Rasoltan 50 mg. 30 tablets

Rasoltan medicinal product of the so-called. angiotensin II receptor blockers. Its therapeutic effect is the reduction of high blood pressure by decreasing the tension in the vascular system.
INDICATIONS
Treatment of hypertension (high blood pressure).
NECESSARY INFORMATION BEFORE USE
CONTRAINDICATIONS
• Allergy to the active substance or to any of the excipients included in the composition of the product;
• Pregnancy and lactation;
• Children.
 
SPECIAL PRECAUTIONS FOR USE
In patients with hypovolemia (low circulating blood volume), for example. such due to therapy with high doses of diuretics may occur symptomatic hypotension (low blood pressure). It can be avoided by discontinuing the use of diuretics and correcting the hypovolemia before treatment Rasoltan. If it is not possible diuretic therapy be discontinued, it is recommended that a lower starting dose Rosaltan - 25 mg. Rosaltan should be used with caution in patients with bilateral renal artery stenosis or a narrowing of the artery to a solitary kidney in patients where renal function is dependent on the renin-angiotensin system (eg. Severe congestive heart failure) due possible deterioration of renal function. Therefore, it is advisable to monitor renal function prior to and during treatment with Rasoltan -Following serum potassium, urea and creatinine. In patients with renal insufficiency and creatinine clearance below 30 ml / s, concentrations of losartan in plasma usually remains unchanged. Possible changes in renal function in susceptible individuals. Therefore, in elderly patients (above 75 years) and patients with impaired renal function, it is recommended to control the level of serum kaliy.Ustanoveno The serum levels of losartan were significantly elevated in patients with liver cirrhosis, which is why in impaired Liver function should be applied lower than usual dozi.Razoltan should be used with caution in patients with a history of a history of angioneurotic edema (swelling of the face, extremities, lips, tongue and / or throat) and those with congenital or idiopathic angioedema. Has been reported in patients treated with losartan, who experienced angioedema of the face, extremities, lips, tongue, glottis and / or larynx. In these cases, treatment should be discontinued and appropriate therapy. In cases of limited swelling of face and lips, allergenic products (eg. Antihistamines) to relieve the symptoms. Angioedema, combined with swelling of the throat and vocal cords is a life-threatening complication. When it is accompanied by obstruction (narrowing) of the airways, immediate therapy is needed: subcutaneous injection of adrenaline solution (0,3 to 0,5 ml - 1: 1000) and / or the necessary measures for airway clearance .
DRUG INTERACTIONS AND OTHER
Combining Rosaltan diuretics (agents that increase urine output) or with other antihypertensive (blood pressure lowering) products may cause a mutual potentiation of their action.
The use of potassium-sparing diuretics (eg. Spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes may increase the risk of hyperkalemia (elevated potassium concentration in the blood). If concomitant use of such products is necessary, it must be done carefully and regular monitoring of plasma kaliy.Ednovremennata use of Rasoltan products containing lithium may enhance the side effects of lithium due to increased renal reabsorption. During concomitant administration of lithium products and Rasoltan requires frequent monitoring of serum litiya.Rifampitsin can stimulate the metabolism of losartan and thus reduce its effectiveness. Therefore, when co-administered having PAD in controlling blood pressure and need to adjust the dose of Razoltan.Ne clinically significant interactions in clinical studies using hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Laboratory studies have shown that inhibitors of cytochrome isoenzymes P4503A4 (ketoconazole, troleandomycin, gestodene) and P4502C9 (fluconazole, sulfaphenazole) significantly suppressed the production of the active metabolite, whereas the combination of ketoconazole and sulfaphenazole almost completely inhibited its formation. Pharmacodynamic effects of concomitant use of losartan with these products have not been studied, so caution is advised with the concomitant upotreba.Nesteroidnite anti-inflammatory agents (eg. Indomethacin.) May reduce the antihypertensive efficacy of Rasoltan when co-administered.
 
WARNINGS FOR SPECIAL GROUPS OF PATIENTS
Use in children:
Rosaltan not recommended for use in children. Its safety and efficacy have not been dokazana.Izpolzvane in the elderly: Elderly (over 75 years) may exhibit increased sensitivity to the action of Rasoltan.
 
 
Pregnancy and lactation
Use during pregnancy:
Rasoltan contraindicated during pregnancy. Medicinal products that inhibit the activity of the renin-angiotensin system can cause injury and even death to the fetus when administered to pregnant women during the second and third trimester of pregnancy .. When pregnancy during treatment with Rasoltan requires immediate discontinuation of product.
Use of ACE inhibitors during the second and third trimester of pregnancy is associated with damage to the fetus and newborn, including hypotension, skull hypoplasia, anuria, reversible or irreversible renal failure and death. Reported oligohydroamnion, probably due to a decreased renal function in the fetus. In such cases oligohydramnios combined with contractures of the fetal extremities, facial deformities and -chelyustni hypoplasia white drob.Novorodeni with a history of intrauterine exposure to the action of angiotensin II receptor blockers should be carefully examined for hypotension, oliguria and hyperkalemia.
Use during lactation:
It is not known whether losartan passes into breast milk. If its use is imperative must discontinue breast-feeding.
 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
In early Rasoltan treatment in individual patients may be a temporary occurrence of faintness and dizziness, which may affect the ability to drive and use machines.
 
