1 mg and 4 mg tablets 
glimepiride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important for you

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours. 
    If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Amaryl is and what it is used for 
2. What you need to know before you take Amaryl 
3. How to use Amaryl 
4. Possible side effects 
5. How to store Amaryl 
6. Contents of the packaging and other information 

1. What Amaryl is and what it is used for

Amaryl is a blood sugar lowering medicine in tablet form that is taken by mouth. This drug belongs to a blood sugar lowering group of medicines called sulphonylureas. Amaryl works by increasing the amount of insulin released from the pancreas. Insulin then lowers your blood sugar level.

What Amaryl is used for:

  • Amaryl is used to treat a special type of diabetes ( type 2 diabetes mellitus ) as diet, exercise and weight loss alone are not enough to control your blood sugar levels.

What you need to know before you take Amaryl

Do not use Amaryl and contact your doctor if:

  • You are allergic to: glimepiride or other sulphonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulphonamides (medicines used to treat bacterial infections such as sulphamethoxazole) or any of the other ingredients of this medicine (listed in section 6).
  • You have type 1 diabetes mellitus
  • You have diabetic ketoacidosis (a diabetic complication where the acid level in your body is elevated and you may feel some of the following symptoms: fatigue, malaise, increased urination, and muscle stiffness)
  • You’re in a diabetes 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 not sure, talk to your doctor or pharmacist before taking Amaryl.

Warnings and cautions

Talk to your doctor or pharmacist before taking Amaryl if:

  • You are recovering from an injury, surgery, fever infection, or any other type of stress, then it may be necessary to temporarily change the treatment
  • You have severe liver or kidney effects

If you are not sure if you have any of the above, talk to your doctor or pharmacist before taking Amaryl.

Decreased hemoglobin levels and degradation of red blood cells ( hemolytic anemia ) may occur in patients lacking enzyme et glucose 6- phosphate dehydrogenase.

Available information on treatment with Amaryl in people under 18 years of age is limited. Treatment of this patient group is therefore not recommended.

Important information about hypoglycemia (low blood sugar) 
When you take Amaryl you may get hypoglycemia (low blood sugar). See below for more information on hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycaemia:

  • Malnutrition, irregular mealtimes, missed or delayed food intake or periods of fasting
  • Dietary changes
  • For high dose Amaryl is administered
  • In case of impaired renal function
  • In severe liver disease
  • If you suffer from certain hormonal disorders (disorders of the thyroid gland, pituitary gland or adrenal cortex )
  • Alcohol consumption (especially if you skip a meal)
  • Concomitant use of certain other medicines (see below “Other medicines and Amaryl”)
  • If you increase your physical activity and do not eat enough or if you eat foods with less carbohydrate content than usual

Signs of hypoglycaemia include:

  • Hunger, headache, nausea, vomiting, sluggishness, fatigue, sleep disturbances, restlessness, aggression, impaired concentration, decreased alertness and reactivity, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, dizziness, dizziness, helplessness
  • The following signs may also occur: sweating, sticky skin, anxiety, increased heart rate, high blood pressure, palpitations, sudden severe chest pain that may radiate to nearby areas ( angina pectoris, heart rhythm disturbance)

If your blood sugar levels continue to drop, you may experience pronounced confusion ( delirium ), develop seizures, loss of self-control, shallow breathing, and slower heart rate, and you may become unconscious. The clinical picture of a severe fall in blood sugar may be similar to that of a stroke.

Treatment of hypoglycaemia: 
In most cases, the signs of low blood sugar disappear very quickly when you consume some kind of sugar, such as sugar cubes, sweet juice, or sugared tea. You should therefore always carry some form of sugar with you (eg sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or see a hospital if you do not get better from sugar intake or if your symptoms return.

Laboratory 
tests The sugar level in your blood or urine should be checked regularly. Your doctor may also want to take blood samples to examine your blood cell levels and your liver function.

Children and young people

Amaryl is not recommended for children under 18 years of age.

Other medicines and Amaryl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may want to change the dose of one of Amaryl if you are taking any other medicines which may weaken or enhance the effect of Amaryl on your blood sugar level.

