PARACETAMOL AND CAFFEINE

Posology Adults (including elderly) and adolescents aged 15-18 years weighing more than 50kg: 1 - 2 tablets according to needs up to 3 times daily. The single dose of 1 tablet is appropriate for individuals weighing less than 60 kg while the single dose of 2 tablets is appropriate only for individuals weighing 60 kg and more.

The maximum single dose is 1 g of paracetamol (2 tablets), the maximum daily dose is 3 g of paracetamol (6 tablets). The specific dose interval depends on the symptoms and the maximum daily dose. Depending on the reoccurrence of symptoms (fever and/or pain), repeated administration is allowed.

It should, however, preferably never fall below 6 hours and in no case fall below 4 hours. If the pain persists for more than 5 days or the fever lasts for more than 3 days, or gets worse or other symptoms appear, the patient should stop the treatment and consult a doctor.

Paediatric Population Adolescents of 15 to 18 years and weighing more than 50 kg: as adults. In children it is imperative to respect the posology defined on the basis of body weight and thus to use the appropriate presentation. Approximate ages based on body weight are given for information.

The product is not suitable for children younger than 15 years.

Impaired Renal Function:

In case of renal insufficiency dose adjustment is necessary: Glomerular filtration Dose 10 – 50 ml/min 1 tablet every 6 hours < 10 ml/min 1 tablet every 8 hours 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 minimal patient exposure. Accordingly, adverse events reported from extensive post-marketing experience at therapeutic/labelled dose are 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).

Blood and lymphatic system disorders Very rare:

Thrombocytopenia, agranulocytosis Immune system disorders Rare: Anaphylactic reaction, allergic dermatitis, rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Skin and subcutaneous tissue disorders:

Very rare: Serious skin reactions Psychiatric disorders: Common: Insomnia, restlessness, anxiety Nervous system disorders Common: Nervousness, dizziness, headache Cardiac disorders Not known: Palpitations, tachycardia Respiratory, thoracic and mediastinal disorders Very rare: Bronchospasm Gastrointestinal disorders Common: Gastrointestinal disorder Hepatobiliary disorders Very rare: Hepatic function abnormal, increased transaminases General disorders and administration site conditions Not known: Irritability When the recommended 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 nervousness, dizziness, insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disorder and palpitations.

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.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Prolonged or frequent use is discouraged. Patients should be advised not to take other Paracetamol containing products concurrently.

Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur. However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful.

In adolescents treated with 60mg/kg daily of Paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness. 2). The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2 grams in such cases. Alcohol should not be used during the treatment with paracetamol. 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.

Paracetamol & Caffeine should be given with care to patients with gout, hyperthyroidism and arrhythmia. The patient should limit the use of caffeine containing products when taking Paracetamol and Caffeine, 500mg / 65mg Tablets as excess caffeine may cause nervousness, irritability, sleeplessness and occasionally rapid heart beat.

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)

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