Swisse Ultiboost Menopause Balance

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Actaea racemosa,calcium citrate tetrahydrate,colecalciferol,Glycine max,Salvia officinalis
Available from:
Swisse Wellness Pty Ltd
Authorization status:
Listed
Authorization number:
351669

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Public Summary

Summary for ARTG Entry:

351669

Swisse Ultiboost Menopause Balance

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street, Collingwood, VIC, 3066

Australia

ARTG Start Date

14/12/2020

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.

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 . Swisse Ultiboost Menopause Balance

Product Type

Single Medicine Product

Effective Date

21/12/2020

Permitted Indications

Decrease/reduce/relieve excessive perspiration/sweating

Maintain/support healthy teeth

Maintain/support teeth strength

Maintain/support bone health

Maintain/support bone strength

A diet deficient in calcium can lead to osteoporosis in later life. Calcium may help prevent osteoporosis when dietary intake is inadequate

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Decrease/reduce/relieve sleeplessness

Helps decrease/reduce/relieve night sweats associated with menopause

Decrease/reduce/relieve symptoms of menopause

Decrease/reduce/relieve hot flushes associated with menopause

Decrease/reduce/relieve aggression/irritability associated with menopause

Indication Requirements

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Indication can only be used for medicines that contain calcium as an active ingredient and the recommended daily dose of the medicine must provide at

least 290 milligrams of elemental calcium.

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose

of 25 micrograms or less of vitamin D and as a minimum, also contain at least 25% of the RDI in the recommended daily dose of vitamin D.

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:30:10 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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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.

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 root and rhizome Extract dry concentrate

4 mg

Equivalent: Actaea racemosa (Dry)

20 mg

calcium citrate tetrahydrate

771.04 mg

Equivalent: calcium

162.5 mg

colecalciferol

.0125 mg

Glycine max seed Extract dry concentrate

86.25 mg

Equivalent: Glycine max (Dry)

13.8 g

Salvia officinalis leaf Extract dry concentrate

236.36 mg

Equivalent: Salvia officinalis (Dry)

1.3 g

Other Ingredients (Excipients)

Acacia

Carnauba Wax

colloidal anhydrous silica

copper chlorophyllin

croscarmellose sodium

crospovidone

dl-alpha-tocopherol

macrogol 3350

magnesium stearate

maize starch

maltodextrin

medium chain triglycerides

microcrystalline cellulose

polyvinyl alcohol

povidone

purified talc

silicon dioxide

sucrose

titanium dioxide

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

Public Summary

Page 2 of

Produced at 11.01.2021 at 08:30:10 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

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 11.01.2021 at 08:30:10 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

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