Partamol Codeine Tab.

Rx

Indications:

The treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone) in patients older than 12 years of age.

Dosage:

• Partamol-Codeine should be used at the lowest effective dose for the shortest period of time. Dosage should be adjusted according to severity of pain and response of patients.
• Adults and children 12 years of age and older: 1-2 tablets, every six hours, maximum of 8 tablets in 24 hours. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Usage:

Partamol-Codeine tablet is administered orally.

Known hypersensitivity to any of the active substances or excipients.

Patients with kidney or liver function failure, ventilatory failure, alcohol dependence.

Patients with deficiency of glucose – 6 – phosphate dehydrogenase.

All paediatric patients (≤ 18 years of age) who undergo tonsillectomy and/or adenoidectomy.

In women who are breastfeeding.

In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.

Common: Headache, dizziness, thirst and feeling of strangeness; nausea, vomiting, constipation; oliguria and urinary retention; tachycardia, bradycardia, palpitation, faintness, orthostatic hypotension.

Uncommon: Pruritus, urticaria, rash; respiratory depression; stomach pain, biliary tract spasm; blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia; nephropathy, nephrotoxicity with chronic abuse.

Using this drug may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

The respiratory depressant effects and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure.

This drug should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused.

Because of a risk of respiratory depression, codeine is only indicated in patients older than 12 years of age for the treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol or ibuprofen (alone). Codeine is not recommended for use in children with breathing problems and children below 12 years of age.

The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).

In patients with an extensive or ultra-rapid metaboliser, there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Caution is recommended when giving codeine to breastfeeding mothers. Infrequent paracetamol should remain the analgesic of choice in pregnancy. Paracetamol and codeine phosphate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Patients should refrain from driving, engaging in potentially hazardous activities or operating machinery.