ASPAR HOT LEMON

Adults, the elderly and children 16 years and over:

One sachet every four to six hours as required. Do not exceed 4 sachets in 24 hours Dose not to be repeated more frequently than 4 – 6 hourly intervals. Dose should not be continued for more than 3 days without consulting a doctor.

Children 12-15 years:

One sachet given three or four times daily as required. Not recommended for children under 12 years. Children should not be given Paracetamol Sachets for more than 3 days without consulting a doctor. These doses should not be repeated more frequently than every 4-6 hours nor should more than 4 doses be given in any 24 hour period.

Adverse events of paracetamol 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 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.

Post marketing data Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported.

*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. 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.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. , 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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. 721 gm sucrose per dose. This should be taken into account by patients with diabetes.

Patients should be advised not to take other paracetamol-containing or any other cold or flu products concurrently. If symptoms persist consult your doctor. Keep medicines out of the sight and reach of children.

Pack Label:

Contains Paracetamol. Do not take anything else containing paracetamol while taking this medicine and talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take more medicine than the label tells you to.

If you do not get better, talk to your doctor. Do not take if you are sensitive to paracetamol or to any of the other ingredients.

Patient Information Leaflet:

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

Known hypersensitivity to paracetamol and/or any other of the constituents.