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Paracetamol, tramadol

Sold as Tramacet, Tramaspen co, Ultracet, Tramazac co, * cetromal, Synotram plus, Trampar odt, Patram, Tamoltra, Temrez, Paracetamol/tramadol cipla, Panrex, Dolotram plus, Painogesic co, Tramadol/paracetamol austell, Tramadol/paracetamol camox, Quelgez, Domadol plus, Trempamol, Cepatresic, Trampangic, Tramadol/ paracetamol ascendis

S5Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
15
Registrations
23
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Janssen Pharmaceutica (Pty) LtdCertificate held by Janssen pharmaceuticaTramacet, Ultracet37.5 mg / 25 mg, 37,5 mg/325 mg350010, 440931S5PIPIL
Pharmacare limited û woodmeadCertificate held by Pharmacare limitedTramaspen co37,5 mg/325 mg440880S5PIPIL
Zydus Healthcare (Pty) LtdCertificate held by Zydus Healthcare SA (Pty) LtdTramazac co, * cetromal37,5, 37,5 mg and 325 mg450303, 450304S5PIPIL
Cospharm Investments (Pty) LtdSynotram plus, Trampar odtNot stated450679, 450680.679Not determinedNone
Ranbaxy Pharmaceuticals (Pty) LtdPatram37,5 mg460449S5PIPIL
Pharma Dynamics (Pty) LtdTamoltra75/650 mg, 37,5/325 mg460976S5PIPIL
Oethmaan Biosims (Pty) LtdTemrez, Panrex37.5/325471053, 480447S5PIPIL
Cipla Medpro (Pty) LtdCancelledParacetamol/tramadol cipla325 mg/37,5 mg, 650 mg/75 mg480066, 480067Not determinedNone
Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) LtdDolotram plus37,5 mg AND 325 mg480698S5PIPIL
Astral Pharma (Pty) LtdPainogesic coNot stated480774Not determinedNone
Austell Pharmaceuticals (Pty) LtdTramadol/paracetamol austell, Tramadol/paracetamol camox37,5/325 mg491063, 491064Not determinedNone
Shanur Healthcare (Pty) LtdQuelgezNot stated491065Not determinedNone
Unichem SA (Pty) LtdDomadol plus, TrempamolNot stated540185, 540186.185Not determinedNone
Biotech Laboratories (Pty) LtdCertificate held by Biotech Laboratories (Pty) Ltd.Cepatresic, Trampangic37,5/325560429, 560430.429S5PIPIL
Ascendis Pharma (Pty) LtdTramadol/ paracetamol ascendis37,5/325 mg570262Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Tramacet

EACH TABLET CONTAINS PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

37.5 mg / 25 mgTablets35001035/2.9/0010Approved 1 September 2022RegisteredS5PIPIL
Tramaspen co37,5 mg/325 mgFilm-coated tablets44088044/2.9/0880Approved 24 August 2023RegisteredS5PIPIL
Ultracet

EACH TABLET CONTAINS PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

37,5 mg/325 mgFilm coated tablets44093144/2.9/0931Approved 1 September 2022RegisteredS5PIPIL
Tramazac co 37,5

EACH TABLET CONTAINS PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

37,5Film-coated tablets45030345/2.9/0303Approved 1 March 2024RegisteredS5PIPIL
* cetromal

EACH TABLET CONTAINS :PARACETAMOL 325,0 mg, TRAMADOL HYDROCHLORIDE 37,5 mg

37,5 mg and 325 mgFilm-coated tablets.45030445/2.9/0304Approved 1 March 2024RegisteredS5PIPIL
Synotram plus

Each Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol 325,0 mg

Not listed45067945/2.8/0679RegisteredNot determinedNone
Trampar odt

Each Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol 325,0 mg

Not listed450680.67945/2.8/0680.679RegisteredNot determinedNone
Patram

EACH TABLET CONTAINS PARACETAMOL 325,0 mg, TRAMADOL HYDROCHLORIDE 37,5 mg

37,5 mgFilm-coated tablets.46044946/2.9/0449Approved 4 February 2026RegisteredS5PIPIL
Tamoltra

EACH TABLET CONTAINS PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

75/650 mg, 37,5/325 mgFilm-coated tablets.46097646/2.9/0976Approved 27 February 2025RegisteredS5PIPIL
Temrez 37.5/325

Each Film coated Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol 325,0 mg

37.5/325Film-coated tablets.47105347/2.9/1053Approved 16 August 2023RegisteredS5PIPIL
Paracetamol/tramadol 325 mg/37,5 MG cipla

