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S5

Schedule 5 (S5) medicines in South Africa

Prescription-only, with tighter controls on repeats.

About S5 Drugs

Where S5 sits on the scale

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Who may supply

A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.

Cited: Act s22A(5)(b), s22A(5)(c), s22A(5)(d), s22A(5)(e)

Prescription: Requires a prescription from an authorised prescriber.

Repeats: Capped at six months in total, and only if the prescriber stated in advance the number of repeats and the interval between them; the same six-month cap applies to anxiolytic, antidepressant or tranquillising use unless a registered psychiatrist has been consulted, and to analgesic use unless another medical practitioner has been consulted. The prescription must also be presented for dispensing within 30 days of issue.

Cited: reg 33(3)(i) (General Regulations, 2017)

Cited: Act s22A(6)(d), s22A(6)(g), s22A(6)(h)

Advertising: May be advertised only to health professionals, not the public.

Cited: reg 42(2), reg 42(3) (General Regulations, 2017)

Labelling: Must show the letter S and the number 5 in a square border, immediately before the product's brand name.

Cited: reg 10(1)(a) (General Regulations, 2017)

What is a Schedule 5 medicine in South Africa?

Prescription-only, with tighter controls on repeats. Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Can a pharmacist sell a Schedule 5 medicine without a prescription?

A prescription is required. A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it. Capped at six months in total, and only if the prescriber stated in advance the number of repeats and the interval between them; the same six-month cap applies to anxiolytic, antidepressant or tranquillising use unless a registered psychiatrist has been consulted, and to analgesic use unless another medical practitioner has been consulted. The prescription must also be presented for dispensing within 30 days of issue.

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

Substances listed under S5

237 listed in the Consolidated Schedules, 118 with a registered medicine.

