LISIGAMMA 5 mg. 30 tablets

Fields of application:
• Lisigamma is indicated for the treatment of essential and renovascular hypertension. It can be used alone or in combination with other classes of antihypertensive agents. • Lisigamma is indicated for the treatment of heart failure as an adjunctive therapy with diuretics and, if appropriate, to the digitalis preparations.
• Lisigamma is indicated for the treatment of haemodynamically stable patients within 24 hours of the acute phase of myocardial infarction in order to prevent leaokamerna dysfunction or heart failure, and to reduce mortality. Patients should also receive the standard recommended therapy with thrombolytics, aspirin and beta-blockers.
 
 
Contraindications
When should take Lisigamma 10 mg Tabletten?
Lisigamma 10 mg Tabletten shall not apply to:
- Hypersensitivity to lisinopril, other ACE inhibitors or other component of Lisigamma®;
- Tendency to edema in the tissues (hereditary angioedema or angioedema, and such a consequence of earlier treatment with an ACE inhibitor).
- Stenosis (narrowing) of the renal arteries (bilateral or unilateral in patients with a solitary kidney)
- Severe renal impairment (significant reduction of renal function)
- Hemodialysis. During treatment with lisinopril is contraindicated hemodialysis or hemofiltration Poly- (acrylonitrif, natrium-2-methyiallylsulfonate) -high-flux-membranes (eg. "AN69") due to possible anaphylactic reactions (anaphylactic shock).
- Changes in heart valves (aortna- or mitral valve stenosis), respectively. Other difficulties in emptying of the left ventricle, which significantly lowers the blood pressure (eg. in hypertrophic cardiomyopathy).
- After acute myocardial infarction in unstable condition of the cardiovascular system (hemodynamic instability)
- Systolic blood pressure (the upper limit of blood pressure) -100 mmHg before treatment with lisinopril
- Cardiogenic shock
- During pregnancy (before therapy should exclude pregnancy or to take contraceptive measures)
- During lactation.
 
 
When you can take Lisigamma 10 mg Tabletten only after consultation with your doctor?
Po as will be described when Lisigamma 10 mg Tabletten can be used only after further consultation with a doctor and especially with great caution. Please talk to your doctor, especially if the listed indications have occurred before.
 
Particularly careful medical supervision is necessary when:
- Diseases that are accompanied by increased excretion of urinary belak
- Disturbances in mineral metabolism
- Renal dysfunction
- Compromised immune responses or some rheumatic diseases (such as collagen. Lupus erythematosus or scleroderma)
- Simultaneous administration of drugs that suppress immune responses, eg. certain adrenal hormones (corticoids), anticancer drugs, or drugs for the treatment of viral infections, as well as medicaments for the treatment of: jaundice, heart rhythm disturbances or mental disorders (lithium).
- Severe cardiac conduction abnormalities
- Reducing the volume of blood circulating in the body (due to dehydration, blood loss, etc.) Narrowing of the blood vessels in the brain and in the heart severe hypertension or hihertoniya caused by kidney disease
- Age over 65 years
 
 
What should I observe during pregnancy and lactation?
Lisigamma 10 mg Tabletten should not apply either during pregnancy or during lactation (compare with "Contraindications").
Lisigamma use is contraindicated during pregnancy. Before initiation of therapy with ACE inhibitors in women of childbearing age should exclude the presence of pregnancy. During treatment, these women should be applied appropriate contraceptive measures.
If pregnancy is detected, Lisigamma® stop as quickly as possible and choose a therapy that is safe for the child. ACE inhibitors can cause illness and death of the fetus if used during the second and third trimester of pregnancy. The use of ACE inhibitors during these periods is associated with disabilities, including: hypotension, renal failure, hyperkalemia and / or skull hypoplasia in the newborn, contractions of the limbs, face and skull deformities and hypoplasia of the lungs. If, despite all this is deemed necessary to use Lisigamma®, the patient should be apprised of the potential hazard to the fetus.
Adverse side effects are not the result of impact of ACE inhibitors on the fetus during the first three months of pregnancy.
In rare cases where the use of ACE inhibitors during pregnancy is necessary, it is a series of ultrasound to monitor the state of the amniotic fluid and fetus.
Infants whose mothers have taken Lisigamma®, should be monitored closely by lekar.Ne is not known whether lisinopril is excreted in human milk. As experience with the therapy in lactating women. Lisigamma use of these patients is undesirable.
 
