Prostate

Main information

  • Trade name:
  • Prostate Care MAX
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Prostate Care MAX
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222780
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222780

Prostate Care MAX

ARTG entry for

Medicine Listed

Sponsor

Australian Naturalcare Products Pty Ltd

Postal Address

PO Box 946,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

24/04/2014

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. Prostate Care MAX

Product Type

Single Medicine Product

Effective date

2/09/2015

Warnings

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

Standard Indications

Male support. Balances and supports normal male physiology and function.

May assist in the management of medically diagnosed benign prostatic hypertrophy.

For the symptomatic relief of medically diagnosed benign prostatic hypertrophy.

Specific Indications

Nettle root is used to help relieve urination difficulties associated with early stage benign prostatic hyperplasia such as nigh time urination, urine retention

and frequent urination.

Nettle root helps relieve the symptoms of medically diagnosed BPH/benign prostatic hypertrophy.

Nettle root has traditionally been used to help reduce difficulty in urination caused by benign prostatic hyperplasia (BPH).

Crateva helps relieve incontinence, urinary frequency, pain and urine retention caused by hypotonic bladder resulting from benign prostatic hyperplasia.

Crateva helps relieve the urinary symptoms of benign prostatic hyperplasia.

Crateva helps increase bladder tone, and increases the force of urination in men with a hypotonic bladder caused by benign prostatic hyperplasia.

Crateva is a bladder tonic / helps tone the bladder.

Crateva may assist bladder tone / may be beneficial in helping bladder tone after a prostatectomy.

Crateva has an anti-inflammatory action which may help relieve prostatic congestion.

Crateva has traditionally been used in Ayurvedic medicine for disorders of the urinary system and in the management of uropathies.

Beta-sitosterol significantly improves urinary symptoms associated with benign prostatic hyperplasia (BPH).

Beta-sitosterol increases maximum urine flow and decreases post urination residual urine volume.

Beta-sitosterol has been shown in clinical trials / Cochrane review to help reduce urinary symptoms associated with benign prostatic hyperplasia.

A Cochrane review/major analysis of clinical trials on beta-sitosterols for benign prostatic hyperplasia showed that non-glucosidic B-sitosterols improve

urinary symptoms and flow measures in men with mild to moderate medically diagnosed benign prostatic hyperplasia.

Beta-sitosterol may help relieve the urinary symptoms including urinary urgency, frequency, incomplete bladder emptying and urinary flow problems

caused by medically diagnosed benign prostatic hyperplasia (an enlarged prostate gland).

It is very common for men over 60 years old to have urinary symptoms caused by benign prostatic hyperplasia an enlarged prostate.

Results of clinical trials have shown nettle root improves the urological / urinary symptoms of medically diagnosed benign prostatic hyperplasia (BPH).

Nettle root may help ease urinary symptoms associated with medically diagnosed benign prostatic hyperplasia / hypertrophy.

Nettle root may assist / help alleviate excessive night time urination, frequent urination, painful urination and urine retention.

Nettle root helps inhibit or reduce the binding of the sex hormone-binding globulin which can play a role in the development of benign prostatic

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:51:11 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

hyperplasia.

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

conifer phytosterol complex

65 mg

Crateva magna

700 mg

Equivalent: Crateva magna (Dry)

Urtica dioica

187.5 mg

Equivalent: Urtica dioica (Dry)

© 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 10:51:11 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