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LEMSIP COUGH MAX FOR MUCUS COUGH AND COLD ORAL SOLUTION

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

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Lemsip Cough Max for Mucus Cough and Cold Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20ml dose contains:
Paracetamol 1000mg
Phenylephrine Hydrochloride 12.18mg
Guaifenesin 200mg
Cetylpyridinium Chloride 3.0mg
Each 20ml dose also contains potassium 23mg, sodium 19mg, propylene glycol
4300mg, sorbitol 3000mg, maltitol liquid 2000mg and ethanol 3000mg.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral Solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the short term symptomatic relief of the symptoms of colds and influenza,
including aches and pains, headache, nasal congestion, tickly sore throat and chesty
coughs.

4.2

Posology and method of administration
For oral administration.
It is important to shake the bottle for at least 10 seconds before use.
Age

Dose and how often to take

Adults (16 years and
over).

Fill the measure cup to the 10ml or 20ml
mark and take one dose.
Wipe the neck of the bottle clean and
replace the cap securely, without overtightening it. Rinse the measure cup after
use.
Leave at least 4 hours between doses, and do
not take more than 4 doses in any 24 hours.

For short term use only.
If symptoms do not go away talk to your doctor.
Do not exceed the stated dose. Do not give to children under 16 years
of age.

4.3

Contraindications
Hypersensitivity to any of the active substances or any other ingredients.
Contra-indicated during pregnancy.
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
The label should contain the following statements:
• Contains paracetamol.
• Do not give this medicine with any other paracetamol-containing
product.
• For oral use only.
• Never give more medicine than shown in the table.
• Do not overfill the measuring cup
• Always use the measuring cup supplied with the pack.
• Do not give more than 4 doses in any 24 hour period.
• Leave at least 4 hours between doses.
• Do not give this medicine to your child for more than 3 days without
speaking to your doctor or pharmacist.
• As with all medicines, if your child is currently taking any medicine
consult your doctor or pharmacist before taking this product.
• Do not store above 25°C. Store in the original package.
• Keep out of the reach and sight of children.







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 (leaflet).
This product is not suitable for long term use.
Paracetamol should be used with care in patients with severe renal or
hepatic impairment. The hazard of overdose is greater in those with
non-cirrhotic alcoholic liver disease.
Do not take with other cold or decongestant medicines or any other
paracetamol-containing products.
Use with caution in patients with Raynaud's phenomenon.



Phenylephrine should be used with care in patients with, diabetes mellitus,
closed angle glaucoma and prostatic enlargement.




Do not exceed the stated dose.
If symptoms persist consult your doctor.

Each 20ml dose contains 2g Liquid Maltitol and approximately 3g of Sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take
this medicine. This product may have a mild laxative effect.
This product contains 19% (v/v) ethanol. Each 20ml dose contains up to 3g of
ethanol (alcohol) equivalent to 32ml of wine or 76ml of beer. Harmful for
those suffering from alcoholism. To be taken into account in pregnant or
breast feeding women, children and high-risk groups such as patients with
liver disease, epilepsy. The amount of alcohol in this medicinal product may
alter the effects of other medicines. The amount of alcohol in this medicinal
product may impair the ability to drive or use machines.
This product contains propylene glycol, which may cause alcohol-like
symptoms.
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 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.
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

Fertility, 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 Cough Max for Mucus Cough and Cold Oral Solution 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.

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:
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 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 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 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. alphareceptor-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

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC code: R05X

Paracetamol has analgesic and antipyretic actions probably due to the
inhibition of prostaglandin biosynthesis. It is effective against pain of mild to
moderate severity, but is less successful against chronic pain.
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct
effect on adrenergic receptors. It has predominantly alpha-adrenergic activity
and is without significant stimulating effects on the central nervous system at
usual doses. It may be given orally to relieve nasal congestion.
Guaifenesin is an expectorant which reduces the viscosity of tenacious
sputum.
Cetylpyridinium Chloride is a cationic disinfectant with properties and uses
similar to other cationic surfactants. These surfactants have bactericidal
activity against Gram-positive and, at higher concentration against some
Gram-negative organisms. Cetylpyridinium Chloride may be used in a variety
of preparations for the local treatment of minor infections.
5.2

Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract and peak
plasma concentrations usually occur 30 minutes to 2 hours after ingestion.
Paracetamol is metabolised in the liver and largely excreted in the urine as
sulphate and glucuronide conjugates. Less than 5% is excreted unchanged.
The elimination half-life varies from about 1 to 4 hours.
Phenylephrine hydrochloride is irregularly absorbed after oral administration
and undergoes first-pass metabolism by monoamine oxidase in the gut and
liver, resulting in reduced bioavailability. Peak plasma concentrations are
achieved in 1 to 2 hours. It is excreted in the urine mainly as the sulphate
conjugate, with less than 20% as unchanged drug.
Guaifenesin is rapidly absorbed from the gastrointestinal tract. It is rapidly
metabolised by oxidation to β-(2 methoxy-phenoxy) lactic acid, which is
excreted in the urine.
Cetylpyridinium Chloride has only a local effect.

5.3

Preclinical safety data
There are no preclinical safety data on these active ingredients in the literature
of relevance to the prescriber or to the recommended dosage and use of the
product which are additional to that already included in other sections of the
SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid Maltitol (E965)
Sorbitol (E420)
Ethanol
Propylene Glycol (E1520)
Glycerol (E422)
Saccharin Sodium (E954)
Sodium Cyclamate (E952)
Acesulfame Potassium (E950)
Sodium Citrate (E331)
Anhydrous Citric Acid (E330)
Xanthan Gum (E415)
Levomenthol
Eucalyptus Oil
Quinoline Yellow (E104)
Patent Blue V (E131)
Purified Water

6.2

Incompatibilities
Not Applicable.

6.3

Shelf life
2 Years.

6.4

Special precautions for storage
Do not store above 25ºC.
Keep the container in the outer carton.
Keep the container tightly closed.

6.5

Nature and contents of container
Clear type III glass bottle and polypropylene child resistant closure with
aluminium foil film liner containing 160ml.
Clear PET bottle and polypropylene child resistant closure with aluminium
foil film liner containing 160ml.
Graduated polypropylene measuring cup

6.6

Special precautions for disposal

No special requirements.
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0712

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/01/2015

10

DATE OF REVISION OF THE TEXT
29/01/2015

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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