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LEMSIP MAX ALL IN ONE LIQUID

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Galpharm Four In One Flu Relief
Lemsip Max All In One Liquid

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20ml dose contains:
Paracetamol 1000mg
Phenylephrine Hydrochloride 12.18mg
Guaifenesin 200mg
Cetylpyridinium Chloride 3.0mg
For excipients, see 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.
Adults and children 16 years and over: One 20ml dose (four 5ml spoonfuls) up to 4
times a day as required.
The dose must not be repeated more frequently than every four hours.
Maximum of 4 doses in any 24 hours.

Not recommended for children under 16 years of age.

4.3

Contraindications
Patients with known hypersensitivity to paracetamol, phenylephrine hydrochloride,
guaifenesin or cetylpyridinium chloride or any of the other ingredients.
Contra-indicated during pregnancy.

4.4

Special warnings and precautions for use
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.
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.

Phenylephrine should be used with care in patients with hyperthyroidism,
cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic
enlargement and hypertension.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Each dose contains 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 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 your
ability to drive or use machines.

4.5

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 colestyramine. The anti-coagulant effect of
warfarin and other coumarins may be enhanced by prolonged regular use of
paracetamol with increased risk of bleeding; occasional doses have no significant
effect. Alcohol may potentiate the hepatotoxicity of paracetamol.
Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive
drugs; the product is contra-indicated in such circumstances.

With phenylephrine there is a possibility that an increased risk of arrhythmias may
occur in patients receiving cardiac glycosides or tri-cyclic anti-depressants.
Phenylephrine interacts with monoamine oxidase inhibitors; it should not therefore,
be taken by patients receiving monoamine oxidase inhibitors or within 14 days of
stopping such medication.
Guaifenesin may interfere with diagnostic measurements of urinary 5hydroxyindoleacetic acid or vanillylmandelic acid.

4.6

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 breast milk but not in a
clinically significant amount. Available published data do not contraindicate breast
feeding.
Phenylephrine should not be taken during pregnancy as it has been reported to cause
foetal hypoxia. Excretion in breast milk is reported to be minimal.
Guaifenesin is considered safe for use in lactating women and at normal doses in
pregnant women.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Undesirable effects with paracetamol are rare, however, hypersensitivity including
skin rashes may occur. There have been a few reports of blood dyscrasias including
thrombocytopenia and agranulocytosis after regular or excessive ingestion of
paracetamol, and of acute pancreatitis after ingestion of above normal dosage.
Undesirable effects are rare with normal doses of phenylephrine, however it can
cause the adverse effects typical of sympathomimetics including: hypertension,
palpitations (tachycardia), headache, dizziness, vomiting, diarrhoea and insomnia.
Guaifenesin has occasionally been reported to cause gastrointestinal discomfort.

4.9

Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol.
Ingestion of 5g 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, phenobarbital, 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
Nacetylcysteine 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 24h from ingestion should be discussed with the NPIS or
a liver unit.
The principal features of phenylephrine overdosage are a rise in blood pressure and
associated reflex bradycardia. A severe hypertensive response can be countered by
administration of an alpha-antagonist and any reflex bradycardia by atropine (but
preferably only after the pressure has been controlled by alpha-adrenergic blockade).
Very large doses of guaifenesin may cause nausea and vomiting.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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 Grampositive 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
Sorbitol Solution, Ethanol, Propylene Glycol, Glycerol, Saccharin Sodium, Sodium
Cyclamate, Acesulphame Potassium, Sodium Citrate, Anhydrous Citric Acid,
Xanthan Gum, Levomenthol, Eucalyptus Oil, Quinoline Yellow (E104), Purified
Water.

6.2

Incompatibilities
None.

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
Amber type III glass bottle and polypropylene child resistant closure with aluminium
foil film liner containing 160ml.
Graduated polypropylene measuring cup.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Hugh House
Upper Cliffe Road
Dodworth Business Park
Dodworth
South Yorkshire
S75 3SP
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16028/0077

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/03/2009

10

DATE OF REVISION OF THE TEXT
15/04/2011

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Further information

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