Instructions for Optix film-coated tablets, blister pack No. 60
Composition
active ingredients:
1 tablet contains: β-carotene 1.5 mg; lutein 2.5 mg; zeaxanthin 0.5 mg; vitamin E 36 mg; vitamin C 225 mg; zinc 5 mg; copper 1 mg;
excipients: calcium sulfate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, colloidal anhydrous silicon dioxide, hypromellose (hydroxypropylmethylcellulose);
shell: Opadry II Yellow film-coating mixture: hypromellose (hydroxypropylmethylcellulose), titanium dioxide (E 171), polydextrose, yellow iron oxide (E 172), maltodextrin, talc, medium chain triglycerides.
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a film coating from light brown-yellow to brown-yellow in color.
Pharmacotherapeutic group
Multivitamin preparations with other additives. ATX code A11A B.
Pharmacological properties
Pharmacodynamics
A combined medicinal product containing vitamins, minerals and plant carotenoids.
Replenishes the deficiency of vitamins and minerals. Has an antioxidant effect. The action of the drug is due to the effects of the substances that make up its composition.
Lutein and zeaxanthin are specific carotenoids found directly in the retina of the eye (the so-called "yellow spot"). The action of these substances is due to their high antioxidant activity and ability to filter the harmful part of the light spectrum.
Lutein and zeaxanthin have antioxidant, screening and absorbing effects, preventing the development of age-related disorders.
β-carotene plays an important role in the construction of the visual pigment rhodopsin, which ensures the adaptation of the eye to low light, and also has an antioxidant effect.
The action of vitamin C – a water-soluble antioxidant – in the preparation is combined with vitamin E, which protects cells and tissues from the damaging effects of excessive free radicals and lipid peroxidation.
Copper and zinc function as components of numerous metalloenzymes, catalyzing their action and preventing the formation of free radicals.
Indication
Replenishment of essential vitamins and minerals in eye diseases (age-related retinal degeneration, cataracts, retinopathy, optic nerve diseases). Prevention of age-related vision impairment and eye diseases in risk groups (over 55 years of age; in patients with diabetes; in the presence of a hereditary predisposition to cataracts or retinal degeneration; in smokers; in people with light-colored eyes). Prevention of eye diseases in case of significant visual stress (working with a computer, under the influence of UV rays, radiation from TV screens); in case of impaired night vision adaptation; during recovery after ophthalmic operations.
Contraindication
Hypersensitivity to the components of the drug, severe renal failure, chronic glomerulonephritis, sarcoidosis, hypervitaminosis A and E, thrombophlebitis, iron or copper metabolism disorders, thyrotoxicosis, simultaneous use of retinoids.
Interaction with other medicinal products and other types of interactions
When used with other medicines containing the same vitamins and minerals, the cumulative effect of the vitamins must be taken into account.
Concomitant use of cholestyramine, colestipol, orlistat, and laxatives reduces the absorption of carotenoids.
Vitamin C enhances the effects and manifestations of adverse reactions of sulfonamides.
Vitamin E absorption can be impaired by iron and silver preparations.
Application features
The maximum effect of carotenoids is observed when taken with food containing fats (especially vegetable oils).
Do not exceed the recommended dose.
The medicinal product contains lactose, therefore it should not be used in patients with hereditary galactose intolerance, glucose-galactose malabsorption or lactase deficiency.
The drug is used with caution in patients with urolithiasis, cardiac decompensation, cholelithiasis, chronic pancreatitis, acute nephritis, and those with a tendency to thromboembolism. It is not used in patients with fructose intolerance.
The drug is not recommended to be prescribed with other multivitamins, as an overdose of the latter in the body is possible.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used only if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus/child.
Method of administration and doses
The drug is taken orally during or after meals. Adults and children over 12 years of age are prescribed 1 tablet once a day for 2-3 months.
The maximum daily dose is 1 tablet. The duration of the course of treatment is determined by the doctor individually. If necessary, in the absence of a stable effect, repeated courses are prescribed after consultation with the doctor.
The medicine is not used in children under 12 years of age.
Overdose
In case of overdose, the side effects of the drug may be enhanced and manifestations of hypervitaminosis (A, C, E) may develop, allergic reactions may occur, dyspeptic disorders may occur, including epigastric pain, nausea, vomiting, flatulence, diarrhea, and increased excitability of the nervous system.
Treatment: activated charcoal, gastric lavage, symptomatic therapy.
Adverse reactions
In individuals with hypersensitivity - allergic reactions (skin rash, urticaria, etc.), including anaphylactic shock, angioedema, hyperthermia, itching, bronchospasm; headache, dizziness.
There have been no reports of adverse effects of lutein, zeaxanthin, or small amounts of vitamin C (up to 2000 mg/day for adults).
Side effects of copper may include abdominal pain, nausea, vomiting, and diarrhea.
Long-term use of excessive amounts of zinc can lead to copper deficiency.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister; 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
