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HSA Approval

PACOFEN TABLETS

SIN06271P

PACOFEN TABLETS

PACOFEN TABLETS

May 7, 1991

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Regulatory Information

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Therapeutic

Pharmacy Only

Formulation Information

TABLET

**DOSAGE:** **Adults:** 1–2 tablets These doses may be given 3–4 times daily as required (Max. 6 tablets a day). **Children and adolescents** Codeine should not be used in children below 12 years old. In those 12 years old and above, codeine may be used for the short-term treatment of acute moderate pain which is not relieved by analgesics such as Ibuprofen or paracetamol alone. The lowest effective dose should be used for the shortest possible duration.

ORAL

Medical Information

**INDICATIONS:** For relief of aches and pain e.g., headache, toothache and dysmenorrhoea. Codeine is not recommended for the treatment of post-operative pain following surgical procedures such as tonsillectomy or adenoidectomy in children and adolescents below 18 years old due to the increased risk of respiratory depression.

**CONTRA-INDICATIONS:** Contraindicated in patients with bronchial asthma, increased intracranial pressure, respiratory depression and nephropathy.

N02BE51

paracetamol, combinations excl. psycholeptics

Manufacturer Information

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

BEACONS PHARMACEUTICALS PTE. LTD.

SRI KRISHNA PHARMACEUTICALS LTD [Intermediate manufacturer]

Active Ingredients

Paracetamol

500 mg

Acetaminophen

Codeine Phosphate

8 mg

Codeine

Caffeine Anhydrous

30 mg

Caffeine

Documents

Package Inserts

Pacofen Tablet PIL.pdf

Approved: March 10, 2022

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