Gazette notice - required advisory statements for medicine labels (RASML)
Published in the Commonwealth of Australia Gazette No. GN 16, 23 April 2008
April 2008
Therapeutic Goods Regulations 1990
I, PIO CESARIN, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration, give notice as follows:
The document entitled Required Advisory Statements for Medicine Labels (edition 1, including update 2) dated April 2006 (RASML) has been updated as follows:
1. Add the following entries to Section 1 MEDICINES TO WHICH ADVISORY STATEMENTS APPLY (in appropriate alphabetical order):
Changes are proposed as follows:
| Substance | Change type |
|---|---|
| Flurbiprofen | New Entry |
| Ketoprofen (Entry 1 of 2) | New Entry |
| Ketoprofen (Entry 2 of 2) | New Entry |
| Larrea tridentata | New Entry |
| Zingiber officinale | New Entry |
| Glucosamine hydrochloride | New Entry |
| Glucosamine sulfate potassium chloride complex (Entry 1 of 2) | New Entry |
| Glucosamine sulfate potassium chloride complex (Entry 2 of 2) | New Entry |
| Glucosamine sulfate sodium chloride 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 |
| Caffeine (Entry 2 of 2) | New Entry |
| Polygonum multiflorum | New Entry |
| Column 1 Medicines Containing ... |
Column 2 Which Meet The Following Conditions ... |
Column 3 Require Statement(s) |
Column 4 Gazettal Date |
|---|---|---|---|
| Flurbiprofen | When included in a Schedule to the SUSDP. | (126, 127, 18, 149, 130, 133, 159, 160)j | 23 April 2008 |
| Ketoprofen (Entry 1 of 2) |
When:
|
(126, 127, 149, 130, 159, 160)j | 23 April 2008 |
| Ketoprofen (Entry 2 of 2) |
When:
|
(126, 127, 149, 18 130, 133, 159, 160)j | 23 April 2008 |
| Larrea tridentata | When included in a Listed medicine | 161, 152 | 23 April 2008 |
| Zingiber officinale | When included in a Listed medicine; AND when the extraction ratio is 25:1 or higher; AND when the equivalent dry weight per dosage unit is 2g or higher |
162, 163 | 23 April 2008 |
| Glucosamine hydrochloride | When included in a Listed medicine and derived from a marine source | 164 | 23 April 2008 |
| Glucosamine sulfate potassium chloride complex (Entry 1 of 2) |
When included in a Listed medicine and derived from a marine source | 164 | 23 April 2008 |
| Glucosamine sulfate potassium chloride complex (Entry 2 of 2) |
When included in a Listed medicine for oral use | 165, 166, 1 | 23 April 2008 |
| Glucosamine sulfate sodium chloride complex | When included in a Listed medicine and derived from a marine source | 164 | 23 April 2008 |
| Glucosamine sulphate | When included in a Listed medicine and derived from a marine source | 164 | 23 April 2008 |
| Propolis (Entry 1 of 2) |
When included in a Listed medicine for internal use | 168 | 23 April 2008 |
| Propolis (Entry 2 of 2) |
When included in a Listed medicine for external use | 169 | 23 April 2008 |
| Royal jelly | When included in a Listed medicine | 170k,l,171 | 23 April 2008 |
| Shark cartilage | When included in a Listed medicine | 167 | 23 April 2008 |
| Phenylalanine | When included in a Listed medicine for oral or sublingual administration, the maximum recommended daily dose of which contains more than 500 mg of phenylalanine | 14 | 23 April 2008 |
| Caffeine (Entry 1 of 2) |
When included in a Listed medicine, except medicines containing less than 1 mg of caffeine in the maximum recommended daily dose:
When the caffeine is from a herbal source |
173 | 23 April 2008 |
| Caffeine (Entry 2 of 2) |
When included in a Listed medicine:
When the caffeine is from a herbal source |
174 | 23 April 2008 |
| Polygonum multiflorum | When included in a Listed medicine | 175, 154 | 23 April 2008 |
2. Remove the following entries from Section 1 - MEDICINES TO WHICH ADVISORY STATEMENTS APPLY:
| Substance | Change type |
|---|---|
| Diclofenac (Entry 1 of 2) | Amendment |
| Diclofenac (Entry 2 of 2) | Amendment |
| Ibuprofen (Entry 1 of 4) | Amendment |
| Ibuprofen (Entry 2 of 4) | Amendment |
| Ibuprofen (Entry 3 of 4) | Amendment |
| Ibuprofen (Entry 4 of 4) | Amendment |
| Mefenamic acid (Entry 1 of 2) | Amendment |
| Mefenamic acid (Entry 2 of 2) | Amendment |
| Naproxen (Entry 1 of 2) | Amendment |
| Naproxen (Entry 2 of 2) | Amendment |
| High selenium yeast | Amendment |
| Selenium yeast - high | Amendment |
| Selenocysteine | Amendment |
| Selenomethionine | Amendment |
| Sodium selenate | Amendment |
| Sodium selenite | Amendment |
| Yeast - high selenium | Amendment |
| Vitamin A | Amendment |
| Cimicifuga racemosa | Amendment |
and replace them with the following:
| Column 1 Medicines Containing ... |
Column 2 Which Meet The Following Conditions ... |
Column 3 Require Statement(s) |
Column 4 Gazettal Date |
|---|---|---|---|
| Diclofenac (Entry 1 of 2) |
When:
|
(126, 127, 149, 130, 159, 160)j | 23 April 2008 |
| Diclofenac (Entry 2 of 2) |
When:
|
(126, 18, 127, 149, 130, 133, 159, 160)j | 23 April 2008 |
| Ibuprofen (Entry 1 of 4) |
For the purpose of exclusion from the Schedules to the SUSDP, when the preparation is for oral use and is indicated exclusively for the treatment of dysmenorrhoea. | 126, 127, 151, 130, 131, 132, 159, 160 | 23 April 2008 |
| Ibuprofen (Entry 2 of 4) |