Registered medicines in S5

Showing 122 of 122 chemicals in schedule S5
Registered products
NameBrandsDosagesApplicantsRegistrationsSchedule
AcitretinAcitretin PHARMC, Neotigason10 mg, 25 mg2 applicants4 registrationsS5
AgomelatineValdoxane25 mgServier Laboratories South Africa (Pty) LtdA400347S5
AlfaxaloneAlfaxan-cd rtu anaesthetic, Alfaxan multidoseinjection, 10mg2 applicants2 registrationsS5
AlprazolamXanor, Biozane, Anxirid, +13 more0,25 mg, 0,5 mg, 1 mg, 1,0 mg, +2 more10 applicants39 registrationsS5
AmitriptylineTrepiline10 mg, 25 mgPharmacare limited û woodmead2 registrationsS5
AripiprazoleApize, Ariphrenz, Aripiprazole alkem5 mg, 10 mg, 15 mg, 30 mgAscend Laboratories (Pty) Ltd12 registrationsS5
AtomoxetineStrattera, Inir, Attentra, +10 more10 mg, 18 mg, 25 mg, 40 mg, +3 more10 applicants68 registrationsS5
BrexpiprazoleRexulti0,25 mg, 0,5 mg, 1 mg, 2 mg, +2 moreH. Lundbeck (Pty) Ltd6 registrationsS5
BromazepamBromaze, Lexotan, Bromazepam kiara, +1 more3, 64 applicants7 registrationsS5
Brotizolam CancelledMederantil10 ml, 50 mlBoehringer Ingelheim Animal Health South Africa (Pty) Ltd2 registrationsS5
BupropionWellbutrin xl, Voxra xl, Nicolift, +12 more150 mg, 300 mg10 applicants23 registrationsS5
BuspironeAstrid, Pasrin10 mg2 applicants2 registrationsS5
CaffeineStilpane150 mgPharmacare limited û woodmeadM0002S5
CariprazineReagila1,5 mg, 3,0 mg, 4,5 mg, 6,0 mgAdcock ingram limited4 registrationsS5
ChlordiazepoxideLibrium, Medchlor5, 10, 253 applicants6 registrationsS5
ChlorpromazineChlorpromazine unimed, Largactil, Klorazin, +5 more10 MG, 25 MG, 25MG/ML, 25 mg/1 ml, +4 more8 applicants23 registrationsS5
Chlorprothixene CancelledTruxal paediatricsyrupScp Pharmaceuticals (Pty) LtdB0716S5
CitalopramCipramil, Adco-talomil, Cilift, +25 more10mg/20mg/40 mg, 10 mg, 20 mg, 30 mg, +1 more21 applicants55 registrationsS5
ClobazamQlocam, Clobazam adco, Clozoby, +5 more5 mg, 10 mg, 20 mg9 applicants16 registrationsS5
ClomipramineApotex-clomipramine, Xixia-clomipramine hydrochloride, Companil, +7 more5 mg, 10 mg, 20 mg, 25 mg, +4 more12 applicants19 registrationsS5
Clomipramine hydrochloride aAnafranil25Equity Pharmaceutical (Pty) LtdB1532S5
ClonazepamClonam, Clonazepam ascendis, Remialz, +2 more0,5 mg, 1 mg, 1 mg/ml, 2 mg, +1 more6 applicants11 registrationsS5
ClozapineCloment, Clozapine oethmaan, Clozapine-hexal, +2 more25 mg, 100 mg, suspension, 25 mg/50 mg/100 mg, +1 more4 applicants10 registrationsS5
CodeineStilpane10 mg/200 mg/350 mg, 150 mg/8 mg/320 mgPharmacare limited û woodmead2 registrationsS5
CyclobenzaprineMyprocam, Pribemak, Tanzof15 mg, 30 mg3 applicants6 registrationsS5
DanazolDanogen100, 200Cipla Medpro (Pty) Ltd2 registrationsS5
DapoxetinePriligy30 mg, 60 mgLebasi Pharmaceuticals (Pty) Ltd2 registrationsS5
DesfluraneSuprane, Torrane240 ml2 applicants2 registrationsS5
Desipramine CancelledPertofan25Ciba-geigy (Pty) LtdB1534S5
DesvenlafaxineExsira, Voloxin, Depven xl, +6 more50 mg, 50mg, 50/100 mg, 100 mg7 applicants18 registrationsS5
