Loratadine

Sold as Clarityne, Demazin anti-allergy, Clarityne reditabs, Pollentyme, Ap-loratadine, Clarinese, Lorano, Lordyno, Lorahist, Rhineton non drowsy, Laura, Adco-loratadine, Allergex non drowsy, Rhinigine, Pollentyme s, Ap loratadine, Demazin once a day, Lorurt, Loratadine ascend, Loratadine austell, Cipla loratadine, Lorfast

S2Read from the PI-PIL document and verified

C₂₂H₂₃ClN₂O₂382.90 g/mol

Ethyl 4-(13-chloro-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene)piperidine-1-carboxylate

Drag to rotate. Structure from PubChem CID 3957.

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Registration

Applicants: 14
Registrations: 27
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Bayer (Pty) Ltd û Isando	Clarityne, Demazin anti-allergy, Clarityne reditabs	effervescent, tablets, syrup	300493, 310364, 310509, 310511, U0027, Z0056	Not determined	None
Astral Pharma (Pty) Ltd	Pollentyme, Pollentyme s	tablets	340507, 370547	Not determined	None
Pharmacare limited û woodmead	Ap-loratadine, Clarinese, Ap loratadine	10 mg, syrup	350084, 350288, 380083, 380087	Not determined	None
Trinity Pharma (Pty) Ltd	Lorano	10	350354	Not determined	None
Biotech Laboratories (Pty) Ltd	Lordyno	10 mg	350355	Not determined	PI PIL
Adcock ingram limited1 of 3 cancelled	Lorahist, Adco-loratadine, Allergex non drowsy	syrup, 5 mg/5 ml, tablets	360008, 360285, 360286	Not determined	None
Ranbaxy (SA) (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd, Ranbaxy Pharmaceuticals (Pty) Ltd.	Rhineton non drowsy, Lorfast	10 mg	360231, A380621	S2	PI PIL
Ranbaxy Pharmaceutical (Pty) Ltd	Laura	10	360232	Not determined	None
Viatris South Africa (Pty) Ltd	Rhinigine	Not stated	370405	Not determined	None
Inova Pharmaceuticals (Pty) Ltd	Demazin once a day	Not stated	410119	Not determined	None
Hetero Drugs South Africa (Pty) Ltd	Lorurt	Not stated	530406	Not determined	None
Ascend Laboratories (Pty) Ltd	Loratadine ascend	syrup, tablet	561149, 570298	Not determined	None
Austell Pharmaceuticals (Pty) Ltd	Loratadine austell	10 mg	A380380	Not determined	None
Cipla Medpro (Pty) Ltd	Cipla loratadine	Not stated	A380491	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Clarityne effervescent EACH TABLET CONTAINS LORATADINE 10 mg	Effervescent	30049330/5.7.1/0493	Registered	Not determined	None
Demazin anti-allergy tablets EACH TABLET CONTAINS LORATADINE 10,0 mg	Tablets	31036431/5.7.1/0364	Registered	Not determined	None
Clarityne reditabs EACH TABLET CONTAINS LORATADINE 10,0 mg	Not listed	31050931/5.7.1/0509	Registered	Not determined	None
Demazin anti-allergy syrup EACH 5,0 ml SYRUP LORATADINE 5,0 mg	Syrup	31051131/5.7.1/0511	Registered	Not determined	None
Pollentyme tablets EACH TABLET CONTAINS :LORATADINE 10,0 mg	Tablets	34050734/5.7.1/0507	Registered	Not determined	None
Ap-loratadine 10 MG tablets EACH TABLET CONTAINS LORATADINE 10,0 mg	10 mgTablets	35008435/5.7.1/0084	Registered	Not determined	None
Clarinese 10 MG tablets EACH TABLET CONTAINS LORATADINE 10,0 mg	10 mgTablets	35028835/5.7.1/0288	Registered	Not determined	None
Lorano 10 EACH TABLET CONTAINS LORATADINE 10,0 mg LORATADINE 10,0 mg	10	35035435/5.7.1/0354	Registered	Not determined	None
