Amlessa 4/10MG N30 Tb

AMLESSA, tablets

Indications for use

Amlessa is indicated for the treatment of patients suffering from essential hypertension and/or stable coronary artery disease requiring treatment with perindopril and amlodipine.

Contraindications

• Hypersensitivity to perindopril. • Hypersensitivity to perindopril and/or ACE inhibitors. • Angioedema associated with previous therapy with ACE inhibitors in the anamnesis. • Hereditary or idiopathic angioedema. • The second and third trimesters of pregnancy.

• Concomitant use of Amlessa with aliskiren-containing medicinal products in patients with diabetes mellitus or impaired renal function (eGFR < 60 ml/min/1.73 m 2) (see section "Interactions with other medicinal products"). • Concomitant administration with combination medicinal products containing sacubitril and valsartan. Treatment with perindopril must be initiated no less than 36 hours after the last dose of the combination medicinal product containing sacubitril and valsartan (also see sections "Special warnings and precautions for use" and "Interactions with other medicinal products").

Contraindications related to amlodipine: • Severe hypotension. • Hypersensitivity to amlodipine or other dihydropyridines.

• Shock, including cardiogenic shock. • Obstruction of the outflow tract of the left ventricle (e.g., in severe aortic stenosis). • Heart failure after acute myocardial infarction (within the first 28 days). All the contraindications listed above that relate to each of the components of Amlessa separately also apply to the fixed combination of perindopril/amlodipine.

• Increased hypersensitivity to the excipients of the medicinal product.

Use during pregnancy and lactation

It is not recommended to take the product in the first trimester of pregnancy. The product is contraindicated in the second and third trimesters of pregnancy. It is not recommended to use the product during lactation. A decision must be made whether to temporarily discontinue treatment, taking into account either breastfeeding or the importance of the indicated therapy for the mother.

Pregnancy Perindopril The administration of ACE inhibitors during the first trimester of pregnancy is not recommended. The administration of ACE inhibitors during the second and third trimesters of pregnancy is contraindicated. Epidemiological data regarding the risk of teratogenicity when ACE inhibitors are taken during the first trimester do not allow a definitive conclusion, but an increase in risk cannot be ruled out. In cases where it is not possible to replace ACE inhibitors with other alternative therapy, women planning pregnancy may be transferred to therapy with medicinal products whose safety profile has been well studied for pregnant women.

When pregnancy occurs, ACE inhibitor therapy must be discontinued immediately and, if necessary, other therapy should be prescribed. During the second and third trimesters of pregnancy, it has been established that ACE inhibitors can cause fetotoxic effects (impaired renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). When ACE inhibitors are administered during the second trimester of pregnancy, it is recommended to perform ultrasound monitoring of renal function and the skull bones. Newborns whose mothers have taken ACE inhibitors should be closely monitored to prevent the development of hypotension.

Amlodipine The safety of amlodipine use in women during pregnancy has not been established. In animal studies, reproductive toxicity has been observed when high doses are administered. It may be considered to use it during pregnancy in cases where there is no safer alternative medicinal product and the disease itself poses a major risk to the mother and the fetus. Lactation Perindopril There is no information on the use of perindopril during lactation.

The medicinal product is not recommended for this category of patients. During breastfeeding, especially when nursing newborns and/or preterm infants, it is recommended to prescribe an alternative medicinal product with an established safety profile. Amlodipine Amlodipine passes into breast milk. The portion of the dose taken by the mother that affects the child has been estimated at around 3–7%, with a maximum of 15%.

The effect of amlodipine on the child is not known. It has been established that calcium channel blockers from the dihydropyridine group are excreted into milk. A decision to continue/stop breastfeeding and/or to continue/stop amlodipine therapy should be made considering the benefit of breastfeeding for the child and the importance of therapy for the mother.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

No studies have been conducted on the effect of the medicinal product on the ability to drive vehicles or operate machinery. When driving vehicles and/or operating technical equipment, the possibility of dizziness or fatigue should be taken into account.

How to use AMLESSA and dosage

For oral administration. Take 1 tablet once daily, preferably before breakfast. The combination of fixed doses is not intended as the start of antihypertensive therapy. When dose adjustment is required, it is recommended to select the individual components of the medicinal product separately.

Patients with impaired renal function and elderly patients In this category of patients, since the elimination of perindopril is delayed, routine medical monitoring should include frequent checks of creatinine and potassium levels. Amlessa can be prescribed when creatinine clearance is ≥ 60 ml/min, and is not suitable when creatinine clearance is < 60 ml/min. For such patients, it is recommended to individually select the separate doses of each component. There is no dependence of changes in the plasma concentration of amlodipine on the degree of renal impairment.

Patients with impaired hepatic function For this category of patients, no dosage regimen has been established; caution is required when prescribing the specified combination. Children and adolescents Not used, because in this category of patients, the safety, efficacy, and tolerability of perindopril and amlodipine have not been studied during monotherapy or in combination.