Hyoscine-n-butyl
Sold as Hyoscine-butyl bromide unimed, A-lennon hyoscine butylbromide, Pharma-q hyoscine butylbromide, Scopex, *Hyoscine butylbromide fresenius, Hyospasmol, Unispasmol, Buscopan, Tranquo-buscopan, Hyospasmol tabblet
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 7
- Registrations
- 16
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unimed Healthcare (Pty) Ltd | Hyoscine-butyl bromide unimed | 20 mg/1 ml | 270427 | Not determined | None |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited | A-lennon hyoscine butylbromide, Hyospasmol, Hyospasmol tabblet | 5 ml, 10 mg, 20mg/1ml, 20 mg, injection | 290560, 310467, A390353, L0059, L0060 | S1 | PIPIL |
| Pharma-q Holdings (Pty) Ltd | Pharma-q hyoscine butylbromide | 20 mg/ml | 320242 | Not determined | None |
| Adcock ingram limitedCertificate held by Adcock Ingram Limited (Pty) Ltd.1 of 4 cancelled | Scopex, Unispasmol | 5 mg, 10 mg, injection | 360327, C0503, C0674, C0688 | Not determined | PIPIL |
| Fresenius Kabi Manufacturing SA (Pty) Ltd | *Hyoscine butylbromide fresenius | 20 mg/ml | 410269 | Not determined | None |
| Sanofi-aventis South Africa (Pty) Ltd | Buscopan | 0,1 %, 10 mg, 20 mg/1 ml | E0500, E0501, Z0093 | Not determined | None |
| Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale | Tranquo-buscopan | Not stated | E0638 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hyoscine-butyl bromide 20 mg/1 ML unimed EACH 1 ml SOLUTION CONTAINS HYOSCINE-N-BUTYL BROMIDE 20 mg | 20 mg/1 ml | 27042727/5.4/0427 | Registered | Not determined | None |
| A-lennon hyoscine butylbromide 20mg/1ml injection EACH 1 ml CONTAINS HYOSCINE-N-BUTYL BROMIDE 20 mg | 20mg/1mlInjection | 29056029/11.2/0560 | Registered | Not determined | None |
| A-lennon hyoscine butylbromide 20 MG EACH 1 ml SOLUTION CONTAINS HYOSCINE-N-BUTYL BROMIDE 20,0 mg | 20 mg | 31046731/11.2/0467 | Registered | Not determined | None |
| Pharma-q hyoscine butylbromide injection 20 mg/ml EACH 1,0 ML SOLUTION CONTAINS HYOSCINE-N-BUTYL BROMIDE 20,0 mg | 20 mg/mlInjection | 32024232/11.2/0242 | Registered | Not determined | None |
| Scopex syrup EACH 5,0 ml SYRUP CONTAINS HYOSCINE-N-BUTYL BROMIDE 5,0 mg | 5 mgSyrup | 36032736/11.2/0327Approved 9 June 2021 | Registered | Not determined | PIPIL |
| *Hyoscine butylbromide 20 mg/ml fresenius EACH 1,0 ml SOLUTION CONTAINS: HYOSCINE-N-BUTYL BROMIDE 20,0 mg | 20 mg/ml | 41026941/11.2/0269 | Registered | Not determined | None |
| Hyospasmol syrup EACH 5,0 ml SYRUP CONTAINS HYOSCINE-N-BUTYL BROMIDE 5,0 mg | 5 mlSyrup | A390353A39/11.2/0353Approved 11 August 2006 | Registered | S1 | PIPIL |
| Unispasmol EACH TABLET CONTAINS HYOSCINE-N-BUTYL BROMIDE A 10 mg | Not listed | C0503 | Cancelled | Not determined | None |
| Scopex tablets EACH TABLET CONTAINS :HYOSCINE-N-BUTYL BROMIDE A 10,0 mg | 10 mgFilm-coated tablet | C0674Approved 8 September 2021 | Old Medicine | Not determined | PIPIL |
| Scopex injection 1 ML HYOSCINE-N-BUTYL BROMIDE A 20 MG | Injection | C0688 | Old Medicine | Not determined | None |
| Buscopan 20 mg/1 ML EACH 1,0 ml SOLUTION CONTAINS HYOSCINE-N-BUTYL BROMIDE A 20,0 mg | 20 mg/1 ml | E0500 | Old Medicine | Not determined | None |
| Buscopan 10 MG EACH TABLET CONTAINS HYOSCINE-N-BUTYL BROMIDE A 10 mg | 10 mg | E0501 | Old Medicine | Not determined | None |
| Tranquo-buscopan TABLET HYOSCINE-N-BUTYL BROMIDE A 10 MG | Not listed | E0638 | Old Medicine | Not determined | None |
| Hyospasmol tabblet 10 MG EACH TABLET CONTAINS HYOSCINE-N-BUTYL BROMIDE 10 MG | 10 mg | L0059L/11.2/59 | Registered | Not determined | None |
| Hyospasmol injection EACH 1 ml CONTAINS HYOSCINE-N-BUTYL BROMIDE 20 mg | Injection | L0060L/11.2/60 | Registered | Not determined | None |
| Buscopan 0,1 % EACH 5 ml SYRUP CONTAINS HYOSCINE-N-BUTYL BROMIDE 5 mg | 0,1 % | Z0093Z/11.2/93 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
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.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.