DetomidineEquidine, Equisedan, DomosedanNot stated3 applicants3 registrationsS5
DexketoprofenSkudexa, Lenizak75 mg, granules2 applicants4 registrationsS5
DexmedetomidineDexdomitor, Precedex, Sedalpha, +15 more000 μg 1, 1 mL, 4 μg, 50 ml, +15 more14 applicants28 registrationsS5
DiazepamDynapam, Tranject, Diazepam pharm c, +14 moreampoules, 10 mg/2 ml, injection, tablets, +3 more17 applicants37 registrationsS5
DibenzepinNoveril40 MGSandoz South Africa (Pty) Ltd2 registrationsS5
DiprenorphineM5050, Activon982 applicants2 registrationsS5
DonepezilAricept, Ariknow, Ran-donepezil, +17 more5 mg, 10 mg15 applicants40 registrationsS5
DothiepinProthiaden, Dosulepin biotech, Thaden25 mg, 75 mg3 applicants6 registrationsS5
DroperidolPharma-q droperidol, Droperidol equity, Inapsin1,25 mg/mL, 5 mg/2 ml3 applicants3 registrationsS5
Drostanolone propionate CancelledMasterilNot statedAdcock ingram limitedG3078S5
DuloxetineCymbalta, Cymgen, Yelate, +11 more20, 30 mg, 30 mg/ 60 mg, 60 mg12 applicants28 registrationsS5
EscitalopramCipralex, Lexamil, Escitalopram be-tabs, +24 more5 mg, 5 mg/ 10mg / 20mg, 10 mg, 15 mg, +1 more21 applicants67 registrationsS5
EsketamineSpravato28 mgJanssen Pharmaceutica (Pty) Ltd530732S5
Ethylestrenol CancelledOrabolinNot statedDonmed Pharmaceuticals (Pty) LtdG3193S5
EtifoxineStresigen, Neusera, Kalmexan, +6 more50 mg6 applicants9 registrationsS5
EtomidateB. Braun etomidate, Etomidate RBC, Hypnomidate2 mg/ml3 applicants3 registrationsS5
FenfluraminePonderaxNot statedServier Laboratories South Africa (Pty) LtdC0518S5
FlumazenilFlumazenil fresenius, Flumazenil b braun, Anexate0,5 MG/ 5 ML, 0,5 mg, 1,0 MG/ 10 ML, 1,0 MG, +2 more4 applicants7 registrationsS5
FluoxetineLilly-fluoxetine, Lorien, Fluoxetine biotech, +17 more20 mg, tablets, 40, oral solution, +1 more15 applicants24 registrationsS5
FluoxymesteroneHalotestin5 MGUpjohn South Africa (Pty) LtdG3216S5
FlupenthixolFluanxol1 mgAdcock ingram limitedB1380S5
Fluphenazine CancelledPheracarm rapid ( ), Anatensol1 MG, 2 MG, 2,5 mg/ml 10 ml, 5 MG2 applicants4 registrationsS5
FlurazepamDalmadorm, Flurazepam15 mg, 30 mg3 applicants5 registrationsS5
FluvoxamineFaverin, Fluvoxamine oethmaan, Fluvoxamine-hexal, +1 more50, 100 mg3 applicants6 registrationsS5
HaloperidolHaloperidol GDC, Haloject, Haloperidol cipla, +6 more1, 1,5, 5 mg, 5 mg/ml8 applicants12 registrationsS5
HalothaneFluothane, Halothane m&b, FluopanNot stated3 applicants3 registrationsS5
HydroxyzineNeurax, Pharma-q hydroxyzine, Hydroxyzine equity, +1 more10MG, 25 mg, 100 mg/2 ml, syrup, +2 more5 applicants9 registrationsS5
ImipramineEthipramine, Imipramine HCL, Imipramine bp, +5 more10 mg, 25 mg, 25MG4 applicants14 registrationsS5
IsofluraneIsofor, Terrell, Pe-isofluraneNot stated2 applicants3 registrationsS5
IsotretinoinAcnetane, Oratane, Acnetret, +2 more5 mg, 8 mg, 10 mg, 16 mg, +2 more5 applicants12 registrationsS5
KetaminePharma-q ketamine, Zenziket, Ketamine equity, +2 more1 mg, 10 mg/ml, 10, 10 mg/1 ml, +5 more5 applicants12 registrationsS5
LemborexantDayvigo5, 10Eisai pharmaceuticals2 registrationsS5
