Amaryl 4 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amaryl 4 mg tablets

glimepiride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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. Storage of Amaryl
6. Contents of the pack and other information

1. What Amaryl is and what it is used for

Amaryl is an oral medication that lowers blood sugar levels. This medicine belongs to a group of medicines that reduce blood sugar levels called sulfonylureas. Amaryl increases the amount of insulin released by your pancreas. Insulin lowers the sugar levels in your blood.

What Amaryl is used for:

• Amaryl is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction have not been able to control your blood sugar levels.

2. What you need to know before starting to take Amaryl

Do not take Amaryl and speak with your doctor if:

• You are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar levels such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole), or to 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 your body rise and you may experience symptoms such as fatigue, dizziness (nausea), frequent urge to urinate, and muscle stiffness).
• You are in a diabetic coma.
• You have severe kidney disease.
• You have severe liver disease.

Do not take this medicine if any of the aforementioned circumstances apply to you. If you are unsure, consult your doctor or pharmacist before taking Amaryl.

Warnings and precautions

Consult your doctor or pharmacist before starting to take your medicine if:

• You are recovering from any illness, surgery, infection with fever, or other forms of stress. Inform your doctor, as it may be necessary to make changes to your treatment.
• You have serious impairment of liver or kidney function.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Amaryl.

It may occur that hemoglobin levels decrease and red blood cells break down (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

The available information regarding the use of Amaryl in individuals under 18 years of age is limited. Therefore, its use is not recommended in these patients.

Important information about hypoglycemia (low blood sugar)

If you are taking Amaryl, you may experience hypoglycemia (low blood sugar). Please see below for further information about hypoglycemia, its signs, and treatment.

The following factors may increase your risk of developing hypoglycemia:

• Malnutrition, irregular meal times, skipping or delaying meals, or periods of fasting
• Changes in your diet
• If you take more Amaryl than you need
• If you have reduced kidney function
• If you have severe liver disease
• If you suffer from other hormonal disorders (such as disorders of the thyroid gland, pituitary gland, or adrenal cortex)
• If you consume alcohol (especially if you skip a meal)
• If you take certain medications (see “Taking Amaryl with other medicines”)
• If you increase your physical exercise and do not eat enough or consume foods lower in carbohydrates than usual.

Signs of hypoglycemia include:

• Feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, aggressiveness, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, slurred speech, tremors, partial paralysis, sensory disturbances, dizziness, feeling helpless.

• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, severe and sudden chest pain that may radiate to nearby areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience marked confusion (delirium), seizures, loss of consciousness, shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of severe hypoglycemia resembles that of a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar disappear quickly after consuming sugar, such as sugar lumps, sweet fruit juices, or sugared tea.

Therefore, you should always carry a source of sugar with you (e.g., sugar lumps). Remember that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if your symptoms do not improve after taking sugar or if symptoms recur.

Blood tests

Your blood and urine sugar levels should be monitored regularly. Your doctor may request blood tests to monitor your blood cell counts and assess liver function.

Children and adolescents

The use of Amaryl is not recommended in children under 18 years of age.

Taking Amaryl with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may wish to adjust your dose of Amaryl if you are taking other medicines that may increase or decrease the effect of Amaryl on blood sugar levels.

The following medicines may increase the hypoglycemic effect of Amaryl. This may lead to an increased risk of hypoglycemia (low blood sugar):

• Other medicines for treating diabetes mellitus (such as insulin or metformin)
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, and aspirin derivatives)
• Medicines for treating urinary tract infections (such as certain long-acting sulfonamides)
• Medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
• Medicines used to thin the blood (coumarin derivatives such as warfarin)
• Medicines used to increase muscle mass (anabolic agents)
• Medicines used in male hormone replacement therapy
• Medicines for treating depression (fluoxetine, MAO inhibitors)
• Medicines used to lower high cholesterol levels (fibrates)
• Medicines used to lower high blood pressure (ACE inhibitors)
• Medicines known as antiarrhythmics, used to control abnormal heart rhythms (disopyramide)
• Medicines for treating gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines for treating cancer (cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used for weight loss (fenfluramine)
• Medicines used to improve circulation when administered at high doses via intravenous infusion (pentoxifylline)
• Medicines for treating nasal allergies such as hay fever (tritoqualine)
• Medicines known as sympatholytics, used to treat high blood pressure, heart failure, or prostate symptoms.

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

• Medicines containing female sex hormones (estrogens, progestogens)
• Medicines used to increase urine production (thiazide diuretics)
• Medicines used to stimulate the thyroid gland (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 colds, or used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics)
• Medicines used to treat high cholesterol (nicotinic acid)
• Medicines used for constipation when used long-term (laxatives)
• Medicines used to treat seizures (phenytoin)
• Medicines used to treat nervousness and sleep problems (barbiturates)
• Medicines used to treat increased eye pressure (acetazolamide)
• Medicines used to treat high blood pressure or severe low blood sugar (diazoxide)
• Medicines used to treat infections, tuberculosis (rifampicin)
• Medicines used to treat severe low blood sugar (glucagon)

The following medicines may either increase or decrease the hypoglycemic effect of Amaryl:

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

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

• Medicines that inhibit blood clotting (coumarin derivatives such as warfarine).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Amaryl. To avoid this interaction, it is recommended to take Amaryl at least 4 hours before colesevelam.

