Amlipin 5/5 Mg N30 Tablet

Amlipin, film-coated tablets

Composition of Amlipin

The composition of Amlipin contains, in 1 tablet: 5 mg amlodipine (as amlodipine besylate), 5 mg lisinopril (as lisinopril dihydrate). Excipients: starch 1500, anhydrous calcium hydrogen phosphate, lactose monohydrate, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate. Film coat: Opadri II 85F250057 red (partially hydrolyzed polyvinyl alcohol, macrogol, titanium dioxide, talc, Ponceau 4R, Sunset Yellow FCF, tartrazine, black iron oxide).

Amlipin, indications

In adults for the treatment of essential arterial hypertension. Amlipin is indicated as an alternative to the simultaneous administration of amlodipine and lisinopril at doses that provide adequate control of arterial blood pressure in adults.

Contraindications

Related to lisinopril: hypersensitivity to lisinopril or to any other ACE inhibitor; angioedema in the history associated with the use of ACE inhibitors; hereditary or idiopathic angioedema; concomitant use of ACE inhibitor-containing drugs with aliskiren in patients with diabetes mellitus or renal impairment. Related to amlodipine: hypersensitivity to amlodipine or other dihydropyridine derivatives; severe arterial hypotension; shock (including cardiogenic); obstruction of the left ventricular outflow tract (e.g., severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction. Related to Amlipin: all contraindications related to the use of individual components; hypersensitivity to excipients; pregnancy planning, pregnancy and lactation periods; children and adolescents under 18 years of age.

Use during pregnancy and lactation

Amlipin must not be used during pregnancy. If pregnancy is confirmed, treatment should be stopped immediately and, if necessary, alternative therapy should be started. Use during lactation is also not recommended. Information regarding the use of lisinopril, amlodipine and other ACE inhibitors during pregnancy and breastfeeding requires caution. Amlodipine is excreted into breast milk, but its effect is unknown. Safety and efficacy in children have not been established.

Amlipin, directions for use

Amlipin tablets are taken orally regardless of food intake. The recommended dose is 1 tablet per day; the maximum daily dose is also 1 tablet. Doses should be determined individually according to the patient’s needs and the composition should be adjusted if necessary. In patients with impaired kidney and liver function, elderly patients, and patients with low body weight, it should be used with caution. Do not use in children.