|The name of the preparation
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:glimepiride
The drug is available on prescription
Oral anti-diabetic drug. A medicine that reduces blood Glucose
(a hypoglycaemic agent), stimulates the release of insulin
What does Amaryl contain and how does it work?
The active substance is Glimepiride
. It is an oral antidiabetic medicine from the group of sulfonylureas. These drugs are used to reduce blood glucose in type 2 diabetes (previously the term "non-insulin dependent diabetes" was used). Glimepiride increases the release of insulin by the pancreatic beta cells in response to a physiological stimulus like glucose. The mechanism of action is the binding of glimepiride to the beta cell membrane protein, which results in closure of the potassium channel and depolarization of the cell membrane. Depolarization causes the opening of Calcium
channels and the inflow of calcium ions into the cell. The increased concentration of intracellular calcium becomes a signal to release insulin. Glimepiride also works extragastric and leads to increased peripheral glucose consumption. Stimulates glucose uptake through muscle and fat tissue cells (increases the number of glucose membrane transporters), stimulates lipogenesis and glycogenogenesis. It also reduces the uptake of insulin by the liver.
In diabetic patients, effective metabolic control is maintained for 24 hours after a single dose. After oral administration, glimepiride is completely absorbed, the maximum concentration in the blood is obtained after about 2.5 hours. Excreted in urine and faeces.
When should I use Amaryl?
The preparation is indicated for the treatment of type 2 diabetes, when non-pharmacological methods (diet, exercise, weight loss) are not sufficiently effective.
The preparation can be used alone or in combination with Metformin
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients of the preparation, to other sulphonylureas or to sulfonamides.
The preparation can not be used in the case of:
· Type 1 diabetes (insulin dependent)
· Diabetic coma
· Severe kidney and / or liver problems (in which case insulin is needed).
The preparation is contraindicated during pregnancy and breastfeeding.
When should you take extra care with Amaryl?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Like other sulphonylurea medicines, the preparation may cause hypoglycaemia, especially if meals are taken irregularly or overlooked.Symptoms of hypoglycaemia may include: headache, uncontrollable hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressiveness, concentration disorders, decreased alertness, longer reaction time, depression, confusion, speech and vision disturbances, tremors, paresis, Sensory disorders, dizziness, helplessness, loss of self-control, delirium, convulsions, loss of consciousness, coma, shallow breathing, reduced heart rate, and symptoms associated with stimulation of the sympathetic nervous system, such as sweating, anxiety, wet skin, increased frequency heart rhythm, hypertension, palpitations, angina pectoris and arrhythmias.
Symptoms of a severe hypoglycemic attack may resemble a stroke. A quick improvement usually takes place after carbohydrate (sugar) administration. Artificial sweeteners are not effective. Relief of hypoglycaemic symptoms may be short-lived and hypoglycaemia may recur. In case of severe or prolonged hypoglycaemia, which can only be partially controlled with the usual amount of sugar, you should immediately consult a doctor; in some situations it is necessary to hospitalize the patient.
The occurrence of hypoglycaemia may be favored by:
· Reluctance or inability to interact with a doctor, frequent in elderly people
· Malnutrition, irregular eating, skipping meals, periods of fasting
· Changing the way of eating
· Carbohydrate intake is not adequate to physical activity
· Alcohol consumption, especially when skipping meals
· Kidney problems
· Severe liver problems
· Taking the product not in accordance with the recommendations, including overdosing
· Unbalanced disorders of endocrine glands, eg some thyroid dysfunction, dysfunction of the anterior pituitary gland, adrenocortical insufficiency
· Parallel use of other medicines.
If you know or suspect you are in any of the above groups, inform your prescriber before using this medicine. Your doctor may recommend that you have more frequent laboratory tests and remain under strict control.
During the treatment period, your doctor will recommend regular checks:
· Blood glucose and urine, and may also recommend glycemic hemoglobin control
· Liver function
· Blood picture, especially the number of white blood cells and platelets (leukocytes and thrombocytes).
During periods of increased stress (eg accidents, acute surgical procedures, fever infections), it may be advisable to temporarily change treatment to insulin; please consult your doctor.
There is no clinical experience with the use of this preparation in people with severe hepatic impairment or in persons undergoing dialysis. In patients with severe renal or hepatic impairment, insulin therapy is indicated.
The use of the preparation as well as other sulphonylureas in patients deficient in glucose-6-phosphate dehydrogenase requires caution. In these people there is a risk of hemolysis of the blood cells (irreversible damage to the blood cells) and the occurrence of haemolytic anemia. If necessary, your doctor may prescribe other non-sulphonylurea medicines.
Additional information about the other ingredients of the preparation:
the preparation contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
The ability to concentrate and react may be impaired if diabetes is not well controlled, especially at the beginning of treatment and when hypoglycaemia occurs (eg when taking too much or missed a meal) and when you have diabetes related vision problems. This can be a hazard when driving or operating equipment / machines. Avoid situations that may lead to hypoglycaemia. If hypoglycaemia occurs frequently or the initial symptoms of hypoglycaemia are difficult to grasp, consult a physician and consider whether driving or operating machines / machines is appropriate.
Dosage of Amaryl
The preparation is in the form of tablets for oral use. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
The preparation should be taken shortly before a meal or during a meal. During the period of treatment should be maintained a proper diet and physical activity. The preparation is not effective if the patient does not follow the recommended diet.
