PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HCL WRAFTON

Route of administration:

Oral. Dissolve the contents of one sachet in a standard mug of hot, but not boiling water (250 ml). Allow to cool to a drinkable temperature. Drink all of the yellow solution within 1½ hours.

For all indications:

Adults, the elderly and children aged 12 years and over: One sachet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours.

Children under 12 years:

Not to be used unless recommended by a doctor. Dosage should not be continued for longer than 5 days without consulting a doctor

The frequency of occurrence of undesirable effect is usually classified as follows: Very common (> 1/10) Commo n (> 1/100 to < 1/10) Uncom mon (> 1/1,000 to < 1/100) Rare (> 1/10,00 0 to 1/1,000) Very rare (< 1/10,000) Not known (incidence cannot be assessed on the basis of the available data).

PARACETAMOL Adverse events from historical clinical trial data are both infrequent and from limited 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 unknown (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare (
1/10,000 to <1/1,000) and serious reactions are very rare (<1/10,000).

Very rare cases of serious skin reactions have been reported. Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bronchospasm* Hepatobiliary disorders Hepatic dysfunction Gastrointestinal disorders Acute pancreatitis *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

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, diarrhoea Skin and subcutaneous disorders Rash, urticaria PHENYLEPHRINE HYDROCHLORIDE The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events though actual frequencies are not available.

e. orally and topically (nasal, aural and eye preparations). Sympathomimetic-containing products should be used with great care in patients suffering from angina. Sympathomimetic-containing products may act as cerebral stimulants giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions.

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants). g. Raynaud’s phenomenon Cardiovascular disease Myasthenia gravis – an autoimmune disorder Severe gastrointestinal diseases.

This medicine should only be recommended if all symptoms (pain and/or fever, nasal congestion and chesty cough) are present. Patients suffering from chronic cough or asthma should consult a physician before taking this product, or is accompanied by a fever, rash or persistent headache.

Patients should stop using this product and consult a health care professional if cough lasts for more than 5 days or comes back. Do not take with a cough suppressant. Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment.

The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. Concomitant use with alcohol should be avoided. Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains aspartame (E951) a source of phenylalanine. May be harmful for people with phenylketonuria. This medicinal product contains 129 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. Special label warnings Contains paracetamol.

Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with other flu, cold or decongestant products. Special leaflet warnings Contains paracetamol.

1. Hepatic or severe renal impairment Heart disease and cardiovascular disorders, including severe haemolytic anaemia. 4). Use in patients with closed angle glaucoma or urinary retention. Use in patients who are currently receiving other sympathomimetic drugs (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).