NEOGLIM. 1 mg. 30 tablets
NEOGLIM. 1 mg. 30 tablets
Qualitative and quantitative composition
Drug Glimepiride 1,2, 3,4 mg.
Lactose , sodium glycolate ( starch ) , magnesium stearate , microcrystalline cellulose , povidone 25000 , colorants : Neoglim 1 mg - Red iron oxide (E 172) ; Neoglim 2 mg - Yellow iron oxide (E 172) , indigo carmine aluminum lake ( E 132 ) Neoglim L mg - yellow iron oxide (E 172) ; Neoglim 4 mg - indigo carmine aluminum lake ( E132 )
Formulation and CONTENTS Tablet 1.2 , 3, and 4 mg . 30 tablets in two blisters
Oral glucose- lowering drugs : sulfonamide, urea derivatives . ATC code: A10VV12 .
Neoglim 1, 2 , 3, 4 mg is indicated for the treatment of type 2 diabetes mellitus , when diet, exercise and weight loss do not give satisfactory effect .
Information needed before use
Neoglim 1, 2 , 3, 4 mg should not be used in the following cases : insulin-dependent diabetes , diabetic coma, ketoacidosis , acute renal or hepatic dysfunction, hypersensitivity to glimegshrid other sulfonamide or sulfonylurea agents or excipients in the tablet .
In cases of renal or hepatic dysfunction is necessary transition to insulin.
Neoglim 1,2,3,4 mg is contraindicated during pregnancy and lactation.
Special precautions for use
Neoglim 1, 2 , 3, 4 mg should be taken just before or during a meal .
When meals are taken irregularly or be bypassed treatment Neoglim 1,2,3 , 4 mg may lead to hypoglycaemia. Possible symptoms of hypoglycaemia include : headache, ravenous hunger , nausea, vomiting , fatigue , drowsiness , sleep disturbances , anxiety , aggression, impaired concentration , voltage and over- reactivity , depression , confusion , speech and visual disorders, aphasia , tremor, paresis , sensory disturbances , dizziness , helplessness , loss of self-control , delirium , cerebral convulsions , somnolence and loss of consciousness including coma , rapid breathing and bradycardia.
Further can be seen signs of adrenergic regulation such as sweating , skin moisturized , anxiety, tachycardia , hypertension , tachycardia , angina pectoris and cardiac arrhythmias .
The clinical picture of a severe hypoglycaemic attack may resemble that many heart attack . Symptoms almost always be promptly controlled by immediate intake of carbohydrates ( sugar). In this case, the artificial sweeteners do not have an effect .
Treatment with other sulphonylureas known that despite the initial success measures hypoglycaemia may recur.
Severe or prolonged hypoglycemia, which temporarily controlled by the quantity of the sugar, require immediate medical treatment and sometimes hospitalization.
Treatment with Neoglim 1, 2 , 3, 4 mg requires regular monitoring of glucose levels in blood and urine. Further recommends determining the proportion of glycosylated hemoglobin.
During treatment with Neoglim 1, 2 , 3, 4 mg requiring regular liver tests and hematology (particularly leukocytes and platelets ) .
During stressful situations (eg accidents, major surgery , infection , accompanied by fever , etc.) may be appointed temporarily switching to insulin therapy.
There is insufficient experience concerning the use of Neoglim 1, 2 , 3, 4 mg in patients with severe liver dysfunction or dialysis patients . In such patients, changes to insulin therapy.
If Neoglim 1, 2 , 3, 4 mg taken with certain other drugs can be observed adverse strengthen or weaken the hypoglycaemic effect of glimepiride. In " Therefore, intake of other drugs should be undertaken with the explicit knowledge (or explicit prescription) of the doctor.
From the collected experience with Neoglim 1, 2 , 3, 4 mg and other sulphonylureas , these interactions should be mentioned.
Potentiation of glucose -lowering effect in the blood and thus in some cases hypoglycaemia when taken any of these medications , eg . :
phenylbutazone, oxyphenbutazone azapropazone and sulfinpyrazone
insulin and oral antidiabetic Metformin
some long-acting sulfonamides Tetra cyclins
salicylate and p- amino- salicylic acid MAOI
anabolic steroids and male hormones quinolone antibiotics
coumarin anticoagulants Miconazole
pentoxifylline ( high dose , i.p.) fenfluramine
ACE inhibitors Fluoxetine
cyclo - , tro - and iphosphamides
Reduction of glucose -lowering effect in the blood and hence elevated blood glucose levels may occur when taking any of these medications , eg . :
- Oestrogens and progestogens
- Saluretics , thiazide diuretics,
- Indent -stimulating agents , glucocorticoids,
- Fenotiazidni derivatives , chlorpromazine,
- Adrenaline and simpatikomimetipi ,
- Nicotinic acid ( high dose ) and its derivatives,
- Laxatives ( long term use ) , phenytoin, diazoxide ,
- Glucagon , barbiturates and rifampicin atsetozolamid .
H2- antagonists , beta- blockers , clonidine and reserpine may lead to either potentiation or decrease in the glucose -lowering effect in the blood.
Under the influence of sympatholytic drugs such as beta- blockers, clonidine, guanethidine and reserpine, the signs of adrenergic regulation of hypoglycemia may be reduced or disappear .
Alcohol intake may potentiate or weaken the hypoglycaemic effect of Glimepiride in an unpredictable way.
Glimepiride may either potentiate or weaken the effect of coumarin derivatives.
Use in pregnant and lactating
Pregnancy: Neoglim 1, 2 , 3, 4 mg is contraindicated during pregnancy. In this situation it is required the use of insulin . Patients who are planning a " pregnant should inform their physician .
