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LEMSIP COLD & FLU BREATHE EASY

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lemsip Cold & Flu Breathe Easy.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients

mg/Sachet

Paracetamol
Phenylephrine hydrochloride

650
10

For a full list of excipients, see section 6.1.
Also includes aspartame and sucrose.

3

PHARMACEUTICAL FORM
Powder for oral solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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.

4.2

Posology and method of administration
Oral use after dissolution in hot water.
Adults and children over 12: Contents of one sachet dissolved by stirring in
hot water and sweetened to taste.
The dose may be repeated after 4 hours.
Not more than four doses should be taken in 24 hours.
There is no indication that dosage need be modified for the elderly.
Not to be given to children under 12.

4.3

Contraindications






4.4

Hypersensitivity to paracetamol, phenylephrine or any other ingredient.
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).

Special warnings and precautions for use
Use with caution in patients with Raynaud's Phenomenon or diabetes. Each
sachet contains approximately 2.6 g of carbohydrate. Due to its aspartame
content this product should not be given to patients with phenylketonuria.
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.
Label warnings: Do not exceed the stated dose. Keep out of the reach of
children. Contains paracetamol (panel). If symptoms persist consult your
doctor. If you are pregnant or are being prescribed medicine by your doctor,
seek his advice before taking this product. Total sugars 2.6 g. Contains
aspartame. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even
if you feel well.
Leaflet: 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. Contains a source of phenylalanine. May be harmful for people with
phenylketonuria. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal
product.

4.5

Interaction with other medicinal products and other forms of interaction
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.
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.

4.6

Pregnancy and lactation
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.

4.7

Effects on ability to drive and use machines
Lemsip Cold & Flu Breathe Easy has no or negligible influence on ability to

drive or use machinery.

4.8

Undesirable effects
Paracetamol
Adverse effects of paracetamol are rare, but hypersensitivity including skin
rash may occur. There have been a few reports of blood dyscrasias including
thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis,
but these were not necessarily causally related to paracetamol.
Acute pancreatitis after ingestion of above normal amounts.
Phenylephrine hydrochloride

High blood pressure with headache and vomiting, probably only in overdose.
Rarely palpitations. Also, rare reports of allergic reactions and occasionally
urinary retention in males.
4.9

Overdose
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 Nacetylcysteine, 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.

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
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.

5.3

Preclinical safety data
No preclinical findings of relevance have been reported.

6.1

List of excipients
Caster sugar, pulverised sucrose, citric acid anhydrous, sodium citrate, lemon
flavour no. 1, menthol flavour, aspartame (E951), saccharin sodium, curcumin
WD and ascorbic acid.

6.2

Incompatibilities
None known.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Store below 25°C in a dry place.

6.5

Nature and contents of container
Heat-sealed laminate sachet of Paper, PE, Aluminium foil and Ionomer
Pack size: 5, 6, 7, 8, 9, 10, 12, 14 and 16 sachets.
Not all pack sizes may be marketed

6.6

Special precautions for disposal and other handling
Oral administration, after dissolution in hot water.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0041

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/02/2009

10

DATE OF REVISION OF THE TEXT
02/10/2012

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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