Patient Information Leaflet
SCHEDULING STATUS Not scheduled
PROPRIETARY NAME AND DOSAGE FORM:
Vitatech Eye Support Tablets 30 Each tablet contains:
* South African Nutrient reference values for individuals 4 years and older
Inactive ingredients:
Microcrystalline cellulose, di-calcium phosphate & magnesium stearate Contains no sugar or artificial sweetener
PHARMACOLOGICAL CLASSIFICATION 34:12 Category D (Health Supplement) [S0]
INDICATIONS Contributes to:
• the maintenance of immune function, skin, nails, bones, hair, testosterone levels in the blood and vision,
• normal acid- base metabolism, cognitive function, DNA synthesis, fertility & reproduction,
• macronutrient metabolism and metabolism of Vitamin A,
• normal collagen for the normal function of blood vessels, the cartilage, the bones, gums, skin and teeth,
• normal function of the muscles- and the immune system,
• normal energy-yielding metabolism, functioning of the nervous system, psychological function,
• function of the immune system, normal growth, normal red blood cell formation, Ingredients/Bestanddele Per tablet NRV% *
Vitamin A (as Beta Carotene) Vitamin B₁ (as Thiamine HCL) Vitamin B₂ (as Riboflavin) Vitamin B₃ (as Nicotinamide) Vitamin B₆ (as Pyridoxine HCL) Vitamin B₁₂ (as Cyanocobalamin) Vitamin B₇ (as D-Biotin)
Vitamin C (as L-Ascorbic Acid)
Vitamin E (as dl-Alpha Tocopherol Acetate) Vitamin B₉ (as Folic Acid)
Vitamin B₅ (as Pantothenic acid) Copper (as Glycinate)
Zinc (as Gluconate) Lutein
Zeaxanthin
243 mcg (RE) 1,2 (mg) 1,3 (mg) 16,0 (mg) 1,7 (mg) 2,4 (mcg) 30,0 (mcg) 100,0 (mg) 15,0 (mg) 400,0 (mcg) 2,5 (mg) 0,9 (mg) 11,0 (mg) 6 (mg) 2 (mg)
27 100 100 100 100 100 100 100 100 100 100 100 100 - -
• the protection of cells from oxidative stress, free radical damage and connective tissue formation,
• iron absorption from food, reduction of tiredness and fatigue,
• regeneration of the reduced form of Vitamin E and wound healing,
• the development and maintenance of strong bones and teeth, eyesight, skin, membranes,
• the immune function, normal cell division, blood calcium levels and
• normal production of the thyroid hormones and thyroid function Helps to:
• metabolising carbohydrates, fats and proteins in the body,
• reduce the risk of neural tube defects when taken daily prior to becoming pregnant and during early pregnancy,
• form red blood cells and helps in their proper function,
• maintain immune function and produce and
• repair connective tissue
Has a role in the process of cell division.
A factor in the maintenance of good health.
Provides support for healthy glucose metabolism
An antioxidant and factor for the maintenance of good health.
Helps in the absorption and use of calcium & phosphorous,
Calcium intake, when combined with sufficient vitamin D, a healthy diet and regular exercise, may reduce the risk of developing osteoporosis.
Helps to maintain eyesight in conditions (associated with sunlight damage).
Helps to improve macular pigment optical density.
Antioxidant that helps fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals.
“A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.”
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
If you are pregnant or breast feeding your baby, please consult your health care provider for advice before taking this medicine.
WARNINGS AND SPECIAL PRECAUTIONS Do not exceed the recommended daily dosage.
Follow all directions on your medicine label and package. Do not use If you are allergic to any ingredient in beta carotene, ascorbic acid (vitamin C), vitamin E, zinc, copper, lutein, zeaxanthin, you smoke or have a history of smoking.
Consult a relevant health care provider prior to use if you are a tobacco smoker, have cardiovascular disease, or use statins to lower cholesterol.
Not recommended for children < 3yrs. KEEP OUT OF REACH OF CHILDREN.
INTERACTIONS
Some products that may interact with other medication. Always consult your healthcare professional if you are taking any other drugs before taking this medicine.
DOSAGE AND DIRECTIONS FOR USE
Adults: Take 1 tablet a day, after food with a full glass of water.
Long term users (3-month continuous use) should be evaluated and practiced under the care of a relevant health care provider.
Do not share medicines prescribed for you with any other person. In the event of over-dosage, consult your doctor or pharmacist.
