Regulatory PathRegulatory requirements compared

Active substance

Hyoscine butylbromide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BUSCOPAN TABLETS 10MG10 mgTablet · Oral use20 BlisterSAR 14.00NCE · OTCA. Nattermann and Cie GmbhValid
DEFOPAN 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 10.80Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
HYOPAN SYRUP 5 MG-5 ML1 mg/mlSyrup · Oral use1 BottleSAR 10.80Generic · OTCKUWAIT SAUDI PHARMACEUTICAL INDUSTRIESValid
Hyponal20 mg/mlSolution for injection · Intramuscular and intravenous use5 AmpouleSAR 8.45Generic · PrescriptionEgyptian International Pharmaceutical Industries Company (EIPICO)Valid
NOSPASM 10 MG TAB10 mgTablet · Oral use30 BlisterSAR 16.25Generic · OTCSPIMACO ADDWAEIHValid
SCOPINAL 20MG AMPOULE20 mgSolution for injection · Intravenous use5 AmpouleSAR 12.70Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
SCOPINAL 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 10.80Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
SCOPINAL TAB 10MG10 mgFilm-coated tablet · Oral use20 BlisterSAR 7.40Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
SPASMOPAN 10MG TAB.10 mgTablet · Oral use20 BlisterSAR 7.40Generic · OTCTHE ARAB PHARMACEUTICAL MANUFACTURING PSC - SultValid
SPASMOPAN 20MG AMP.20 mg/mlInjection · Intravenous use5 AmpouleSAR 12.70Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Spasmopan10 mgCoated tablet · Oral use1000 BlisterSAR 158.80Generic · OTCTHE ARAB PHARMACEUTICAL MANUFACTURING COMPANYValid
BUSCOPAN TABLETS 10MG10 mgTablet · Oral use20 BlisterSAR 11.65NCE · OTCBOEHRINGER INGELHEIMWithdrawn by MAH · Not Marketed
HOLOPON TAB 1MG1 mgTablet · Oral use20 Tablet ContainerSAR 8.65Generic · OTCNYCOMEDWithdrawn by MAH · Not Marketed
HYOBAN 10MG F.C TABLET10 mgFilm-coated tablet · Oral use30 BlisterSAR 9.20Generic · OTCTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
RIASPASM1 mg/mlSyrup · Oral use1 BottleSAR 7.30Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIASPASM 10 mg film-coated tablet10 mgFilm-coated tablet · Oral use20 BlisterSAR 6.80Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
SPASMO- H 10MG FILM COATED TABLETS10 mgFilm-coated tablet · Oral use20 BlisterSAR 4.60Generic · OTCSHAPHACO PHARMACEUTICALInvalid · Not Marketed
SPASMONORE SUPP.ADULT10 mgSuppository · Rectal use5 BlisterSAR 1.70NCE · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
SPASMONORE SUPP.CHILD 7.5MG7.5 mgSuppository · Rectal use5 BlisterSAR 1.40NCE · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
SPASMONORE TAB 10MG10 mgTablet · Oral use30 BlisterSAR 3.15Generic · OTCThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ABDOMINAL SPASM; ANESTHESIA-SUPPORTIVE AGENTS/ INHIBITION OF SALIVARY GLAND AND RESPIRATORY TRACT SECRETIONS; IRRITABLE BOWEL SYNDROME

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACCEL-HYOSCINE0251233510 MGTABLET · ORALACCEL PHARMA INC
BUSCOPAN0036381210 MGTABLET · ORALSANOFI CONSUMER HEALTH INC
BUSCOPAN0036383920 MG / MLSOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULARSANOFI CONSUMER HEALTH INC
HYOSCINE BUTYLBROMIDE INJECTION0222986820 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
HYOSCINE BUTYLBROMIDE INJECTION BP0250841920 MG / MLSOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULAROMEGA LABORATORIES LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffHyoscine butylbromide 10mg tablets£6.5356 tablet1 Oct 2026
NHS Drug TariffHyoscine butylbromide 20mg tablets£15.95100 tablet1 Oct 2026
NHS Drug TariffHyoscine butylbromide 20mg/1ml solution for injection ampoules£4.1910 ampoule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 2.3. Medicines for other common symptoms in palliative care · core
    Palliative care
    Parenteral > General injections > unspecified: 20 mg per mL injection

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.