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

• The drug 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.
• Elderly and patients with hepatic impairment:
  The dosage should be reduced.
• Children aged 12 years to 18 years:
  One or two tablets every six hours with a maximum dose of eight tablets in any 24 hour period.
• Children aged less than 12 years:
  Partamol Codein Tab. is not recommended for the treatment of pain relief because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.
• Dosage should be adjusted accordingly to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related.

Usage

• Orally administered.

• Patients who have shown hypersensitivity or idiosyncrasy to any of the ingredients.
• Patients with impaired kidney or liver function.
• Patients with alcohol dependence.
• Patients with deficiency of glucose-6-phosphate dehydrogenase.
• Ventilatory failure.
• In all paediatric patients (0 – 18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions.
• In women who are breastfeeding (see section Pregnancy and lactation).
• In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.

Paracetamol

• Skin rash and other allergic reactions occur occasionally. The rash is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by drug fever and mucosal lesions.

Codeine

• Headache, dizziness, thirst and feeling of strangeness.
• Nausea, vomiting, constipation.
• Oliguria and urinary retention (antidiuretic effect).
• Tachycardia, bradycardia, palpitation, faintness, orthostatic hypotension.

• Partamol Codein Tab. contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine since there is lactose in composition.
• The respiratory depressant effects of narcotics 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.
• The administration of this product or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
• 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.
• Codeine should be used at the lowest effective dose for the shortest period of time.
• Codeine is not recommended for use in children with breathing problems (e.g. dyspnea, wheezing during sleep…).
• The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson Syndrome, toxic epidermal necrolysis or Lyell’s syndrome, acute generalized exanthematous pustulosis.
• This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Partamol Codein Tab. is not recommended for use in during breastfeeding
• Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery. Such tasks should be avoided while taking this product.