Symptomatic relief of symptoms of influenza, feverishness, chills and colds including feverish colds.

The symptomatic relief of nasal congestion and difficult breathing arising from this, sinusitis and its associated pain, acute nasal catarrh.

Adults (including elderly) and children aged 16 years and over:

2 capsules every 4 to 6 hours as required, but no more than 12 capsules in any 24 hours.

Do not take continuously for more than 7 days without medical advice

Do not exceed the stated dose.

Use the lowest amount needed to achieve benefit for the shortest duration of treatment.

Not recommended for children under the age of 16 years.

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Closed angle glaucoma

Known hypersensitivity to paracetamol or any of the other ingredients. 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. Patients should be advised not to take other paracetamol-containing products concurrently. 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 other decongestants or cold and flu medicines should be avoided.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Underlying liver disease increases the risk of paracetamol-related liver damage.

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

• Medical advice should be sought before taking this medicine in patients with: glutathione depletion due to metabolic deficiencies.

• An enlargement of the prostate gland

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

• Cardiovascular disease

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Keep out of the sight and reach of children

Do not exceed the stated dose

If symptoms persist consult your doctor

If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product.

Special Label Warnings

Do not take with any other paracetamol-containing products. Do not take anything else containing paracetamol while taking this medicine.

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.

Special Leaflet Warnings

Seek immediate medical advice 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.

Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs:

Pregnancy

This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy. Pregnant women should seek medical advice before taking paracetamol.

Breast-feeding

This product should not be used while breast-feeding without medical advice. Avoid the use of the product during lactation, unless the benefits to the mother outweigh the risks to the infant. If used, the lowest effective dose and shortest duration of treatment should be considered.

Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages.

Caffeine in breast milk may have a stimulating effect on breast-fed infants but significant toxicity has not been observed.

Phenylephrine may be excreted in breast milk.

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

Adverse events of paracetamol 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. The frequency of these adverse events is not known (cannot be estimated from available data).

Paracetamol

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Caffeine

Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continue monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the Yellow Card Scheme, www.mhra/gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paracetamol

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

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 and signs

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 and have peaked after 4-6 days. 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.

Treatment

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. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.

Caffeine

Symptoms and signs

Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.

Treatment

No specific antidote is available, but supportive measures such as beta adrenoceptor antagonists to reverse the cardiotoxic effects may be used.

Phenylephrine

Symptoms and signs

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

Treatment

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

If overdose is confirmed or suspected, seek immediate advice from your Poison Centre and refer patient to nearest Emergency Medical Centre for management and expert treatment. This should happen even in patients without symptoms or signs of overdose due to the risk of delayed liver damage.

Paracetamol: An analgesic and antipyretic.

Caffeine: A mild stimulant

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.

Caffeine: is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

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 foetus-toxicity from paracetamol in animal studies.

Lactose

Colloidal silica

Magnesium stearate

Sodium starch glycollate

Sodium lauryl sulphate

Shell capsule (G dye/100g capsule part)

Red Iron Oxide (E172)

Yellow Iron Oxide (E172)

Titanium dioxide (E171)

Gelatin

Shell body (G dye/100G capsule part)

Gelatin

Titanium dioxide (E171)

None known

Two years

Store below 25° C. Store in the original package in order to protect from moisture.

Child-resistant (CRSF) opaque blisters of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) flexible film/laminate and an aluminium push through strip. 10 or 16 capsules are blistered and packed into boxboard cartons.

Not applicable