Amaryl

Each tablet contains 2 mg or 4 mg of glimepiride.
Excipients/Inactive Ingredients: lactose monohydrate, sodium starch glycollate (type A), magnesium stearate, microcrystalline cellulose, povidone 25000.
In addition, the tablets contain colouring agents: 2 mg tablets contain yellow iron oxide (E172) and indigo-carmine aluminium lake (E132).
4 mg tablets contain indigo-carmine aluminium lake (E132).

Amaryl is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas.
Amaryl works by increasing the amount of insulin released from the pancreas. The insulin then lowers blood sugar levels.

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

Always take this medicine exactly as the doctor has told the patient. Check with the doctor or pharmacist if not sure.
Taking the medicine: Take the medicine by mouth, just before or with the first main meal of the day (usually breakfast). If the patient does not have breakfast, the patient should take the medicine on schedule as prescribed by the doctor. It is important not to leave out any meal when on Amaryl.
Swallow the tablets with at least half glass of water. Do not crush or chew the tablets.
Each tablet can be divided into equal doses.
How much to take: The dose of Amaryl depends on the patient's needs, condition and results of blood and urine sugar tests and is determined by the doctor. Do not take more tablets than the doctor has prescribed.
The usual starting dose is one Amaryl 1 mg tablet once a day.
If necessary, the doctor may increase the dose after each 1-2 weeks of treatment.
The maximum recommended dose is 6 mg Amaryl per day.
A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be initiated. In such a case the doctor will determine the proper doses of glimepiride, metformin or insulin individually for the patient.
The dose of Amaryl may need to be adjusted if the patient changes weight, changes lifestyle, or if the patient is under a lot of stress. Please speak to the doctor if any of these situations apply.
If the patient feels the effect of the medicine is too weak or too strong, the dose should not be changed by the patient, but ask the doctor.
If the patient has forgotten to take Amaryl: If the patient forgets to take a dose, do not take a double dose to make up for the forgotten doses.
If the patient stops taking Amaryl: If the patient interrupts or stops the treatment, the patient should be aware that the desired blood sugar lowering effect is not achieved or that the disease will get worse again.
Keep taking Amaryl until the doctor tells to stop.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.

If the patient has taken too much Amaryl or an additional dose, there is a danger of hypoglycaemia (see Signs of hypoglycaemia under Precautions) and therefore, should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately. When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink.
Since the state of hypoglycaemia may last for some time, it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of consciousness and coma are cases of medical emergency requiring immediate medical admission into hospital. It may be helpful to tell the patient's family and friends to call a doctor immediately if this happens to the patient.

Do not take Amaryl and tell the doctor if: The patient is allergic to: glimepiride or other sulfonylureas (medicines used to lower blood sugar such as glibenclamide) or sulphonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in Description).
The patient has Diabetes mellitus type I.
The patient has diabetic ketoacidosis (a complication of diabetes when acid level is raised in the body and may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness).
The patient is in a diabetic coma.
The patient has severe kidney disease.
The patient has a severe liver disease.
This medicine should not be taken if any of the above apply to the patient. If not sure, talk to the doctor or pharmacist before taking Amaryl.

Talk to the doctor or pharmacist before taking the medicine if: The patient is recovering from an injury, operation, infections with fever, or from other forms of stress, inform the doctor as temporary change of treatment may be necessary.
The patient has a severe liver or kidney disorder.
If not sure if any of these apply to the patient, talk to the doctor or pharmacist before taking Amaryl.
Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.
The information available on the use of Amaryl in people under 18 years of age is limited. Therefore, its use in these patients is not recommended.
Important information about hypoglycaemia (low blood sugar): When taking Amaryl, the patient may get hypoglycaemia (low blood sugar). Please see below for additional information about hypoglycaemia, its signs and treatment.
Following factors could increase the patient's risk of getting hypoglycaemia: Undernourishment, irregular meal time, missed or delayed meal or period of fasting.
Changes to the diet.
Taking more Amaryl than needed.
Having kidneys that do not work properly.
Having severe liver disease.
If the patient suffers from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex).
Drinking alcohol (especially when skipping a meal).
Taking certain other medicines (see Interactions).
If the patient increases the amount of exercise and doesn't eat enough or eat food containing less carbohydrate than usual.
Signs of hypoglycaemia include: Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems, sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with speech and sight, slurred speech, shakiness, partial paralysis, dizziness, helplessness.
The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of heart beat, sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris and cardiac arrhythmias). If blood sugar levels continue to drop, the patient may suffer from considerable confusion (delirium), develop fits, lose self control, breathing may be shallow and heart beat slows down, the patient may fall into unconsciousness. The clinical procedure of a severe reduced blood sugar level may resemble that of a stroke.
Treating hypoglycaemia: In most cases the signs of reduced blood sugar vanish very quickly when the patient consumes some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea.
The patient should therefore always keep some form of sugar (e.g. sugar cubes). Remember that artificial sweeteners are not effective. Please contact the doctor or go to the hospital if taking sugar does not help or if the symptoms recur.
Laboratory tests: The level of sugar in the blood or urine should be checked regularly. The doctor may also take blood tests to monitor the blood cell levels and liver function.
Amaryl contains lactose: If the patient has been told by the doctor that some sugars cannot be tolerated, contact the doctor before taking this medicine.
Driving and using machines: The ability to concentrate or react may be reduced if blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if visual problems develop as a result of such conditions. Bear in mind that the patient could endanger himself/herself or others (e.g. when driving a car or using machines). Please ask the doctor whether the patient can drive a car if the patient: has frequent episodes of hypoglycaemia; has fewer or no warning signals of hypoglycaemia.
Use in Children: Amaryl is not recommended for use in children under 18 years of age.