Lithium carbonateCamcolit250, 400Pharmacare limited û woodmead2 registrationsS5
Lofepramine CancelledEmdalen hsNot statedMerck (Pty) LtdN0204S5
LoprazolamDormonoct2 mgSanofi-aventis South Africa (Pty) LtdQ0355S5
LorazepamAtivan, Ativan sl, Tranqipam0,5 mg, 0,5 mg/1 mg/2,5 mg, 1 mg, 1 ml, +2 more2 applicants8 registrationsS5
LormetazepamGenoct, Loramet0,5 mg, 1 mg, 2 mg2 applicants6 registrationsS5
LurasidoneLatumak20 mg, 40 mg, 60 mg, 80 mg, +1 moreMacleods Pharmaceuticals SA (Pty) Ltd5 registrationsS5
Maprotiline CancelledLuprodil, Ludiomil10, 25, 50, 752 applicants5 registrationsS5
Meclofenoxate CancelledLucidrilNot statedKeatingsB1543S5
MedetomidineDomivet, Dorbene, DomitorNot stated2 applicants3 registrationsS5
MeprobamateMeprepose, Meprobamate, Genprobamate, +2 more400 MG4 applicants5 registrationsS5
MesteroloneProvironNot statedBayer (Pty) Ltd û IsandoB0137S5
Methandriol CancelledDepahor, Oraject orabol hNot statedRhone-poulenc Animal Health SA (Pty) Ltd2 registrationsS5
MethoxyfluranePenthropNot statedEquity Pharmaceutical (Pty) Ltd451118S5
Methyltestosterone CancelledLennon methyltestosterone5 mgPharmacare limited û woodmeadG2966S5
MianserinLantanon, Aspen mianserin ( ), Mianserin hydrochloride (lennon)10 mg, 30 mg2 applicants4 registrationsS5
MidazolamSedolam, Dormicum, Midazolam hexal biotech, +18 more1 mg/ml, 1 mg/ml 5 ml, 1,0 mg, 5 mg/5 ml, +12 more15 applicants49 registrationsS5
MirtazapineRemeron, Aspen mirtazapine, Mirtazapine viatris, +9 more15 mg, 15 mg / 30 mg, 30 mg, 45 mg12 applicants26 registrationsS5
MoclobemideAdco-moclobemide, Depnil, Moclobix150 mg, 300 mg2 applicants4 registrationsS5
ModafinilProvigil, Modalert, Modafinil ipharma, +2 more100mg, 100 mg, 2004 applicants8 registrationsS5
NalbuphineLanphi, Nalbain, Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous, +1 more10 MG/ML, 10,0 mg, 20 MG/ML3 applicants6 registrationsS5
NitrazepamLyladorm, Ormodon, Arem, +3 more5 mg, 10 mg4 applicants7 registrationsS5
OlanzapineZyprexa, Zyprexa im, Olexar, +24 more2,5 mg, 5 mg, 10.0 mg, 10 mg, +2 more17 applicants74 registrationsS5
OxazepamSerepax forte, Serepax, Purata, +4 more10 mg, 15 mg, 30 mg5 applicants17 registrationsS5
PaliperidoneInvega, Xeplion3 mg, 6 mg, 9 mg, 12 mg, +5 moreJanssen Pharmaceutica (Pty) Ltd9 registrationsS5
ParacetamolTramacet, Tramaspen co, Ultracet, +9 more37.5 mg / 25 mg, 37,5 mg/325 mg, 37,5 mg, 37,5 mg and 325 mg, +3 more8 applicants12 registrationsS5
ParoxetineXixia paroxetine, Adco-paroxetine, Paroxetine oethmaan, +13 more12,5, 20 mg, 20 mg -, 25, +2 more13 applicants21 registrationsS5
PemolineDynalertNot statedAdcock ingram limitedB1497S5
PerampanelFycompa0,5 mg/ml, 2 mg, 4 mg, 6 mg, +3 more2 applicants7 registrationsS5
PhenterminePhentolene, Musalos, Minex, +3 more15 mg, 30 mg4 applicants11 registrationsS5
PimozideOrap1 mg, 4 mgLebasi Pharmaceuticals (Pty) Ltd2 registrationsS5
Prazepam CancelledDemetrin10 mgPfizer Laboratories (Pty) LtdG0188S5
PregabalinAlond, Pregabalin viatris, Pregabalin ivax, +29 more25 mg, 25/50/75/150 mg, 25 mg/ 75 mg /150 mg, 25 / 75 / 150, +5 more19 applicants106 registrationsS5
