Hyoscine butylbromide (Butyronex)
Hyoscine butylbromide
Lebasi Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Lebasi Pharmaceuticals (Pty) Ltd
- Registrations
- 1
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Butyronex 20 EACH 1,0 ml VIAL CONTAINS HYOSCINE BUTYLBROMIDE 20,0 mg | 20 | 56026856/11.2/0268 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S3: Hyoscine butylbromide
- substances, preparations and mixtures thereof-
- except when intended for oral administration; (S1, S2) and
- except transdermal preparations when intended for the prevention of the symptoms of motion sickness. (S2)
Consolidated Schedules 06 July 2026, lines 3727 to 3732
S2: Hyoscine butylbromide
- substances, preparations and mixtures thereof-
- when intended for oral administration in pack sizes exceeding 20 tablets or 100 ml, or strengths exceeding 10 mg per oral solid dosage form or 0.1% mass/ volume; (S1)
- transdermal preparations when intended for the prevention of the symptoms of motion sickness; (S3)
- except when intended for parenteral administration. (S3)
Consolidated Schedules 06 July 2026, lines 2119 to 2124
S1: Hyoscine butylbromide
- substances, preparations and mixtures thereof-
- when intended for oral administration in pack sizes not exceeding 20 tablets of 10 mg strength or less, or 100 ml of oral liquid dosage of 0.1% mass/ volume or less; (S2)
- except transdermal preparations when intended for the prevention of the symptoms of motion sickness; (S2)
- except when intended for parenteral administration. (S3)
Consolidated Schedules 06 July 2026, lines 523 to 529
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.