BLACKMORES

Main information

  • Trade name:
  • BLACKMORES MENOPAUSE DAY/NIGHT RELIEF
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLACKMORES MENOPAUSE DAY/NIGHT RELIEF
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222224
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222224

BLACKMORES MENOPAUSE DAY/NIGHT RELIEF

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

9/04/2014

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. BLACKMORES MENOPAUSE DAY/NIGHT RELIEF

Product Type

Composite Pack

Effective date

9/04/2014

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Contains lactose (or words to that effect).

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

Standard Indications

Specific Indications

May assist with the management of menopausal (and peri-menopausal) hot flushes (and night sweats).

Zizyphus is traditionally used in Traditional Chinese Medicine (TCM) to relieve night sweats.

May relieve night sweats associated with menopause.

May help to [relieve/reduce] [fatigue/tiredness/lack of energy].

Siberian ginseng is [a/an adaptogenic] herb traditionally used in Western Herbal Medicine to assist in [adapting to/coping with] [changes/stressors].

Schisandra is [a/an adaptogenic] herb is traditionally used in Traditional Chinese Medicine (TCM) to assist in [adapting to/coping with]

[changes/stressors].

Withania is [a/an adaptogenic] herb traditionally used in Ayurvedic Medicine (or Indian Herbal Medicine) to assist in [adapting to/coping with]

[changes/stressors].

Contains herbs (withania, zizyphus and schisandra) traditionally used in Traditional Chinese Medicine (TCM) and Ayurvedic Medicine to relieve

irritability.

Withania is traditionally used in Ayurvedic Medicine to relieve nervous tension.

Contains herbs (withania & zizyphus) traditionally used in Traditional Chinese Medicine (TCM) and Ayurvedic Medicine to relieve anxiety.

[Contains herbs that/Withania and zizyphus] are traditionally used in Ayurvedic Medicine and Traditional Chinese Medicine (TCM) to reduce difficulty

sleeping.

Withania is traditionally used in Ayurvedic (or Indian Herbal Medicine) as an aphrodisiac.

(Soy) isoflavones [reduce/relieve] (menopausal) hot flushes with regular use.

Schisandra (chinensis) is traditionally used in Traditional Chinese Medicine (TCM) to help relieve spontaneous sweating.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:52:00 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

1. Daytime tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Eleutherococcus senticosus

133.33 mg

Equivalent: Eleutherococcus senticosus (Dry)

Glycine max

68 mg

Schisandra chinensis

375 mg

Equivalent: Schisandra chinensis (Dry)

1.5 g

2. Night-time Tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Glycine max

68 mg

Withania somnifera

240 mg

Equivalent: Withania somnifera (Dry)

Ziziphus jujuba var. spinosa

3 g

Equivalent: Ziziphus jujuba var. spinosa (Dry)

171.43 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 26.11.2017 at 11:52:00 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