INTESTICIN

Main information

Documents

Localization

  • Available in:
  • INTESTICIN
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212491
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212491

INTESTICIN

ARTG entry for

Medicine Listed

Sponsor

Australian Naturopathics Pty Ltd

Postal Address

2 / 80 Cecil Avenue,CASTLE HILL, NSW, 2154

Australia

ARTG Start Date

23/07/2013

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. INTESTICIN

Product Type

Single Medicine Product

Effective date

28/02/2017

Warnings

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

Drink plenty of water (or words to that effect).

Standard Indications

Source of calcium. May assist in the prevention and/or treatment of osteoporosis.

Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention

and/or treatment of osteoporosis.

Relief of menstrual pain. [Warning S required]

May assist in the management of dysmenorrhoea. [Warning S required]

Relief of menstrual cramps. [Warning S required]

Relief of menstrual symptoms. [Warning S required]

For the symptomatic relief of pre-menstrual tension/syndrome. [Warning S required]

Helps maintain healthy digestive function.

For the symptomatic relief of dysmenorrhoea. [Warning S required]

May assist in the management of pre-menstrual tension/syndrome. [Warning S required]

Relief of pre-menstrual symptoms/syndrome. [Warning S required]

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

Aids digestion.

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

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

Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.

Source of calcium. Women's calcium requirements are increased after menopause.

Treatment of mild digestive disorders. [Warning S required]

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:15:58 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

Specific Indications

* Supports/maintains the health of the digestive tract.

* Supports/maintains gastrointestinal health and function.

* Aloe vera contains substances that help maintain the integrity of the gut lining.

* Supports the health and function of the immune system.

* Helps to maintain healthy immune function.

* Aloe has antioxidant or free radical scavenging activity.

* The antioxidant activity of aloe is beneficial in helping to protect the tissues against oxidative damage.

* Aloe has a long history of use in traditional Chinese Medicine for the relief of constipation, irritability and insomnia.

* In traditional Chinese medicine, Aloe is used to clear excess liver heat. This action of the herb may help to relieve symptoms of abdominal pain,

headache, dizziness, irritability, constipation and mild fever.

* Aloe has a long history of use in the Chinese Medicine systems for strengthening the stomach.

* The pure 'inner gel' of the Aloe vera plant contains numerous plant phytonutrients and active components such as saponins and polysaccharides,

which support normal cell growth and renewal.

* May aid healing of minor wounds.

* Calcium is important for the development and maintenance of the bones and teeth.

* 99% of the calcium in the body is found in the bones.

* Calcium is essential for cellular structure, muscle contraction, nerve transmission, enzyme activation, and hormone function.

* Source of calcium. A calcium supplement formulated to strengthen bone and tissue in mature users.

* Supports the growth and maintenance of strong, healthy bones.

* Magnesium is an essential constituent of the bones and it supports the health and strength of the bones.

* Magnesium assists in maintaining healthy bone mineral density.

* Adequate magnesium is important for healthy bones.

* Magnesium plays a necessary role in over 300 enzymatic reactions in the body.

* Magnesium plays a critical role in energy production in the body.

* Magnesium is involved in the production of ATP.

* Magnesium is required for the production of cellular energy.

* Magnesium plays an important role in cellular activity.

* Magnesium plays a vital role in calcium metabolism.

* Magnesium plays a vital role in the body in neuromuscular transmission.

* Magnesium is necessary for proper muscle and nerve function.

* Magnesium helps to maintain normal healthy functioning of the nervous system.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

Aloe vera

2 mg/g

Equivalent: Aloe vera (Dry)

400 mg/g

Astragalus membranaceus

2 mg/g

Equivalent: Astragalus membranaceus (Dry)

20 mg/g

Calcium carbonate

273.4 mg/g

Foeniculum vulgare

15 mg/g

Glycyrrhiza glabra

5 mg/g

magnesium carbonate hydrate

273.4 mg/g

Olea europaea

4 mg/g

Equivalent: Olea europaea (Dry)

60 mg/g

Psyllium Husk Powder

10 mg/g

Salix alba

.8 mg/g

Equivalent: Salix alba (Dry)

20 mg/g

Slippery Elm Bark Powder

70 mg/g

Zingiber officinale

.75 mg/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 27.11.2017 at 12:15:58 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