GOPTEN 0.5 mg. 20 capsules

Qualitative and quantitative composition
Active substance: Trandolapril
Excipients: corn starch, lactose, polyvidone, sodium stearyl fumarate, gelatin, titanium dioxide, erythrosine, and iron oxide yellow.


Pharmaceutical form and quantity in one package
Each package Gopten 0,5 mg contains 20 capsules. Each package Gopten® 2 mg contains 28 capsules.

Indications
Mild to moderate hipertoniya.Narushena left ventricular function after myocardial miokarda.Dokazano that Gopten enhances survival after myocardial infarction in patients with left ventricular dysfunction (impaired left ventricular function) (ejection fraction <35%) with or without symptoms of heart failure and / or with or without residual ishemiya.Prodalzhitelnoto Gopten treatment significantly reduced the overall mortality from cardiovascular disease. It leads to a significant reduction in the risk of sudden death and cases of severe or treatment-resistant heart failure.


Contraindications
Known hypersensitivity to trandolapril.Izvestna hypersensitivity to any of the excipients produkt.Anamnestichni data za'- angioneurotic edema associated with the use of ACE inhibitori.Nasledstven / idiopathic angioneurotic edema. Aortic stenosis and bilateral stenosis a.renalis. Pregnancy or breastfeeding. Is contraindicated in children.


Special warnings and precautions for use
Gopten should not be used in patients with aortic stenosis or obstruction of the blood flow outlet.
Impaired renal function
In patients with severe renal impairment may be necessary to reduce the dosage of Gopten; their renal function should be carefully monitored. In the prevailing case renal function does not change. In patients with renal insufficiency, congestive heart failure or unilateral or bilateral renal artery narrowing in patients with one kidney, and after a kidney transplant, there is a risk of impairment of renal function. For early detection like renal function is reversible upon withdrawal of the drug.
Some hypertensive patients without previous renal disease may develop minor and usually transient increases in blood urea and serum creatinine when Gopten be coadministered with a diuretic. It is possible to have correct dose of Gopten and / or withdrawal of the diuretic. Also, patients with kidney failure should assess the risk of hyperkalemia and regularly check the electrolyte status of the patient.

Impaired liver function
As trandolapril is a prodrug which is metabolized to the active substance in the liver, particular caution and close monitoring of patients with impaired hepatic function.

Symptomatic hypotension
In patients with uncomplicated hypertension, symptomatic hypotension has been observed rarely after the initial dose of Gopten, and then increase the dosage of Gopten. Symptomatic hypotension is more likely to occur in patients with an aqueous salt-depleted by prolonged diuretic therapy, dietary salt diet, dialysis, diarrhea or vomiting. Therefore, in these patients, diuretic therapy should be discontinued and volume and / or salt depletion should be corrected before treatment with Gopten.
Angioneurotic edema
Rarely, ACE inhibitors such as trandolapril may cause angioneurotic edema involving swelling of the face, extremities, tongue, glottis and / or larynx. Patients with angioneurotic edema must immediately discontinue Gopten and be monitored until resolution of edema.Angionevrotichniyat facial edema usually resolves spontaneously. Eden, covering not only the face but also the glottis may be life-threatening because of the risk of airway obstruction patishta.Angionevrotichniyat edema, covering the tongue, glottis or larynx requires immediate subcutaneous administration of 0,3 -0,5 ml adrenaline solution (1 : 1000); alongside other appropriate therapeutic measures for the case.
Caution should be exercised in patients with a history of idiopathic angioneurotic edema. Gopten is contraindicated if angioneurotic edema was an adverse reaction to an ACE inhibitor.
Cough
During treatment with an ACE inhibitor is possible occurrence of dry, nonproductive cough, which subsides with the withdrawal of the drug.

Interactions
Diuretics: Patients on diuretics and especially volume and / or sodium depletion can be observed a strong decrease in blood pressure and / or renal dysfunction. Following initiation of therapy with an ACE inhibitor, the risk of hypotension may be reduced by discontinuation of the diuretic, by increasing the pre-salt intake and by initiation of therapy with low dose, eg. 0,5 mg Gopten. Further dose increase should be done carefully.
Lithium: the co-administration of ACE inhibitors and lithium may reduce the excretion of lithium. Serum lithium levels should be monitored regularly.
Antihypertensive drugs: Commonly observed increase the hypotensive effect of ACE inhibitors.
Allopurinol, cytostatic agents, immunosuppressants, systemic corticosteroids or procainamide:
Ednoremennata use with ACE inhibitors leads to increased risk of leucopenia.
NSAIDs: the appointment of NSAIDs may reduce the antihypertensive effect of ACE inhibitors.
Antacids: antacids decrease the bioavailability of ACE inhibitors (recommended these products be adopted separately).
ANTIDIABETICS: although clinical studies showed no increased risk of hypoglycemia in patients with diabetes treated with both insulin and oral antidiabetic drugs and ACE inhibitor may occasionally occur hypoglycemia. Therefore, in diabetic patients treated with antidiabetic agents and Gopten, blood sugar levels should be monitored carefully, especially at the beginning of treatment or when increasing the dose.

Use in children and pregnant
Pregnancy
When people were not conducted adequate and well-controlled studies. ACE inhibitors cross the placenta and can cause fetal or neonatal morbidity and mortality when administered to pregnant women. Therefore ACE inhibitors are contraindicated during pregnancy.

Breastfeeding
Due to lack of data, if treatment is needed during breastfeeding should be discontinued or nursing or therapy Gopten.

Children
Safety and effectiveness in children Gopten not been studied.


Effects on ability to drive and use machines
Some side effects associated with lowering blood pressure can impair the ability of patients to concentrate and react, and in particular their ability to drive or use machines. This applies mainly for the initial phases of treatment.


Dosage
Dosage in elderly hypertensive patients with normal renal and hepatic function without acute heart failure
The usual dose is 2 mg Gopten once daily. It can be increased to a maximum dose of 4 mg once daily Gopten.
Dosage in adult patients with impaired left ventricular function after myocardial infarktSled myocardial infarction therapy should begin as early as the third day. Treatment should be initiated at a daily dose of 0,5 mg Gopten® as gradually increased to 4 mg Gopten as a single daily dose.
Dosage in adults with pre-existing diuretic therapy diuretic therapy should be discontinued at least three days before starting therapy with Gopten® and / or initiation of therapy with 0,5 mg Gopten as a single daily dose can be titrated based on clinical otgovor.Korigirane dosage in renal impairment
In patients with mild to moderate renal impairment (creatinine clearance 10-70 ml / min) is recommended usual dose for adults and elderly patients vazrast.Pri patients with severe renal impairment (creatinine clearance <10 ml / min) also recommended usual dosage for adults and elderly patients, but the maximum daily dose should not exceed 2 mg. In these patients, treatment should be initiated under close medical supervision.


Usage
Gopten must be taken once daily in the appropriate dosage, at the same time denya.Kapsulite should be swallowed whole with a sufficient amount of liquid. Since absorption of Gopten is not affected by food, it may be administered before, during or after meals.


Side effects
Reported side effects are generally umereni.V long-term clinical trials with Gopten most commonly reported side effects are cough, headache, malaise and dizziness.

Overdose
The symptoms expected with ACE inhibitors include severe hypotension, shock, bradycardia, electrolyte disturbances and renal failure. In case of overdose after recent administration should consider gastric lavage. Blood pressure should be monitored and if hypotension, take measures to increase blood volume.

Abuse and dependence
No risk of abuse and dependence therapy Trandolapril.

Storage conditions and shelf life
Store at room temperature.
Medicinal product not store after the expiration of Labelling date.
Keep away from children!