Required Advisory Statements for Medicine Labels

Update 3.1

Record of Decisions and Reasons

Historical document

April 2008 Required Advisory Statements for Medicine Labels –Update 3.1

Record of Decisions and Reasons

PURPOSE

This document is to record changes to the Required Advisory Statements for Medicine Labels (edition 1, including update 2) dated April 2006 (RASML) and to provide details of reasons for decision.

All the changes included in this update are results of:

• TGA review of NSAIDs and Medicines Evaluation Committee (MEC) recommendations; or • Decisions by the National Drugs and Poisons Schedule Committee (NDPSC) to amend the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) entries for Vitamin A and and Complementary Medicines Evaluation Committee (CMEC) recommendations; or • Black cohosh safety review; or • CMEC recommendations which have been accepted by the TGA; or • Formalisation of RASML in inclusion of advisory statements that the TGA and Complementary Medicines Industry have longstanding agreement.

AMENDMENTS

Introductory Sections

No changes proposed in this update.

Section 1 – Medicines to Which Advisory Statements Apply

Summary of Proposed Changes

Changes are proposed as follows:

HistoricalSubstance documentChange Type (Entry 1 of 2) Amendment Diclofenac (Entry 2 of 2) Amendment New Entry (Entry 1 of 4) Amendment Ibuprofen (Entry 2 of 4) Amendment RASML – UPDATE 3.1 – Record of Decisions and Reasons

Substance Change Type Ibuprofen (Entry 3 of 4) Amendment Ibuprofen (Entry 4 of 4) Amendment (Entry 1 of 2) New Entry Ketoprofen (Entry 2 of 2) New Entry (Entry 1 of 2) Amendment Mefenamic acid (Entry 2 of 2) Amendment (Entry 1 of 2) Amendment Naproxen (Entry 2 of 2) Amendment High selenium yeast Amendment Selenium yeast - high Amendment Selenocysteine Amendment Selnomethionine Amendment selenate Amendment Sodium selenite Amendment Yeast - high selenium Amendment Vitamin A Amendment Cimicifuga racemosa Amendment Larrea tridentata New Entry Zingiber officinale New Entry Glucosamine hydrochloride New Entry Glucosamine sulfate chloride complex New Entry (Entry 1 of 2) Glucosamine sulfate complex New Entry (Entry 2 of 2) Glucosamine sulfate complex New Entry Glucosamine sulphate New Entry Propolis (Entry 1 of 2) New Entry Propolis (Entry 2 of 2) New Entry Royal jelly New Entry Shark cartilage New Entry Phenylalanine New Entry Caffeine (Entry 1 of 2) New Entry HistoricalCaffeine (Entry 2 of 2) documentNew Entry Polygonum multiflorum New Entry

2 RASML – UPDATE 3.1 – Record of Decisions and Reasons

The tables below show:

• the entry being amended (including headings where appropriate for reference purposes and showing text to be deleted in blue and strikethrough); • the amended/new entry (inserted details in blue and underlined). Note that underlining is used to highlight the changes made in this document is and is not required on the label itself; • the reasons for the decision to amend/include the entry; and • transitional arrangements.

Medicines Which Meet The Following Conditions ... Require Statement(s) Gazettal Date Containing Entry text Diclofenac When: (126, 127, 128, 5 April 2006 j (Entry 1 of 2) (a) included in a Schedule to the 149, 130) SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Diclofenac When: (126, 127, 149, 23 April 2008 130, 159, 160 j entry (Entry 1 of 2) (a) included in a Schedule to the ) SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Entry text Diclofenac When: (126, 18, 127, 5 April 2006 128 (Entry 2 of 2) (a) included in a Schedule to the , 149, 130, 133)j SUSDP; and (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Diclofenac When: (126, 18, 127, 23 April 2008 149, 130, 133, entry (Entry 2 of 2) (a) included in a Schedule to the 159, 160)j SUSDP; and (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decisionHistorical recommendations. document Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Flurbiprofen When included in a Schedule to the (126, 127, 23 April 2008 entry SUSDP. 18, 149, 130, 133, j 159, 160) Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC entry recommendations. Statements 18, 126, 130, 133 and 149 are included to harmonise with similar non-selective NSAIDs. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s)

