Qsilica

Main information

  • Trade name:
  • Qsilica ONE-A-DAY
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Qsilica ONE-A-DAY
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222538
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222538

Qsilica ONE-A-DAY

ARTG entry for

Medicine Listed

Sponsor

Planet Health Pty Ltd

Postal Address

42 Bowral Street,BOWRAL, NSW, 2576

Australia

ARTG Start Date

15/04/2014

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. Qsilica ONE-A-DAY

Product Type

Single Medicine Product

Effective date

26/06/2015

Warnings

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.

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

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

For vitamin (may state the vitamin) supplementation.

For mineral (may state the mineral) supplementation.

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

Specific Indications

Helps maintain healthy skin, hair and nails.

Qsilica one-a-day tablets contain premium quality ingredients to assist in the maintenance of healthy skin, hair and nails.

Contains a combination of ingredients to support the healthy growth, function and appearance of skin, hair and nails.

Contains ingredients such as silicon and zinc that are important / play a role in the formation and cross linking of collagen. Collagen provides a structural

framework for skin by supporting its thickness and structural integrity.

Helps maintain healthy looking skin by assisting the body's antioxidant defences. Free radical damage may contribute to cell damage and signs of

premature skin ageing.

Contains a clinically trialled dose of biotin.

Biotin assists the condition of nails by promoting the strength of soft, brittle nails and by reducing breaking and splitting.

May increase nail plate thickness and assist the management of nail splitting.

Zinc is required for normal skin repair and wound healing.

Zinc may relieve symptoms of minor skin disorders such as superficial wounds and mild acne.

Zinc is involved in the structure and function of cell membranes and contributes to the maintenance of normal skin, hair and nails.

Zinc is an important antioxidant contributing to the protection of cells from oxidative stress.

Zinc has essential structural, regulatory or catalytic roles in many enzyme systems in the body.

Contains silica, an important mineral for the formation of connective tissue including skin, nails and hair.

Mineral silica/silicon is important for the health, strength and integrity of connective tissue including hair, skin, nails, bones and cartilage.

Selenium acts as an antioxidant reducing oxidative stress and protecting cells from free radical damage.

Zinc and Selenium contribute to the normal functioning of the immune system.

Public Summary

Page 1 of

Produced at 18.10.2017 at 02:45:00 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

Qsilica one-a-day tablets assist the health and strength of bones, joints and ligaments.

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

Biotin

2.5 mg

colloidal anhydrous silica

556.94 mg

Selenomethionine

250 microgram

zinc citrate dihydrate

75.3 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 18.10.2017 at 02:45:00 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