Expiration date: 09/2026

Active substance:

Amlodipine + Losartane

Pharmaceutical form and composition:

Tablets, film-coated 1 tablet contains active substances: 

amlodipine camsylate of 7.84 mg

(in terms of amlodipine 5 mg) 

losartan potassium 50 mg

excipients: butylhydroxytoluene 0.1 mg, carboximetilkrahmal sodium — 17 mg, MKC — 265,1 mg, mannitol 40 mg, povidone K30 5 mg, crospovidone — 12 mg magnesium stearate 3 mg 

shell film: hypromellose-2910 — 8 mg hyprolose 2 mg, titanium dioxide — 1,8 mg talc 0.2 mg 

Tablets, film-coated 1 tab.

Tablets, film-coated 1 tablet contains active substances: 

amlodipine camsylate of 7.84 mg

(in terms of amlodipine 5 mg) 

losartan potassium 100 mg

excipients: butylhydroxytoluene 0.1 mg, carboximetilkrahmal sodium — 17 mg, MKC — 407,1 mg, mannitol 40 mg, povidone K30 5 mg, crospovidone — 18 mg magnesium stearate 5 mg 

shell film: hypromellose-2910 — 12 mg hyprolose — 3 mg titanium dioxide 2.7 mg, talc — 0.3 mg, dye iron oxide yellow — 0,045 mg, dye iron oxide red — 0,045 mg 

Indications:

• Arterial hypertension patients, which shows the combined therapy.
  

Contraindications:

• hypersensitivity to active ingredients and/or auxiliary components of the drug,
  
• pregnancy and period of breast-feeding (see "pregnancy and breastfeeding"),
  
• severe hepatic insufficiency (more 9 points on a scale child-Pugh),
  
• hemodynamically signicant aortic mouth,
  
• shock
  
• the age of 18 years (efficacy and safety not established),
  
• severe hypotension.
  

With caution in: patients with reduced BCC, for example, when high doses of diuretics, severe diarrhea, vomiting and other conditions leading to hypovolemia, patients on restricted diet of salt, patients with renal insufficiency (Cl creatinine <,,,20 9="" -="" ii="" iv="" nyha="" 1="" p="">,, 

Application of pregnancy and breast-feeding:

Asaar contraindicated in pregnancy, and its reception should be discontinued immediately when pregnancy.

The toxic and lethal effect on the fetus and newborn

Amlodipine

Drugs directly acting on the RAAS can cause injury and death of the fetus and newborn in appointing pregnant. Described isolated cases of ACE inhibitors during pregnancy.

The use of in II and III trimester of pregnancy, drugs that directly affect the RAAS is associated with damage of the fetus and newborn as hypotension, neonatal skull bone hypoplasia, anuria, reversible and irreversible renal failure and death. There have also been instances of oligohydramnion, presumably developed as a result of reduced renal function in the fetus. In these cases, oligohydramnios was associated with limb contractures, craniofacial deformations and hypoplastic lung of the fetus. In addition, there have been cases of premature birth, intrauterine growth retardation and cleft of the ductus arteriosus, however, the effects of the drug in these cases was found. Listed side effects, apparently, are not a result of the use of the drug in the first trimester of pregnancy. However, pregnant women who took drugs ARA in the first trimester should be informed of the consequences of taking these drugs in the II–III trimesters.

Depending on the duration of pregnancy, it is possible to apply a stress test to uterine contractions, stress-free test or assessment biophysical profile of the fetus. At the same time as the doctor and the patient should be aware that oligohydramnios may occur after the development of irreversible damage to the fetus. Children exposed to history in utero??????????? drugs ARA, should be under medical supervision because of the increased likelihood of hypotension, oliguria and hyperkalemia. In the case of oliguria in the first place a correction HELL and renal perfusion. Exchange blood transfusion or hemodialysis is necessary for the correction of arterial hypotension and/or as a substitution of kidney function.

Losartan

The use of in II and III trimestrah pregnancy drugs acting on the RAAS can cause serious injury or even death of the developing fetus, so when pregnancy taking losartan should be stopped immediately. Since renal perfusion of the fetus, depending on the RAAS develops in the second trimester of pregnancy, the risk to the fetus increases when taking losartan in II or III trimesters.