ProchlorperazineAllmetic, Stemetil, Mitil5 mg, tablets3 applicants3 registrationsS5
ProlintaneCatovit-nNot statedIngelheim Pharmaceuticals (Pty) Ltd û FerndaleG2697S5
PropofoPropofol ps fresenius10 mg per mLFresenius Kabi South Africa (Pty) Ltd491233S5
PropofolDiprivan pfs, Propofol fresenius, Recofol, +11 more1 % 20 ml, 1 % 50 ml, 1 %, 1 % 100 ml, +13 more11 applicants36 registrationsS5
QuetiapineSeroquel, Quetiapine viatris, Seroquel xr, +27 more25 mg, 25 mg / 100 mg / 200 mg / 300mg, 25mg / 100mg / 200mg / 300mg, 50 mg, +5 more21 applicants126 registrationsS5
Reboxetine CancelledEdronax4 mgPfizer Laboratories (Pty) Ltd330246S5
RisperidoneRisperdal, Risperdal consta, Rutra, +31 more0,25 mg, 0,5 mg, 0,50 mg/ 1mg/ 3mg, 1 mg, +19 more23 applicants136 registrationsS5
RomifidineSedivet1 %Boehringer Ingelheim Animal Health South Africa (Pty) Ltd97/2S5
SertralineZoloft, Serlife, Tralidep, +17 more50 mg, 100 mg16 applicants33 registrationsS5
SevofluraneUltane, Sojourn, Sevoflurane baxterbreathed in (inhalation) Liquid, 100 mg3 applicants3 registrationsS5
SulpiridePrem-sulpiride, Sulpiride biotech, Endepex, +2 more5 ml, 50, 200, elixir4 applicants6 registrationsS5
TemazepamVernison, Normison, Temazepam oethmaan10 mg, 20 mg4 applicants4 registrationsS5
TestosteroneTestogel, Testafeme, Testaforte, +2 more10 mg, 50 mg/5 g, 50 mg in 1 ml or 100 mg in 2 ml, 1000 mg3 applicants5 registrationsS5
Testosterone propionateTestosterone propionate, Pasuma50 MG/ ML 10 ML, ampoule2 applicants2 registrationsS5
Testosterone undecanoateTestosterone PD, Nebido1000 mg/ 4 mL, 1000 mg / 4 ml2 applicants2 registrationsS5
TramadolNobligan, Tramal sr, Tramahexal, +16 more50 mg, 50 mg/100 mg, 50mg, 100 mg, +6 more14 applicants38 registrationsS5
TrazodoneAspen trazodone, Bio-trazodone, Zadopax, +3 more50 mg, 100 mg5 applicants12 registrationsS5
TriazolamHalcion0,125, 0,25Pfizer Laboratories (Pty) Ltd2 registrationsS5
TrimipramineTrimipramine bliss, Tydamine10 mg, 25 mg, 502 applicants3 registrationsS5
VareniclineChampix, Nikabex, Cabrexxa, +5 more0,5 mg, 1 mg6 applicants16 registrationsS5
VenlafaxineEfexor xr, Venlor, Odiven, +20 more37,5 mg, 50, 75 mg, 150 mg, +2 more13 applicants56 registrationsS5
VortioxetineBrintellix, Vorellix, Vortioxetine cipla, +13 more2,4 mg, 5 mg, 5 mg/ 10 mg/ 20 mg, 5,10,15,20 mg, +3 more10 applicants50 registrationsS5
Vortioxetine hydrobromide to vortioxetineElibrin5Zydus Healthcare (Pty) Ltd550791S5
XylazineXylavet, Xylavet for horses, Rompun, +1 more2 %, 10 %3 applicants4 registrationsS5
ZiprasidoneGeodon, Geodon im, Zipsid, +3 more20 mg, 20 mg/ml, 40 mg, 60 mg, +1 more4 applicants18 registrationsS5
ZolpidemStilnox, Noxidem, Zolpihexal, +18 more5 mg, 10 mg, 12,5 mg14 applicants28 registrationsS5
ZopicloneSandoz zopiclone, Alchera, Adco zopimed, +12 more3,75 mg, 7,5 mg, 7.5 mg11 applicants17 registrationsS5
ZuclopenthixolClopixol, Clopixol acuphase2 mg, 10 mg, 50 mg/mlAdcock ingram limited3 registrationsS5