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LEMSIP MAX DAYTIME COLD AND FLU RELIEF

Active substance(s): CAFFEINE ANHYDROUS / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / CAFFEINE ANHYDROUS / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / CAFFEINE ANHYDROUS / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Lemsip Max Daytime Cold & Flu Relief

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient

mg/Capsule

Paracetamol
Caffeine
Phenylephrine hydrochloride

500
25
6.1

For excipients see 6.1.

3.

PHARMACEUTICAL FORM
Red/yellow hard gelatine capsules.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of symptoms associated with the common cold and influenza, including relief
of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and
lowering of temperature.

4.2.

Posology and method of administration
Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or worsen.
Posology
Adults, the elderly and children aged 16 years and over:
Take two capsules every 4-6 hours as required to a maximum of four doses in any 24 hours, or up to
a maximum of three doses in any 24 hours if a night-time paracetamol-containing product is taken
before bedtime.
Do not take more than 8 capsules (4 doses) in any 24 hours.
Do not give to children under 16 years of age.

Elderly Population: No dosage adjustment is considered necessary in the elderly.
Method of administration
For oral administration. Swallow whole with water. Do not chew.
4.3.

Contraindications
Hypersensitivity to paracetamol, phenylephrine, caffeine or to any of the excipients listed in section 6.1.
Due to the presence of phenylephrine, use of the product is contraindicated in:
• Patients with severe coronary heart disease and cardiovascular disorder.
• Patients with hypertension.
• Patients with hyperthyroidism.
• Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors
(MAOIs).
• Concomitant use of other sympathomimetic decongestants

4.4

Special warnings and precautions for use
Use with caution in patients with Raynaud’s Phenomenon and 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 concurrently.
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 (see section 4.9).
Phenylephrine should be used with care in patients with closed angle glaucoma and prostatic enlargement.
The product should not be used during pregnancy unless recommended by a healthcare professional (see
section 4.6).
Use during breastfeeding should be avoided, unless recommended by a healthcare professional (see section
4.6).
Due to the presence of caffeine, the product should be taken with care in patients with a history of peptic
ulcers.

4.5

Interaction with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors (including moclobemide) (MAOIs): Hypertensive interactions occur
between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).
Cardiac glycosides: Concomitant use of cardiac glycosides (e.g. digoxin) with phenylephrine may increase the
risk of irregular heartbeat or heart attack.
Tricyclic antidepressants: Tricyclic antidepressants (e.g. amitriptyline) may increase the risk of
cardiovascular side effects with phenylephrine (see section 4.3).
Sympathomimetic agents: Concomitant use of phenylephrine with other sympathomimetic amines can
increase the risk of hypertension and other cardiovascular side effects (see section 4.3).
Phenylephrine may reduce the efficacy of beta–blockers and other antihypertensives (including debrisoquine,
guanethidine, reserpine, methyldopa).
Anticoagulants: 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.

Antiemetics: The speed of absorption of paracetamol may be increased by metoclopramide or domperidone
and absorption reduced by cholestyramine.
CYP Inhibitors: Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450, factors
known to alter the activity of this enzyme system may influence caffeine clearance. Thus, caffeine elimination
is enhanced in cigarette smokers and inhibited by cimetidine, disulfiram, and oral contraceptive steroids.
4.6

Fertility, Pregnancy and Lactation
Pregnancy
The product should not be used during pregnancy unless recommended by a healthcare professional.
The safety of this medicine during pregnancy and lactaction 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.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the
recommended dosage.
Taken during pregnancy it appears that the half-life of caffeine is prolonged. This is a possible contributing
factor in hyperemesis gravidarum.
Breast-feeding
The product should be avoided during lactation unless recommended by a healthcare professional. There are
limited data on the use of phenylephrine in lactation.
Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do
not contraindicate breastfeeding.
Caffeine/metabolites are excreted in human milk, but at therapeutic doses of the product, no effects on the
breastfed newborns/infants are anticipated.
Fertility
There are no available data regarding the effects of the active ingredients on fertility.

4.7

Effects on ability to drive and use machines
This medicinal product has no or negligible influence on ability to drive or use machinery.

4.8

Undesirable effects
Adverse effects of paracetamol are rare.
The most commonly reported adverse events following dosing with caffeine are GI irritation and CNS
stimulation.
Adverse events which have been associated with paracetamol, phenylephrine and caffeine are given below,
tabulated by system organ class and frequency.Frequencies are defined as: Very common (≥1/10); Common
(≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<
1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse
events are presented in order of decreasing seriousness.
System Organ Class
Blood and Lymphatic
System Disorders

Frequency
Not known

Adverse Events
Thrombocytopenia, leucopenia,
pancytopenia, neutropenia, agranulocytosis1

Immune System Disorders
Psychiatric Disorders
Gastrointestinal

Not known
Not known
Not known

Hypersensitivity
Insomnia, restlessness, nervousness, delirium
Epigastric discomfort, nausea, vomiting

Disorders
Skin and Subcutaneous
Tissue Disorders

Very rare

Cases of serious skin reactions have been
reported

Not known
Renal and Urinary
Disorders

Not known

Skin rash
Urinary retention2

Description of Selected Adverse Reactions
1
There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia,
neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
2
Especially 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 Yellow Card Scheme at:
http:www.mhra.gov.uk/yellowcard.
4.9

Overdose
Paracetamol
The main cause for concern in overdosage is Paracetamol intake.
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g of 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.
Caffeine

Symptoms - emesis and convulsions may occur. No specific antidote. However, treatment is usually fluid
therapy. Fatal poisoning is rare. If symptoms become apparent or overdose is suspected, consult a doctor
immediately.
Phenylephrine hydrochloride
Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with
respiratory depression. Treatment includes 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, reflex bradycardia, 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,
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.

5.1.

Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, Anilides;
ATC Code: N02BE51, 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.
Caffeine: Caffeine is a central nervous system stimulant. It inhibits the enzyme
phosphodiesterase and has an antagonistic effect at central adenosine receptors. Its action
on the central nervous system is mainly on the higher centres and it produces a condition of
wakefulness and increased mental activity.
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.

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.
Caffeine: Caffeine is absorbed readily after oral, rectal or parenteral administration, but
absorption from the gastrointestinal tract may be erratic. There is little evidence of
accumulation in any particular tissue. Caffeine passes readily into the central nervous
system and into saliva. Concentrations have also been detected in breast milk. It is

metabolised almost completely and is excreted in the urine as 1-methyluric acid, 1methylxanthine and other metabolites with only about 1% unchanged.
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.

5.3.

Preclinical safety data

No preclinical findings of relevance have been reported.

6.1

List of excipients
Starch
Croscarmellose sodium
Sodium lauryl sulphate
Magnesium stearate
Talc
Gelatine
Titanium dioxide (E171)
Quinoline yellow (E104)
Patent blue V (E131)
Erythrosin (E127)
Shellac

6.2.

Incompatibilities
None known.

6.3.

Shelf life
Three years.

6.4.

Special precautions for storage
Store up to 25°C.

6.5

Nature and contents of container
250 micron opaque uPVC blister with a foil/paper laminate, 35gsm paper/9 micron soft-temper foil
and heat-seal coated, contained in an outer cardboard carton.
Pack sizes: 4, 6, 8 and 16 capsules. Not all pack sizes may be marketed.

6.6.

Special precautions for disposal and other handling
No special requirements for disposal.

7.

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

8.

MARKETING AUTHORISATION NUMBER
PL 00063/0148

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26th November 2004

10

DATE OF REVISION OF THE TEXT
22/03/2017

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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