HEALTHY EYES

Main information

Documents

Localization

  • Available in:
  • HEALTHY EYES
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Listed
  • Authorization number:
  • 188951
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188951

HEALTHY EYES

ARTG entry for

Medicine Listed

Sponsor

Australian Naturalcare Products Pty Ltd

Postal Address

PO Box 946,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

8/09/2011

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. HEALTHY EYES

Product Type

Single Medicine Product

Effective date

21/10/2015

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Contains lactose (or words to that effect).

Keep out of reach of children (or words to that effect).

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

Standard Indications

Aids, assists or helps in the maintenance or improvement of general well-being.

Eyes formula. Support of healthy eye function.

Maintenance of healthy eyes.

Specific Indications

Lutein and Zeaxanthin provide nutritional support for the macula region of the eyes. The antioxidants Betacarotene, Zinc, Selenium, Copper and Vitamin

C help combat free radical activity.

Lutein and Zeaxanthin are the only carotenoids found in the macula and lens of the human eye. In the macula they form a layer of yellow pigment which

serves as an effective natural filter or "internal sunglasses" effect, against harmful blue light that could reach the retina.

Dunaliella salina is a red algae cell extract which provides a diverse selection of natural-source powerful antioxidant nutrients called carotenoids,

including beta-carotene, alpha carotene, cryptoxanthin, zeaxanthin and lutein. Natural carotenoids are powerful quenchers of free radical molecules, and

may help protect cell membranes and help maintain general wellbeing.

Free radical scavenging activity is provided by the antioxidants zinc, selenium, copper and vitamin C. These nutrients are beneficial for optimal eye

health as they provide protection from free radical activity that can result in oxidative damage to the tissues. Increasing the concentration of antioxidants

in the macula helps protect it from oxidative free radical damage.

Selenium is provided in the highly bioavailable form of selenomethionine. Selenium is utilised by the body as part of a natural antioxidant enzyme called

glutathione peroxidase (GSH) which has an important role in preserving healthy eye function.

It has been established through scientific literature that Zinc provides antioxidant benefits to support macula health and eye function. Copper provides

nutrient support for eye health, and helps balance the zinc:copper ratio of the formula.

Vitamin C concentrates in the eyes (particularly the lens) where it exerts antioxidant effects against free radical damage, and provides nutritional support

for the maintenance of healthy eye function.

Epidemiological studies indicate that diets rich in antioxidants such as those contained in Healthy Eyes (Lutein, Zeaxanthin, Carotenoids, Zinc and

Vitamin C) help maintain healthy vision in the older age group.

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:47:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Carotenoids are recognised as safer than Vitamin A supplements because the human body only converts carotenoids into Vitamin A when it needs the

vitamin A. Natural sourced Beta-carotene is the most potent of the carotenoids as a source of pro-vitamin A.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

250 mg

Cupric sulfate pentahydrate

982 microgram

Dunaliella salina

26.67 mg

lutein

5 mg

Selenomethionine

17.4 microgram

Zeaxanthin

1 mg

zinc amino acid chelate

50 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 29.11.2017 at 12:47:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information