Entry text Ibuprofen For the purpose of exclusion from the 126, 127, 5 Apr 2006 Schedules to the SUSDP, when the 128 (Entry 1 of 4) , 151, preparation is for oral use and is 130, 131, indicated exclusively for the treatment 132 of dysmenorrhoea. Amended Ibuprofen For the purpose of exclusion from the 126, 127, 23 April 2008 entry (Entry 1 of 4) Schedules to the SUSDP, when the 151, 130, preparation is for oral use and is 131, 132,

indicated exclusively for the treatment 159, 160 of dysmenorrhoea. Entry text Ibuprofen For the purpose of exclusion from the 126, 18, 5 Apr 2006 (Entry 2 of 4) Schedules to the SUSDP, when the 127, 128, preparation is for oral use and is NOT 151, 130, indicated exclusively for the treatment 131, 132, of dysmenorrhoea. 133 Amended Ibuprofen For the purpose of exclusion from the 126, 18, 23 April 2008 entry (Entry 2 of 4) Schedules to the SUSDP, when the 127, 151, preparation is for oral use and is NOT 130, 131, indicated exclusively for the treatment 132, 133, Historicalof dysmenorrhoea. document159, 160

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s)

Entry text Ibuprofen When: (126, 127, 23 Jun 2004 128, 149, (Entry 3 of 4) (a) included in a Schedule to the 130)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Ibuprofen When: (126, 127, 23 April 2008 149, 130, entry (Entry 3 of 4) (a) included in a Schedule to the 159, 160)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Entry text Ibuprofen When: (126, 18, 23 Jun 2004 127, 128, (Entry 4 of 4) (a) included in a Schedule to the SUSDP; and 149, 130, 133)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Ibuprofen When: (126, 18, 23 April 2008 127, 149, entry (Entry 4 of 4) (a) included in a Schedule to the 130, 133, SUSDP; and 159, 160)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Historical document

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry Amended Ketoprofen When: (126, 127, 23 April 2008 entry (Entry 1 of 2) 149, 130, (a) included in a Schedule to the j 159, 160) SUSDP; and (b) the preparation is indicated exclusively for the treatment of

dysmenorrhoea. Ketoprofen When: (126, 127, 23 April 2008 (Entry 2 of 2) (a) included in a Schedule to the 149, 18 130, 133, 159, SUSDP; and j 160) (b) the preparation is NOT indicated exclusively for the treatment of

dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Statements 18, 126, 130, 133 and 149 are included to harmonise with similar non-selective NSAIDs. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Entry text Mefenamic When: (126,127, 23 Jun 2004 acid 128, 149, (a) included in a Schedule to the j (Entry 1 of 2) SUSDP; and 130) (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Mefenamic When: (126, 127, 23 April 2008 acid 149, 130, entry (a) included in a Schedule to the 159, 160 j (Entry 1 of 2) SUSDP; and ) (b) the preparation is indicated exclusively for the treatment of Historicaldysmenorrhoea. document

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Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Entry text Mefenamic When: (126, 18, 23 Jun 2004 acid 127, 128 (a) included in a Schedule to the , (Entry 2 of 2) SUSDP; and 149, 130, 133)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Amended Mefenamic When: (126, 18, 23 April 2008 acid 127, 149, entry (a) included in a Schedule to the 130, 133, (Entry 2 of 2) SUSDP; and 159, 160)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Entry text Naproxen When: (126, 127, 23 Jun 2004 128 (Entry 1 of 2) (a) included in a Schedule to the , 149, 130)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Amended Naproxen When: (126, 127, 23 April 2008 149, 130, entry (Entry 1 of 2) (a) included in a Schedule to the 159, 160)j SUSDP; and (b) the preparation is indicated exclusively for the treatment of dysmenorrhoea. Entry text Naproxen When: (126, 18, 23 Jun 2004 Historical document127, 128, (Entry 2 of 2) (a) included in a Schedule to the 149, 130, SUSDP; and 133)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea.

