Lucifer yellow, which is excitable with blue light.

Carotenoids were incorpo- the mother´s milk and its effects on the infant.
DIARIS ® rated in the lipophilic membrane. The fluorescent emission in the carotenoid-
containing liposomes was lower than that in the carotenoid-free controls
exposed to the blue light, thus indicating its filtrating effect. The filtering
efficacy was as follows: Lutein > zeaxantine > beta-carotene > lycopene.
LUTEIN - VITAMIN C - VITAMIN E - Vitamin C (ascorbic acid) is one of the most powerful reducing agents in the
body and the main water-soluble anti-oxidizing agent and for these reasons
ZINC - COPPER
Pediatric use
DIARIS ® is a medication intended for treatment of adult patients only.
Influence on diagnosis methods
In diabetic patients, vitamin C may alter the glycosuria values without influ-
encing those of glycemia; therefore, vitamin C intake should be suspended a
few days before performing said test.

CAPSULES
Made in Argentina - RxONLY
Formula:
Each capsule contains:
Lutein 6.00 mg (as 5% Lutein TG 120.00 mg)
Coated Vitamin C 60.00 mg
Vitamin E 30 IU (as dl-alpha tocopheryl acetate 30.00 mg)
Zinc 15.00 mg (as Zn oxide 18.67 mg)
Copper 2.00 mg (as Copper oxide 2.50 mg)
Colloidal silicon dioxide 1.90 mg; Crospovidone 19.00 mg; magnesium
stearate 1.05 mg; Lactose monohydrate 118.63 mg.
Therapeutic action:
Vitamin-mineral supplement.
DIARIS ® combines antioxidant vitamins with mineral oligoelements.
ATC Code: A11AA.
Indications:
Supplement in case of a deficient vitamin and mineral oligoelements
intake necessary for ophthalmic antioxidant enzymatic activity, beneficial
in ocular processes such as age-related macular degeneration.
Pharmacological characteristics / Properties:
Pharmacological action
Lutein is a carotenoid belonging to the xanthophil family, which is natu-
rally present in our blood and also in some foods. It can be found in the
retina, mainly at the macular region.
Yellow carotenoids such as lutein are the constituents of the yellow pig-
ment of the macula lutea. This pigment forms a yellow dot at the center
of the retina, which is the site of highest carotenoid concentration in the
human body; therefore, a dietary supplement containing such carotenoids
may reduce the risk of suffering from age-related macular degeneration.
The yellow color of carotenoids results from the fact that they absorb
blue light, which may cause damage at the retina level; its physiological
action is based on this property. The relationship between the blue light
wavelength and its potential damage to the retina is maximum at 450
nm, where carotenoids work, that is to say where they absorb light before
it can cause any damage to the photoreceptors.
Studies have confirmed that lutein has a significant protective action
against the damages caused by light, thus reducing the aging process
of the retina and the evolution of irreversible and serious degenera-
tive pathologies such as age-related macular degeneration (AMD) and
cataracts.
The function of lutein is to protect tissues and to avoid free radical forma-
tion by creating a shield that is capable of absorbing the dangerous waves
of the blue light.
In addition, due to its antioxidant characteristic, it protects the retina cells
from the oxidation of the membrane phospholipids.
635
635
it performs its function in the aqueous cell phase, further reducing the lipidic
peroxidation by regenerating vitamin E after oxidation thereof. Drug-drug interactions:
Ascorbic acid is principally absorbed at the higher portions of the small intes- Cholestyramine, cholestipol or mineral oil: may interfere with vitamin E
tine through active transport of sodium ions. At high concentrations, absorp- absorption.
tion occurs through passive diffusion. After oral administration of a dose not Iron-containing supplements: may increase daily vitamin E requirements (it
greater than 180 mg, absorption is in the 70-90% range. After ingestion of may be necessary to adjust the dose).
1-12 g, the percentage decreases to approximately 50% to 15%; however, Vitamin C may reduce the activity of oral anticoagulants as well as excretion
the absolute amount of absorbed substance keeps increasing. About 24% of of salicylates with consequent salicylemia increase.
the ascorbic acid binds to plasmatic proteins. Serum concentrations typically
rise up to 10 mg/L (60 mmol/L). Ascorbic acid is partly metabolized first to Adverse reactions:
dehydroascorbic acid and then to oxalic acid. When its provision is too high, At the recommended doses of the product, no adverse reactions have been
it is eliminated unchanged through urine and feces. In urine, it is also identi- described.
fied with another metabolite, ascorbate 2-sulfate. After an oral dose of 50 mg
of vitamin C, its half life is about 14 days. Intake of a daily amount smaller Overdosage:
than 1-3 g of vitamin C results in a substantially renal elimination. With doses There have been no reports to date of cases of non-treated overdosage.
higher than 3 g, increasing amounts of the unchanged substance are elimi- Overdosage during long periods may cause development of toxic states
nated through the feces. which would require stopping administration of the medicament.
Vitamin E (alpha-tocopherol) is a liposoluble compound which oxidizes very In case of overdosage, go to the nearest hospital or toxicology centers.
slowly, this property lends it an outstanding antioxidant role, particularly at
the cell biomembrane level, thus avoiding lipid peroxidation. Vitamin E is the How supplied:
main liposoluble anti-oxidizing agent transported by blood. Packages containing 30 capsules.
Vitamin E is an essential nutritional element. As an antioxidant, vitamin E
protects poly-unsaturated fatty acids at membranes and other cell structures Storage conditions:
from free radical attack and protects red blood cells from hemolysis. Also, Store below 30°C.
vitamin E acts as a cofactor in several enzymatic systems.
As concerns vitamin E kinetics, it is absorbed from 50 to 60% from the Once the container is opened for the first time, it should be used within 4
gastrointestinal tract (duodenum), the presence of bile salts, fats provided weeks.
by the diet and a normal pancreatic function being necessary for an efficient
absorption. In blood, vitamin E binds to betaIipoproteins and accumulates in Keep out of the reach of children.
all tissues, especially fat tissues. It suffers hepatic biotransformation and bili-
ary and renal excretion. Delicate use product. To be administered under prescription and medical
Zinc and copper are oligoelements, i.e. elements occurring at very low surveillance.
amounts in the body and being indispensable for good health keeping.
Zinc and copper are simple elements which are part of the structure of anti- LABORATORIOS POEN S.A.C.I.F.I.
oxidizing enzymes, i.e. of the endogenous antioxidant system of the body. Bermúdez 1004 - C1407BDR Buenos Aires, Argentina
Zinc is a constituent of the Copper-Zinc Superoxide Dismutase enzyme; Elaborado por: Laboratorios ROEMMERS S.A.I.C.F.
copper is a component of ceruloplasmin and Copper-Zinc Superoxide José E. Rodo 6424 (C1440AKJ) Buenos Aires, Argentina
Dismutase. www.poen.com.ar
Posology and Way of administration: Technical Director:
The recommended dose for adults is 1 capsule, once or twice a day; or Victor D. Colombari, Pharmacist.
according to the physician´s judgment.
Contraindications:
DIARIS ® is contraindicated in patients having known hypersensitivity to any
formula components.
Warnings and Precautions:
Do not exceed the recommended doses, except specific medical indication.
DIARIS ® is a specialty intended for the treatment of adult patients.
Carcinogenesis, mutagenesis and fertility disorders
No long-term studies have been conducted with the product.
Pregnancy
No appropriate studies have been conducted in pregnant women; therefore,