Pregnancy: Amaryl should not be taken during pregnancy. Tell the doctor if the patient is, thinks she might be or is planning to become pregnant.
Breast-feeding: Amaryl may pass into breast milk. Amaryl should not be taken during breast-feeding.
Ask the doctor or pharmacist for advice before taking any medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor immediately if the patient experiences any of the following symptoms: Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock.
Abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.
Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions.
Severe hypoglycaemia including loss of consciousness, seizures or coma.
Some patients experienced the following side effects whilst taking Amaryl: Rare side effects (may affect up to 1 in 1,000 people): Lower blood sugar than normal (hypoglycaemia) (see Contraindications and Precautions).
Decrease in the number of blood cells: Blood platelets (which increases risk of bleeding or bruising), White blood cells (which makes infections more likely), Red blood cells (which can make the skin pale and cause weakness or breathlessness).
These problems generally get better after you stop taking Amaryl: Weight gain; Hair loss; Changes in the 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) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock. If the patient experiences any of these symptoms, tell the doctor immediately.
Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If the patient experiences any of these symptoms, tell the doctor immediately.
Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain.
Decrease in the amount of sodium level in the blood (shown by blood tests).
Not known, frequency cannot be estimated from the available data: Allergy (hypersensitivity) of the skin may occur, such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of the lips, throat or tongue. Therefore in the event of one of these side effects, tell the doctor immediately.
Allergic reactions with sulfonylureas, sulphonamides, or related medicines may occur.
Problems with sight may occur when beginning treatment with Amaryl. This is due to changes in blood sugar levels and should soon improve.
Increased liver enzymes.
Severe unusual bleeding or bruising under the skin.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed above.
By reporting side effects, it can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
The doctor may wish to change the dose of Amaryl if the patient is taking other medicines, which may weaken or strengthen the effect of Amaryl on the level of sugar in the blood.
The following medicines can increase the blood sugar lowering effect of Amaryl. This can lead to a risk of hypoglycaemia (low blood sugar): Other medicines to treat diabetes mellitus (such as insulin or metformin).
Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines).
Medicines to treat urinary infections (such as some long acting sulphonamides).
Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
Medicines to inhibit blood clotting (coumarin derivatives such as warfarin).
Medicines supporting muscle build up (anabolics).
Medicines used for male sex hormone replacement therapy.
Medicines to treat depression (fluoxetine, MAO-inhibitors).
Medicines lowering high cholesterol level (fibrates).
Medicines lowering high blood pressure (ACE inhibitors).
Medicines called anti-arrhythmic agents used to control abnormal heart beat (disopyramide).
Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone).
Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide).
Medicines used to reduce weight (fenfluramine).
Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline).
Medicines to treat nasal allergies such as hay fever (tritoqualine).
Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms.
The following medicines may decrease the blood sugar lowering effect of Amaryl. This can lead to a risk of hyperglycaemia (high blood sugar level): Medicines containing female sex hormones (oestrogens, progestogens).
Medicines to treat high blood pressure called thiazide diuretics (water tablets).
Medicines used to stimulate the thyroid gland (such as levothyroxine).
Medicines to treat allergies and inflammation (glucocorticoids).
Medicines to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives).
Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics).
Medicines to treat high cholesterol level (nicotinic acid).
Medicines to treat constipation when they are used long term (laxatives).
Medicines to treat fits (phenytoin).
Medicines to treat nervousness and sleep problems (barbiturates).
Medicines to treat increased pressure in the eye (azetazolamide).
Medicines to treat high blood pressure or low blood sugar (diazoxide).
Medicines to treat infections, tuberculosis (rifampicine).
Medicines to treat severe low blood sugar levels (glucagon).
The following medicines can increase or decrease the blood sugar lowering effect of Amaryl: Medicines to treat stomach ulcers (called H2 antagonists).
Medicines to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine. These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines.
Amaryl may either increase or weaken the effects of the following medicines: Medicines inhibiting blood clotting (coumarin derivatives such as warfarin).
Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Amaryl. To avoid this effect, the patient should be advised to take Amaryl at least 4 hours before colesevelam.
Amaryl with food, drink and alcohol: Alcohol intake may increase or decrease the blood sugar lowering action of Amaryl in an unpredictable way.

Do not use this medicine if there are visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient is no longer using. These measures will help protect the environment.

Do not store above 30°C.
Store in the original package in order to protect from moisture.

Antidiabetic Agents

A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.

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