Esomeprazole, naproxen (Rarzulite, Vimovo)
Esomeprazole, naproxen
Adcock ingram limited
Registration
- Applicant
- Adcock ingram limited
- Registrations
- 2
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rarzulite 500/20 EACH TABLET CONTAINS ESOMEPRAZOLE 20,0 mg NAPROXEN 500,0 mg | 500/20 | 45012045/3.1/0120 | Registered | Not determined | None |
| Vimovo 500/20 EACH TABLET CONTAINS ESOMEPRAZOLE 20,0 mg NAPROXEN 500,0 mg | 500 mg/20 mgFilm-coated tablet | 45017945/3.1/0179Approved 21 July 2022 | Registered | Not determined | PIPIL |
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
S4: Esomeprazole
- except when indicated for the temporary, short-term relief of heartburn and hyperacidity, subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S2)
Consolidated Schedules 06 July 2026, lines 6239 to 6244
S3: Naproxen
- when contained in preparations intended for application to the skin; (S1, S2)
- when contained in oral medicinal preparations, intended for human use only containing naproxen as the only active therapeutic substance intended for patients over 16 years of age, for the treatment of mild to moderate pain or fever of inflammatory origin at a maximum dose of 600 milligrams naproxen base (660 milligrams naproxen sodium) in a 24 hour period for a maximum treatment period of 5 days and supplied in a solid dose form as divided doses contained in packs not exceeding the stated maximum treatment peroid. (S1, S2)
- when intended for the treatment of acute gout attacks, for a maximum treatment period of 5 days in patients over 16 years of age. (S1, S2)
Consolidated Schedules 06 July 2026, lines 3978 to 3994
S2: Esomeprazole
- when indicated for the temporary, short-term relief of heartburn and hyperacidity subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S4)
Consolidated Schedules 06 July 2026, lines 1921 to 1925
S2: Naproxen
- when intended for the treatment of acute gout attacks, for a maximum treatment period of 5 days in patients over 16 years of age; (S3)
- except when contained in preparations intended for application to the skin;(S1) and
- except when contained in oral medicinal preparations, intended for human use only containing naproxen as the only active therapeutic substance intended for patients over 16 years of age, for the treatment of mild to moderate pain or fever of inflammatory origin at a maximum dose of 600 milligrams naproxen base (660 milligrams naproxen sodium) in a 24 hour period for a maximum treatment period of 5 days and supplied in a solid dose form as divided doses contained in packs not exceeding the stated maximum treatment period; (S1, S3)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 2368 to 2386
S1: Naproxen
- when contained in preparations intended for application to the skin; (S2, S3)
- when contained in oral medicinal preparations, intended for human use only containing naproxen as the only active therapeutic substance intended for patients over 16 years of age, for the treatment of mild to moderate pain or fever of inflammatory origin at a maximum dose of 600 milligrams naproxen base (660 milligrams naproxen sodium) in a 24 hour period for a maximum treatment period of 5 days and supplied in a solid dose form as divided doses contained in packs not exceeding the stated maximum treatment period; (S2, S3)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 866 to 877
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.