MedPath
HSA Approval

NAUSICALM TABLET 50MG

SIN15193P

NAUSICALM TABLET 50MG

NAUSICALM TABLET 50MG

March 20, 2017

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAPEX PHARMA MARKETING PTE. LTD.
Licence HolderAPEX PHARMA MARKETING PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET

**Dosage and Administration** _For the Treatment of nausea induced by radiotherapy:_ Adults and children over 12 Years: One tablet every 6 to 8 hours, as required with a little water (up to a maximum of 3 tablets in 24 hours) Use in the Elderly: There have been no specific studies of cyclizine in the elderly. Experience has indicated that normal adult dosage is appropriate. _For the Prevention of Travel Sickness:_ Adults and children over 12 Years: One tablet every 6 to 8 hours (up to a maximum of 3 tablets in 24 hours), as required with a little water, first taken 1–2 hours before departure. The score line only serves to facilitate breaking for ease of swallowing and does not divide the tablet into equal half-doses. **This product should not be used for more than 48 hours at a time**

ORAL

Medical Information

**Indications** Nausicalm is indicated for the prevention and treatment of nausea and vomiting associated with motion sickness and radiotherapy.

**Contraindications** Nausicalm should not be given to individuals with known hypersensitivity to cyclizine or in individuals with severe heart failure.

R06AE03

cyclizine

Manufacturer Information

APEX PHARMA MARKETING PTE. LTD.

Sigma Laboratories Ltd.

Active Ingredients

Cyclizine hydrochloride

50mg

Cyclizine

Documents

Package Inserts

Nausicalm Tablet PI.pdf

Approved: June 14, 2017

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NAUSICALM TABLET 50MG - HSA Approval | MedPath