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LEMSIP MAX LEMON FLAVOUR TABLETS
Active substance(s): PARACETAMOL DC 96% / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL DC 96% / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL DC 96% / PHENYLEPHRINE HYDROCHLORIDE
NAME OF THE MEDICINAL PRODUCT
Lemsip Max Lemon Flavour Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol and 6.10 mg of phenylephrine
Each tablet contains 38 mg of aspartame.
For a full list of excipients, see Section 6.1.
Convex pale yellow oval shaped tablet with lemon odour.
For relief of symptoms of colds and influenza, including the relief of aches and
pains, sore throat, headache, nasal congestion and lowering of temperature.
Posology and method of administration
Adults (16 years and over): Two tablets every 4-6 hours to a maximum of four
doses in any 24 hours.
Do not exceed eight tablets in any 24 hours.
Children 12-15 years: One tablet every 4-6 hours to a maximum of four doses
in any 24 hours.
Do not exceed four tablets in any 24 hours.
Swallow whole with water. Do not chew.
Oral administration after dissolution in water.
Adults 16 years and over: Two tablets dissolved by stirring in half a mug of
hot, not boiling water and sweetened to taste.
Dose may be repeated in 4-6 hours. No more than four doses (eight tablets)
should be taken in 24 hours.
Children 12 – 15 years: One tablet dissolved by stirring in half a mug of hot,
not boiling water and sweetened to taste.
Dose may be repeated in 4-6 hours to a maximum of four doses in any 24
hours. Do not exceed four doses (four tablets)
Once prepared the drink should be taken as soon as possible and should not be
Not recommended for children under 12 years of age.
Hypersensitivity to any of the active substances or any other ingredient.
Severe coronary heart disease and cardiovascular disorders.
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 mellitus.
Patients with prostatic hypertrophy may have increased difficulty with micturition.
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 noncirrhotic alcoholic liver disease.
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
The stated dose must not be exceeded. To be kept out of the reach and sight of
children. Contains paracetamol. If symptoms persist a doctor should be consulted. If
the patient is pregnant or being prescribed a medicine, medical advice needs to be
sought before taking this product. Must not be taken with any other paracetamolcontaining products. The physician or pharmacist should check that sympathomimetic
containing preparations are not simultaneously administered by several routes, i.e.
orally and topically (nasal, aural and eye preparations).
Due to its aspartame content this medicinal product should not be given to patients
Phenylephrine should be used with care in patients with closed angle glaucoma and
Interaction with other medicinal products and other forms of interaction
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.
Medicinal products which induce hepatic microsomal enzymes, such as
alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic
antidepressants, may increase the hepatotoxity of paracetamol, particularly
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.
Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of
cardiovascular side effects with phenylephrine.
Digoxin and cardiac glycosides: concomitant use of phenylephrine may
increase the risk of irregular heartbeat or heart attack.
Pregnancy and lactation
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 breastmilk, but not in a
clinically significant amount. Available published data do not contraindicate breast
Due to the vasoconstrictive properties of phenylephrine the product should not be
used in patients with a history of pre-eclampsia. Phenylephrine may reduce placental
perfusion. There is no information on use in lactation. 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.
Effects on ability to drive and use machines
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.
High blood pressure with headache, vomiting, probably only in overdosage.
Rarely, palpitations. Also, rare reports of allergic reactions and occasionally
urinary retention 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 national reporting system detailed in the
label or leaflet.
Liver damage is possible in adults who have taken 10 g or more of
paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage
if the patient has risk factors (see below).
If the patient:
Is on long-term treatment with carbamazepine, phenobarbitone,
phenytoin, primadone, rifampicin, St. John’s Wort or other drugs that induce
liver enzymes, or
Regularly consumes ethanol in excess of recommended amounts, or
Is likely to be glutathione depleted, e.g. eating disorders, cystic
fibrosis, HIV infection, starvation, cachexia.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Liver damage may become apparent
12-48 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.
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.
Features of severe overdosage 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.
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 post-synaptic 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: Paracetamol is absorbed readily after taking the product and is
detected in the plasma within 5 minutes or oral dosing. The pharmacokinetic
model shows faster absorption seen over the first 30 minutes for the product
compared to a standard does of two paracetamol tablets, however, the overall
extent of absorption of both products remains the same. Actual mean plasma
levels at each time point show the time to achieve a level of 5 µg/ml is less
than 14 minutes, compared to 22 minutes for standard paracetamol tablets; the
speed to achieve 10 µg/ml being 19 minutes versus 30 minutes.
The median time to maximum plasma concentration (tmax) was 35 minutes
which was the same as a standard dose of two tablets of 500 mg paracetamol.
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 gastro-intestinal 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 nasal mucosa. When
taken by mouth as a nasal decongestant, phenylephrine is usually given at
intervals of 4-6 hours.
Preclinical safety data
There are no findings of relevance to the prescriber other than those already
mentioned elsewhere in the SPC.
List of excipients
Pre-gelatinised maize starch
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Tablets are packed in blister trays of cold-form aluminium base and peelable
paper/aluminium laminate lidding.
Pack sizes: 6 tablets and 12 tablets.
Not all pack sizes may be marketed.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, East
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
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.