Amaryl (Glimepiride) 30 Tablets

1. What is AMARYL and what is it used for? 2. Things to consider before using AMARYL 3. How to use AMARYL 4. What are the possible side effects? 5. The AMARYL storage

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1. What is AMARYL and what is it used for? AMARYL is an active blood glucose lowering medication. It is a drug belonging to the group of drugs that decreases the blood glucose level called sulfonylurea. AMARYL acts by increasing the amount of insulin released from your pancreas. Then insulin lowers blood sugar. AMARYL contains glimepiride. There are 2 mg of active substance in 1 tablet. AMARYL also has other dosages which contain 1 mg, 3 mg and 4 mg of glimepiride. All dosage forms are available in blister packs containing 30 tablets. AMARYL is used to treat the type of non-insulin-dependent diabetes (Type 2 diabetes) in which blood glucose levels cannot be controlled through diet, exercise and weight gain.

USE AMARYL CAREFULLY,If

•you have experienced an accident, surgery, a feverish illness, or any other condition that creates stress, and you are still in a recovery period, please inform your doctor as you may need a temporary change in your treatment.

• If you have severe liver or kidney disease,

consult your pharmacist or doctor before taking AMARYL.

• If you have an enzyme deficiency called glucose-6-phosphate dehydrogenase (in such a case, the hemoglobin level in your blood may decrease, red blood cells may break down, and hemolytic anemia may

occur. It is not recommended for use in patients.

blood sugar decrease (hypoglycemia) important information about AMARYL while low blood sugar (you may experience hypoglycemia). blood sugar decrease (hypoglycemia) see below for additional information.

the following factors of low blood sugar (hypoglycemia) life may increase your risk:

• Malnutrition, irregular meal intervals, omitted meals or delayed meals, staying open for a period of time,

• Making changes in the diet,

• Using more AMARYL than required,Decreasing your

•kidney function,

• Liver functions. Severe deterioration in the,

brain• Infections related to the gland (thyroid gland, pituitary and adrenal gland disorders)

• Alcohol consumption (especially when you skip meals)

• Taking other medicines with AMARYL (see gı Using with other drugs İç)

• Increasing physical exercise, not receiving enough food, or lower than normal carbohydrates,

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Low blood sugar (hypoglycemia) may manifest itself in the following symptoms: _ Excessive feeling of hunger, headache, nausea, vomiting, laziness, drowsiness, sleep disturbance, restlessness, aggression , impaired concentration, deterioration in giving attention and reactions, depressed mood (depression), confusion (confusion), speech and visual disturbances, unsteadiness, self-control loss, partial paralysis, sensory disturbances, dizziness, helplessness,

following signs may include: _ Sweating, moist ci lt, anxiety, increased heart rate, palpitations, increased blood pressure, sudden and severe pain in the chest (angina pectoris and cardiac arrhythmia), which may spread to neighboring body regions, heart beat irregularities

If the blood sugar level continues to decrease, the following symptoms may occur:

• Blurring of the mind (delirium), development of contraction (convulsions), loss of self-control, superficial breathing, decrease in heart rate. Unconsciousness. Severe blood glucose may be similar to a stroke table.

Treatment of hypoglycemia In most cases, the symptoms associated with low blood sugar disappear rapidly (such as sugar cubes, sugary fruit juice, sugared tea) with a sugared food or drink. For this reason, always have a sugar food (sugar) with you. Artificial sweeteners are not effective. If you get sugar and your symptoms do not pass or repeat, tell your doctor or contact the hospital.

Laboratory tests Regularly check the sugar level in your blood and urine. Your doctor may also ask you to take some blood tests to monitor the level of your blood cells and control your liver function.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of AMARYL with food and drink Alcohol intake may increase or decrease the blood glucose lowering effect of AMARYL.

Pregnancy Consult your doctor or pharmacist before using the medicine. Do not use AMARYL during pregnancy. Tell your doctor if you are pregnant or are planning to become pregnant. Abnormalities in the blood sugar level during pregnancy may increase the risk of congenital anomaly or prenatal / postnatal death in the baby. Therefore, check your blood sugar levels frequently during your pregnancy. If there are problems with blood sugar levels, your doctor may recommend that you use insulin.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine.

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AMARYL can switch to milk. Do not use AMARYL during breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Use of tools and machines The low level of sugar in your blood (hypoglycemia) or high (hyperglycemia) can disrupt your ability to concentrate and react, or as a result, develop a vision problem. Keep in mind that this may endanger yourself or others. (eg when driving a vehicle and machine)

If,If

•you experience frequent low blood sugar,If

•you do not recognize signs of low blood sugar in yourself, or if you do not have these symptoms, ask your doctor if you can use a vehicle or machine.