Lordyno EACH TABLET CONTAINS LORATADINE 10,0 mg	10 mgTablet.	35035535/5.7.1/0355Approved 30 September 2021	Registered	Not determined	PI PIL
Lorahist syrup EACH 5,0 ml SYRUP CONTAINS LORATADINE 5,0 mg	Syrup	36000836/5.7.1/0008	Registered	Not determined	None
Rhineton non drowsy EACH TABLET CONTAINS: LORATADINE 10,0 mg	10 mgTablets	36023136/5.7.1/0231Approved 15 August 2022	Registered	S2	PI PIL
Laura 10 tablets EACH TABLET CONTAIN: LORATADINE 10,0 mg	10Tablets	36023236/5.7.1/0232	Registered	Not determined	None
Adco-loratadine 5 mg/5 ML EACH 1,0 ml SYRUP CONTAINS LORATADINE 1,0 mg	5 mg/5 ml	36028536/5.7.1/0285	Cancelled	Not determined	None
Allergex non drowsy tablets EACH TABLET CONTAINS LORATADINE 10,0 mg	Tablets	36028636/5.7.1/0286	Registered	Not determined	None
Rhinigine EACH TABLET CONTAINS LORATADINE 10,0 mg	Not listed	37040537/5.7.1/0405	Registered	Not determined	None
Pollentyme s EACH 5,0 ml SYRUP CONTAINS LORATADINE 5,0 mg	Not listed	37054737/5.7.1/0547	Registered	Not determined	None
Ap loratadine syrup EACH 5,0 ml SYRUP CONTAINS LORATADINE 5,0 mg	Syrup	38008338/5.7.1/0083	Registered	Not determined	None
Clarinese syrup EACH 5,0 ml SOLUTION CONTAINS LORATADINE 5,0 mg	Syrup	38008738/5.7.1/0087	Registered	Not determined	None
Demazin once a day EACH TABLET CONTAINS LORATADINE 10,0 mg	Not listed	41011941/5.7.1/0119	Registered	Not determined	None
Lorurt EACH 5,0 ml SOLUTION CONTAINS LORATADINE 5,0 mg	Not listed	53040653/5.7.1/0406	Registered	Not determined	None
Loratadine syrup ascend EACH 5,0 ml SOLUTION CONTAINS LORATADINE 5,0 mg	Syrup	56114956/5.7.1/1149	Registered	Not determined	None
Loratadine tablet ascend Each Tablet contains: Loratadine 10,0 mg	Tablet	57029857/5.7.1/0298	Registered	Not determined	None
Loratadine 10 MG austell EACH TABLET CONTAINS LORATADINE 10,0 mg	10 mg	A380380A38/5.7.1/0380	Registered	Not determined	None
Cipla loratadine EACH TABLET CONTAINS LORATADINE 10,0 mg	Not listed	A380491A38/5.7.1/0491	Registered	Not determined	None
Lorfast EACH TABLET CONTAINS LORATADINE 10,0 mg	10 mgTablet	A380621A38/5.7.1/0621Approved 9 October 2022	Registered	S2	PI PIL
Clarityne tablets TABLET LORATADINE 1O MG	Tablets	U0027U/5.7.1/27	Registered	Not determined	None
Clarityne syrup EACH 5 ml SYRUP CONAINS LORATADINE 5 mg	Syrup	Z0056Z/5.7.1/56	Registered	Not determined	None

Regulatory status

Where S2 sits on the scale

S0S1S2S3S4S5S6S7S8

A pharmacist can sell it directly, without a prescription.

Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S1; the leaflet's S2 applies to this product.

Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Loratadine

S1: Loratadine
Consolidated Schedules 06 July 2026, line 805

Pharmacological class: Antihistaminics. (class 5.7.1)

2 of 2 approved products with this ingredient carry S2 on their leaflet.

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

Professional information (PI)For healthcare professionalsLordyno, Biotech Laboratories (Pty) Ltd Patient information leaflet (PIL)For patients and carersLordyno, Biotech Laboratories (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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