SIDE EFFECTS
Signs of an allergic reaction like:
• rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever;
• wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking;
• unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Upset stomach or throwing up.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.
STORAGE INSTRUCTIONS
Close the container properly after usage. Store in a cool, dry place below 25 ᵒC. Do not leave container open or store in a fridge.
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
PRESENTATION
White with red lid packaged container with tamperproof induction seal, clearly labelled with detailed information printed on the label, containing 30 tablets.
IDENTIFICATION White, round or oval tablet REGISTRATION NUMBER To be allocated.
NAME AND BUSINESS ADDRESS OF THE APPLICANT Serfie Imports & Exports (PTY) Ltd
Cnr Parkin & Delson Street, North End, Gqeberha 6001 Tel no: +27 (0) 41 816 3100
Email: [email protected] Website: www.vitatechhealth.com
DATE OF PUBLICATION OF THIS PATIENT INFORMATION LEAFLET August 2021
Complementary Medicine: Health Supplement Classification: Category D
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
This medicine is not intended to diagnose, treat, cure or prevent any disease.
Pasiënt Inligtingsblaadjie
SKEDULERINGSTATUS [S0]
Nie geskeduleer nie
HANDELSNAAM EN DOSERINGSVORM:
Vitatech Eye Support tablette 30 Elke tablet bevat:
Bestanddele Per tablet NRV% *
Vitamien A (as Beta-Karoteen) Vitamien B₁ (as Tiamien-soutsuur) Vitamien B₂ (as Riboflavoon) Vitamien B₃ (as Nikotinamied
Vitamien B₆ (as Piridoksien-soutsuur) Vitamien B₁₂ (as Sianokobalamien) Vitamien B₇ (as D-Biotien)
Vitamien C (as L-Askorbiensuur)
Vitamien E (as dl-Alfa Tocopherol Asetaat) Vitamien B₉ (as Foliensuur)
Vitamien B₅ (as Pantoteensuur) Koper (as Aminosuurchelaat) Sink (as Glukonaat)
Lutein Zeaxanthin
243 mcg (RE) 1,2 (mg) 1,3 (mg) 16,0 (mg) 1,7 (mg) 2,4 (mcg) 30,0 (mcg) 100,0 (mg) 15,0 (mg) 400,0 (mcg) 2,5 (mg) 0,9 (mg) 11,0 (mg) 6 (mg) 2 (mg)
27 100 100 100 100 100 100 100 100 100 100 100 100 - -
* Suid Afrikaanse Voedings verwysingswaardes vir persone 4 jaar en ouer
FARMAKOLOGIESE KLASSIFIKASIE 34.12 Kategorie D (Gesondheidsaanvuller) [S0]
Ander bestanddele
Mikrokristalien sellulose, magnesiumstearaat & silikoondioksied Bevat geen suiker of kunsmatige versoeter.
INDIKASIES Dra by tot:
• Die instandhouding van die liggaam se immuniteitsfunksies, vel, naels, bene, hare, testosteroonvlakke en sig,
• normale suur-basis metabolisme, kognitiewe funksie, DNA sintese, vrugbaarheid &
reproduksie, makro-voedingstof metabolisme, metabolisme van vitamien A,
• normale kollageenvlakke,
• die normale funksionering van die bloedvate, kraakbeen, bene, tandvleis, vel en tande,
• normale funksionering van die spiere, die immuunstelsel, metabolisme wat energie oplewer, funksionering van die senuweestelsel, sielkundige funksie,
• die normale groei en vorming van rooibloedselle,
• die beskerming van selle teen oksidasionele spanning en vrye radikale skade asook bindweefselvorming, ysterabsorpsie uit voedsel,
• vermindering van tam- en moegheid, wond genesing en regenerering van ‘n vitamien E tekort.
• die ontwikkeling en instandhouding van sterk bene, tande, visie, vel, membrane,
• normale seldeling en bloed kalsiumvlakke en die
• normale produksie en funksionering van skildklierhormone.
Help met die:
• metabolisering van koolhidrate, vette en proteïene in die liggaam,
• indien die medisyne daagliks geneem word, kan dit die risiko van neurale buisdefekte voor swangerskap of gedurende vroeë swangerskap voorkom,
• vorming en normale funksionering van rooibloedselle,
• handhawing van ‘n gesonde immuniteitstelsel en
• vervaardiging, asook herstel van die bindweefsel Speel 'n rol in die seldelingsproses.
Is 'n antioksidant en faktor met die handhawing van goeie gesondheid.
