Short term symptomatic relief of symptoms of influenza, feverishness, chills and colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.

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 dose 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.

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.

Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).

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.

Medical advice should be sought before taking this product in patients with these conditions:

• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)

• Cardiovascular disease

• Glutathione depletion due to metabolic deficiencies

Use with caution in patients taking the following medications (see interactions).

• digoxin and cardiac glycosides

• ergot alkaloids (e.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.

Special label warnings

Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported

Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. This product should not be used during pregnancy or lactation unless the expected benefit to the mother justifies the potential risk to the foetus or newborn. The lowest effective dose and shortest duration of treatment should be considered. Phenylephrine may be excreted in breast milk.

Patients should be advised not to drive or operate machinery if affected by dizziness.

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.

* 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.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors:

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management:

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N- acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under advserse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol- related toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Ascorbic acid

Symptoms and signs

High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.

Paracetamol: An analgesic and antipyretic.

Ascorbic acid: A common ingredient of cold and influenza combination products included to compensate for Vitamin C losses which may occur in the initial stages of acute viral infections.

Phenylephrine hydrochloride: A sympathomimetic decongestant.

The active ingredients are not known to cause sedation.

Paracetamol: is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucoronide and sulphate conjugates.

Ascorbic Acid: is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic Acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine Hydrochloride: is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability.

It is excreted in the urine almost entirely as the sulphate conjugate.

Pre-clinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.

The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD₅₀ values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foeto-toxicity from paracetamol in animal studies.

Sucrose Citric

acid Sodium

citrate Maize

starch

Sodium cyclamate

Saccharin sodium

Colloidal anhydrous silica

Lemon flavour

Natural curcumin (E100).

None known

Three years

Store below 25° C.

The product is packed in laminate sachets comprising paper/polythene/aluminium foil/polythene. Five or ten sachets may be contained in a box board carton.

Not applicable.