BEECHAMS COLD RELIEF ORANGE FLAVOUR

The product should be dissolved in at least half a tumbler of water.

Adults and children aged 16 years and over:

Two tablets up to 4 times daily as required. Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children aged 12-15 years:

One tablet up to 4 times daily as required. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years. Method of administration Paracetamol and caffeine 500 mg/65 mg Soluble Tablets are for oral administration only.

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). Post marketing 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). Respiratory, thoracic and mediastinal disorders Bronchospasm- more likely in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Hepatic dysfunction 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 the 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. 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.

g. coffee, tea and some canned drinks) should be avoided while taking this product. 7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Each tablet contains sorbitol powder (E 420) at 50 mg per tablet. Patients with hereditary fructose intolerance should not take this medicine.

If symptoms persist, medical advice must be sought. Keep out of the sight and reach of children.

Pack Label:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

Hypersensitivity to paracetamol, caffeine or any of the other constituents. Patients with rare hereditary problems of fructose intolerance should not take this medicine.