BEECHAMS MAX STRENGTH ALL IN ONE HOT CRANBERRY AND BLACKCURRANT

Posology Adults (including the elderly) and children aged 16 years and over:

One sachet, dissolved in a standard mug of hot water but not boiling water (approximately 250 ml), to be taken every four to six hours, up to a maximum of four sachets in any 24 hours. Minimum dosing interval: four hours Do not exceed the stated dose.

Maximum duration of continued use without medical advice: 7 days.

Paediatric population Children under 16 years of age:

Not to be given to children under 16 years of age, except under medical advice. 1). No data are available.

Populations Patients with hepatic impairment:

Patients who have been diagnosed with hepatic impairment must seek medical advice before taking this medicine. The restrictions related to the use of such combinations in patients with hepatic impairment are primarily a consequence of the paracetamol content of the product (see Section

The drug substances paracetamol, phenylephrine hydrochloride and guaifenesin are usually well tolerated in normal use. Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ 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.

Paracetamol The frequency of these paracetamol-related adverse reactions is unknown but based on estimate from post-marketing data are likely to be very rare. Body System Undesirable effect Blood and lymphatic system Thrombocytopenia.

disorders Agranulocytosis. These are not necessarily causally related to paracetamol Immune system disorders Anaphylaxis. Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson Syndrome. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients).

(Frequency not known). Respiratory, thoracic and mediastinal disorders Bronchospasm in patients sensitive to aspirin and other NSAIDs. Hepatobiliary disorders Hepatic dysfunction Gastrointestinal disorders Acute pancreatitis Guaifenesin The frequency of these guaifenesin-related adverse reactions is unknown but based on estimate from post-marketing data are likely to be rare.

Body System Undesirable effect Immune system disorders Allergic reactions, angioedema, anaphylactic reactions. Respiratory, thoracic and mediastinal disorders Dyspnoea* Gastrointestinal disorders Nausea, vomiting, abdominal discomfort Skin and subcutaneous disorders Rash, urticaria *dyspnoea has been reported in association with other symptoms of hypersensitivity Phenylephrine hydrochloride: The following adverse events have been observed in clinical studies involving phenylephrine hydrochloride and are considered to be the most commonly occurring.

).

Patients with renal impairment:

Patients who have been diagnosed with renal impairment must seek medical advice before taking this medicine. 4 Special Warnings and Precautions for Use). Method of administration For oral use. Dissolve one sachet in a standard mug of hot water but not boiling water (approximately 250 ml).

A purple solution slightly cloudy with an odour of cranberry will be obtained. To be taken as a warm drink. 3 Contraindications - Hypersensitivity to any of the drug substances or to any of the excipients. - Use in patients who are taking, or have taken, within the last two weeks, monoamine oxidase inhibitors (MAOIs) (see Section

Hypersensitivity to any of the drug substances or to any of the excipients. - Use in patients who are taking, or have taken, within the last two weeks, monoamine oxidase inhibitors (MAOIs) (see Section