Hydralyte

Main information

  • Trade name:
  • Hydralyte Lemon Lime Effervescent Electrolyte Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hydralyte Lemon Lime Effervescent Electrolyte Tablets
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217300
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217300

Hydralyte Lemon Lime Effervescent Electrolyte Tablets

ARTG entry for

Medicine Listed

Sponsor

Care Pharmaceuticals Pty Ltd

Postal Address

PO Box 1674,BONDI JUNCTION, NSW, 1355

Australia

ARTG Start Date

14/11/2013

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'.

Sponsors with a product containing Potassium chloride must comply with the following condition of listing. All products must carry the label statement -

Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your

doctor or pharmacist before use. Keep out of reach of children.

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.

Preparations that contain, as their therapeutically active ingredient, sodium bicarbonate for oral rehydration therapy, are subject to the following

conditions: (i) the formulation complies with the requirements specified in the British Pharmacopoeia monograph for Oral Rehydration Salts; (ii) the

sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are

consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document, Expert

consultation on oral rehydration salts formulation, 18 July 2001.

Preparations that contain, as their therapeutically active ingredient, potassium chloride for oral rehydration therapy, are subject to the following

conditions: (i) the formulation complies with the requirements specified in the British Pharmacopoeia monograph for Oral Rehydration Salts; (ii) the

sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are

consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document, Expert

consultation on oral rehydration salts formulation, 18 July 2001.

Preparations that contain, as their therapeutically active ingredient, potassium chloride for oral rehydration therapy, are subject to the following

conditions: (i) Must include the label warning (UOAD) Use only as directed; and (ii) Must include the label warning (DIAR3) If diarrhoea persists, seek

medical advice.

Products

1. Hydralyte Lemon Lime Effervescent Electrolyte Tablets

Product Type

Single Medicine Product

Effective date

6/03/2015

Warnings

Use only as directed

If diarrhoea persists, seek medical advice

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your

doctor or pharmacist before use. Keep out of reach of children.

If diarrhoea persists for more than 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3-6 years or 48 hours

in adults and children over 6 years, seek medical advice (or words to that effect).

Standard Indications

Specific Indications

Public Summary

Page 1 of

Produced at 26.11.2017 at 06:24:48 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 replace water and electrolytes lost due to vomiting, diarrhoea, heavy sweating, vigorous exercise and other dehydrating conditions such as

excessive consumption of alcohol or due to a hot or dry environment.

Dehydration occurs when the body loses more fluid and essential mineral salts (electrolytes) than it needs to function properly. This happens after

vomiting or bouts of diarrhoea. Dehydration can also occur after sweating from excessive heat or exercise,or due to a lack of fluid intake during times of

ill health or nausea, or after consuming excessive amounts of alcohol. Dehydration following vomiting or diarrhoea can be dangerous in young children

under 5 years old and in elderly people. Hydralyte effervescent tablets, when prepared as directed, produce a specifically formulated electrolyte solution

containing balanced essential electrolytes.

Seek medical advice if diarrhoea or vomiting persists.

Hydralyte contains sodium, an electrolyte essential for water retention and uptake; and potassium, vital for nerve and muscle function. It also contains

glucose to assist with the absorption of electrolytes and water.

NB: Avoid mixing Hydralyte with soft drink, sports drink, cordial or fruit juice as these can interfere with the rehydration process or worsen the

dehydration.

Hydralyte is readily absorbed making it possible to rehydrate quickly. By restoring lost fluid it helps to restore or maintain good health.

Osmolality of the prepared dosage form (2 tablets into 200 ml water) is about 240 +/- 20 mOsmol/kg

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, effervescent

Route of Administration

Oral

Visual Identification

Active Ingredients

citric acid

672 mg

glucose

1.62 g

potassium chloride

149.2 mg

sodium bicarbonate

378 mg

sodium chloride

87.5 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 2 of

Produced at 26.11.2017 at 06:24:48 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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