EACH TABLET CONTAINS : PARACETAMOL 325,0 mg TRAMADOL HYDROCHLORIDE 37,5 mg

325 mg/37,5 mg48006648/2.9/0066CancelledNot determinedNone
Paracetamol/tramadol 650 mg/75 MG cipla

EACH TABLET CONTAINS : PARACETAMOL 650,0 mg TRAMADOL HYDROCHLORIDE 75,0 mg

650 mg/75 mg48006748/2.9/0067CancelledNot determinedNone
Panrex 37.5/325

Each Film coated Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol 325,0 mg

37.5/325Film-coated tablets.48044748/2.9/0447Approved 16 August 2023RegisteredS5PIPIL
Dolotram plus

EACH TABLET CONTAINS: TRAMADOL HYDROCHLORIDE 37,5 mg PARACETAMOL 325,0 mg

37,5 mg AND 325 mgFilm-coated tablets.48069848/2.9/0698Approved 22 August 2025RegisteredS5PIPIL
Painogesic co

Each Tablet contains: Tramadol Hydrochloride 37,5 mg, Paracetamol 325,0 mg

Not listed48077448/2.9/0774RegisteredNot determinedNone
Tramadol/paracetamol 37,5/325 MG austell

EACH TABLET CONTAINS: TRAMADOL HYDROCHLORIDE 37,5 mg PARACETAMOL 325,0 mg

37,5/325 mg49106349/2.9/1063RegisteredNot determinedNone
Tramadol/paracetamol 37,5/325 MG camox

EACH TABLET CONTAINS: TRAMADOL HYDROCHLORIDE 37,5 mg PARACETAMOL 325,0 mg

37,5/325 mg49106449/2.9/1064RegisteredNot determinedNone
Quelgez

Each Tablet contains: Tramadol Hydrochloride 37,5 mg ; Paracetamol 325,0 mg

Not listed49106549/2.9/1065RegisteredNot determinedNone
Domadol plus

EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 37,5,0 mg PARACETAMOL 325,0 mg

Not listed54018554/2.9/0185RegisteredNot determinedNone
Trempamol

EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 37,5,0 mg PARACETAMOL 325,0 mg

Not listed540186.18554/2.9/0186.185RegisteredNot determinedNone
Cepatresic 37,5/325

EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 37,5 mg PARACETAMOL 325,0 mg

37,5/325Film-coated tablets56042956/2.9/0429Approved 23 April 2024RegisteredS5PIPIL
Trampangic 37,5/325

EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 37,5,0 mg PARACETAMOL 325,0 mg

37,5/325Film-coated tablets560430.42956/2.9/0430.429Approved 23 April 2024RegisteredS5PIPIL
Tramadol/ paracetamol 37,5/325 MG ascendis

EACH TABLET CONTAINS: TRAMADOL HYDROCHLORIDE 37,5 mg PARACETAMOL 325,0 mg

37,5/325 mg57026257/2.9/0262RegisteredNot determinedNone

Regulatory status

Where S5 sits on the scale

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.

Consolidated Schedules listings for Paracetamol, tramadol hydrochloride

  • S5: Tramadol

    Consolidated Schedules 06 July 2026, line 9725

  • S3: Paracetamol

    • when intended for injection.

    Consolidated Schedules 06 July 2026, line 4093

  • S2: Paracetamol

    • when contained in rectal suppositories, or
    • when contained in modified release formulations. (S0, S1, S3)

    Consolidated Schedules 06 July 2026, lines 2496 to 2500

  • S1: Paracetamol

    • immediate release tablets or capsules each containing 500 milligrams or less of paracetamol, or in individually wrapped powders or in sachets containing 1 000 milligrams or less of paracetamol, subject to - (i) a maximum of 12,5 grams of paracetamol per primary pack, and (ii) in the case of tablets or capsules, presented in blister strip packaging or in containers with child-resistant closures; and (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
    • in liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres or in paediatric drops containing 120 milligrams or less of paracetamol per 1,2 millilitres, subject to - (i) a maximum of 100 millilitres per primary pack in the case of the liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres; (ii) a maximum of 20 millilitres per primary pack in the case of the paediatric drops; (iii) labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton): “CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)
    • when contained in rectal suppositories. (S2)
    • when contained in modified release formulations. (S2)
    • when intended for injection. (S3)

    Consolidated Schedules 06 July 2026, lines 958 to 997

Pharmacological class: Other analgesics. (class 2.9)

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

Tramacet, Janssen Pharmaceutica (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsTramacet, Janssen Pharmaceutica (Pty) LtdPatient information leaflet (PIL)For patients and carersTramacet, Janssen Pharmaceutica (Pty) Ltd

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

Research articles

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