The following medicines may increase the blood sugar-lowering effect of Amaryl, which may lead to an increased risk of hypoglycaemia (low blood sugar):

  • Other medicines used to treat diabetes (such as insulin, or metformin )
  • Medicines for the treatment of pain and inflammation (phenylbutazone, azapropazone and oxyphenbutazone, and aspirin-like medicines)
  • Medicines used to treat urinary tract infections (such as long-acting sulfonamides)
  • Medicines used to treat bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinolone antibiotics, clarithromycin)
  • Drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )
  • Drugs that promote muscle building (anabolic steroids )
  • Drugs used in the replacement of male sex hormone
  • Drugs used to treat depression ( fluoxetine, MAO inhibitors )
  • Drugs that lower high cholesterol levels (fibrates)
  • Drugs that lower high blood pressure ( ACE inhibitors )
  • Drugs called antiarrhythmics used to control abnormal heart rhythms ( disopyramide )
  • Medicines for the treatment of gout (allopurinol, probenecid, sulfinpyrazone)
  • Drugs used to treat cancer (cyclophosphamide, ifosfamide, trophosphamide)
  • Medicines used for weight loss (fenfluramine)
  • Drugs that increase blood circulation when given in high doses by intravenous infusion (pentoxifylline)
  • Medicines for the treatment of allergies in the nose such as hay fever (tritoqualin)
  • Medicines called sympatholytics used in the treatment of high blood pressure , heart failure or prostate symptoms

The following medicines may lower the blood sugar lowering effect of Amaryl. This may lead to an increased risk of hyperglycaemia (high blood sugar):

  • Medicines containing female sex hormones ( estrogens, progestogens)
  • Drugs that act as diuretics ( thiazides , diuretics )
  • Drugs that stimulate the thyroid gland (such as levothyroxine)
  • Medicines for the treatment of allergies and inflammation ( glucocorticoids )
  • Medicines for the treatment of severe mental disorders (chlorpromazine and other phenothiazine derivatives)
  • Medicines used to increase the heart rate, to treat asthma or nasal congestion, coughs, and colds, to treat obesity, or medicines used in life-threatening situations ( adrenaline and sympathomimetics )
  • Medicines for the treatment of high cholesterol levels ( nicotinic acid )
  • Medicines for long-term treatment of constipation ( laxatives )
  • Medicines for the treatment of seizures ( phenytoin )
  • Medicines for the treatment of anxiety and sleep problems ( barbiturates )
  • Medicines for the treatment of increased pressure in the eye (acetazolamide)
  • Medicines for the treatment of high blood pressure or for the treatment of low blood sugar (diazoxide)
  • Drugs used to treat infections, tuberculosis (rifampicin)
  • Medicines for the treatment of severe low blood sugar (glucagon)

The following medicines may enhance or weaken the blood sugar lowering effect of Amaryl:

  • Medicines for the treatment of stomach ulcers (so-called H 2 – antagonists )
  • Medicines for the treatment of high blood pressure or heart failures such as beta-blockers, clonidine, guanethidine, and reserpine. These medicines can also hide the signs of hypoglycemia, so special precautions should be taken when using them.

Amaryl may either potentiate or attenuate the effects of the following medicines:

  • Drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )

Colesevelam, a drug used to lower cholesterol, has an effect on the uptake of Amaryl. To avoid this effect, you should take Amaryl at least 4 hours before colesevelam.

Amaryl with food, drink, and alcohol

Alcohol intake can enhance or weaken the blood sugar lowering effect of Amaryl in an unpredictable way.

Pregnancy and breastfeeding

Pregnancy

Amaryl should not be used during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Breast-feeding

Amaryl can pass into breast milk. Amaryl should not be used during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate and react may be impaired if your blood sugar is lowered ( hypoglycaemia ) or elevated ( hyperglycaemia ) or if your vision is impaired as a result of these conditions. Always keep in mind that you may expose yourself or others (eg when driving or operating machines) to danger. Consult your doctor if you can drive if you:

  • often have episodes of hypoglycemia,
  • have less or no warning signs of hypoglycemia

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Amaryl contains lactose

Amaryl contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Amaryl

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Use of this medicine

  • The medicine is taken orally, just before or in connection with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to the instructions given to you by your doctor. It is important that you do not miss a meal while using Amaryl.
  • The tablets should be swallowed together with at least half a glass of water. The tablets must not be crushed or chewed.
  • Each tablet can be divided into two equal doses.

Dosage instructions 
Dosage one of Amaryl depends on your needs, conditions and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed.

  • The usual starting dose is one tablet of Amaryl 1 mg daily
  • If necessary, your doctor may increase the dose one after every 1-2 weeks of treatment
  • The maximum recommended dose is 6 mg Amaryl daily
  • Combination therapy with glimepiride plus metformin or with glimepiride plus insulin may be appropriate. In these cases, your doctor will prescribe the appropriate dose of glimepiride, metformin or insulin for you
  • If your weight changes or if your lifestyle changes or if you are in a stressful situation, you should inform your doctor as it may be necessary to adjust someone.
  • If you find that the effect of your medicine is too weak or too strong, in such cases do not change the dosage yourself without first consulting your doctor.

