Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Stress Relief
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Stress Relief
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218380
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218380

Swisse Ultiboost Stress Relief

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

11/12/2013

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. Swisse Ultiboost Stress Relief

Product Type

Single Medicine Product

Effective date

14/02/2014

Warnings

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

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

Standard Indications

Specific Indications

- Withania helps support/maintain general well being and quality of life.

- Withania is used in traditional Ayurvedic medicine as a rejuvenative tonic.

- KSM-66 ashwagandha extract is drawn only from the roots of the plant, using no other parts like leaves. The extract is standardised to 5% withanolide

content. It is produced by a propiretary extraction process, based on the principles of 'Green chemistry' and using no alcohol or synthetic solvents.

- Withania may help to reduce/provide support for/relieve symptoms of emotional stress. Provides the body with support during stress./Withania may help

calm the emotions and is useful in times of stress.

- The adaptogenic properties of Withania may help to improve resistance towards stress/the body to manage stress.

- Withania may/can help to relieve/reduce symptoms of stress and mild anxiety/ help the body manage stress and tension.

- Stress, either physical or mental may lead to an increase in the levels of the hormone cortisol in the body. Withania helps reduces serum cortisol levels

demonstrating that the extract may help to reduce/relieve the effect of stress in the body.

- Withania is used in traditional Ayurvedic medicine as a nervine tonic, helping to support/maintain a healthy nervous system.

- Withania is traditionally used in Ayurvedic medicine as a strengthening tonic.

- Vitamin C is found in high concentrations in the adrenal glands. It is important/essential/required for the synthesis of hormones involved in the stress

response/body's response to stress.

Supports the body's ability to respond to stress.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:57:28 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

Route of Administration

Oral

Visual Identification

Active Ingredients

calcium ascorbate dihydrate

484.15 mg

Withania somnifera

300 mg

Equivalent: Withania somnifera (Dry)

3.75 g

© 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 26.11.2017 at 04:57:28 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