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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

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


修訂日期:二零一五年十二月十八日