Important information on some excipients contained in AMARYL AMARYL contains lactose as an excipient. If you have been told by your doctor that you have not been able to tolerate some sugars, contact your doctor before taking this medicinal product.

Use with other drugs The following drugs may increase the blood glucose lowering effect of AMARYL and may lead to a lower risk of hypoglycemia (such as insulin or metformin) _ Other drugs used in the treatment of diabetes (medications used in the treatment of pain and inflammation) (phenylbutazone, azopropazone, oxifenbutazone and aspirin-like medications Drugs used in the treatment of infections in the urinary tract (such as long-acting sulfonamides) _ Drugs used in the treatment of infections caused by bacteria or fungi (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin) (coumarin derivatives such as warfarin) _ Drugs that support muscle development (anabolic drugs) _ Drugs used in male sex hormone replacement therapy drugs used in the treatment of depression (fluoxetine, MAO-inhibitors) _ Drugs that reduce high cholesterol levels (fibrates) Drugs used for high blood pressure (Angiotensin Converting Enzyme Inhibitors) _ Drugs used in the treatment of gout (allopurinol, probenecid, sulfinpyrazone) _ Drugs used in cancer treatment (cyclophosphamide, ifosfamide, trophosphamide) _ For weight loss drugs used to regulate blood circulation; when used with a high dose (pentoxifylline) _ drugs used in the treatment of allergic conditions such as hay fever (tritocualin) _ Used in the treatment of conditions such as high blood pressure, prostate complaints and heart failure, so-called sympatholytics Drugs

listed below can reduce the effect of lowering the blood sugar of AMARYL and blood glucose elevation (hyperglycemia) can lead to risk: medicaments containing _ female sex hormones (estrogens and progestogens) _ that diuretics are used to treat high blood pressure (a thiazide diuretic)

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_ thyroid gland stimulant drugs (such as levothyroxine) _ allergies and inflammation in treating drugs (glucocorticoids) used in the treatment of severe mental illness (chlorpromazine and other phenothiazine derivatives) _ To increase the number of heart beats or asthma, nasal congestion, cough and cold to treat, clay drugs used in the treatment of high cholesterol levels (nicotinic acid) _ used drugs for the treatment of constipation (laxatives) - drugs used to prevent seizures of seizures (phenytoin) Drugs used in the treatment of nervousness and sleep disorders (barbiturates) _ Drugs used in the treatment of intraocular pressure (acetazolamide) _ Drugs used to treat high blood pressure or to reduce blood sugar (diazoxide) _ Medications used to treat infections such as tuberculosis (rifampicin) _ Serious blood Drugs used in the treatment of sugars (glucagon)

The following drugs may reduce and increase the blood glucose lowering effect of AMARYL: _ Medications used to treat gastric ulcers (H2 antagonistl) beta-blockers used in the treatment of high blood pressure or heart failure, drugs such as clonidine, guanetidine and reserpine. These medications can also lead to the suppression of symptoms of hypoglycemia. Special care is required when taking these medications.

AMARYL may increase or weaken the effect of the following medication:

• Drugs that inhibit blood clotting (coumarin derivatives such as warfarin) If you are currently using any prescription or non-prescription medication or if you have recently used it, please inform your doctor or pharmacist.

3. How to use AMARYL Instructions for appropriate use and dose / frequency of administration: Always take this medicine exactly as your doctor told you. If you are not sure, consult your doctor or pharmacist.

The dose of AMARYL depends on your needs, conditions, and the results of sugar tests in blood and urine and is determined by your doctor. Do not take more tablets than your doctor prescribes.

• The usual starting dose of AMARYL is 1 mg tablet once a day.

• If necessary, your doctor may increase the dose after 1-2 weeks of treatment.

• The recommended maximum daily AMARYL dose is 8 mg.

• If adequate control is not achieved with the highest recommended dose of AMARYL, a combination therapy with glimepiride and insulin with metformin or glimepiride can be initiated. In such a case, your doctor will individually determine the dose of glimepiride, metformin or insulin that is suitable for you.

• If your body weight changes or your lifestyle changes, or if you are in a stressful situation, they may require changing the dose of AMARYL; so please inform your doctor.

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Method and method of:

administration• AMARYL is taken orally.

• Take this medicine orally before the first meal of the day (usually at breakfast) or during meals. If you have not had breakfast, you should take the medicine at the time of your doctor's prescription. It is important that you do not skip any meals when buying AMARYL.

• Swallow the tablets together with at least half a glass of water. Do not crush or chew the tablets.

Different age groups: Use in children: AMARYL is not recommended for children under 18 years of age.

Use in the elderly: Your doctor will decide if dose adjustment is required in elderly patients.

