Amlessa 8/5MG 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 who require 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 medical history. • 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 started no earlier 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, related to each of the components of Amlessa separately, also apply to the fixed-dose 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 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. When it is not possible to replace ACE inhibitors with other alternative therapy, women planning pregnancy may be switched to treatment 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 inhibitor administration can lead to fetotoxic effects (impaired renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). When ACE inhibitors are taken 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 observed 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 was observed when high doses were administered. It may be considered to use it during pregnancy only if there is no safer alternative 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 product is not recommended for this patient category. During breastfeeding, especially when nursing newborns and/or preterm infants, it is recommended to prescribe an alternative medicinal product with a defined 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. Dizziness and fatigue should be considered when driving vehicles and operating technical equipment.

How to use AMLESSA and dosage

For oral administration. 1 tablet once daily, preferably before breakfast. The combination of fixed doses is not intended as the starting regimen for 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 patient category, since the elimination of perindopril is slowed, routine medical monitoring should include frequent checks of creatinine and potassium levels. Amlessa may 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 doses of each component separately. There is no relationship between changes in the plasma concentration of amlodipine and the degree of impairment of renal function.

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