有用資料
The following is issued on behalf of the Registration Committee of the Hong Kong Pharmacy and Poisons Board:
Plan to de-register appetite suppressants containing PPA
November 24, 2000
The Registration Committee of the Hong Kong Pharmacy and Poisons Board brought forward its December meeting to this morning (Nov 24) to discuss the latest reported side effects of phenylpropanolamine (PPA).
The committee studied in detail the report of the U.S. Yale University School of Medicine which finds that PPA may be associated with haemorrhagic stroke (internal bleeding of the brain), particularly when used in appetite suppressant products. The committee also considered the use of PPA products available in Hong Kong, and follow-up regulatory decisions of other health authorities.
The committee has concluded that:
(1) According to all available evidence, the association of PPA with haemorrhagic stroke is significant only when PPA is used in appetite suppressant products. Such use is often on a long-term basis. Accordingly, such products should be deregistered and should no longer be legally sold in Hong Kong. There are 3 such products:
Bolarmine Capsule (Registration No. HK-45560)
Diet-B Capsule (Registration No. HK-45561)
Slimonin Capsule (Registration No. HK-35791)
The manufacturers of the 3 products are being informed of the above decision, which will take effect on December 23 (at the lapse of the 4-week statutory period for the lodgement of an appeal against the decision, if any). Meanwhile, these manufacturers are requested to immediately recall the 3 products from dispensaries and doctors' clinics, and the public is advised to cease using them and to consult their doctor or pharmacist for alternative treatments.
(2) Cough-and-cold remedies should be upgraded from Part 1 to Part 1 Schedule 1 poison. (This means that every time a pharmacist sells the product, he must make a record of the sale, sign it and ask the customer to sign it too. Currently, the requirement is that the product should only be sold under the pharmacist's supervision). In the case of these remedies, the labelling will have to be revised, where necessary, to limit the dosage to no more than 100 mg daily. Also, Manufacturers will be required to strengthen the warning section in the product literature, including not using the product as an appetite suppressant.
Doctors, pharmacists and dispensaries are being issued a letter highlighting the above decision of the Registration Committee and reminding them to exercise caution when products containing PPA are supplied to members of the public.
The above information, together with the list of products containing PPA will be uploaded onto the Department of Health (DH)'s Website. For enquiries on PPA products, members of the public can use DH's Pharmaceutical Service Hotline (2961 8789). The Hotline will be operated until 9:00 pm today (November 24) and from 9:00 am until 6:00 pm tomorrow (November 25).
