PARACETAMOL PHENYLEPHRINE HYDROCHLORIDE AND ASCORBIC ACID

Directions for use Empty contents of sachet into a beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired. Recommended Dose and Dosage Schedule Adults (including elderly) and children aged 16 years and over: One sachet to be taken every four to six hours as necessary.

Do not exceed four sachets per 24 hours. The lowest does necessary to achieve efficacy should be used for the shortest duration of treatment. Not to be given to children under 16 years of age, except on medical advice. The product should not be used continuously for more than seven days without medical advice.

Paracetamol Adverse events 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.

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.

Phenylephrine 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 cross- sensitivity with other sympathomimetics Very rare cases of serious skin reactions have been reported.

Renal and urinary disorders Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Contains paracetamol. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. 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.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 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. Raynaud’s Phenomenon) - Cardiovascular disease - Glutathione depletion due to metabolic deficiencies Use with caution in patients taking the following medications (see interactions). g. ergotamine and methysergide) This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains 4g sucrose per dose. This should be taken into account in patients with diabetes.

This medicinal product contains 131 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet. Do not exceed the stated dose. Patients should be advised not to take other paracetamol-containing or other cold, flu or decongestant products concurrently.

Medical advice should be sought if symptoms worsen, persist for more than 7 days, or are accompanied by high fever, skin rash or persistent headache. Keep out of the reach and sight of children. Consult your doctor if you are taking warfarin.

Known hypersensitivity to paracetamol or any of the other constituents. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. An enlargement of the prostate gland. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.

5).