Treatment of miId to moderate pain and relief of fever including:
Box of 10 blisters x 12 tablets.
Paracetamol ................... 500 mg
Caffeine ........................... 65 mg
This product is contraindicated in patients with a previous history of hypersensitivity to paracetamol, caffeine or excipients.
Not recommended for use during pregnancy.
As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.
Caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.
Not recommended for use during breast feeding.
Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.
Post Marketing Data
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare <1/10,000).
|Blood and lymphatic system disorders||Thrombocytopenia|
|Immune System disorders||Anaphylaxis
Cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Stevens Johnson syndrome and toxic epidermal necrolysis.
|Respiratory, thoracic and mediastinal Disorders||Bronchospasm in patients sensitive to aspirin and other NSAIDs|
|Hepatobiliary disorders||Hepatic dysfunction|
|Central Nervous System||Dizziness, headache|
|Psychiatric disorders||Insomnia, restlessness, anxiety and irritability, nervousness|
|Gastrointestinal Disorders||Gastrointestinal disturbances|
When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.