Lactation: Since sulphonylureas such as glimepiride pass into breast milk Neoglim 1, 2 , 3, 4 mg should not be taken by nursing mothers.
Effects on ability to drive and use machines
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example . resulting in impaired vision . This may constitute a risk in situations where these abilities are of special importance ( eg driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia while driving . This is particularly important for those patients is reduced or absent ability to assess the warning symptoms of hypoglycaemia or have frequent episodes such . Should consider whether it is appropriate to drive or operate machinery in these circumstances.
Information on proper use
The initial dose is 1 mg Glimepiride day. If good control, this dose may be used for maintenance therapy.
If control is unsatisfactory , the dose should be increased based on glycemic control gradually , at intervals of 1 to 2 weeks between each increase to 2, 3 or 4 mg Glimepiride day.
Dose of more than 4 mg Glimepiride day gives better results only in exceptional cases.
The maximum recommended dose is 6 mg Glimepiride day.
For patients inadequately controlled with a maximum daily dose Metforminn, can be assigned concomitant therapy with Glimepiride. Keeping the dose Metformin, therapy Glirnepiride started with a low dose and then gradually increased depending on the desired level of metabolic control , until the maximum daily dose. Combination therapy should be initiated under close medical supervision.
For patients inadequately controlled with a maximum daily dose Neoglim 1, 2 , 3, 4 mg , if necessary, can be assigned concomitant insulin therapy. Keeping the dose Glimepiride, Insulin therapy starts with a low dose and then gradually increased depending on the desired level of metabolic control. Combination therapy should be initiated under close medical supervision.
If a patient is observed hypoglycemic reactions at 1 mg glimepiride daily, this is a sign that it can only be controlled through diet.
In the process of treatment , since the improvement in the control of diabetes, e associated with higher insulin sensitivity , the need of glimepiride can be reduced. Order to avoid hypoglycaemia must be considered timely dose reduction or discontinuation. Dose adjustments may also be necessary if any weight or lifestyle of the patient or other factors that increase the risk of hypo-or hyperglycemia .
Tablets should be swallowed whole with some liquid .
Frequency of administration
Typically, a single daily dose of Glimepiride was enough . It is recommended that this dose be taken shortly after a hearty breakfast or - failing that - shortly before or during the first main meal.
Symptoms of overdose
Overdose can occur hypoglycemia, which lasts 12 to 72 hours and may recur after initial improvement. Symptoms may not occur until 24 hours after dosing. In general it is recommended that hospital surveillance. - May occur nausea , vomiting and epigastric pain . Usually hypoglycemia is accompanied by neurological symptoms such as restlessness , tremors, visual disturbances , problems with coordination , drowsiness, coma and convulsions .
Emergency measures in overdose
Treatment consists primarily of Absorption by preventing emesis and subsequent reception of water or lemonade with activated charcoal ( adsorbent ) and sodium sulphate ( laxative ) . If accepted by the large amounts of the drug, having a gastric lavage, followed by absorption of activated carbon and sodium sulfate. In case of severe overdosage hospitalization in intensive care. Immediately should be initiated by glucose, if necessary in the form of an intravenous injection of 50 ml of 50% solution , followed by infusion of a 10 % solution with strict monitoring the level of glucose in the blood. Further treatment should be symptomatic .
In some cases when treating hypoglycaemia due to accidental intake obtained Neoglim of 1, 2 , 3, 4 mg of young children , the dose of the assigned glucose should be carefully controlled to avoid the possibility of induction of dangerous hyperglycemia . Blood glucose levels should be closely monitored .
Mode of action in the event of missed doses
If a dose is missed , it should be corrected by increasing the next dose.
Based on clinical experience with Neoglim 1, 2 , 3, 4 mg and other sulphonylureas should be mentioned these side effects.
In very rare cases mild hypersensitivity reactions may develop into serious reactions with the display , fall in blood pressure and sometimes anaphylactic shock . In very rare cases, allergic vasculitis .
Cross-allergenicity with sulfonylureas , sulfonamides and other similar products.
Blood and lymphatic system
Hematological changes were frequently seen during treatment with Neoglim 1, 2 , 3, 4 mg . Possible moderate to severe thrombocytopenia , leukopenia, erythrocytopenia , granulocytopenia , agranulocytosis, hemolytic anemia and pancytopenia .
In general, these changes are reversible after discontinuation. Metabolism and nutrition
In rare cases, the appointment of Neoglim 1, 2 , 3, 4 mg were observed hypoglycemic reactions. Most often these reactions occur suddenly and can be severe and not always easy to master. These reactions depends , as with other hypoglycemic therapies on individual factors , such as dietary habits and dosage (see " Special precautions for use").
Due to changes in blood glucose levels are possible temporary visual disturbances , especially at the beginning of therapy.
Gastro- intestinal tract
Gastrointestinal complaints such as nausea , vomiting and diarrhea, weight or sense occupancy in the stomach and abdominal pain, are very rare and usually does not lead to discontinuation of therapy.
It is possible to increase the level of liver enzymes. In very rare cases may develop hepatic function ( eg with cholestasis and jaundice) , as well as hepatitis, which may progress to stop functioning liver drob.Kozha and subcutaneous tissue
Possible hypersensitivity reactions such as irritation, rash and urticaria.
In rare cases, it may be observed hypersensitivity to light.
In rare cases, a decrease in the serum sodium concentrations.
Special precautions for storage
Do not store above 25 ° C.
Three years . Do not use after the expiry date shown on the packaging.