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Medicines Which Meet The Following Conditions.. Require Gazettal Date Containing Statement(s) Amended Naproxen When: (126, 18, 23 April 2008 127, 149, entry (Entry 2 of 2) (a) included in a Schedule to the 130, 133, SUSDP; and 159, 160)j (b) the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea. Reason for Entries amended to include the outcome of TGA Review of NSAIDs and MEC decision recommendations. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text High When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 selenium Division 3 Item 11 of the Regulations. yeast Amended High When included in Schedule 4 Part 5 27, 28 23 April 2008 entry selenium Division 3 Item 11 of the Regulations. yeast Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is decision to be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Selenium When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 yeast – high Division 3 Item 11 of the Regulations.

Amended Selenium When included in Schedule 4 Part 5 27, 28 23 April 2008 entry yeast – high Division 3 Item 11 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is decisionHistorical to be removed from this entry and its effdocumentect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement( s) Entry text Selenocysteine When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 Division 3 Item 13 of the Regulations.

Amended Selenocysteine When included in Schedule 4 Part 5 27, 28 23 April 2008 entry Division 3 Item 13 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is to decision be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Selenomethionine When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 Division 3 Item 12 of the Regulations.

Amended Selenomethionine When included in Schedule 4 Part 5 27, 28 23 April 2008 entry Division 3 Item 12 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is to decision be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Sodium When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 selenate Division 3 Item 14 of the Regulations.

Amended Sodium When included in Schedule 4 Part 5 27, 28 23 April 2008 entry selenate Division 3 Item 14 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is to decision be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products Historicalwill be required to comply immediately. document

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Sodium When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 selenite Division 3 Item 15 of the Regulations.

Amended Sodium When included in Schedule 4 Part 5 27, 28 23 April 2008 entry selenite Division 3 Item 15 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is decision to be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Yeast – high When included in Schedule 4 Part 5 27, 28, 8 23 Jun 2004 selenium Division 3 Item 11 of the Regulations.

Amended Yeast – high When included in Schedule 4 Part 5 27, 28 23 April 2008 entry selenium Division 3 Item 11 of the Regulations. Reason for Changes subsequent to a recommendation of the 63rd meeting of CMEC. Statement 8 is decision to be removed from this entry and its effect incorporated in revised statement 28. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Statement(s) Gazettal Date Containing d,e d,e,c Entry text Vitamin A For the purpose of exclusion from 31 , 32 1 June 2005 d,e,c (see also the Schedules to the SUSDP when 33

Vitamins) for human therapeutic use in preparations for internal use OTHER THAN those: (a) containing 100 International Units or less of vitamin A per dosage unit of a divided preparation; or (b) 100 International Units or less of Historicalvitamin A per gram of documentan undivided preparation.

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) d,e d,e,c Amended Vitamin A In medicines for internal use containing 31 , 32 23 April 2008 33d,e,c entry (see also 3000 micrograms retinol equivalents or Vitamins) less of vitamin A other than those containing: (a) 33 micrograms retinol equivalents or less of vitamin A per dosage unit of a divided preparation; or (b) 33 micrograms retinol equivalents or less of vitamin A per gram of an undivided preparation. Reason for The entry has been changed to align RASML with the SUSDP changes for vitamin A. decision Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text Cimicifuga When included in a Listed medicine 153,154 5 April 2006 racemosa

Amended Cimicifuga When included in a Listed medicine 153,172 23 April 2008 entry racemosa

Reason for Following the receipt of additional adverse event reports associated with black cohosh, decision an expert advisory group reviewed the available data and recommended that although black cohosh remains suitable for use in Listed medicines, a revised warning statement is required. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Historical document

11 RASML – UPDATE 3.1 – Record of Decisions and Reasons

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Larrea When included in a Listed medicine 161, 152 23 April 2008 entry tridentata Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Zingiber When included in a Listed medicine; 162, 163 23 April 2008 entry officinale AND when the extraction ratio is 25:1 or higher; AND when the equivalent dry weight per

dosage unit is 2g or higher Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Glucosamine When included in a Listed medicine and 164 23 April 2008 entry hydrochloride derived from a marine source Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Historical document

12 RASML – UPDATE 3.1 – Record of Decisions and Reasons

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Glucosamine When included in a Listed medicine and 164 23 April 2008 entry sulfate derived from a marine source potassium chloride complex (Entry 1 of 2)

