Short term symptomatic relief of colds, chills and influenza including chesty coughs.

Adults and children aged 16 years and over:

One 20 ml measured dose (or four 5 ml spoonfuls). Repeat every four hours as necessary. Do not exceed four doses per 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: Four doses (2000 mg paracetamol, 800 mg guaifenesin, 40 mg phenylephrine HCl) in any 24 hour period.

Not to be given to children under 16 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

Known hypersensitivity to any of the ingredients.

Concomitant use of other sympathomimetic decongestants.

Phaeochromocytoma.

Closed angle glaucoma.

An enlargement of the prostate gland

Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5).

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.

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

• Occlusive vascular disease (e.g. Raynaud's Phenomenon)

• Glutathione depletion due to metabolic deficiencies

• Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

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

• vasoconstrictor agents such as ergot alkaloids (e.g. ergotamine and methysergide)

• digoxin and cardiac glycosides

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)

Concomitant use with alcohol, should be avoided.

If symptoms persist consult your doctor.

Do not exceed the recommended dose.

Keep out of the sight and reachof children.

Special label warnings

Contains paracetamol. Do not take anything else containing paracetamol whilst taking this medicine. Do not take more medicine than the label tells you to. Talk to a doctor at once if you take too much of this medicine, even if you feel well. If you do not get better, talk to your doctor.

Special leaflet warnings

Contains paracetamol. Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

Contains sunset yellow (E110) which may cause allergic-type reactions.

Contains sorbitol (E420): Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains 31 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains 19% v/v ethanol (alcohol) i.e. 3.8 ml per 20 ml dose, equivalent to 76 ml beer or 31.6 ml wine.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. The hepato-toxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

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

If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).

This product should not be used during pregnancy without medical advice.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. The safety of guaiphenesin and phenylephrine during pregnancy has not been established.

Paracetamol and phenylephrine are excreted in breast milk but not in a clinically significant amount. This product should not be used whilst breastfeeding without medical advice.

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

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.

* 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.

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

Guaifenesin

The frequency of these events is unknown but considered 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, even if symptoms of overdose are not present. 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 arrythmias may occir. 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.

Guaifenesin

Symptoms and signs

Very large doses of guaifenesin cause nausea and vomiting.

Treatment

Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.

Paracetamol is an analgesic and antipyretic

Guaifenesin is an expectorant

Phenylephrine Hydrochloride is 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 glucuronide and sulphate conjugates.

Guaifenesin is rapidly absorbed after oral administration. It is rapidly metabolised by oxidation to ß - (2 methoxy-phenoxy) lactic acid, which is excreted in the urine.

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.

Preclinical 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.

Sorbitol 70 % (crystallising, E420), glycerol, ethanol (96%), propylene glycol, sodium cyclamate, acesulfame potassium, sodium citrate, xanthan gum, citric acid monohydrate, coughsweet flavour, sunset yellow FCF (E110), patent blue V (E131), water.

None known.

3 years

Store below 25° C.

Amber glass bottle fitted with a PP 28 mm child resistant, tamper-evident polypropylene/HDPE closure fitted with a polyester-coated, aluminium faced boxboard wad.

Each bottle is packed in a boxboard carton. Contents 160ml.

Not applicable.