Bied ondersteuning vir gesonde glukose-metabolisme Help met die absorbsie en gebruik van Kalsium & Fosfor.
Voldoende Kalsium inname, gekombineer met voldoende Vitamien D, 'n gesonde dieet en gereelde oefening, kan die risiko van osteoporose verminder.
Help om visie te behou in toestande (wat verband hou met sonskade).
Help om die optiese digtheid van die makulêre pigment te verbeter.
Antioksidant wat help om (sel) te beveg/te beskerm teen (verminder die oksidatiewe effek van/die oksidatiewe skade veroorsaak deur/selskade veroorsaak deur) vrye radikale.
“'n Omvattende en gebalanseerde eetplan is die mees doeltreffend- en veiligste manier vir die handhawing van goeie gesondheid om geestelike en fisiese doelwitte te bereik."
KONTRAINDIKASIES
Hipersensitiwiteit vir enige van die bestanddele.
Indien swanger of borsvoed, raadpleeg jou gesondheidsorgverskaffer voordat hierdie medisyne gebruik word.
WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLS Moenie die aanbevole dosis oorskry nie.
Moet dit nie gebruik nie as u allergies is vir enige bestanddeel, byvoorbeeld beta -karoteen, askorbiensuur (vitamien C), vitamien E, sink, koper, luteïen, zeaxanthien, rook of 'n geskiedenis van rook het.
Raadpleeg 'n relevante gesondheidsorgverskaffer voor gebruik as u 'n tabaksroker is, kardiovaskulêre siektes het of statiene gebruik om cholesterol te verlaag.
Volg altyd die aanwysings op die etiket of verpakking. Raadpleeg altyd u gesondheidsorgverskaffer indien u enige ander medikasie gebruik.
Word nie vir kinders aanbeveel < 3 jaar. HOU BUITE BEREIK VAN KINDERS
INTERAKSIES
Interaksies kan plaasvind as u enige ander medisyne neem. Raadpleeg altyd u gesondheidsorgverskaffer alvorens u hierdie medikasie gebruik.
DOSERING EN GEBRUIKSAANWYSINGS:
Volwassenes: Neem 1 tablet per dag met ‘n glas water na ‘n maaltyd.
Moenie medisyne met enige ander persoon deel nie. In die geval van ‘n oordosis, raadpleeg dadelik u gesondheidsorgverskaffer. Indien nie beskikbaar, kontak die naaste hospitaal of mediese sentrum vir advies.
NEWE-EFFEKTE
Tekens van 'n allergiese reaksie, soos:
• uitslag; jeukerigheid; rooi-, geswelde-, blase of afskilferende vel met of sonder koors;
• benoudheid in die bors of keel; probleme met asemhaling, te sluk of praat;
• ongewone heesheid; of swelling van die mond, gesig, lippe, tong of keel en
• maagontsteldheid of braking.
Nie alle newe-effekte is in hierdie pamflet gelys nie. Indien u algemene gesondheidstoestand versleg of as u enige newe-effekte ervaar, raadpleeg u gesondheidsorgverskaffer vir advies.
BERGINGSINSTRUKSIES
Verseël die houer behoorlik na gebruik. Bêre op 'n koel, droë plek onder 25 ᵒC. Moenie die houer oop laat of in die yskas bêre nie.
STOOR ALLE MEDISYNE BUITE BEREIK VAN KINDERS.
AANBIEDING
Verpak in ‘n Wit houer, met Groen deksel en 'n peuterbestande induksie-seël. ‘n Gedrukte etiket met volledige aanwysings is op die houer aangebring. Bevat 30 tablette.
IDENTIFIKASIE Wit ronde of ovaal tablet REGISTRASIE NOMMER Nie toegeken nie.
NAAM EN BESIGHEIDSADRES VAN DIE AANSOEKER Serfie Invoere & uitvoere (Edms.) Bpk
H/V Parkin & Delsonstrate, Noordeinde, Gqeberha 6001 Tel no: +27 (0) 41 816 3100
e-Posadres: [email protected] Webwerf: www.vitatechhealth.com
DATUM VAN PUBLIKASIE VAN HIERDIE PASIËNT INLIGTING PAMFLET Augustus 2021
Aanvullende Medisyne: Gesondheidsaanvuller Klassifikasie: D (HS)
Hierdie medisyne is nie deur SAHPRA geëvalueer ten opsigte van die kwaliteit, veiligheid of beoogde gebruik daarvan nie. Hierdie medisyne is nie bedoel vir die diagnosering