Glucosamine When included in a Listed medicine for 165, 166, 23 April 2008

sulfate oral use 1 potassium chloride complex

(Entry 2 of 2) Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Glucosamine When included in a Listed medicine and 164 23 April 2008 entry sulfate derived from a marine source sodium chloride

complex Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) EntryHistorical text No existing entry document

Amended Glucosamine When included in a Listed medicine and 164 23 April 2008 entry sulphate derived from a marine source Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Propolis When included in a Listed medicine for 168 23 April 2008 entry (Entry 1 of 2) internal use

Propolis When included in a Listed medicine for 169 23 April 2008

(Entry 2 of 2) internal use Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry k,l Amended Royal jelly When included in a Listed medicine 170 ,171 23 April 2008 entry Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Shark When included in a Listed medicine 167 23 April 2008 entry cartilage Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Historical document

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Phenylalanine When included in a Listed medicine for 14 23 April 2008 entry oral or sublingual administration, the maximum recommended daily dose of which contains more than 500 mg of

phenylalanine Reason for The addition of this statement to RASML is formalisation of a statement that the TGA decision has longstanding agreement with the Industry. Transition Immediate implementation.

Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Caffeine When included in a Listed medicine, 173 23 April 2008

entry (Entry 1 of 2) except medicines containing less than 1 mg of caffeine in the maximum recommended daily dose: • for oral or sublingual administration, and • the maximum recommended daily dose of which contains 10 mg of caffeine or less. When the caffeine is from a herbal

source

Caffeine When included in a Listed medicine: 174 23 April 2008

(Entry 2 of 2) • for oral or sublingual administration, and • the maximum recommended daily dose of which contains more than 10 mg of caffeine; and When the caffeine is from a herbal

source Reason for Entries included following CMEC recommendation to assist consumers in making more decisionHistorical informed decisions about caffeine-containing document products. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

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Medicines Which Meet The Following Conditions ... Require Gazettal Date Containing Statement(s) Entry text No existing entry

Amended Polygonum When included in a Listed medicine 175, 154 23 April 2008 entry multiflorum Reason for Entry included as a result of CMEC recommendation (CMEC 61) relating to adverse decision liver events associated with Polygonum multiflorum use. Transition The normal RASML transition period would apply, that is, the new requirement would apply to all new products approved after the date of gazettal, and to existing products one year from the date of gazettal.

Section 2 – Advisory Statements

Summary of Proposed Changes

It is proposed to:

• amend statements 27, 28, 30 - 32 and 153. • add statements 159 – 173 inclusive. • archive original statement 30.

Statement 27 and 28 amended line with CMEC recommendations as shown below: No Statement Text Gazettal Date Entry text 27 Selenium is toxic in high doses. 23 Jun 2004

Amended 27 This product contains selenium which is toxic in high doses. 23 April 2008 entry Entry text 28 Selenium in dietary supplements should not exceed a daily 23 Jun 2004 dose of 100 μg. Amended 28 A daily dose of 150 micrograms for adults of selenium from 23 April 2008 entry dietary supplements should not be exceeded. Reason for The statements revised as a result of CMEC recommendation (CMEC 63). decision TransitionHistorical For existing products, a one-year transiti documenton period is proposed. However, new products will be required to comply immediately.

Statement 30 is deleted as it is no longer used.

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Statement 31 amended as shown below in line with the updated SUSDP entry and CMEC recommendations. No Statement Text Gazettal Date Entry text 31 The recommended adult daily amount of vitamin A from all 23 Jun 2004 sources is 2 500 International Units.

Amended 31 The recommended adult daily intake of vitamin A from all 23 April 2008 entry sources is 700 micrograms retinol equivalents for women and

900 micrograms retinol equivalents for men. Note: Products that are clearly only for consumers of one sex may omit the RDI for the other sex. Examples may include products for conditions that are generally understood to be sex-specific such as period pain and prostate health, and products explicitly labeled as being for men or women (eg women’s multivitamins). Reason for The change includes the CMEC recommendations and aligns the label advisory decision statement to the National Health and Medical Research Council’s Nutrient Reference Values. At present, sponsors are required by the Therapeutic Goods Order No. 69 (TGO 69) to use International Units on medicine labels to express vitamin A content. However, the amendments to TGO 69 that gives this revision of RASML legal force will also amend the units of expression of vitamin A quantity. Transition For existing products, a one-year transition period is proposed. However, new products will be required to comply immediately.

