yellow
The 4 mg tablets are blue
Available in blister packs of 14, 20, 28, 30, 50, 60, 90, 112, 120, 280 and 300 tablets.
Not all pack sizes and strengths may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan, Italy
Manufacturers:
For all strengths:
Sanofi S.r.l., Strada Statale 17, Km 22, 67019 Scoppito (L’Aquila), Italy
Sanofi-Aventis Deutschland GmbH, Industriepark Höchst-Brüningstraße 50, 65926 Frankfurt am Main, Germany
For 2 mg, 3 mg and 4 mg tablets:
Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France
For 2 mg and 3 mg tablets:
Sanofi-Aventis Private Co. Ltd, Budapest Logistics and Distribution Platform Bdg. DC5, Campona utca 1, Budapest, 1225, Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

• Amaryl: Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Romania, Slovakia, Spain, Sweden, United Kingdom, Czech Republic
• Amaryl Tablete: Slovenia
• Amaryl Tabletes: Latvia
• Amaryl Tablètes: Lithuania
• Amarylle: Belgium, Luxembourg
• Amarel: France
• Solosa: Greece