Amseril 5/5 Mg N30 Tablet

Amseril, film-coated tablets

Amseril composition

Active substances: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 5 mg 
lisinopril (as lisinopril dihydrate). 

Contraindications 

Related to lisinopril: hypersensitivity to lisinopril or to any other ACE inhibitor; in the anamnesis, angioedema in the context of taking ACE inhibitors; hereditary or idiopathic angioedema; in patients with diabetes mellitus or renal impairment (eGFR < 60 ml/min/1.73m2), concomitant use of ACE inhibitors with aliskiren-containing medicinal products.
Related to amlodipine: hypersensitivity to amlodipine or other dihydropyridine derivatives; severe arterial hypotension; shock (including cardiogenic); obstruction of the outflow tract of the left ventricle (e.g., severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction.
Related to Amseril: all the contraindications listed above related to the use of the individual components also apply to Amseril; hypersensitivity to any of the excipients; pregnancy planning, pregnancy and lactation periods.

Use during fertility, pregnancy and lactation 

Pregnancy 
Amseril must not be taken during pregnancy planning and during pregnancy.
There is no information on the use of Amseril in pregnant women within the framework of adequately controlled clinical studies. When pregnancy is confirmed, the intake of the product must be stopped immediately and, if necessary, alternative treatment should be started. Patients planning pregnancy should be switched to alternative antihypertensive 
agents with a known safety profile during pregnancy.
Lactation 
Amseril must not be used during breastfeeding (there is no data). If 
use of the product during lactation becomes necessary, alternative antihypertensive 
agents with a known safety profile should be prescribed (especially during breastfeeding in 
newborns and premature infants).
Fertility 
There are no data from adequately controlled clinical studies regarding the effect of Amseril on fertility.
Lisinopril 
Pregnancy 
The use of ACE inhibitors in the first trimester is not recommended and is contraindicated in the second and third 
trimesters of pregnancy.
Based on the results of epidemiological studies, it is not possible to draw definitive conclusions about the risk of teratogenic effects caused by the use of ACE 
inhibitors during the first trimester; however, a slightly increased risk cannot be ruled out. If continuing treatment with ACE 
inhibitors is not considered essential, patients planning pregnancy should be switched to alternative therapy with antihypertensive 
agents from other pharmacological 
classes with a known safety profile during pregnancy. If pregnancy 
is diagnosed, treatment with ACE inhibitors must be stopped immediately and, if necessary, alternative medicinal products should be used.
It has been established that ACE inhibitors, when used in women in the second and third 
trimesters of pregnancy, have a toxic effect on the fetus (impaired kidney function, low 
amniotic fluid, delayed ossification of the skull bones and the newborn (renal 
failure, arterial hypotension, hyperkalemia).
During the use of ACE inhibitors in the second trimester of pregnancy, it is recommended to perform an ultrasound examination of the fetus’s kidneys and skull.
In newborns whose mothers have taken ACE inhibitors, careful monitoring is recommended with regard to the detection of arterial hypotension.
Lactation 
The use of lisinopril is not recommended because there is no information regarding its use during breastfeeding. During breastfeeding, especially in 
newborns or premature infants, preference should be given to the use of alternative medicinal products with a known safety profile.
Amlodipine 
Pregnancy 
The safety of amlodipine use during pregnancy in humans has not been established.
In animal studies, it has been determined that amlodipine, at high doses, 
has reproductive toxicity. The use of amlodipine during pregnancy is recommended only if there is no safer alternative treatment and if the disease itself is considered to pose a significant risk to the health of the mother and the child.
Lactation 
Amlodipine is excreted into breast milk. Based on the dose taken by the mother, it has been determined that the amount of the medicinal product received by the breastfed infant has an interquartile range of 3–7%, with a maximum of 15%. It is not known how amlodipine affects newborns. When making a decision about whether to continue/stop breastfeeding and whether to continue/stop therapy with amlodipine, it is necessary to assess the benefit of using the medicinal product for the mother and the advantage of breastfeeding for the child.
Fertility 
During the use of CCBs, information has been reported in some patients about reversible biochemical 
changes in the head of spermatozoa. There is insufficient clinical data to assess the possible effect of amlodipine on fertility. Studies in rats have shown that it has a negative effect on the fertility of males.

Directions for use and dosage 

Tablets are taken orally regardless of food intake. The recommended dose is one tablet 
once daily; the maximum daily dose is one tablet.
As a rule, preparations consisting of a combination of medicinal products at fixed doses are considered an indication as initial therapy for diseases. For patients, the effective dose of each component included in the composition of the individual medicinal product must be determined. When it is necessary to change the dose of any of the components of the combination, 
it is recommended to select the appropriate dosing of the combination during supportive therapy or to switch to separate intake of the medicinal products.  
If a patient forgets to take the Amseril tablet, a double dose should not be taken to restore the missed dose.
Patients with impaired renal function 
In patients with renal impairment, to determine the optimal starting and maintenance dose of Amseril, 
the doses of amlodipine and lisinopril must be selected separately. During treatment with Amseril, 
it is necessary to monitor kidney function and the levels of potassium and sodium in blood plasma. If kidney function worsens, 
the intake of the medicinal product should be discontinued and therapy with amlodipine and lisinopril should be continued at correctly selected doses.
Patients with impaired liver function 
In patients with impaired liver function, the elimination of amlodipine may be delayed.
There are no precise recommendations regarding the dosing regimen of Amseril in patients with mild to moderate hepatic impairment; therefore, the product should be taken with caution and the minimal recommended dose should be used in the initial stages of treatment. In patients with hepatic impairment, to determine the optimal starting and maintenance dose of Amseril, 
the doses of amlodipine and lisinopril must be selected separately.
In patients with severe hepatic impairment, the pharmacokinetic parameters of amlodipine have not been studied. In such patients, treatment with amlodipine should be started with the minimal dose and increased slowly up to the optimal dose.
Elderly patients (over 65 years) 
Elderly patients should use Amseril with caution. In clinical studies, no age-related changes were found in the efficacy profiles of amlodipine and 
lisinopril. To determine the optimal maintenance dose of Amseril, 
the doses of amlodipine and lisinopril must be selected separately.
Children 
The safety and efficacy of Amseril in children under 18 years of age have not been established.