Bedtime Buddy

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

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Active ingredient:
Crateva magna,Equisetum arvense,Lindera strychnifolia
Available from:
Seipel Group Pty Ltd
INN (International Name):
Crateva magna,Equisetum arvense,Lindera strychnifolia
Authorization status:
Listed
Authorization number:
290162

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Public Summary

Summary for ARTG Entry:

290162

Bedtime Buddy

ARTG entry for

Medicine Listed

Sponsor

Seipel Group Pty Ltd

Postal Address

PO Box 3449,NEWMARKET, QLD, 4051

Australia

ARTG Start Date

14/06/2017

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. Bedtime Buddy

Product Type

Single Medicine Product

Effective date

14/06/2017

Warnings

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

Standard Indications

Specific Indications

Bedtime Buddy reduces symptoms of bedwetting (enuresis).

Horsetail is traditionally used in Ayurvedic medicine to relieve the symptoms of bladder weakness and

for bladder control

Horsetail is traditionally used for enuresis (bedwetting) in children.

Research has shown that Horsetail and Crateva combined resulted in improvements in enuresis (bedwetting).

Horsetail is a urinary astringent and has soothing effects on healthy urinary mucosa.

Horsetail has an antispasmodic action, which helps to soothe an irritated bladder sphincter

Horsetail helps to reduce kidney and bladder stone formation

Horsetail improves connective tissue and may improve the appearance of skin, hair and nails

Horsetail herb is traditionally used in Ayurvedic medicine for urinary-related conditions.

Horsetail is a natural source of silica. Silica strengthens and stabilises connective tissues.

Crataeva is traditionally used in Ayurvedic medicine to relieve the symptoms of bladder weakness and

for bladder control

Crataeva is traditionally used in Ayurvedic medicine to maintain bladder health

Crataeva has a tonic effect on the bladder and assists symptoms of poor bladder tone

Crataeva has kidney protective effects

Crataeva decreases residual urine volume

Crataeva helps to reduce kidney and bladder stone formation

Crataeva is thought to help tone the walls of the bladder

Crataeva bark is a bladder tonic that helps to improve bladder tone.

Lindera is traditionally used Chinese medicine to relieve the symptoms of bladder weakness and for

healthy bladder control

Lindera assists with the toning of urinary tissues

Lindera helps to protect the kidneys

Lindera is an antioxidant and promotes anti-aging effects for the bladder and kidneys.

The herbs in Bedtime Buddy help to maintain strong and toned healthy bladder muscles that assist with urinary

urgency and frequency.

Supports and improves healthy bladder tone and promotes effective bladder function.

Provides healthy bladder support and maintains bladder function.

Public Summary

Page 1 of

Produced at 24.11.2017 at 08:58:53 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

Promotes healthy bladder control

The effectiveness of Bedtime Buddy is supported by traditional herbal medicine and clinical research.

Research has shown Bedtime Buddy is effective in improving bladder control after 2-4 weeks of use.

Research has shown Bedtime Buddy is effective in reducing the symptoms of urinary frequency, nocturia

and bladder accidents.

Research has shown Bedtime Buddy is effective in reducing symptoms of overactive bladder including

bladder frequency, urgency and nocturia.

Bedtime Buddy is traditional herbal formula that helps to support healthy bladder function and promote bladder control, both in the Day and Night.

Bedtime Buddy helps to reduce bedwetting.

Bedtime Buddy can help to relieve the symptom of bedwetting.

Bedtime Buddy improves QOL (quality of life) for individuals with poor bladder tone and control.

Crateva nurvala, an Ayurvedic herb, has been used for many centuries for urinary support and to help

with bladder health. It has tonic effects on the bladder and is recommended for poor bladder tone and

to improve bladder control.

Crataeva and Horsetail balance urinary minerals and reduce the likelihood of stone formation

Crataeva and Horsetail help to improve the tone of the bladder wall. Crataeva acts to

increase the tone of the bladder and the expulsive force of urine, thereby helping effective evacuation.

Crataeva normalises the tone of the urinary bladder and significantly decreases residual urine volume.

Research supports the effectiveness of the combined Crataeva and Horsetail for bladder control.

Lindera has a long history of use in Traditional Chinese Medicine for kidney and bladder health and is

specifically recommended for frequent urination and loss of bladder control.

The herbs in Bedtime Buddy are recommended for symptoms of urinary infections.

All three herbs show anti-inflammatory effects. Crataeva and Lindera have anti-inflammatory and

antibacterial properties.

Lindera has potent antioxidant effects to preserve tissue and function of urinary system. It has potent

antioxidant scavenging activity against ROS and RNS (reactive oxygen species and reactive nitrogen

species, both common oxidants that damage body tissues) that effectively inhibits lipid peroxidation.

Bedtime Buddy has been clinically proven to promote and improve bladder control, reduce urinary frequency, decrease the need for night-time toilet

visits, reduce

nocturesis (bedwetting), reduce urinary urgency, reduce bladder accidents or weakness, improve bladder control,

improve quality of life and reduce pad use.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Crateva magna

120 mg

Equivalent: Crateva magna (Dry)

Equisetum arvense

150 mg

Equivalent: Equisetum arvense (Dry)

1.5 g

Lindera strychnifolia

150 mg

Equivalent: Lindera strychnifolia (Dry)

1.5 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 24.11.2017 at 08:58:53 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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