Makulin (Capsules) Instructions for Use

Marketing Authorization Holder

Fidifarm, d.o.o. (Croatia)

Contact Information

FARMAS RUS LLC (Russia)

Dosage Form

Makulin

Capsules: 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 361.0 mg±27.08 mg.

* percentage of the recommended daily intake level.

Composition gelatin capsule (gelatin, glycerol, sweetener sorbitol, water), partially hydrogenated soybean oil, unrefined soybean oil, Flora Glo^® suspension (lutein, Zeaxanthin), carrier yellow wax, DL-α-tocopheryl acetate, soy lecithin.

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

Therapeutic Category

Dietary supplement – source of lutein and zeaxanthin

Properties

Makulin is a source of lutein and zeaxanthin of natural origin.

Lutein and Zeaxanthin are carotenoids that filter the harmful effects of high-energy spectrum light (blue light) and act as antioxidants, helping to protect cells from damage and support eye health. Of the 600 carotenoids found in nature, only 2 are present in significant amounts in the retina: lutein and Zeaxanthin.

Many facts support the role of lutein and zeaxanthin in reducing the risk of age-related macular degeneration (AMD). The National Eye Institute (USA, Bethesda, Maryland) completed the international multicenter placebo-controlled AREDS2 study in 2013. The main objective of the study was to evaluate the effect on the course of AMD of a formula containing specific doses of vitamins and minerals.

Key findings of the study

• A complex of 10 mg of lutein and 2 mg of zeaxanthin in combination with vitamins C and E and zinc significantly reduces the risk of AMD progression (RR 0.72);
• Significantly reduces the risk of vision loss (RR 0.73);
• Significantly reduces the risk of developing the wet form of AMD (RR 0.63).

Lutein and Zeaxanthin, which are part of the Makulin supplement, are not produced by the human body on its own and must be included in the daily diet to maintain eye health and reduce the risk of age-related degenerative changes in the retina.

Lutein Flora Glo^®, produced from marigolds, is the world’s leading patented brand of free lutein used to improve eye health. Lutein Flora Glo^® is the most clinically studied in the world and has proven its effectiveness in treating retinal disease (AREDS2 study).

Retinal dystrophy is a disease in which dystrophic changes occur in the macula. Photoreceptors are affected and a person gradually loses vision.

The development of retinal dystrophy is associated with atherosclerotic changes in the vessels of the choriocapillary layer of the eyeball. Impaired blood circulation in the choriocapillaries, which are essentially the only source of nutrition for the macular area against the background of age-related changes in the retina, can serve as a trigger for the development of a dystrophic process. The mechanism of development of atherosclerotic changes in the eye vessels is the same as in the vessels of the heart, brain and other organs. It is assumed that this disorder is associated with genetically determined sclerosis of the vessels related to the macula.

The level of macular pigment is of great importance in the development of retinal dystrophy. Macular pigment is the only antioxidant of the retina that neutralizes the action of free radicals and limits blue light, which has a phototoxic effect on the retina.

Risk factors for age-related macular degeneration

• Age (50 years and older);
• Gender (women get sick more often than men, in a ratio of 3:1);
• Genetic predisposition (presence of the disease in relatives);
• White skin and blue iris;
• Cardiovascular diseases (arterial hypertension, vascular atherosclerosis);
• Unbalanced diet;
• High blood cholesterol levels;
• Overweight, obesity;
• Smoking;
• Frequent and prolonged stress;
• Deficiency of vitamins and antioxidants in food;
• Unfavorable environmental conditions.

Scope of Application

Of the Makulin product

Recommended as a dietary supplement to food as a source of lutein and zeaxanthin, vitamin E

• As part of complex therapy for myopia, dry forms of AMD, diabetic retinopathy, cataract;
• For increased visual stress, computer work, to improve twilight vision.

ICD codes

Dosage Regimen

Take orally with meals.

Adults are prescribed 1 caps. 1 time/day.

The duration of administration is at least 1 month. If necessary, the course can be repeated.

The recommended intake of the dietary supplement provides 47% (4.7 mg) of the body’s daily requirement for vitamin E.

Contraindications

• Individual intolerance to the components;
• Pregnancy;
• Lactation period (breastfeeding).

Use during pregnancy and lactation

Use during pregnancy and lactation is contraindicated.

Special instructions

It is recommended to consult a doctor before use.

Storage Conditions

Makulin should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years from the date of manufacture.

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.