BEST-IN PARACETAMOL EXTRA PAIN RELIEF

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 listed below by system class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Post marketing data Paracetamol System Organ Class (SOC) Frequency Adverse Reaction Blood and lymphatic Very rare Thrombocytopenia, system disorders agranulocytosis Rare AnaphylaxisImmune system disorders Very rare Allergies (not including angioedema) Respiratory, thoracic and mediastinal disorders Very rare Bronchospasm* Hepatobiliary disorders Very rare Hepatic dysfunction Very rare Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.

Skin and subcutaneous tissue disorders Very rare Very rare cases of serious skin reactions have been reported. Toxic epidermal necrolysis (TEN), drug-induced dermatitis, Stevens-Johnson syndrome (SJS), Acute generalized exanthematous.

pustulosis (AGEP). Renal and urinary disorders Very rare Sterile pyuria (cloudy urine) Metabolism and nutrition disorders Frequency not known (cannot be estimated from the available data) High anion gap metabolic acidosis** * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Caffeine System Organ Class (SOC) Frequency Adverse reaction Central nervous system disorders Not known Nervousness, Dizziness 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 such as restlessness and palpitations.

Undesirable effects are not normally observed in healthy individuals taking caffeine at doses up to 520 mg per day. However some users who are caffeine naïve, have abstained from caffeine for a period or who are more sensitive to caffeine may experience effects more commonly seen at higher doses.

These include tremor, insomnia, nervousness, irritability, anxiety, headache, tinnitus, arrhythmia, and tachycardia, diuresis, gastrointestinal disturbances and elevated respiration. Individuals who experience these effects must stop taking this medicine (and any others containing caffeine) and any other dietary caffeine.

Following regular use of caffeine, cessation of intake may lead to withdrawal symptoms which may last for up to a week and which include headache, tiredness and decreased alertness. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

4. Special Warnings and Special Precautions for Use – Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued.

The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. – Patients should be advised not to take other paracetamol containing products concurrently.

9). – Underlying liver disease increases the risk of paracetamol-related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

– Paracetamol should be administered only with particular caution under the following circumstances: o Hepatocellular insufficiency o Renal failure (GFR≤50ml/min) o Gilbert’s Syndrome (familial non-haemolytic jaundice) o Concomitant treatment with medicinal products affecting hepatic function o Glucose-6-phosphate dehydrogenase deficiency o Haemolytic anaemia o Glutathione deficiency o Dehydration o Chronic malnutrition o The elderly, adults and children weighing less than 50kg.

– Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid, since mild bronchospasms are reported in association with paracetamol (cross reaction). g. 9: Overdose, caffeine). g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

1. This medicine should not be used by people who have been diagnosed with hypertension or who are receiving antihypertensive medication, or who have a history of cardiac arrhythmia. This medicine should not be used by patients recovering from chronic alcoholism who are taking disulfiram.

This medicine should not be used if antidepressants (including lithium carbonate), anxiolytics (including clozapine) and sedatives are being used , or by persons with anxiety disorders. 5). Caffeine shares the same metabolic pathway as theophylline and therefore this medicine should not be used concurrently with theophylline.