The dosage depends on the results of blood glucose and urine tests. Initially, 1 mg a day; if you do not get adequate glycemic control, your doctor will advise you to increase your dose at intervals of 1-2 weeks to a dose that ensures effective control of your blood glucose (2, 3 or 4 mg a day). A dose greater than 4 mg / day only in exceptional cases leads to a further increase in efficacy. The maximum dose is 6 mg per day.
The preparation should be taken once a day, preferably immediately before breakfast or during breakfast or other main meal. The tablets should be swallowed whole (not chewed) with liquid. If you miss a dose, do not increase the next dose.
The preparation can be used in combination with metformin or insulin. Combination therapy can only be started under the close supervision of a physician.
The doctor may also prescribe a preparation to replace other oral hypoglycemic agents previously used. In this case, to avoid the occurrence of hypoglycaemia due to the mutual aggravation of the action of drugs, the doctor's instructions should be strictly followed.
Dose adjustment may be required during treatment. To help prevent hypo- or hyperglycaemia, consult your doctor if you change your lifestyle, change your weight or experience other conditions that affect blood glucose control.
In the case of severe hepatic or renal impairment, the use of the preparation is contraindicated; treatment with insulin is necessary.
Children and youth:
Due to the lack of clinical experience in the use of the preparation in children under the age of 8 and only limited experience in the use of the preparation in children 8.-17. It is not recommended to use the preparation in this age group.
Can Amaryl be used during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The use of the preparation during pregnancy is contraindicated. If during pregnancy, a woman becomes pregnant or plans to become pregnant, please consult a doctor as soon as possible because it is recommended to change the treatment for insulin therapy as soon as possible.
The use of the preparation during breast-feeding is contraindicated.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter. During the period of application, taking any other medicines can only take place with the consent of the doctor or on his recommendation.
Glimepiride is metabolised by the cytochrome P450 2C9 isoenzyme. Parallel use of drugs that inhibit the activity of this isoenzyme, such as, for example, Fluconazole
, significantly increases the systemic exposure to glimepiride. Parallel use of drugs that increase the activity of 2C9 isoenzyme, such as, for example, rifampicin, may reduce the effectiveness of the preparation.
Parallel use of the following drugs increases the hypoglycemic effect of the preparation and may lead to hypoglycaemia:
· Oral antidiabetic agents (e.g. metformin)
· Phenylbutazone, oxyfenbutazone, azapropazon
· Salicylates and p-aminosalicylic acid
· Anabolic steroids and male sex hormones
· Some long acting sulfonamides
· Anticoagulants of coumarin derivatives such as Warfarin
, phenprocoumon, acenocoumarol
· Angiotensin converting enzyme inhibitors (ACE inhibitors)
· MAO inhibitors
· Sulfinpyrazone, probenecid, Allopurinol
· Miconazole, fluconazole
· Cyclophosphamide, trofosfamide, ifosfamide
(only for high parenteral doses)
Parallel use of the following drugs weakens the hypoglycemic effect of the preparation and may lead to hyperglycaemia:
· Estrogens, progestagens
· Diuretics (saluretics, thiazide diuretics)
· Medicines used to treat thyroid problems
· Phenothiazine derivatives, chlorpromazine
· Adrenaline and sympathomimetics
· Nicotinic acid (high doses) and nicotinic acid derivatives
· Laxatives (long-term use)
Clonidine, reserpine, beta-blockers, and H2-receptor antagonists may both increase and decrease the hypoglycaemic effect. Symptoms of hypoglycaemia may be impaired or suppressed by the simultaneous use of: beta-blockers, other sympatholytics, clonidine, guanethidine, and reserpine. Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Consumption of alcohol may weaken or exacerbate the hypoglycemic effect of the preparation in an unpredictable way.
What side effects can occur?
Like all medicines, also Amaryl 1, -2, -3, -4 can cause side effects, although they will not occur in all patients using this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Rarely possible haematological disorders: thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, erythropenia, haemolytic anemia and pancytopenia. Possible acute thrombocytopenia and thrombocytopenic purpura. Rare: hypoglycaemia (usually occurring suddenly, sometimes severely, sometimes difficult to compensate). Very rare: nausea, vomiting, diarrhea, bloating, abdominal pain and discomfort, liver dysfunction, cholestatic jaundice, hepatitis, hepatic insufficiency, decreased blood sodium, leukoclastic vasculitis, hypersensitivity reactions, including severe dyspnoea, low blood pressure, sometimes shock. Adverse reactions may also occur for which their incidence has not been established: cross-sensitivity to sulphonylureas, sulfonamides and their derivatives, visual disturbances (especially at the start of treatment due to hypoglycaemia), increased hepatic transaminases, cutaneous hypersensitivity reactions including pruritus , rash, urticaria and photosensitivity.
Other preparations on the Polish market containing glimepiride
Amaryl 2 (tablets)
Amaryl 3 (tablets)
Amaryl 4 (tablets)
Glibetic 1 mg (tablets)
Glibetic 2 mg (tablets)
Glibetic 3 mg (tablets)
Glibetic 4 mg (tablets)
GlimeHexal 1 (tablets)
GlimeHexal 2 (tablets)
GlimeHexal 3 (tablets)
GlimeHexal 4 (tablets)
GlimeHexal 6 (tablets)
Glimepiride Accord (tablets)
Glimepiride Genoptim (tablets)