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HSA Approval

PENGESIC CAPSULE 50 mg

SIN10512P

PENGESIC CAPSULE 50 mg

PENGESIC CAPSULE 50 mg

December 8, 1998

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

CAPSULE

**DOSAGE AND ADMINISTRATION** Oral, 50mg orally. The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, Pengesic should be taken as follows – independent of meals: Single dose: For adults and adolescents over 14 years of age: One 50 mg capsule to be taken with a little liquid. This is usually sufficient to relieve the pain. However, if pain relief is unsatisfactory, a further 50mg capsule may be taken after about 30–60 minutes. In general the daily dose: Should not exceed 400mg Pengesic. In impaired renal or hepatic function it may be necessary to adjust the dose. Duration of treatment: During long-term treatment with Pengesic, the possibility of dependence cannot be entirely excluded. Therefore the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily. Pengesic should not be given for longer than therapeutically necessary. Note: The information given here is limited. For further information, consult your doctor or pharmacist.

ORAL

Medical Information

**INDICATIONS** In the treatment of moderate to severe acute or chronic pain and in painful diagnostic or therapeutic measures.

**CONTRAINDICATIONS** It is generally contraindicated in the following conditions: - Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. - In the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised. - It should not be used in patients receiving MAO inhibitors. - Previous hypersensitivity to Pengesic.

N02AX02

tramadol

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

HOVID BHD

HOVID Bhd.

Active Ingredients

TRAMADOL HCl

50.00 mg

Tramadol

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PENGESIC CAPSULE 50 mg - HSA Approval | MedPath