It is unknown whether the excretion of amlodipine and/or losartan in breast milk, but in preclinical studies in animals have observed significant concentrations of amlodipine and/or the active metabolite of losartan in breast milk. Asaar not recommended for use during breast-feeding.

Side effects:

Side effects (PE), observed during studies of the drug Ansaar submitted in accordance with the who classification by frequency of occurrence: very often (more 1/10), often (more 1/100, less than 1/10), uncommon (more than 1/1000, less than 1/100), rare (more 1/10000, less than 1/1000) and very rare (less than 1/10000), including individual messages, frequency unknown (to estimate the frequency according to the available data).

From the nervous system: often — dizziness, headache, rarely — drowsiness.

General disorders injection site: often — asthenia, discomfort or pain in the chest, fullness in the abdomen, peripheral edema.

Gastrointestinal: rarely — constipation, discomfort in the abdomen, indigestion, vomiting, reflux esophageal.

The skin and subcutaneous tissue: rare — skin itching, urticaria.

From the CCC: often — palpitations, rush of blood to the skin, orthostatic hypotension.

The respiratory system of the chest and mediastinum:infrequently — shortness of breath.

On the part of the organ of hearing and labyrinth disorders: infrequent — systemic dizziness.

The kidneys and urinary tract: rarely — increased frequency of urination.

PE observed when taking Ashara components (amlodipine and losartan), can also serve as a potential PE, despite the fact that these PE were not observed in clinical trials and post-approval period of application Amsara.

Amlodipine

CNS: frequently — headache (especially at the beginning of treatment), dizziness, fatigue, drowsiness, rarely — malaise, hyperesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, unusual dreams, irritability, anxiety, rarely — headache, lethargy, agitation, ataxia, amnesia, asthenia, sweating.

Psychiatric disorders: rarely, mood lability, depression.

From the digestive system: often — nausea, abdominal pain, rarely — vomiting, constipation or diarrhoea, flatulence, dyspepsia, anorexia, dry mucous membranes of the mouth, thirst, rare — giperplazia gums, increased appetite, very rarely — pancreatitis, gastritis, jaundice (due to cholestasis), hyperbilirubinemia, elevated liver transaminases, hepatitis.

From the CCC: often — palpitations, rarely — excessive decrease in blood pressure, very rare — fainting, shortness of breath, vasculitis, orthostatic hypotension, development or aggravation of chronic heart failure, arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema, edema of the lower extremities.

From the hematopoietic and lymphatic system: very rarely — thrombocytopenic purpura, leukopenia, thrombocytopenia.

From the urinary system: rarely — urinary frequency, painful urination, nocturia, very rarely — dysuria, polyuria.

From the genital organs and mammary glands: rarely — gynecomastia, impotence.

The respiratory system: infrequently — shortness of breath, rhinitis; very rarely cough.

From the side of musculoskeletal system: infrequently — muscle cramps, myalgia, arthralgia, back pain, arthritis rarely myasthenia gravis.

With the skin: often — a rush of blood to the face, rarely — exfoliative dermatitis, Stevens-Johnson syndrome, very rarely — alopecia, xeroderma, cold sweat, disturbance of skin pigmentation.

Allergic reactions: rarely — itching, rash (including erythematous, maculopapular, urticaria), angioedema, erythema multiforme, photosensitivity reaction.

From the sensory organs: rare — tinnitus, diplopia, violation ccomodation, xerophthalmia, conjunctivitis, eye pain, rarely — parosmia.

From the metabolic: very rarely — hyperglycemia.

Other: rare — reducing body weight, increasing of body mass, nasal bleeding.

Losartan

CNS: frequently — dizziness, asthenia, headache, fatigue, increased weakness, insomnia, rarely — violation of cerebral circulation, insomnia, drowsiness, memory disorder, peripheral neuropathy, paresthesia, hyperesthesia, tremor, ataxia, systemic dizziness, memory impairment, migraine, nervousness.

General disorders injection site: swelling of the face, fever, asthenia, increased weakness.

From the digestive tract: often — nausea, diarrhea, dyspepsia, abdominal pain, rarely — anorexia, taste disturbance, constipation, toothache, dry mouth, flatulence, gastritis, hepatitis, abnormal liver function, pancreatitis.