Precautions for use and warnings
 
What precautions must be observed?
hypotension
 
A. Symptomatic hypotension
Lisigamma 10 mg Tabletten can lead to a sharp drop in blood pressure, especially after the first dose and patients at risk. These are patients with:
o congestive heart failure, with or without renal failure
o severe hypertension with hypertensive complications
o hypertension-induced renal disease;
o dehydration (deficit of salts and / or liquids), e. as a result of treatment with high doses of loop diuretics, renal impairment, low salt diet, dialysis, vomiting or diarrhea. In such patients, therapy should be initiated under medical supervision.
A change in dose Lisigamma and / or diuretic patients should be monitored closely. This also applies to patients with ischemic heart disease or cerebrovascular disease, where a sudden drop in blood pressure can lead to heart attack or stroke / transient impairment in cerebral blood flow.
If hypotension occurs, patients are placed in a supine position, shall be informed physician who in need can infuse intravenous saline. Transient hypotensive response is not a contraindication to further treatment. It may continue after normalization of blood pressure and restore intravascular volume.
In some patients with congestive heart failure who have normal or low blood pressure can occur further reduction of blood pressure after administration of Lisigamma®. This effect is predictable and usually is not a cause for discontinuation of therapy. If hypotension becomes symptomatic, may require dose reduction or discontinuation of Lisigamma®.
 
 
B / Hypotension in acute myocardial infarction
Implementation of Lisigamma 10 mg Tabletten is contraindicated in those patients with acute myocardial infarction who are at high risk of serious hemodynamic instability after the use of a vasodilator (vasodilators product). These are patients with an upper limit of blood pressure - 100 mmHg or in cardiogenic shock. Judgment of the therapeutic regimen of Lisigamma®, and to eventual cessation of therapy with lisinopril is taken by the physician.
Aortic stenosis (narrowing of the aortic valve) Hypertrophic cardiomyopathy
As vasodilators, ACE inhibitors should be used with caution in patients with obstruction of blood flow at the exit of the left ventricle (disorders of preventing the blood from the left ventricle to be pushed and aorta).
 
Impaired renal function
In patients with congestive heart failure, hypotension induced by therapy with ACE inhibitors, may lead to further deterioration of renal function. In such cases often develop acute renal failure, which is usually obratima.Pri Some hypertensive patients with no evidence of pre-existing renovascular disease, serum urea and creatinine increased, but this increase is minimal and transient, especially after the combination of Lisigamma ® with a diuretic. This reaction is most likely to occur in patients with pre-existing renal impairment. It is possible to require a dose reduction or even discontinuation of the diuretic or Lisigamma.
Should not begin therapy with lisinopril in patients with acute myocardial infarction, if there is a history of significant renal dysfunction. If renal impairment occurs during treatment with Lisigamma®, your doctor may discontinue therapy Lisigamma®.
 
Stenosis (narrowing) of the renal arteries
In patients with disease of the renal vessels indicating its high blood pressure and / or stenosis (narrowing) of the renal arteries, the risk of a drop in blood pressure and renal failure during therapy with lisinopril.
When treating patients with unilateral renal artery stenosis (narrowing of the artery only one kidney) is held constant close supervision by attending lekar.Patsientite with bilateral renal artery stenosis, or narrowing of the renal artery to a solitary kidney should not take Lisigamma ®.
 
Hemodialysis ("artificial kidney")
With concomitant Lisigamma * and special membranes for hemodialysis (eg. "AN 69") in the case ma emergency, there is a risk of occurrence of severe hypersensitivity reaction to a state of shock.
Patients undergoing regular hemodialysis should not take Lisigamma
If the grounds of the need for emergency medical care is still necessary to take dialysis, should the doctor, dialysis necessarily be aware of the treatment Lisigamma 10 mg Tabletten.
 
Increasing the concentration of potassium in the blood (hyperkalemia)
During treatment with Lisigamma can increase the concentration of potassium in the blood, especially in the case of kidney and / or heart failure, and diabetes mellitus. Intake of potassium supplements (or potassium-containing salt food additives) or the inclusion of kaliysahranyavashti diuretics (water pills) can lead to a significant increase in the potassium concentration in the blood. If you still need both la adopt the above-mentioned drugs, then your doctor should regularly monitor potassium concentration in the blood during treatment. Hypokalemia induced by application of potassium-wasting diuretics, can be reduced by combining a diuretic with Lisigamma®.
angioneurotic edema
Painful tissue swelling of the skin and mucous membranes may be an expression of the specific reaction of intolerance. Angioneurotic edema of the face, extremities, lips, tongue, glottis and / or larynx has been observed rarely in patients treated with ACE inhibitors, including Lisigamma®. Swelling may occur at each stage of treatment. In such cases, the intake of Lisigamma treated immediately should immediately be informed doctor or doctor of ambulance. You may need the patient to be admitted urgently to hospital for observation and written on there only after the complete disappearance of the edema. When the swelling is localized only on the face and lips, the condition resolves without treatment, but may be appointed, and antihistamines, as they improve symptoms.
Angioneurotic edema of the larynx can be fatal. When the tongue, glottis and larynx and the risk of obstruction (narrowing) of the airways must immediately seek emergency medical care to take immediate measures to liberate the airways from obstruction.
Patients with a history of angioedema unrelated to ACE inhibitors are at higher risk no-acceptance of ACE inhibitors.
 
 
ethnic differences
There are reports that angioedema occurred more frequently in black patients treated with ACE inhibitors, compared with patients of other races.
 
