PANADEINE TABLET [SIN05369P]

Product Info

PANADEINE TABLET

[SIN05369P]

Indications
Panadeine is indicated for the relief of painful disorders such as headache, dysmenorrhea, conditions involving musculoskeletal pain, myalgias and neuralgias. it is also indicated as an analgesic and antipyretic in conditions accompanied by discomfort and fever, such as the common cold and viral infections. Panadeine is an effective analgesic after dental work and tooth extractions.

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.

Dosage and Administration
Adults and children over 12 years:
Two tablets, to be taken with a glass of water, not more frequently than every 4 hours, do not exceed 8 tablets in any 24 hour period.

Children and adolescents
Children aged less than 12 years: Codeine is contraindicated in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.
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.

Children aged 12 years to 18 years: Panadeine is contraindicated for use in children aged 12 years to 18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy to treat obstructive sleep apnoea.

Contraindications
Panadeine must not be used in patients with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency, patients with severe hepatocellular insufficiency, or severe respiratory disease, acute respiratory disease and respiratory depression, for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition.

Panadeine is contraindicated for use in patients who are:

• younger than 12 years (see section Special Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• aged between 12–18 years in whom respiratory function might be compromised including post tonsillectomy and/or adenoidectomy to treat obstructive sleep apnoea, due to an increased risk of developing serious and life-threatening adverse reactions (see section Special Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• breastfeeding (see section Pregnancy, Fertility and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• CYP2D6 ultra-rapid metabolisers (see section Special Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth.