BLACKMORES

Main information

  • Trade name:
  • BLACKMORES DIGESTIVE AID
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLACKMORES DIGESTIVE AID
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217722
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217722

BLACKMORES DIGESTIVE AID

ARTG entry for

Medicine Listed

Sponsor

Blackmores Ltd

Postal Address

PO Box 1725,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

25/11/2013

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. BLACKMORES DIGESTIVE AID

Product Type

Single Medicine Product

Effective date

25/11/2013

Warnings

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

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words

to that effect].

Standard Indications

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

Specific Indications

Amylases are enzymes that aid the digestion of polysaccharides (carbohydrates).

Proteases are enzymes which aid protein digestion.

Cellulases are enzymes that break down [plant fibre/cellulose].

Lipase is an enzyme which aids the breakdown of lipids (fats) in the diet.

Tilactase is an enzyme which aids the digestion of lactose.

Bromelain is a proteolytic enzyme.

Bromelain may [assist/aid] the digestion of protein.

Contains microbially-derived enzymes ±amylase, protease, lipase and tilactase-which aid the digestion of carbohydrates, proteins, fats and lactose in the

diet.

Gentian (Gentiana lutea) has been traditionally used in Western Herbal Medicine as a bitter tonic and digestive stimulant, for digestive complaints such

as indigestion, loss of appetite, burping, bloating, fullness and flatulence, digestive discomfort/sluggish digestion.

Contains gentian, traditionally used in Western Herbal Medicine as a digestive tonic to aid digestion.

Contains gentian, traditionally used in Western Herbal Medicine to help relieve digestive disturbances, such as [dyspepsia/indigestion].

Fennel (Foeniculum vulgare) has been traditionally used in Western Herbal Medicine for [digestive complaints/disturbances] including flatulence,

bloating, [belching/burping] and sluggish digestion.

Fennel (Foeniculum vulgare) has been traditionally used as an antispasmodic and [carminative/to relieve flatulence].

Contains fennel, traditionally used in Western Herbal Medicine to help relieve flatulent [dyspepsia/indigestion].

Contains fennel, traditionally used in Western Herbal Medicine to help relieve digestive disturbances including bloating and flatulence.

Provides a combination of herbal extracts (gentian and fennel) traditionally used in Western Herbal Medicine to relieve symptoms such as gas, bloating

and feelings of fullness with digestive enzymes to aid in the digestion of dairy (food), proteins, fats and complex carbohydrates.

Offers relief from symptoms of [indigestion/poor digestion] with traditionally used herbs.

Offers dual action digestion support.

Digestive enzymes can help digest some "problem foods" (including dairy) (proteins, carbohydrates and fats).

Supports digestion of the 5 food groups.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:57:55 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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Amylase

10 thousand DU

Bromelains

33.3 mg

cellulase

150 CU

Foeniculum vulgare

100 mg

Equivalent: Foeniculum vulgare (Dry)

400 mg

Gentiana lutea

67 mg

Equivalent: Gentiana lutea (Dry)

335 mg

Lipase

800 LipU

Protease

60 Thousand HUT

Tilactase

1 thousand ALU

© 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 05:57:55 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