BOOTS HEADACHE AND UPSET STOMACH RELIEF, SUPERDRUG HEADACHE AND UPSET STOMACH RELIEF, BOOTS RECOVERY

For oral administration. Dissolve the contents of the sachet in a glass of water (150 – 200 ml) before taking.

Adults, elderly and adolescents aged 16 years and over:

One sachet every 4 to 6 hours as required. Do not take more than 4 sachets in any 24 hours. Not to be given to adolescents and children under 16 years of age. 9). Minimum dosing interval: 4 hours. If pain or fever persist for more than 3 days or get worse, or if any other symptoms occur, treatment should be discontinued and a physician should be consulted.

Elderly patients:

Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing.

Renal impairment:

Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours.

4).

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).

Organ System Class Adverse reaction Frequency Blood and lymphatic system disorders Thrombocytopaenia Agranulocytosis Rare Anaphylaxis Very rareImmune system disorders Allergies (not including angioedema) Rare Respiratory, thoracic and mediastinal disorders Bronchospasm in patients sensitive to aspirin and other NSAIDs Very rare Hepatobiliary disorders Hepatic dysfunction Very rare Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.

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

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.

4. Special warnings and special precautions for use Underlying liver disease increases the risk of paracetamol-related liver damage. 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: • Chronic alcoholism • Renal failure (GFR≤50ml/min).

3). 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 monitoringis 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. 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. 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).

The stated dose should not be exceeded. 9). Patients should be advised not to take paracetamol containing products concurrently. This medicine contains 50 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if patients have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. 125mg Sunset Yellow which may cause allergic reactions.

1. Hepatic or severe renal impairment. Patients on sodium-restricted diets. Patients on potassium-restricted diets