PARACETAMOL / CAFFEINE

Posology Adults (16 years and over):

Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults. Not recommended for children under 16 years.

Impaired Renal Function:

In case of renal insufficiency dose adjustment is necessary: Impaired Hepatic Function: In patients with impaired hepatic function or Gilbert’s syndrome, the dose must be reduced or the dosing interval prolonged. The daily effective dose of paracetamol should not exceed 60 mg/kg/day (up to maximum 2 g paracetamol /day) in the following situations: - Adults or adolescents weighing less than 50 kg - Mild to moderate hepatic insufficiency, Gilbert’s syndrome (familial non- heamolytic jaundice) - Dehydration - Chronic malnutrition - Chronic alcoholism Method of administration Route of administration: Oral

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 attribute 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 listed below by system organ class and frequency.

Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000 including isolated reports) and not known (cannot be estimated from available data).

PARACETAMOL Body system Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Very rare cases of serious skin reactions have been reported. Anaphylaxis Cutaneous hypersensitivity reactions including (amongst others) skin rashes and angioedema.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. CAFFEINE 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.

Body System Undesirable effect Central nervous system Dizziness Headache Cardiac disorders Palpitation Psychiatric disorders Insomnia Restlessness Anxiety and irritability Gastrointestinal disorders Gastrointestinal disturbances 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Do not exceed stated dose. Contains paracetamol. Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure, which may require liver transplant or lead to death.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. 9). Caution is advised in asthmatic patients sensitive to aspirin, because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested.

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. Paracetamol & Caffeine 500mg/65mg Tablets should be given with care to patients with gout, hyperthyroidism and arrhythmia.

g. coffee, tea and some canned drinks) should be avoided while taking this product. as excess caffeine may cause nervousness, irritability, sleeplessness and occasionally rapid heart beat. Glomerular filtration Dose 10-50 ml/min 1 tablet every 6 hours < 10 ml/min 1 tablet every 8 hours As caffeine is found naturally in tea, coffee and chocolate, and in some carbonated drinks there is the potential for users to take more than the recommended 390 mg/day of caffeine (6 tablets) per day.

Patients should take account of dietary and other medicinal sources of caffeine and ensure that they do not exceed the stated dose. Typical amounts of caffeine available from dietary sources are Brewed coffee; 50-100mg/100ml* Instant coffee and tea: 20-73mg/100ml* Carbonated drinks (cola) 9-19mg/100ml* Chocolate 5-20mg/100ml (*100ml is equivalent to about 1 small cup of fluid) Important information regarding the excipients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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