Swisse

Main information

Documents

Localization

  • Available in:
  • Swisse Women's Ultivite 65+
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220454
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220454

Swisse Women's Ultivite 65+

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

25/02/2014

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'.

All products containing Cimicifuga racemosa must comply with the following condition of listing by carrying the label statement - Warning: In very rare

cases, black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes, dark urine, nausea,

vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see your doctor.

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.

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph

Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27) as in force or existing from time to time. This

condition does not apply to powdered or dried leaf.

Products

1. Swisse Women's Ultivite 65+

Product Type

Single Medicine Product

Effective date

5/11/2015

Warnings

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

Not for the treatment of iron deficiency conditions (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.

Warning: In very rare cases, black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes, dark

urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see

your doctor.

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

Do not take while on warfarin therapy without medical advice.

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

Standard Indications

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

Specific Indications

Vitamin D helps/supports the absorption of calcium and phosphorus. Vitamin D and vitamin A help in/support the development and maintenance of

bones and teeth.

Public Summary

Page 1 of

Produced at 23.11.2017 at 12:33:37 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

Helps support/Assists with women's health and wellbeing. / Helps fill nutritional gaps.

Contains over 40 vitamins, minerals, antioxidants and herbs to help meet/support the nutritional needs and maintain general wellbeing of women aged

65+.

Vitamin C, selenium and cranberry act as antioxidants to help protect against potential free radical damage/provide antioxidant support.

Knotweed is a rich/great source of resveratrol, a potent antioxidant, which may act to protect against potential free radical damage.

Helps provide nutritional support during periods of nervous tension and stress. / B vitamins help support/maintain a healthy nervous system.

B complex vitamins are needed/essential/important for the metabolism of food into energy, they assist with/support energy production, stamina, vitality.

Vitamin A helps in the maintenance of eyesight/supports healthy eyesight and in the maintenance and development of night vision.

Vitamin A helps to maintain skin membranes/structure.

Zinc helps support/maintain connective tissue formation.

Zinc helps to maintain/support/is essential for healthy skin.

May assist in/support the management of dietary folate deficiency.

Folate, iron, vitamin B6 and vitamin B12 support/maintain red blood cell formation. Iron supports/assists/helps maintain proper red blood cell function.

A factor in the maintenance of good health. / Helps support general health and wellbeing.

Zinc and vitamin A helps maintain/support immune function/supports a healthy immune system.

B vitamins are involved/important in the metabolism of fats, carbohydrates and protein.

Folate helps the body metabolise protein.

Contains folic acid. Folic acid has a role in a number of reactions in the body essential for normal brain function.

B vitamins help support energy production.

Black cohosh is used in Traditional Western Herbal medicine to help relieve the symptoms associated with menopause.

Black cohosh has been used in Traditional Western Herbal medicine to help relieve the symptoms associated with menopause/provide symptomatic

relief of menopause symptoms. /Black cohosh has been used in Traditional Western Herbal medicine to help support symptomatic relief of nervous

irritability associated with menopause. / Traditionally used in Western Herbal Medicine to support health and wellbeing during and post menopause.

Black cohosh is traditionally used in Western Herbal Medicine to help ease/relieve nervous irritability associated with menopause.

Vitamin C helps to regulate normal immune function. Vitamin C helps to support healthy immune function. /Vitamin C is important/essential for

maintaining/supporting a healthy immune response/healthy immune system.

Healthy adrenal gland function plays an important role in an individual's stress response. Vitamin B5 and vitamin B6 are important for adrenal function,

helping to support the adrenal glands during periods of stress. Provides adrenal support during times of stress. During stress vitamin B5 and B6 may be

decreased/may/can be lower during times of stress. / The body may have an increased need for B group vitamins during periods of nervous tension and

stress. Vitamins B5 & B6 are important for the adrenals. Healthy adrenal function helps support the body's response to stress.

Pantothenic acid/Vitamin B5 contributes to/supports/maintains normal/healthy mental performance.

Vitamin C helps/is involved in the synthesis of collagen which is important/essential for the development/maintenance of healthy skin, bones, tendons,

cartilage and gums.

Vitamin C helps with the formation of connective tissue and healing process of minor wounds.

Adequate levels of zinc help to support healthy skin and minor wound healing. / Zinc assists with minor wound healing.

B Vitamins in the body may be lower when lifestyles include processed foods, alcohol, sugar, or caffeine.

Contains vitamin B6, vitamin B6 is important/essential for the synthesis of some neurotransmitters.

Contains zinc. Zinc is found in high concentrations in the retina of the eye. Retinal zinc content may decline with age.

Contains lutein, one of the key antioxidant carotenoids found in healthy eyes/to support healthy eye function.

Contains vitamins D, K and manganese. These nutrients are required for bone health.

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

Actaea racemosa

20 mg

Equivalent: Actaea racemosa (Dry)

200 mg

Bacopa monnieri

2.5 mg

Biotin

200 microgram

calcium ascorbate dihydrate

200 mg

Calcium orotate

100 mg

Calcium pantothenate

109.15 mg

Chromium picolinate

402.3 microgram

Citrus bioflavonoids extract

20 mg

colecalciferol

.025 mg

colloidal anhydrous silica

20 mg

Copper gluconate

8.57 mg

Crataegus monogyna

25 mg

Equivalent: Crataegus monogyna (Dry)

100 mg

Curcuma longa

10 mg

Equivalent: Curcuma longa (Dry)

100 mg

Cyanocobalamin

200 microgram

Cynara scolymus

1 mg

Equivalent: Cynara scolymus (Fresh)

50 mg

Public Summary

Page 2 of

Produced at 23.11.2017 at 12:33:37 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

d-alpha-Tocopheryl acid succinate

20 mg

Ferrous fumarate

16.01 mg

Folic acid

500 microgram

Ginkgo biloba

20 mg

Equivalent: Ginkgo biloba (Dry)

lutein

1 mg

Magnesium aspartate dihydrate

100 mg

Manganese amino acid chelate

30 mg

molybdenum trioxide

67.5 microgram

Nicotinamide

100 mg

Phytomenadione

60 microgram

potassium iodide

196 microgram

pyridoxine hydrochloride

50 mg

retinol acetate

.8625 mg

Reynoutria japonica

80 mg

Equivalent: Reynoutria japonica (Dry)

Riboflavin

50 mg

Scutellaria lateriflora

12.5 mg

Equivalent: Scutellaria lateriflora (Dry)

50 mg

Selenomethionine

64.6 microgram

Silybum marianum

21.43 mg

Equivalent: Silybum marianum (Dry)

1.5 g

soy phosphatidylserine-enriched soy lecithin powder

10 mg

Spearmint Oil

2 mg

Thiamine hydrochloride

50 mg

Turnera diffusa

50 mg

Equivalent: Turnera diffusa (Dry)

500 mg

Ubidecarenone

2 mg

Urtica dioica

10 mg

Equivalent: Urtica dioica (Dry)

100 mg

Vaccinium macrocarpon

1.6 mg

Equivalent: Vaccinium macrocarpon (Fresh)

800 mg

Vaccinium myrtillus

1 mg

Equivalent: Vaccinium myrtillus (Fresh)

100 mg

Vitis vinifera

8.33 mg

Equivalent: Vitis vinifera (Dry)

Withania somnifera

50 mg

Equivalent: Withania somnifera (Dry)

500 mg

zinc amino acid chelate

75 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 3 of

Produced at 23.11.2017 at 12:33:37 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