Skip to Content

UK Edition. Click here for US version.

LEMSIP MAX ALL IN ONE BREATHE EASY POWDER FOR ORAL SOLUTION

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

1

NAME OF THE MEDICINAL PRODUCT
Lemsip Max All In One Breathe Easy Powder for Oral Solution
Lemsip Cough Max for Chesty Cough & Cold Powder for Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet (4.8g) contains:
Paracetamol 1000mg
Guaifenesin 200mg
Phenylephrine Hydrochloride 12.2mg
Excipients:
Each sachet of this product contains:
61.5mg Aspartame – a source of phenylalanine
1973.3mg of sucrose
129.0mg (5.6mmol) of sodium
Also contains lactose and sulphite
For full list of excipients, see Section 6.1.

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 years of age without medical advice.

4.3

Contraindications
Hypersensitivity to any of the ingredients
Severe coronary heart disease and cardiovascular disorders
Hypertension
Hyperthyroidism
Concurrent use of monamine oxidase inhibitors (MAOI)

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.
Phenylephrine should be used with care in patients with hyperthyroidism,
cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic
enlargement and hypertension.
This product contains 1973.3mg sucrose per dose (total sugars 2g). Patients with
rare hereditary problems of fructose intolerance, glucose-galactose malabsorption
or sucrase-isomaltase insufficiency should not take this medicine.
This product contains 129.0mg (5.6mmol) sodium per dose - to be taken into
consideration for patients on a controlled sodium diet.
The following warnings will appear on the package label and/or leaflet:
Contains a source of phenylalanine. May be harmful for people with
phenylketonuria.
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.
CONTAINS PARACETAMOL. Do not take with any other paracetamolcontaining products. Immediate medical advice should be sought in the
event of an overdose, even if you feel well.
Keep out of the reach and sight of children.
If symptoms persist, consult your doctor.
DO NOT TAKE IF: allergic to any of the ingredients, if you have heart
disease or high blood pressure.
Do not store above 25oC
Store in the original package.
This medicinal product contains 129.0mg of sodium per dose. To be taken
into consideration by patients on a controlled sodium diet.
Contains sulphite; may rarely cause severe hypersensitivity reactions and
bronchospasm.
If you are pregnant or are being prescribed medicine by your doctor, seek

his advice before taking this product.
Also includes aspartame, sucrose, lactose, sulphite and sodium.
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 may be reduced by cholestyramine.
The anticoagulant 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.
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

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.
contraindicate breast-feeding.

Available published data do not

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 preeclampsia. 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
This medicine 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 and vomiting, probably only in overdose.
Rarely, palpitations. Also, rare reports of allergic reactions and 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 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. 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.
Guaifenesin
Very large doses may cause nausea and vomiting. The active substance 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.
The active ingredients are not known to cause sedation.

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 half-life in
plasma is approximately 1 hour. Guaifenesin may increase the rate of absorption of paracetamol.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional
to those already included in other sections of the SmPC.

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 00063/0538

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/09/2008

10

DATE OF REVISION OF THE TEXT
19/04/2016

11

DOSIMETRY (IF APPLICABLE)
N/A

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)
N/A

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.

Hide