ArmoLIPID (Tablets) Instructions for Use

Marketing Authorization Holder

Mylan Pharma, LLC (Russia)

Manufactured By

Meda Pharma, S.p.A. (Italy)

Dosage Form

ArmoLIPID

Tablets: 30 pcs.

Dosage Form, Packaging, and Product Composition

Tablets with a mass of 0.8 g.

* as a mixture of natural fatty alcohols contained in the wax matrix of sugar cane (Saccharum officinarum) standardized to a policosanols content of 90%.
** as a dry extract of microalgae (Haematococcus pluvialis) standardized to an astaxanthin content of 2.5%.

Excipients : stabilizers: dibasic calcium phosphate (E341ii), microcrystalline cellulose (E460i); emulsifiers: magnesium stearate (E470b), mono- and diglycerides of fatty acids (E471), silicon dioxide (E551).

10 pcs. – blisters (3) – cardboard packs.

Therapeutic Category

Dietary supplement for the correction of plasma lipid profile in dyslipidemia

Properties

Dietary supplement – a source of astaxanthin, an additional source of folic acid. The product also contains Policosanols, red fermented rice, and coenzyme Q₁₀.

Red fermented (yeast) rice is a product of the fermentation of the fungus Monascus purpureus and contains monacolin K, which is able to modulate blood lipid levels. In this product, red yeast rice is obtained under standard conditions with a specific strain of Monascus purpureus, selected for an optimal yield of monacolin K (the main active ingredient of red yeast rice), with a clearly defined and guaranteed analysis of titer. Experimental and clinical studies have shown that red yeast rice reduces total cholesterol and LDL cholesterol.

Policosanols are a mixture of natural fatty alcohols found in the wax matrix of sugar cane (Saccharum officinarum), rice bran (Oryza sativa), and beeswax (Apis mellifera). The Policosanols contained in this product are derived from sugar cane. Policosanols enhance the effectiveness of blood cholesterol control.

Astaxanthin is one of the most powerful antioxidants found in nature. Its antioxidant activity is 100-500 times higher than that of vitamin E, 6 times greater than that of beta-carotene, and 4 times greater than that of lutein. Due to its antioxidant properties, Astaxanthin inhibits peroxidation and prevents the formation of pro-atherogenic particles. Astaxanthin stabilizes the cell membrane, protecting phospholipids from damage caused by intracellular and extracellular reactive oxygen species (ROS). This effect is necessary to prevent endothelial dysfunction, a condition that plays a key role in the development of atherosclerosis.

Coenzyme Q₁₀ is synthesized in the human body. It is an important co-factor necessary for ATP synthesis, which is required for the functioning of all cells, tissues, and organs, especially those with high energy demands.

The results of the clinical efficacy assessment of this product showed a reduction in total cholesterol and LDL cholesterol, a reduction in homocysteine, and a favorable safety profile.

Scope of Application

For improving the plasma lipid profile in dyslipidemia.

ICD codes

Dosage Regimen

This product may be recommended in addition to lifestyle changes, as well as a supplement to a balanced diet (as indicated in current guidelines) for mild to moderate hypercholesterolemia and to reduce oxidative stress.

Recommended for adults: 1 dose once/day.

Side effects

Possible gastrointestinal disorders, and muscle pain, particularly in individuals with statin intolerance. If muscle pain occurs, consult a doctor.

Contraindications

Individual intolerance to the components of the product used; pregnancy, breastfeeding period; do not use in combination with lipid-lowering drugs.

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and breastfeeding.

Special instructions

Dietary supplement. Not a medicine.

Do not exceed the recommended daily dose.

The product should be used in combination with a varied and balanced diet while maintaining a healthy lifestyle.

Consult a doctor before use.

Drug Interactions

Do not use in combination with lipid-lowering drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.