Statement 32 amended as shown below in line with the updated SUSDP entry and CMEC recommendations. No Statement Text Gazettal Date Entry text 32 WARNING – When taken in excess of 8 000 IU vitamin A can 23 Jun 2004 cause birth defects.

Amended 32 WARNING – When taken in excess of 3 000 micrograms 23 April 2008 entry retinol equivalents, vitamin A may cause birth defects. Reason for On recommendation of CMEC, this statement is being revised to align the label decision advisory statement to the National Health and Medical Research Council’s Nutrient Reference Values. Transition For existing products, a one-year transition period is proposed. However, new Historicalproducts will be required to comply immediately. document

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Statement 153 amended as shown below in line with the recommendations of the Complementary Medicines Advisory Committee and the Black Cohosh Expert Advisory Group. No Statement Text Gazettal Date Entry text 153 Warning: Black cohosh may harm the liver in some 5 April 2006 individuals.

Amended 153 Warning: In very rare cases, Black cohosh has been associated 23 April 2008 entry with liver failure Reason for Following consultation with expert advisory committees, the mandatory warning for decision products containing black cohosh (Cimicifuga racemosa) is being strengthened. Transition A one-year phase-in period is to be provided

The advisory statements below are required to give effect to the changes described under Section 1 above.

No Statement Text Gazettal Date 159 “If you get an allergic reaction stop taking and see your doctor 23 April 2008

immediately.” 160 ”Do not use for more than a few days at a time unless a doctor has told 23 April 2008 you to. Do not exceed the recommended dose. Excessive use can be

harmful” Reason for Statements included as a result of the TGA Review of NSAIDs and MEC decision recommendations to which the TGA made a slight amendment. Transition Agreed transition period for this statement no later than 23 April 2008 for existing products (ie. entry applies to all new products approved after date of gazettal, and to existing products from no later than 23 April 2008.

No Statement Text Gazettal Date

161 Warning: Chaparral may harm the liver in some people. 23 April 2008 162 Individuals taking anticoagulants should seek medical advice before 23 April 2008

taking this product. 163 Individuals at risk of bleeding problems should seek advice from their 23 April 2008 Historicalhealthcare practitioner prior to taking thisdocument product

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No Statement Text Gazettal Date

164 Derived from seafood. 23 April 2008 Reason for Included in line with CMEC recommendations and current practice decision Transition The addition of this statement to RASML is the formalisation of a statement that the TGA and Industry have long agreed to. It is proposed that its implementation be immediate.

No Statement Text Gazettal Date

165 Contains [amount of potassium in milligrams] mg of potassium. 23 April 2008 166 If you have kidney disease or are taking heart or blood pressure 23 April 2008

medicines, consult your doctor or pharmacist before use. Reason for Included in line with CMEC recommendations following NDPSC scheduling process. decision Transition A one-year phase-in period is to be provided

No Statement Text Gazettal Date 167 Children, pregnant or breastfeeding women, and those who have 23 April 2008 recently had a heart attack, surgery or a major accident should not

consume this product without medical advice 168 WARNING: Propolis may cause allergic reactions. If irritation or 23 April 2008

swelling of the mouth or throat occurs - discontinue use.

169 WARNING: Propolis may cause skin irritation. Test before use. 23 April 2008

170 Not to be taken by asthma and allergy sufferers 23 April 2008

171 This product contains royal jelly which has been reported to cause 23 April 2008 severe allergic reactions and in rare cases fatalities - especially in

asthma and allergy suffers Reason for Included in line with CMEC recommendations and current practice decisionHistorical document Transition The addition of this statement to RASML is the formalisation of a statement that the TGA and Industry have long agreed to. It is proposed that its implementation be immediate.

