BEECHAMS ALL IN ONE

Adults and children 12 years and over Two tablets. Repeat every four hours as necessary. Do not take more than 8 tablets in 24 hours. Do not exceed the stated dose. Minimum dosing interval: 4 hours. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

Maximum daily dose:

Eight tablets (2000 mg paracetamol, 800 mg guaifenesin, 40 mg phenylephrine HCl) in any 24 hour period. Not to be given to children under 12 years except on medical advice. Elderly The normal adult dose may be taken. Do not take continuously for more than 5 days without medical advice.

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.

Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Immune system disorders Very rare cases of serious skin reactions have been reported.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. ** There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Undesirable effect Psychiatric disorders Nervousness, irritability, restlessness, and excitability Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, Vomiting, diarrhoea Adverse reactions identified during post-marketing use are listed below.

The frequency of these reactions is unknown but likely to be rare. g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions - including that cross-sensitivity may occur with other sympathomimetics. Renal and urinary disorders Dysuria, urinary retention.

This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Guaifenesin The frequency of these events is unknown but considered 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 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Contains paracetamol. Do not take 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 Concomitant use of decongestants and other cough and cold medicines should be avoided.

g. Raynaud’s Phenomenon) • Glutathione depletion due to metabolic deficiencies • Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. 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. ergotamine and methysergide) • digoxin and cardiac glycosides Patients suffering from chronic cough or asthma should consult a physician before taking this product. Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant. This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) Keep out of the sight and reach of children.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Special label warnings Contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.

Do not take with other flu, cold or decongestant products. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Known hypersensitivity to any of the ingredients. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. 5).