Special Use Cases: Kidney Failure / Liver Failure In case of severe renal failure or hepatic failure should be used with caution. If you have an impression that the effect of AMARYL is too strong or too weak, talk to your doctor or pharmacist.

If you have used more AMARYL than you should: Talk to a doctor or pharmacist if you have used more than you should use from AMARYL.

If you use more AMARYL than you should use, there is a danger of low blood sugar (hypoglycemia). Low blood sugar can occur within 12-72 hours. For the symptoms of hypoglycemia, see section, Important information on low blood sugar (hypoglycemia)) in section 2 above. Symptoms of hypoglycemia may not appear within 24 hours of using more AMARYL than you should use. Hypoglycemia can usually be accompanied by restlessness, tremors, visual disturbances, coordination problems, insomnia, coma, and referrals. You should therefore consume enough sugar in such a situation (eg sugar, sweet juice, sweetened tea) and tell your doctor immediately. In children, hypoglycemia due to accidental overdose of the drug is being treated, the amount of sugar given must be carefully checked to avoid the possibility of developing dangerous hyperglycemia. People who are in a state of unconsciousness should not be given food or drink.

Since the condition of hypoglycemia may persist for a while, it is very important to carefully monitor the patient until there is no further danger. A preventive measure may be required in the hospital. Show the medicine box or the remaining tablets to find out how much the doctor was taken.

Severe hypoglycemia may be accompanied by loss of consciousness and severe neurological deficits; they are considered to be medical emergencies and require immediate medical treatment by contacting the hospital. There should always be a pre-informed person who can call a doctor if there is an emergency.

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If you forget to use AMARYL Do not take double doses to compensate for the missed doses.

Effects that may occur when treatment is discontinued with AMARYL If you interrupt the treatment or stop treatment, you should know that the desired blood glucose-lowering effect cannot be achieved and the disease will worsen. Continue to take AMARYL until your doctor tells you to leave the medicine. If you have any further questions regarding the use of this product, ask your doctor or pharmacist.

4. What are the possible side effects? As with all medicines, AMARYL may have side effects in people who are sensitive to the ingredients.

If you experience any of the following symptoms, tell your doctor immediately:

• Allergic reactions (often associated with skin rash, including inflammation of blood vessels). Difficulty in breathing can lead to severe reactions such as a drop in blood pressure, and sometimes progress to a state of shock.

• Liver function disorders include yellowing of the skin and eyes (jaundice), problems in the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.

• Allergy to the skin (hypersensitivity). It may occur in the form of pruritus, rash, hives and increased sensitivity to the sun. Some of the mild allergic reactions can become serious reactions such as breathing or swallowing difficulties, swelling of the lips, tongue or throat.

• Severe hypoglycemia. Unconsciousness, seizures or coma may be seen.

Some patients experienced the following side effects when receiving AMARYL:

Rare side effects (less than 1 in 1000 patients)

• Lower blood sugar than normal (hypoglycemia) (See Section 2 - Particular attention should be paid to Amaryl)

• Decrease in the number of blood cells: - Platelet (increases the risk of bleeding and bruising) - White blood cells (increases the likelihood of infection) - Red blood cells (the appearance of pale skin color, symptoms such as weakness and breathing)

These problems generally improve when AMARYL reception is stopped.

Very rare side effects (less than 1 in 10,000 patients)

• Allergic reactions (often associated with skin rash, including inflammation of blood vessels). Difficulty in breathing can lead to severe reactions such as a drop in blood pressure, and sometimes progress to a state of shock. If you experience any of these symptoms, tell your doctor immediately.

• Disorder of liver function. Yellowing of the skin and eyes (jaundice), problems in the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately.

• Feeling sick or sick, feeling diarrhea, toughness or swelling and abdominal pain

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• Reduction of sodium levels in your blood (indicated by blood tests)

Other side effects include:

• Allergy to the skin, itching, rash, hives and sun may occur in the form of increased sensitivity. Some of the mild allergic reactions may develop into severe reactions, such as difficulty breathing or swallowing, swelling of the lips, tongue or throat; therefore, if any of these side effects develop, tell your doctor immediately.

• Allergic reactions with sulfonylureas, sulfonamides or related drugs may occur.

• Vision-related problems may occur at the start of treatment with AMARYL. This is due to changes in your blood sugar level and will improve in a short time.

• Increased liver enzymes

• Severe unusual bleeding or bruising under the skinmentioned in

If you experience any side effects notthis manual, please inform your doctor or pharmacist.

5. Storage of AMARYL Keep AMARYL in a place where children cannot and cannot reach them.

Store at room temperature below 25 ° C and in its original packaging.

Use in accordance with the expiration date Do not use AMARYL after the expiration date in the packaging.