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HSA Approval

HORGESIC TABLET 35MG/450MG

SIN16415P

HORGESIC TABLET 35MG/450MG

HORGESIC TABLET 35MG/450MG

January 7, 2022

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGOLDPLUS UNIVERSAL PTE LTD
Licence HolderGOLDPLUS UNIVERSAL PTE LTD

Product Classification

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

Formulation Information

TABLET

**Dosage and Administration** Adult:Oral, 1 to 2 tablets three to four times daily up to a maximum of 8 tablets per day.Children:Not recommended in children. Note: The information given here is limited. For further information consult your doctor or pharmacist.

ORAL

Medical Information

**Indications** Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.

**Contraindications** Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis.

M03BC51

orphenadrine, combinations

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Hovid Berhad

Active Ingredients

Orphenadrine Citrate

35 mg

Orphenadrine

Paracetamol

450 mg

Acetaminophen

Documents

Package Inserts

Horgesic Tablet PI.pdf

Approved: January 7, 2022

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