Amlessa 4/5 mg N30 Tablet

AMLESSA®, tablets

Amlessa composition

 Tablets 4 mg/5 mg: each tablet contains 4 mg perindopril erbumine (tert-butylamine) and 5 mg amlodipine (as bezylate).

Excipients:

 microcrystalline cellulose, gelatinized starch, sodium starch glycolate, calcium chloride hexahydrate, sodium bicarbonate, colloidal anhydrous silica, magnesium stearate.

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:

 Related to perindopril

 • Hypersensitivity to perindopril or to 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 m2) (see section “Interactions with other medicinal products”).

 • Concomitant administration with combination medicinal products containing sacubitril and valsartan. Treatment with perindopril must be started at least 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”). 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 an acute myocardial infarction (within the first 28 days). All the contraindications listed above, each related to any 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 it in the first trimester of pregnancy. In the second and third trimesters, the medicinal product is contraindicated. It is not recommended to use the medicinal product during lactation. A decision must be made to either temporarily discontinue breastfeeding or to discontinue/avoid the specified therapy, taking into account the benefit of breastfeeding for the mother and the importance of the therapy for the mother. Pregnancy Perindopril In the first trimester of pregnancy, taking ACE inhibitors is not recommended. In the second and third trimesters, taking ACE inhibitors is contraindicated. Epidemiological data during the first trimester do not allow a definitive conclusion regarding teratogenicity risk, but an increased risk cannot be ruled out. If ACE inhibitors cannot be replaced with other alternative therapy, women planning pregnancy may be switched to therapy with medicinal products whose safety profile has been well studied for pregnant women. When pregnancy occurs, ACE inhibitor treatment must be stopped immediately and, if necessary, other therapy should be prescribed. During the second and third trimesters, ACE inhibitor use has been associated with fetotoxic effects (impaired renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). When ACE inhibitors are taken in the second trimester, it is recommended to monitor renal function and skull bone ultrasound. 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 during pregnancy only if there is no safer alternative medicinal product and the disease itself poses a significant risk to the mother and 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 a safety profile established. Amlodipine Amlodipine passes into breast milk. The proportion of the dose taken by the mother that reaches the child has been estimated at about 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/discontinue breastfeeding and/or to continue/discontinue amlodipine therapy should be made considering the benefit of breastfeeding for the child and the importance of therapy for the mother.

Amlessa dosage and how to use

 For oral use. Take 1 tablet once daily, preferably in the morning before meals. 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 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 dose of each component separately. There is no dependence of changes in plasma amlodipine concentration on the degree of renal impairment. Patients with impaired liver function No dosage regimen has been established for this category of patients; 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 population during monotherapy or in combination.