Taking Amaryl with food, drinks, and alcohol

Alcohol intake may unpredictably increase or decrease the hypoglycemic action of Amaryl.

Pregnancy, breastfeeding, and fertility

Pregnancy

Amaryl must not be taken during pregnancy. Consult your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.

Breastfeeding

Amaryl may pass into breast milk. Amaryl must not be used during breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycaemia) or rise (hyperglycaemia), or if you experience vision problems resulting from these conditions. Be aware that this may put both you and others at risk (for example, when driving or operating machinery). Please consult your doctor to determine whether you are allowed to drive if:

• you have frequent episodes of hypoglycaemia,
• you have absent or reduced warning symptoms of hypoglycaemia.

Amaryl contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Amaryl contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take Amaryl

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist.

How to take this medicine

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

How much to take

The dose of Amaryl depends on your individual needs, condition, and blood and urine sugar test results, and will be determined by your doctor. Do not take more tablets than your doctor has prescribed.

• The usual starting dose is one 1 mg Amaryl tablet once daily.
• If necessary, your doctor may gradually increase your dose after 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of Amaryl per day.
• You may start combination therapy with glimepiride plus metformin or glimepiride plus insulin. In such cases, your doctor will individually determine the appropriate doses of glimepiride, metformin, and insulin for you.
• If your weight changes, if you change your lifestyle, or if you are under stress, your Amaryl dose may need adjustment; therefore, inform your doctor.
• If you think that the effect of Amaryl is too strong or too weak, do not adjust the dose yourself—inform your doctor or pharmacist.

If you take more Amaryl than you should

If you accidentally take too much Amaryl or an extra dose, there is a risk of hypoglycemia (see section 2 for symptoms of hypoglycemia). You should immediately consume sufficient sugar (for example, sugar lumps, sweet fruit juice, sugared tea) and contact your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar administered must be carefully controlled to avoid causing dangerous hyperglycemia. Unconscious individuals must not be given food or drink.

Since hypoglycemia can last for some time, it is very important that the patient is carefully monitored until there is no further danger. Hospital admission may also be necessary as a precaution. Show the packaging or remaining tablets to the doctor so they can determine what you have taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and serious neurological impairment are medical emergencies requiring immediate medical treatment and hospitalization. Make sure that someone is always informed and able to call a doctor in case of emergency.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Amaryl

If you forget 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, keep in mind that the desired effect of lowering blood sugar will not be achieved, or your condition may worsen again. Continue taking Amaryl until your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Consult your doctor immediately if you experience any of the following symptoms:

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

Some patients have experienced the following adverse effects while taking Amaryl:

Rare adverse effects (may affect up to 1 in 1,000 people)

? Blood sugar levels below normal (hypoglycemia) (see section 2).

? Reduction in blood cell count:

o Platelets (which increases the risk of bleeding or bruising).

o White blood cells (making infections more likely to occur).

o Red blood cells (which may cause the skin tone to become pale and produce weakness or difficulty breathing).

In general, these alterations disappear upon discontinuation of treatment with Amaryl.

? Weight gain.

? Hair loss.

? Change in your sense of taste.

Very rare side effects (may affect up to 1 in 10,000 people)

• Allergic reactions (including inflammation of blood vessels, often with skin rash) that may trigger severe reactions with breathing difficulties, low blood pressure, and sometimes lead to shock. If you experience any of these symptoms, inform your doctor immediately.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Nausea, vomiting, diarrhea, stomach discomfort or bloating, and stomach pain.
• Decreased levels of sodium in the blood (detectable in blood tests).

Frequency not known, cannot be estimated from available data:

• Skin allergy (hypersensitivity), such as itching, skin rash, hives, and light sensitivity. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, or swelling of the lips, throat, or tongue. Therefore, if you experience any of these side effects, inform your doctor immediately.
• Allergic reactions to sulfonylureas, sulfonamides, or related medicines.
• You may experience vision disturbances when starting treatment with Amaryl. This is due to changes in blood sugar levels and should improve quickly.
• Increased liver enzymes.
• Unusual severe bleeding or bruising under the skin.

Reporting of side effects:

If you experience any kind of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amaryl

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Amaryl

• The active substance is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components are: monohydrate lactose, sodium starch glycolate (type A), magnesium stearate, microcrystalline cellulose and povidone 25000.
• In addition, the tablets contain colouring agents: 4 mg tablets contain indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Each Amaryl tablet is oblong and marked on both sides. Each tablet can be divided into equal doses.

The 4 mg tablets are light blue.

Available in blister packs of 14, 20, 28, 30, 50, 60, 90, 112, 120, 280 and 300 tablets. Only certain pack sizes and strengths may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

• Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France.
• 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.

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

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

Date of the most recent review of this leaflet: September 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/