Other hypersensitivity reactions
A. Anaphylactic reaction desensibipizatsiya to lepidopteran insects
In patients with hypersensitivity to poison lepidopteran insects (bees / wasps) undergoing desensitization therapy (to reduce / suppress the ability of an allergic reaction) and simultaneously treated with ACE inhibitors are at increased risk of severe allergic reactions, including . life-threatening anaphylactic reactions. These reactions were avoided by temporarily discontinuing treatment with ACE inhibitors prior to any desensitization.
B. Anaphylactic reactions during LDL-apheresis
In rare cases, patients receiving ACE inhibitors during LDL-apheresis with dextran sulphate have developed life-threatening anaphylactic reactions. These reactions were avoided by temporarily discontinuing treatment with ACE inhibitors before any apheresis.
 
Surgery / Anesthesia
In patients undergoing anesthesia with lekarsteni products that cause a decrease in blood pressure (hypotension), Lisigamma® may enhance the hypotensive effect. The anesthetist must necessarily be informed in advance of the treatment provided Lisigamma®.
 
Changes in hematopoiesis
In patients with high blood pressure, in rare cases been observed a reduction in the number of certain types of white blood cells, or loss of a major part of the white blood cells. If in the course of therapy with 10 mg Tabletten Lisigamma symptoms such as fever, swollen lymph nodes and / or sore throat, you should immediately visit a doctor and check white blood count.
 
ethnic differences
Lisigamma 10 mg Tabletten can less lowering blood pressure in patients with black skin color than in patients with other skin color.
 
What has to be observed when driving, operating machinery and working in places without secure support?
Treatment with this medicine requires regular medical nablyudenie.Na basis of individual differences occurring in the reactions is possible so to change the ability to respond as to affect the ability to actively participate in traffic, use machines or work without safe foothold. This is even more true for the initial period of treatment with increasing doses and during a change of the medicinal product, and reacting with an alcohol.
 
What must be observed in children and adults?
Use in children
No data on treatment with lisinopril in children, therefore the use of Lisigamma in children is not recommended.
 
Administration to adult patients
Clinical studies have demonstrated an age-related change in the efficacy and safety of the product. When, advanced age is associated with deterioration of renal function may occur no-strong reduction in blood pressure from the application of tablets Lisigamma®, than in younger patients. In patients 65 years and older is recommended less starting dose (2,5 mg lisinopril), and medical monitoring of blood pressure and renal function, especially at the beginning of therapy. Your doctor may adjust the dose depending on the blood pressure values.
 
 
Interactions with other medicinal products
What other drugs povliyatat action of Lisigamma 10 mg Tabletten and how Lisigamma 10 mg Tabletten affect the way other medicines?
 
Lisigamma used in combination with nitro-preparations without noticeable clinically significant adverse interactions.
In some patients with renal impairment treated with NSAIDs, combination with ACE inhibitors may worsen renal function. This effect is usually reversible.
Hypotensive action of Lisigamma 10 mg Tabletten can be enhanced by:
- Other blood pressure lowering drugs, especially diuretics (water pills). The risk of symptomatic hypotension may be minimized if you stop taking the diuretic prior to initiation of therapy Lisigamma®.
- Alcohol (with possible simultaneously strengthening and alcohol effects).
Reduce the hypotensive effect of Lisigamma 10 mg Tabletten possible when taking:
- Painkillers and anti-inflammatory drugs (eg. Aspirin, indomethacin).
- Medicines used in the treatment of fever and spastic constriction of the airways (sympathomimetic)
- Salt (table salt)
- Medicines to neutralize stomach acids (antacids).
 
Lisigamma 10 mg Tahletten may potentiate the effect of:
- Potassium-containing medicinal products (and supplements), some water pills (eg., Spironolactone, amiloride, triamterene), and other drugs which reduce the emission of potassium from the body, and this leads to an increase in serum potassium concentration.
- Medicines containing lithium (as lisinopril reduces the emission of lithium by the kidneys)
- Oral medicines for lowering the blood sugar level
- insulin
- Certain medicines appointed operations (especially for narcosis) can be augmented by concomitant tablets Lisigamma or lead to severe side effects. (Anesthetist must necessarily be informed of treatment Lisigamma®.
Reduction in the number of leukocytes may occur with concomitant use of Lisigamma 10 mg Tabletten with:
- Drugs to treat gout (allopurinol)