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LEMSIP COLD & FLU LEMON

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

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lemsip Cold & Flu Lemon

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
mg/sachet
Specification
Paracetamol

650

Phenylephrine hydrochloride

*10

PhEur
Ph Eur

*Equivalent to phenylephrine base 8.21mg.
Excipient(s) with known effect:
Sucrose
Sodium
Aspartame
Lactose
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral powder

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
Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or
worsen.
Posology:
Adults and children 12 and over: Contents of one sachet dissolved by stirring in hot water and
sweetened to taste.

The dose may be repeated every 4 to 6 hours as required.
No 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.
Method of Administration:
Oral administration after dissolution in water.

4.3

Contraindications







4.4

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

Special warnings and precautions for use
Use with caution in patients with Raynaud's phenomenon or diabetes mellitus.
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 and prostatic
enlargement.
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).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
Each sachet contains approximately 2.6g of carbohydrate. Due to its aspartame content this
product should not be given to patients with phenylketonuria.
4.5

Interaction with other medicinal products and other forms of interaction
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.
Phenylephrine hydrochloride
Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between
sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section
4.3).
Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines
can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine,
methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The
risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).
Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects
with phenylephrine (see section 4.3).
Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of
irregular heartbeat or heart attack.
4.6

Fertility, Pregnancy and Lactation
Pregnancy
The product should not be used during pregnancy unless recommended by a healthcare
professional.
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
preeclampsia.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in
the recommended dosage.
Breast-feeding
The product should be avoided during lactation unless recommended by a healthcare professional.
There are limited data on the use of phenylephrine in lactation.
Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available
published data do not contraindicate breast feeding.
Fertility
There are no available data regarding the effects of the active ingredients on fertility.

4.7

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

machinery.

4.8

Undesirable effects
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.
System Organ Class

Frequency

Adverse Events

Blood and Lymphatic
System Disorders
Immune System
Disorders
Gastrointestinal
Disorders
Skin and Subcutaneous
Tissue Disorders

Not known
Not known

Thrombocytopenia, leucopenia, pancytopenia,
neutropenia, agranulocytosis1
Hypersensitivity

Not known

Abdominal discomfort, nausea, vomiting

Very rare

Cases of serious skin reactions have been reported
Skin rash

Not known
Renal and Urinary
Disorders

Not known

Urinary retention2

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.

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 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, seizures and arrhythmias. However, smaller amounts of the
paracetamol and phenylephrine hydrochloride combination product would be required to cause
paracetamol related liver toxicity than to cause serious phenylephrine-related toxicity.. Treatment
includes 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, reflex bradycardia, 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, 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
Pharmacotherapeutic group: Analgesics, Anilides;
ATC Code: N02BE51. Paracetamol, combinations excl. 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 Hydrochloride

Phenylephrine hydrochloride: Phenylephrine is sympathomimetic post-synaptic α1–adrenergic
receptor
agonist with low cardioselective beta receptor affinity and minimal central nervous
stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema
and nasal swelling.

5.2

Pharmacokinetic properties
Paracetamol
Paracetamol is absorbed rapidly and completely mainly from the small intestine
producing peak plasma levels after 15-20 minutes following oral dosing. 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 T1/2 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 active substance 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,
Aspartame,
Ascorbic acid,
Saccharin sodium and
Curcumin WD (curcumin (E100), Lactose, Polysorbate 80 (E433) and Silica (E551)).

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 40 gsm paper/12 gsm PE extrusion/8 micron
aluminium foil/18 gsm Surlyn. 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.

6.6

Special precautions for disposal
No special requirements.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0034

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/04/2005

10

DATE OF REVISION OF THE TEXT
08/06/2017

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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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