Epidemiological data suggest that intake of a lutein-rich diet reduces DIARIS ® should be used during pregnancy only if the potential benefits justify
the risk of age-related macular degeneration, which is the main cause of the potential risks for the fetus.

4291128841
visual damage in the elderly. In a clinical study, an assessment was made

C.V. 2 - 30
Lactation
of the efficacy of carotenoids in filtering the blue light in the unilamelar Care should be taken when the product is administered to nursing women
liposomes contained in the core hydrophilic space with a fluorescent ink,

635
as studies have not been conducted concerning passage of components into

SURCAN S.R.L. Laboratorio/Laboratory: LABORATORIOS POEN Tamaño/Size: Fecha/Date: 08/SET/16

Alvarez Thomas 198 3°A
Buenos Aires - C1427CCO
Tel/Fax: 4553-2422
disenografico@surcan.com.ar
www.surcan.com.ar
ancho/wide: 150 mm Version N°: 1
Producto/Product: DIARIS alto/high: 180 mm
Contenido/Content: CÁPSULAS Guía de colores/Colours Guide
N° Material: 4291128841 Pantone Black C
País/Country: EXPORTACION INGLÉS
Pharmacode N°: 635
Elemento/Item: PROSPECTO (FRENTE Y DORSO) Código visual/Visual code: 2 - 30 Colores/Colours: 1