List of Products containing PPA |
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REGISTRATION NUMBER |
PRODUCT NAME | |
19703 |
ALKA-SELTZER PLUS COLD MEDICINE TAB | |
45684 |
AMETAPP SYRUP | |
34941 |
ANTAMIN TAB | |
8373 |
ANTICOL TAB | |
35773 |
ANTI-COLD 4P CAP | |
31850 |
ANTICOLD INSTANTLY CAP | |
31809 |
ANTICOLD-A CAP | |
4941 |
ANTIFLU CAP | |
22812 |
ANTIFLU FORTE CAP | |
23872 |
ANTIFLU FORTE CAP (BLUE/GREY) | |
26055 |
AUI COUGH SYRUP | |
23980 |
B P P CAP | |
22065 |
B.P.P TAB | |
23738 |
B.P.P TAB | |
35146 |
B.P.P.TAB | |
39545 |
BAROTIN CAP | |
42009 |
BEACOGEN TAB | |
12233 |
BEPIPTON CAP | |
32900 |
BERIMON CAP | |
40379 |
BISOLIN CAP | |
45560 |
BOLARMINE CAP | |
8380 |
BPP COUGH SYRUP FOR ADULTS | |
8370 |
BPP COUGH SYRUP FOR CHILDREN | |
5438 |
BPP SYRUP | |
40466 |
BRIERS CAP | |
40680 |
BRIGADER CAP | |
45495 |
BROCOTAPP SYRUP | |
18985 |
BROM P P SYRUP | |
8593 |
BROM P P TAB | |
40698 |
BROMATAPP EXTENDED RELEASE TAB | |
40961 |
BROMATAPP EXTENDED RELEASE TAB | |
9371 |
BROMETANE ELIXIR | |
20732 |
BROMETAPP SYRUP | |
17742 |
BROMITANE CAP | |
42400 |
BROMPHENIRAMINE & PHENYLPROPANOLAMINE TAB | |
45615 |
BROMPHENYL ELIXIR | |
35821 |
BROM-RAMINE CO.SYRUP | |
15571 |
BROMTAPP ELIXIR | |
25423 |
C P P INJ | |
19751 |
C P P SYRUP | |
41149 |
C.B.COUGH SYRUP | |
42219 |
C.P.P. SYRUP | |
40098 |
CABOL SYRUP (IMPROVED) | |
44873 |
CHILDREN'S COLTALIN TAB | |
23386 |
COBAN CAP | |
37893 |
COFETOL SYRUP | |
42096 |
COLD & ALLERGY RELIEF SYRUP | |
30579 |
COLD & INFLUENZA CAP | |
41367 |
COLD TABLETS MP | |
31808 |
COLDCAP-A CAP | |
41147 |
COLDICIN TAB | |
9262 |
COLDKILL SYRUP | |
5034 |
COLDKILL TAB | |
34434 |
COLD-STOP TAB | |
5681 |
COLDTAB TAB | |
22209 |
COLDTAB TAB | |
13834 |
COLPELIN COUGH SYRUP | |
44872 |
COLTALIN TAB | |
33888 |
COLTEX COLD CAP | |
26049 |
CONACOL COUGH SYRUP | |
39583 |
CONALIN COUGH SYRUP | |
45470 |
CONSAILINE TAB | |
14117 |
CONTAC 500 CAP | |
28259 |
COPARINE SYRUP | |
19336 |
CORHISDIN EXPECTORANT WITH CODEINE | |
35469 |
CORITAB TAB | |
32555 |
CORITUSSAL SYRUP | |
2070 |
CORYAID CAP | |
4465 |
CORYZAC CAP | |
8606 |
CORYZOL TAB | |
19324 |
COSTAR SYRUP | |
6551 |
COSYR COUGH SYRUP | |
22813 |
D.P.P SYRUP | |
27668 |
D-B-P COUGH SYRUP | |
20348 |
D-B-P COUGH SYRUP WITH G.G. | |
40545 |
DECOLDIN TAB | |
6553 |
DECOLGEN SYR | |
34580 |
DECONGESTANT SUSTAINED RELEASE TAB | |
30886 |
DELIX PAED LINCTUS | |
15590 |
DENORAL TAB | |
1660 |
DEX-TON NOSE DROPS | |
45561 |
DIET-B CAP | |
9487 |
DIMAXIN SYRUP | |
9479 |
DIMAXIN TAB | |
22267 |
DIMECO SYRUP | |
45392 |
DIMECOL SYR | |
45393 |
DIMECOL TAB | |
20452 |
DIMEFORT SYRUP | |
21492 |
DIMEFORT TAB | |
45969 |
DIMEFORT-P TAB | |
21715 |
DIMETA SYRUP | |
21719 |
DIMETA TAB | |
41247 |
DIMETAPP COLD AND COUGH LIQUI-GELS | |
37273 |
DIMETAPP EXTENTABS TAB | |
43219 |
DIMETAPP LIQ | |
43218 |
DIMETAPP ORAL INFANT DROPS | |
40453 |
DIME-TIME EXTENDED-RELEASE TAB | |
26575 |
