Indomethacin

Sold as Gulf indomethacin, Amdocin, Xixia indomethacin, M-indomethacin, Adco-indogel, Aflamin, Indocid, Flamecid, Arthrexin, Rumacid, Indomethacin oethmaan, Restameth-sr, Elmetacin, Indomethacin biotech, Indoflex, Mediflex, Nisaid, Betacin, Flamaret, A-lennon indomethacin, Acuflex, Famethacin

S3Read from the PI-PIL document and verified

C₁₉H₁₆ClNO₄357.80 g/mol

2-[1-(4-Chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid

Drag to rotate. Structure from PubChem CID 3715.

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Registration

Applicants: 17
Registrations: 27
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Gulf Drug Company (Pty) Ltd	Gulf indomethacin	25	270136	Not determined	None
Innovata pharmaceuticals	Amdocin	25 mg	270169	S3	PI PIL
Viatris South Africa (Pty) Ltd	Xixia indomethacin	capsules	280020	Not determined	None
Merck Generics Rsa (Pty) LtdCancelled	M-indomethacin	25 mg	280211	Not determined	None
Adcock ingram limited1 of 3 cancelled	Adco-indogel, Flamecid, Restameth-sr	25	280219, K0174, S0300	Not determined	None
Hexal Pharma (SA) (Pty) Ltd	Aflamin	Not stated	280411	Not determined	None
Pharmacare limited û woodmeadCertificate held by Pharmacare limited1 of 5 cancelled	Indocid, Arthrexin, A-lennon indomethacin	25, 50, 100 mg, capsules	C0504, K0222, K0285, K0286, Z0145	S3	PI PIL
Msd (Pty) Ltd	Indocid	100	C0505	Not determined	None
The Premier Pharmaceutical Co LtdCancelled	Flamecid, Indoflex	50	K0175, V0002	Not determined	None
Alliance Pharma (Pty) Ltd	Rumacid, Nisaid	25	M0211, X0323	Not determined	None
Oethmaan Biosims (Pty) Ltd	Indomethacin oethmaan	25	P0259	Not determined	None
Acino Pharma (Pty) Ltd	Elmetacin	solution	T0173	Not determined	None
Biotech Laboratories (Pty) Ltd	Indomethacin biotech, Famethacin	25 mg	U0177, Z0278	S3	PI PIL
Shanur Healthcare (Pty) Ltd	Mediflex	Not stated	X0167	Not determined	None
Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd	Betacin	25 mg	X0347	S3	PI PIL
Unimed Healthcare (Pty) Ltd	Flamaret	suppositories	X0370, Y0425	Not determined	None
Resmed healthcare	Acuflex	Not stated	Z0219	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Gulf indomethacin 25 EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25	27013627/3.1/0136	Registered	Not determined	None
Amdocin EACHC CAPSULE CONTAINS INDOMETHACIN 25 mg	25 mgCapsules	27016927/3.1/0169Approved 28 April 2024	Registered	S3	PI PIL
Xixia indomethacin capsules* EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	Capsules	28002028/3.1/0020	Registered	Not determined	None
M-indomethacin 25 MG EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25 mg	28021128/3.1/0211	Cancelled	Not determined	None
Adco-indogel EACH 1 g GEL CONTAINS INDOMETHACIN 10 mg	Not listed	28021928/3.1/0219	Cancelled	Not determined	None
Aflamin CAPSULE INDOMETHACIN 25 MG	Not listed	28041128/3.1/0411	Registered	Not determined	None
Indocid 25 EACH CAPSULE CONTAINS INDOMETHACIN A 25 mg	25	C0504	Old Medicine	Not determined	None
Indocid 100 EACH SUPPOSITORY CONTAINS INDOMETHACIN A 100,0 mg	100	C0505	Old Medicine	Not determined	None
Flamecid 25 EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25	K0174K/3.1/174	Registered	Not determined	None
Flamecid 50* EACH CAPSULE CONTAINS INDOMETHACIN 50 mg	50	K0175K/3.1/175	Cancelled	Not determined	None
Arthrexin EACH SUPPOSITORY CONTAINS INDOMETHACIN 100 MG	100 mgSuppositories	K0222K/3.1/222Approved 23 August 2022	Registered	S3	PI PIL
Arthrexin 25 EACH CAPSULE CONTAINS INDOMETHACIN 25 MG	25	K0285K/3.1/285	Registered	Not determined	None
Arthrexin-50 EACH CAPSULE CONTAINS INDOMETHACIN 50 MG	50	K0286K/3.1/286	Registered	Not determined	None
Rumacid EACH SUPPOSITORY CONTAINS INDOMETHACIN 100 mg	Not listed	M0211M/3.2/211	Registered	Not determined	None
Indomethacin 25 oethmaan EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25	P0259P/3.1/259	Registered	Not determined	None
Restameth-sr EACH CAPSULE CONTAINS INDOMETHACIN 75,0 mg	Not listed	S0300S/3.1/300	Registered	Not determined	None
Elmetacin solution EACH GRAM SOLUTION CONTAINS INDOMETHACIN 10,0 mg	Solution	T0173T/3.1/173	Registered	Not determined	None
Indomethacin biotech 25 EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25 mgCapsules	U0177U/3.1/177Approved 6 July 2023	Registered	S3	PI PIL
Indoflex* EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	Not listed	V0002V/3.1/0002	Cancelled	Not determined	None
Mediflex EACH CAPSULE CONTAINS INDOMETHACIN 25,0 mg	Not listed	X0167X/3.1/167	Registered	Not determined	None
Nisaid 25 EACH CAPSULE CONTAINS INDOMETHACIN 25,0 mg	25	X0323X/3.1/323	Registered	Not determined	None
Betacin* EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	25 mgCapsule	X0347X/3.1/347Approved 22 December 2021	Registered	S3	PI PIL
Flamaret suppositories* EACH SUPPOSITORY CONTAINS INDOMETHACIN 100 mg	Suppositories	X0370X/3.1/370	Registered	Not determined	None
Flamaret* EACH CAPSULE CONTAINS INDOMETHACIN 25,0 mg	Not listed	Y0425Y/3.1/425	Registered	Not determined	None
A-lennon indomethacin capsules EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	Capsules	Z0145Z/3.1/145	Cancelled	Not determined	None
Acuflex EACH CAPSULE CONTAINS INDOMETHACIN 25 mg	Not listed	Z0219Z/3.1/219	Registered	Not determined	None
Famethacin EACH CAPSULE CONTAINS :INDOMETHACIN 25 mg	Not listed	Z0278Z/3.1/0278	Registered	Not determined	None

Regulatory status

Where S3 sits on the scale

S0S1S2S3S4S5S6S7S8

Needs a doctor's prescription, dispensed by a pharmacist.

Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S3, read from the product's PI-PIL leaflet.

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; 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

Schedule verified from official documents

Schedule Verification

Amdocin, Innovata pharmaceuticals is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAmdocin, Innovata pharmaceuticals Patient information leaflet (PIL)For patients and carersAmdocin, Innovata pharmaceuticals

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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