For the purpose of exclusion from the Schedules to the SUSDP, when the preparation is for oral use and is NOT indicated exclusively for the treatment of dysmenorrhoea. | 126, 18, 127, 51, 130, 131, 132, 133, 159, 160 | 23 April 2008 |
| Ibuprofen (Entry 3 of 4) |
When:
|
(126, 127, 149, 130, 159, 160)j | 23 April 2008 |
| Ibuprofen (Entry 4 of 4) |
When:
|
(126, 18, 127, 149, 130, 133, 159, 160)j | 23 April 2008 |
| Mefenamic acid (Entry 1 of 2) |
When:
|
(126, 127, 149, 130, 159, 160)j | 23 April 2008 |
| Mefenamic acid (Entry 2 of 2) |
When:
|
(126, 18, 127, 149, 130, 133, 159, 160)j | 23 April 2008 |
| Naproxen (Entry 1 of 2) |
When:
|
(126, 127, 149, 130, 159, 160)j | 23 April 2008 |
| Naproxen (Entry 2 of 2) |
When:
|
(126, 18, 127, 149, 130, 133, 159, 160)j | 23 April 2008 |
| High selenium yeast | When included in Schedule 4 Part 5 Division 3 Item 11 of the Regulations. | 27, 28 | 23 April 2008 |
| Selenium yeast - high | When included in Schedule 4 Part 5 Division 3 Item 11 of the Regulations. | 27, 28 | 23 April 2008 |
| Selenocysteine | When included in Schedule 4 Part 5 Division 3 Item 13 of the Regulations. | 27, 28 | 23 April 2008 |
| Selenomethionine | When included in Schedule 4 Part 5 Division 3 Item 12 of the Regulations. | 27, 28 | 23 April 2008 |
| Sodium selenate | When included in Schedule 4 Part 5 Division 3 Item 14 of the Regulations. | 27, 28 | 23 April 2008 |
| Sodium selenite | When included in Schedule 4 Part 5 Division 3 Item 15 of the Regulations. | 27, 28 | 23 April 2008 |
| Yeast - high selenium | When included in Schedule 4 Part 5 Division 3 Item 11 of the Regulations. | 27, 28 | 23 April 2008 |
| Vitamin A (see also Vitamins) |
In medicines for internal use containing 3 000 µg retinol equivalents or less of vitamin A other than those containing:
|
31d,e, 32d,e,c, 33d,e,c | 23 April 2008 |
| Cimicifuga racemosa | When included in a Listed medicine | (153,172) | 23 April 2008 |
3. Remove the entries for statements 27, 28, 30*, 31, 32 and 153 of Section 2 - ADVISORY STATEMENTS:
| No | Statement Text | Gazettal Date |
|---|---|---|
| 27 | Selenium is toxic in high doses. | 23 Jun 2004 |
| 28 | Selenium in dietary supplements should not exceed a daily dose of 100 µg. | 23 Jun 2004 |
| 30 | Recommended daily amount is 5000 International Units or less of Vitamin A. | 23 Jun 2004 |
| 31 | The recommended adult daily amount of vitamin A from all sources is 2 500 International Units. | 23 Jun 2004 |
| 32 | WARNING - When taken in excess of 8 000 IU vitamin A can cause birth defects. | 23 Jun 2004 |
| 153 | WARNING: Black cohosh may harm the liver in some individuals. | 5 Apr 2006 |
and replace 27, 28, 31, 32 and 153 with the following:
*NB: statement 30 is not replaced as it is no longer used.
| 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 supplements should not be exceeded. | 23 April 2008 |
| 31 | The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men. | 23 April 2008 |
| 32 | WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects. | 23 April 2008 |
| 153 | Warning: In very rare cases, Black cohosh has been associated with liver failure. | 23 April 2008 |
4. Add the following entries (after entry number 158) to Section 2 - ADVISORY STATEMENTS after entry number 158:
| No | Statement Text | Gazettal Date |
|---|---|---|
| 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. Do not exceed the recommended dose. Excessive use can be harmful. | 23 April 2008 |
| 161 | Warning: Chaparral may harm the liver in some people. | 23 April 2008 |
| 162 | Individuals taking anticoagulants should seek medical advice before taking this product. | 23 April 2008 |
| 163 | Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this product. | 23 April 2008 |
| 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, consult your doctor or pharmacist before use. | 23 April 2008 |
| 167 | Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice. | 23 April 2008 |
| 168 | WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs - discontinue use. | 23 April 2008 |
| 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 severe allergic reactions and in rare cases fatalities - especially in asthma and allergy suffers. | 23 April 2008 |
| 172 | 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. | 23 April 2008 |
| 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 |
5. Add the entries k and l to Section 3 - ADDITIONAL REQUIREMENTS:
| Additional requirement | Gazettal Date | |
|---|---|---|
| k | Statement(s) must be printed in type of 3 mm height or larger. | 23 April 2008 |
| l | Statement(s) must be printed on the front of the goods. | 23 April 2008 |
Other minor consequential and editorial amendments have been made in accordance with the RASML Update 3.1 Consultation document.
The RASML Update 3.1 Record of Decisions and Reasons <http://www.tga.gov.au/meds/rasml.htm#updates>, incorporating details of changes made and the reasons for decisions have been published on the TGA's website.
The updated RASML <http://www.tga.gov.au/meds/rasml.htm#rasml> incorporating the changes outlined above will be published on the TGA's website from April 2008.
This Notice comes into effect on the date it is gazetted.
Dated 14 April 2008
Pio Cesarin
Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration