For the relief of the symptoms of colds and influenza, including the relief of aches and pains and nasal congestion, sore throat and lowering of temperature.

Patients should consult a doctor or a pharmacist if symptoms persist for more than 3 days, or worsen.

Posology

Adults, the elderly and children aged 16 and over: Content of one sachet dissolved by stirring in hot water and sweetened to taste.

Dose may be repeated every 4-6 hours as required.

Do not take more than 4 sachets in 24 hours.

Do not give to children under 16 years of age.

Elderly Population: No dosage adjustment is considered necessary in the elderly.

Method of Administration

Oral administration after dissolution in water.

• Hypersensitivity to paracetamol, phenylephrine or to any of the excipients listed in section 6.1.

• Severe coronary heart disease and cardiovascular disorders.

• Hypertension.

• Hyperthyroidism.

• Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors (see section 4.5).

• Concomitant use of other sympathomimetic decongestants.

• Avoid in patients with prostatic enlargement.

• Contraindicated in patients with phaeochromocytoma

Use with caution in patients with Raynaud's Phenomenon or diabetes.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease.

Patients should be advised not to take other paracetamol-containing products concurrently.

Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of delayed serious liver damage (see section 4.9).

Phenylephrine should be used with care in patients with closed angle glaucoma.

The product should not be used during pregnancy unless recommended by a healthcare professional (see section 4.6).

Use during breastfeeding should be avoided, unless recommended by a healthcare professional (see section 4.6).

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

Each sachet contains approximately 2.6g of carbohydrate.

This medicinal product contains 120.74 mg sodium per dose, equivalent to 6 % of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 24.1 % of the WHO recommended maximum daily intake for sodium.

Lemsip Cold & Flu Breath easy is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

This medicine contains 45 mg aspartame in each sachet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

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.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)

Phenylephrine hydrochloride:

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers. Drugs which induce hepatic microsomal enzymes such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol particularly after overdosage.

Not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.

Paracetamol

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. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Phenylephrine hydrochloride

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia.

In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.

Lemsip Cold & Flu Breathe Easy has no or negligible influence on ability to drive or use machinery.

Adverse events which have been associated with paracetamol and phenylephrine hydrochloride are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥ 1/10); Common (≥ 1/100 and <1/10); Uncommon (≥ 1/1000 and <1/100); Rare (≥ 1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Description of Selected Adverse Reactions

¹ There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

² Especially in males

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: http: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 10 g or more of paracetamol. Ingestion of 5 g of 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 depleted, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose 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 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine hydrochloride

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent.

Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).

Additional symptoms may include, 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 should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicinal products such as phentolamine.

ATC Code

N02BE51 - paracetamol, combinations excluding psycholeptics.

Paracetamol

Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Phenylephrine

Phenylephrine is a postsynaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

Paracetamol

After oral dosing paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Phenylephrine

Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4 to 6 hours.

No preclinical findings of relevance have been reported.

Caster sugar,

Pulverised sucrose,

Citric acid anhydrous,

Sodium citrate,

Lemon flavour no. 1,

Menthol flavour,

Aspartame (E951),

Saccharin sodium,

Curcumin WD,

Ascorbic acid.

None known.

Two years.

Store below 25° C in a dry place.

Heat-sealed laminate sachet of 40 gsm paper, 12 gsm PE extrusion, 8 micron aluminium foil and ethylene/methacrylic acid copolymer. In a cardboard outer carton.

Pack size: 5, 6, 7, 8, 9, 10, 12, 14, and 16 sachets.

Not all pack sizes may be marketed.

Oral administration, after dissolution in hot water.