Skip to Content

UK Edition. Click here for US version.

LEMSIP MAX ALL IN ONE LEMON

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

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT
Lemsip Max All in One Lemon
Lemsip Cough Max for Mucus Cough & Cold 1000mg/200mg/12.2mg Powder for
Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
mg/sachet
Paracetamol
1000.00
Phenylephrine hydrochloride
12.2
Guaifenesin
200.00

3

PHARMACEUTICAL FORM
Powder for oral solution. Pale yellow powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of symptoms of colds and influenza, including the relief of aches
and pains, sore throat, headache, nasal congestion, lowering of temperature
and chesty coughs.

4.2

Posology and method of administration
Oral administration after dissolution in water. Adults and adolescents 12 years
and over: One sachet dissolved by stirring in hot water and sweetened to taste.
Dose may be repeated in 4-6 hours. No more than four doses should be taken
in 24 hours. Not to be given to children under 12 without medical advice.

4.3

Contraindications
Hypersensitivity to any of the active substances 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.

4.4

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 or other cold and decongestant medicines concurrently.
Phenylephrine should be used with care in patients with diabetes mellitus, closed
angle glaucoma and prostatic enlargement.
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.
Do not exceed the stated dose.
If symptoms persist, consult your doctor.
Keep out of the reach and sight of children.
Contains a source of phenylalanine. .May be harmful for people with
phenylketonuria.
Total sugars 2g. This product also contains 1973.3mg sucrose per sachet dose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains 129.0 mg (5.61 mmol) sodium per dose - to be taken into
consideration for patients on a controlled sodium diet.

4.5

Interaction with other medicinal products and other forms of interaction
Paracetamol
The rate 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 hepatotoxicity of paracetamol, particularly after overdose.
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
sympathomimetic amines can increase the risk of cardiovascular side effects.

other

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.
Guaifenesin
Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may
interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or
vanillylmandelic acid.

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 breastfeeding.
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.
Guaifenesin:
Has been linked with an increased risk of neural tube defects in a small number of
women with febrile illness in the first trimester of pregnancy. The product should be
used in pregnancy only if the benefits outweigh this risk. There is no information on
use in lactation.

4.7

Effects on ability to drive and use machines
Lemsip Max All in One Lemon 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 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, vomiting probably
only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and
occasionally urinary retention in males.
Guaifenesin: Guaifenesin has occasionally been reported to cause gastro-intestinal
discomfort, nausea and vomiting, particularly in very high doses. Also,
hypersensitivity reactions may occur.

4.9

Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g or more of
paracetamol. Ingestion of five 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:
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. 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 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.
Guaifenesin: Very large doses may cause nausea and vomiting. The drug is, however,
rapidly metabolised and excreted in the urine. Patients should be kept under
observation and treated symptomatically.
5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, Anilides;
ATC Code: N02B E51. 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 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.

Guaifenesin: Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.
5.2

Pharmacokinetic properties
Paracetamol: Paracetamol is absorbed rapidly and completely 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 T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate
conjugates (>80%) which are excreted in urine.
Phenylephrine hydrochloride: 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 4-6 hours.
Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is rapidly metabolised
by oxidation to ί-(2 methoxy-phenoxy) lactic acid; which is excreted in the urine. Within 3
hours, approximately 40% of a single dose is excreted in the urine as this metabolite. The halflife in plasma is approximately 1 hour. Guaifenesin may increase the rate of absorption of
paracetamol.

5.3

Preclinical safety data
None available specific to the product.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ascorbic acid
Sucrose
Citric acid
Sodium citrate
Lemon flavour no. 1
Aspartame (E951)
Saccharin sodium
Curcumin WD (curcumin (E100), Lactose, Polysorbate 80 (E433) and Silica (E551)).

6.2

Incompatibilities
None Known

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package.

6.5

Nature and contents of container
Heat-sealed sachet of paper/polyethylene/aluminium foil/ polyethylene
laminate in an outer cardboard carton. Packs: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
sachets.

6.6

Special precautions for disposal
Not applicable.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0168.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/12/2006

10

DATE OF REVISION OF THE TEXT
19/04/2016

Expand view ⇕

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.

Hide