INFORMATION FOR PROPER USE
 
DOSAGE AND METHOD OF USE
Medical prescription. It is in ustata.Pri treatment of arterial hypertension, the usual starting and maintenance dose is 50 mg once daily. If after 3 to 6 weeks of treatment did not get satisfactory effect, the daily dose may be divided into two equal parts, to be taken in the morning and evening or increase to a maximum of 1 00 mg taken once or twice a day. With an insufficient response should be given combination therapy with the addition of low-dose diuretic. Maximum daily dose - 100 mg dnevno.Preporachitelnata starting dose for patients with hypovolemia (decreased volume of circulating blood) and with impaired hepatic function is 25 mg once daily. The dose is adjusted depending on the effect and tolerability after 3 to 6 weeks of treatment.
Elderly:
Does not require adjustment of the initial dose for elderly patients or patients with impaired renal function (incl. Dialysis patients), unless with hypovolemia.
Children:
This product is not recommended for children. Its safety and efficacy have not been dokazana.Tabletkite be taken with plenty of water, regardless of meals, preferably in the morning.
 
OVERDOSE
In clinical overdose, symptomatic and supportive treatment. Rasoltan therapy should be discontinued and the patient should be put under strict medical supervision. Therapeutic measures depend on the nature and severity of clinical symptoms and include measures to reduce absorption and accelerate elimination, and to maintain vital functions. Typical symptoms of overdose are severe hypotension (low blood pressure) and tachycardia (fast heartbeat) is possible and bradycardia (slow heart rate) due to parasympathetic stimulation. If severe hypotension, the patient should be placed in the supine position and rapidly infused necessary amount of saline. Vital signs should be monitored and, if necessary, should be given symptomatic treatment. Losartan and its active metabolite are not eliminated by hemodialysis.
 
SIDE EFFECTS
In - mostly side effects during losartan treatment are mild, transient and do not require discontinuation of terapiyata.Po - common side effects (> 1%): dizziness, hipotoniya.Redki (0.1 orthostatic hypotension (low blood pressure standing) .Many rare (<1%):
Allergy: Angioedema of the face, extremities, lips, tongue, glottis and / or larynx occurs rarely, but can be fatal. There is a PAD in patients with a history of events in the past angioedema, mainly during treatment with other drugs including ACE inhibitori.Mnogo rarely observed the development of vascular impairment, including purpura, similar to that of Shonlayn-Schonlein purpura with abdominal pain, gastrointestinal bleeding, joint pain and nephritis.
Digestive system:
Diarrhea, dry mouth, dyspepsia, nausea, abdominal pain, flatulence, hepatit.Dihatelna system:
Dry irritating cough, stuffy nose, bronchitis, sometimes dyspnoea, epistaxis.
Cardiovascular:
Rare cases of angina pectoris, myocardial infarction, transient ischemic blood flow or cerebrovascular accident, which are secondary, due to a sharp drop in blood pressure. Other related cases: orthostatic hypotension (when standing), syncope (temporary loss of consciousness), palpitations, arrhythmia, Raynaud's phenomenon.
Neurological / Psychiatric:
Dizziness, migraine, anxiety, dizziness, confusion, depression, sleep disorders, nervousness, peripheral nerve (paresthesia, dysesthesia). Musculoskeletal, joint and muscle pain, muscle weakness, numbness. Skin: Rash, pruritus, erythema, dermatitis, sweating, bleeding, alopecia, photosensitivity.
Genitourinary:
Dysuria and nocturia (frequent urination and night), urinary tract inflammation, reduced sexual desire. Metabolic: gout.
Hematologic: anemia.
Senses: blurred vision, burning and irritation of the eyes, conjunctivitis, weight loss of visual acuity, taste perversion, tinnitus. Changes in laboratory parameters: The observed changes in laboratory parameters were rarely of clinical significance. The most common is hyperkalemia (elevated potassium levels). Reversible slight increase in blood urea nitrogen and serum creatinine were observed in a small proportion of patients treated with losartan. A slight decrease in hematocrit and hemoglobin occurs often, but not clinically significant and does not require discontinuation of treatment. Slight increase in liver enzymes were infrequent and usually rapidly disappears after discontinuation of therapy.
 
STORAGE
At temperatures below 25 ° C. Out of reach of children!