19 RASML – UPDATE 3.1 – Record of Decisions and Reasons

No Statement Text Gazettal Date 172 If you experience yellowing of the skin or eyes, dark urine, nausea, 23 April 2008 vomiting, unusual tiredness, weakness, stomach or abdominal pain,

and/or loss of appetite, stop using this product and see your doctor Reason for Included as a result of a review by an expert advisory of the regulatory status of black decision cohosh following the receipt of adverse reaction reports. Transition A one-year phase-in period is to be provided

No Statement Text Gazettal Date 173 The recommended dose of this medicine provides small amounts of 23 April 2008

caffeine Reason for This statement to apply to Listed medicines containing more than 1 mg but less than 10 decision mg of caffeine in the maximum recommended daily dose. Transition A one-year phase-in period is to be provided

No Statement Text Gazettal Date

174 Contains [amount of caffeine in milligrams] mg of caffeine 23 April 2008 Reason for This statement to apply to Listed medicines containing more than 10 decision mg of caffeine in the maximum recommended daily dose. Transition A one-year phase-in period is to be provided

No Statement Text Gazettal Date

175 Warning: Polygonum multiflorum may harm the liver in some people 23 April 2008 Reason for The statement proposed was recommended by CMEC. Consultation with ADRAC has decision been undertaken. Transition A one-year phase-in period is to be provided Historical document

20 RASML – UPDATE 3.1 – Record of Decisions and Reasons

Summary of new RASML statements

No Statement Text Gazettal Date

27 This product contains selenium which is toxic in high doses. 23 April 2008

28 A daily dose of 150 micrograms for adults of selenium from dietary 23 April 2008

supplements should not be exceeded. 31 The recommended adult daily intake of vitamin A from all sources is 700 23 April 2008 micrograms retinol equivalents for women and 900 micrograms retinol

equivalents for men. 32 WARNING – When taken in excess of 3 000 micrograms retinol equivalents, 23 April 2008

vitamin A may cause birth defects.

159 If you get an allergic reaction stop taking and see your doctor immediately. 23 April 2008

160 Do not use for more than a few days at a time unless a doctor has told you to. 23 April 2008

Do not exceed the recommended dose. Excessive use can be harmful

161 Warning: Chaparral may harm the liver in some people. 23 April 2008

162 Individuals taking anticoagulants should seek medical advice before taking this 23 April 2008

product. 163 Individuals at risk of bleeding problems should seek advice from their 23 April 2008

healthcare practitioner prior to taking this product

164 Derived from seafood. 23 April 2008

165 Contains [amount of potassium] potassium. 23 April 2008

166 If you have kidney disease or are taking heart or blood pressure medicines, 23 April 2008

consult your doctor or pharmacist before use. 167 Children, pregnant or breastfeeding women, and those who have recently had a 23 April 2008 heart attack, surgery or a major accident should not consume this product

without medical advice 168 WARNING: Propolis may cause allergic reactions. If irritation or swelling of 23 April 2008

the mouth or throat occurs - discontinue use.

169 WARNING: Propolis may cause skin irritation. Test before use. 23 April 2008

170 Not to be taken by asthma and allergy sufferers 23 April 2008

171Historical This product contains royal jelly which has been document reported to cause severe 23 April 2008 allergic reactions and in rare cases fatalities - especially in asthma and allergy

suffers 172 If you are experiencing yellowing of the skin or whites of the eyes, dark urine, 23 April 2008 nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain,

and/or loss of appetite, you should stop using this product and see your doctor

21 RASML – UPDATE 3.1 – Record of Decisions and Reasons

No Statement Text Gazettal Date

173 The recommended dose of this medicine provides small amounts of caffeine 23 April 2008

174 Contains [amount of caffeine in milligrams] mg of caffeine 23 April 2008

175 Warning: Polygonum multiflorum may harm the liver in some people 23 April 2008

The following advisory statements are no longer in use and will be archived.

No Statement Text Gazettal Date 30 Recommended daily amount is 5000 International Units or less of 23 Jun 2004 Vitamin A.

Section 3 and Appendices k. Statement(s) must be printed in type of 3 mm height or larger l. Statement(s) must be printed on the front of the goods

No other changes proposed except for consequential archive entries in appendices 2.1 and 2.2.

Historical document

22