If you forget to take Amaryl

If you forget to take a dose , do not take a double dose to make up for a forgotten dose .

If you stop taking Amaryl

If you stop or stop treatment, you should be aware that the desired blood sugar lowering effect can not be achieved and that the disease may worsen again. Continue to use Amaryl until your doctor tells you to stop treatment.

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

4. Possible side effects

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

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

  • Allergic reactions (including inflammation of a vessel wall, often with a rash) that can develop into severe reactions with difficulty breathing, a drop in blood pressure and sometimes even shock .
  • Abnormal liver function including yellowing of the skin and whites of the eyes (jaundice), problems with bile secretion (bile stasis), liver inflammation ( hepatitis ), or liver failure
  • Allergic skin reactions (hypersensitivity) such as itching, rash, hives, and photosensitivity. Some mild allergic reactions can develop into severe reactions
  • Severe hypoglycemia with unconsciousness, seizures, or coma

Some patients experienced the following side effects during treatment with Amaryl:

Rare side effects are (may affect up to 1 in 1000):

  • Lower blood sugar (hypoglycemia) than normal (see section 2)
  • Reduction in the number of blood cells:
    • Platelets (increases the risk of bleeding or the risk of bruising)
    • White blood cells (increases the risk of infection)
    • Red blood cells (skin may become pale and weakness or shortness of breath may occur)

These problems usually get better as soon as you stop using Amaryl

  • Weight gain
  • Hair loss
  • Changes in the taste experience

Very rare side effects are (may affect up to 1 in 10 000 users):

  • Allergic reactions (including inflammation of a vessel wall, often with a rash) that can develop into severe reactions with difficulty breathing, a drop in blood pressure and sometimes even shock . If you experience any of these symptoms, contact your doctor immediately
  • Abnormal liver function including yellowing of the skin and whites of the eyes (jaundice), problems with bile secretion (bile stasis), hepatitis ( hepatitis ), or liver failure. If you experience any of these symptoms, contact your doctor immediately
  • Feeling sick or sick, diarrhea, satiety or bloated stomach and abdominal pain
  • Decrease in sodium levels in the blood (seen on blood tests)

Has been reported (occurs in an unknown number of users) :

  • Allergic skin reactions (hypersensitivity) such as itching, rash, hives, and photosensitivity. Some mild allergic reactions may develop into severe reactions with difficulty swallowing or breathing, swelling of the lips, throat or tongue. Therefore, if you get any of these symptoms, contact your doctor immediately.
  • Allergic reactions to sulphonylureas, sulphonamides, or similar medicines may occur
  • Visual disturbances may occur at the beginning of treatment due to changes in blood sugar levels. However, this problem improves.
  • Elevated liver enzyme levels
  • Severe unusual bleeding or bruising under the skin.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 blister after “EXP”. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

Do not use this medicine for visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is glimepiride. 
    Each tablet contains 1 mg or 4 mg glimepiride, depending on the strength of the blister or pack.
  • The other ingredients are: lactose monohydrate, sodium starch glycollate (type A), magnesium stearate, microcrystalline cellulose, povidone 25000
  • In addition, the tablets contain dyes:
    • 1 mg tablets contain red iron oxide (E172)
    • 4 mg tablets contain indigo carmine aluminum lacquer (E132)

What the medicine looks like and the contents of the pack

Each tablet of Amaryl is oblong and notched on both sides. Each tablet can be divided into equal doses. The different strengths differ in color:

  • 1 mg tablets are pink
  • 4 mg tablets are light blue

Amaryl is available in blister packs of 14, 15 (Amaryl 1 mg only), 20, 28, 30, 50, 60, 90, 112, 120, 280 and 300 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer


Manufacturer:

  • Sanofi SpA, Strada Statale17, Km 22, 67019 Scoppito (L`Aquila) Italy
  • Sanofi-Aventis Deutschland GmbH, Industrial Park Höchst-Brüningstraße 50, 65926 Frankfurt am Main, Germany
  • Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, 37100 Tours, France

This medicine is authorized in the EEA Member States under the following names:

  • Amaryl: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Romania, Slovakia, Spain, UK
  • Amaryl Tablets: Slovenia
  • Amaryl Tablets: Latvia
  • Amaryl Tablets: Lithuania
  • Amarylle: Belgium, Luxembourg
  • Amarel: France
  • Solos: Greece

Muhammad Nadeem

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