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  4. ACUGESIC CAPSULE 50 MG [SIN08953P]

ACUGESIC CAPSULE 50 MG [SIN08953P]

Active ingredients: ACUGESIC CAPSULE 50 MG

Last updated 26 October 2025

Product Info

ACUGESIC CAPSULE 50 MG

[SIN08953P]

Product information

Active Ingredient and Strength

TRAMADOL HCL - 50 MG

Dosage Form

CAPSULE

Manufacturer and Country

DUOPHARMA (M) SDN BHD - MALAYSIA

Registration Number

SIN08953P

Licence Holder

DUOPHARMA (SINGAPORE) PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

N02AX02

INDICATION:
Severe acute and chronic pain.

RECOMMENDED DOSAGE:
The dosage should be adjusted to the intensity of the pain. Unless otherwise prescribed, TRAMADOL should be taken as follow - independent of meals:
Adults and adolescents (12 years and older): Acugesic is not approved for use in patients below 12 years old.
Paediatric population: The safety and efficacy of Acugesic has not been studied in the paediatric population. Therefore, use of Acugesic is not recommended in patients under 12 years of age.
Single dose for adults and adolescents over 12 years of age: 1 capsule/tablet to be taken with a little liquid. This is usually sufficient to relieve the pain. If, however, pain relief is unsatisfactory, a further TRAMADOL capsule/tablet can be taken after about 30–60 minutes. In general, the daily dose should not exceed 400 mg Tramadol HCl (equivalent to 8 TRAMADOL capsules/tablets). In impaired renal or hepatic function it may be necessary to adjust the dose.
Duration of treatment: During long-term treatment with TRAMADOL 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 Therefore, the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily. TRAMADOL should not be given for longer than therapeutically necessary.

CONTRAINDICATIONS:
Acute intoxication with alcohol, hypnotics, analgesics or other CNS-acting drugs and hypersensitivity to tramadol or any excipients.
Note: In accordance with currently prevailing recommendation medication with the preparation during pregnancy should only be resorted to after careful consideration of the risks. So far no reports are available on its use during lactation. The preparation should be used with care in patients with increased reactivity to opioids.

  • Children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

  • Adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

  • In patients who are receiving MAO inhibitors or who have taken them within the last 14 days.

  • In patients with epilepsy not adequately controlled by treatment.