DL-PHENYLPROPANOLAMINE HYDROCHLORIDE | |
30322 |
DM-CORDYL SYRUP | |
45522 |
DR FREEMAN COLD SYRUP | |
45007 |
DR FREEMAN EXPECTORANT SYR | |
45487 |
DR FREEMAN MULTI-SYMPTOM COLD RELIEF SYR | |
44673 |
DR FREEMAN QUIET COUGH SYRUP | |
5475 |
D'TAPP ELIXIR | |
16922 |
D'TAPP TAB | |
43693 |
DUADACIN COLD CAP | |
45398 |
EASCOLD FORTE SYRUP | |
9284 |
EASCOLD SYRUP | |
9260 |
EASCOLD TAB | |
27686 |
EUROCOSYN DM SYRUP | |
27685 |
EUROTAPP SYRUP | |
27682 |
EUROTAPP TAB | |
26257 |
FARGIN TAB | |
41988 |
FEBRICOL ELIXIR | |
31544 |
FEBRICOL TAB | |
21596 |
FLUDANE CAP | |
43592 |
FLUDREX TAB | |
34562 |
FLUENCY CAP | |
16400 |
FLUZA TAB | |
4700 |
FUTUSSIN SYRUP | |
45809 |
GUAIFENESIN CF COUGH SYRUP (MOVA) | |
40679 |
HIROXIM CAP | |
10635 |
HOTIMIN TAB | |
8611 |
JEM C P P TAB | |
1661 |
JEM CPP (SPECIAL) TAB | |
46105 |
JUNIOR COLD SYRUP | |
15775 |
KAREN C P P C TAB | |
15769 |
KARENTAPP ELIXIR | |
12645 |
KO-FLU CAP (BLUE/WHITE) | |
34834 |
KOSYPHAN COUGH SYRUP | |
22670 |
LEPETONE CAP | |
43369 |
MARTUSINE COUGH SYRUP | |
35921 |
MAX-COLD CAP | |
30767 |
MEHISDIN SYRUP REVISED | |
24183 |
MEYERTAPP ELIXIR | |
29146 |
MEYERTAPP TAB | |
45192 |
MINTAPP ELIXIR | |
28070 |
MOTOVIN SYRUP | |
16994 |
MUCORAMA CAP | |
43366 |
NALTUS COUGH SYRUP | |
21570 |
NEO B P P TAB | |
43498 |
NEO-COPHEN TAB | |
12912 |
NEO-DEXMIN SYRUP | |
45394 |
NEOZA TAB | |
6539 |
NEOZEP COLD TAB | |
6530 |
NEOZEP FORTE TAB | |
7364 |
NICE-BPP SYRUP | |
31932 |
NICE-ZEP TAB | |
26186 |
NUMPER 2A COUGH SYRUP | |
3170 |
ORNEX CAP | |
26563 |
PAEDISED COUGH SYRUP | |
5382 |
PARACETAMOL TAB (SPECIAL FORMULA) | |
22669 |
PARAMETON CAP | |
38499 |
PARAMINE TAB | |
36004 |
PARCLORPHEN FILM COATED TAB | |
45742 |
PARCLORPHEN FORTE FILM-COATED TAB | |
1636 |
PECLIN COUGH SYRUP | |
33635 |
PHENTAMOL-S TAB | |
4125 |
PHENYLPROPANOLAMINE HCL (ALPS PHARM) | |
42671 |
PHENYLPROPANOLAMINE HCL (CHENG FONG) | |
4931 |
PHOLCODINE COMPOUND SYRUP | |
30269 |
PHOLCOF SYRUP | |
19749 |
PHOLCOLIN COUGH SYRUP | |
18320 |
PHOLIX COUGH SYRUP | |
26776 |
PROPAHISTINE SYRUP | |
46548 |
PROPALIN SYRUP 5% (VET) | |
41097 |
QUALIZEP TAB | |
32551 |
RHINOPRONT SYRUP | |
46994 |
RHINOZEP TAB | |
38086 |
ROBITUSSIN CF SYRUP | |
45143 |
S-B P.P. SYRUP | |
38479 |
SETRAMINE SYRUP | |
40045 |
SINUS TAB | |
6142 |
SINUTAB TAB | |
19360 |
SINUTON TAB | |
31306 |
SINUZEP TAB | |
35791 |
SLIMOMIN CAP 75MG (SUSTAINED RELEASE) | |
1170 |
STONARHINI TAB | |
25143 |
STOPCOL TAB | |
32127 |
SYNCOLDTAB-M TAB (YELLOW) | |
31290 |
TRINITIS CAP | |
12701 |
TRIPLE 'P' COUGH SYRUP | |
45327 |
TUSERAN FORTE CAP | |
28796 |
U-CORY-D CAP | |
5293 |
U-DPC COUGH SYRUP | |
28773 |
U-NILCOLD TAB | |
45655 |
UNI-TAPP TAB | |
7154 |
UNI-VASIN LIQUID | |
5300 |
U-TAPP (P) SYRUP | |
5303 |
U-TAPP SYRUP | |
28772 |
U-TAPP TAB | |
24466 |
VICOZA CAP | |
35819 |
VIDA COLD TAB | |
19392 |
VIDA COLD TAB FOR CHILDREN | |
20462 |
VIDATAPP SYRUP | |
21473 |
VIDATAPP TAB | |
37209 |
XICODINE CAP | |
18548 |
ZECOL TAB |