The skin and subcutaneous tissue: often — alopecia, dry skin, rash, redness of the skin, Henoch-Schonlein purpura, photosensitivity, pruritus, sweating.

Allergic reactions: rare — urticaria, angioneurotic edema.

From the CCC: often — myocardial infarction, angina, arrhythmias (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), palpitations, orthostatic hypotension, fainting (syncope), hypotension, vasculitis.

The blood and lymphatic system: rare — anemia, rarely — thrombocytopenia.

The respiratory system of the chest and mediastinum:often — shortness of breath, bronchitis, dry cough, discomfort in the throat, epistaxis, rhinitis, laryngitis, chest pain.

On the part of the organ of hearing and labyrinth disorders: rare — ringing in the ears.

The kidneys and urinary tract: rarely — violation frequency of urination, nocturia, urinary tract infection, very rarely — renal failure.

Psychiatric disorders: rare — anxiety, anxiety disorder, confusion, depression, abnormal dreams, panic disorder.

On the part of the organ of vision: often — blurred vision, burning/pricking in the eye, conjunctivitis, decrease in visual acuity.

From the genital organs and mammary glands: rarely — decreased libido, impotence.

From the metabolism and nutrition: rare — gout.

From the musculoskeletal and connective tissue: often — cramps, musculoskeletal pain, swelling of joints, stiff joints, rarely — arthralgia, arthritis, fibromyalgia, and rarely rhabdomyolysis.

Overdose:

Overdoses Asahara unknown.

Below are data on overdose of amlodipine and losartan taken separately.

Amlodipine

Symptoms: overdose amlodipine may cause excessive peripheral vasodilatation and possibly reflex tachycardia. In the described cases there was a long pronounced hypotensive effect, until shock and death.

Treatment: use activated charcoal to healthy volunteers immediately or within 2 h after ingestion of 10 mg of amlodipine reduces the absorption of the latter. If necessary shown gastric lavage. Clinically significant hypotension in overdose Ashara requires carrying out a complex of measures to normalize the status of SSS: it is necessary to lift the leg of the patient, to continuously monitor the functional parameters of the heart and respiratory system, BCC and volume of diuresis. To restore vascular tone and the AD may require the introduction of a vasoconstrictor, if you are sure that there are no contraindications to their use. To eliminate the blockade of calcium channels effectively in/with the introduction of calcium gluconate. Excretion of amlodipine by hemodialysis is unlikely.

Losartan

Symptoms: limited data Are available on overdose in humans. The most common symptoms: hypotension and tachycardia may develop bradycardia due to parasympathetic (vagal) stimulation.

Treatment: in the case of symptomatic arterial hypotension should designate supportive therapy. Neither losartan nor its active metabolite cannot be removed from the body by hemodialysis.

Method of application and dose:

Inside, regardless of meals, with a small amount of water once a day. To start treatment with Amsair necessary in the case of pre-titration of the doses of amlodipine and losartan, respectively, 1 table. Amsara 5 mg+50 mg or 5 mg+100 mg. If needed, direct switch from monotherapy with amlodipine or losartan therapy drug Asar. Asaar can be administered to patients of AD which is insufficiently controlled by amlodipine or losartan at the same doses that are present in combination (5/50 mg and 5/100 mg).

Patients simultaneously receiving losartan and amlodipine, may be transferred to Asar with the same doses of these drugs.

Use in renal failure

When Cl creatinine from 50 to 20 ml/min dose adjustment is not required.

Asaar is not recommended in patients with Cl creatinine less than 20 ml/min and hemodialysis patients, because may require dose adjustment of the drug components.

Use in patients with reduced BCC

Not recommended the use of the drug Amsaar in patients with reduced BCC (for example, when high doses of diuretics).

In the case of volume replacement the drug Asaar possible, if not recommended a lower dose of losartan to 25 mg.

Use in hepatic insufficiency

The use of the drug Asaar possible in patients with liver failure (less than 9 points on a scale child-Pugh), which by decision of the doctor allowed the appointment of losartan 50 mg.

Use in elderly

Drug Asar may be used in patients older than 65 years, with portability the dose losartan 50 mg.

Use in children and adolescents

Asaar not recommended for use in patients below 18 years due to insufficient data on the efficacy and safety of applying in this group (see "Contraindications").