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LEMSIP MAX COLD & FLU CAPSULES

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 Cold & Flu Capsules
Lemsip Max Plus Cold & Flu Relief Capsules

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Paracetamol
Caffeine
Phenylephrine hydrochloride

mg/capsule
500
25
6.1

For excipients, see Section 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








4.4

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.

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).

4.5

Due to the presence of caffeine, the product should be taken with care in patients with a
history of peptic ulcers.
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 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.
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 new-borns/infants are anticipated.

4.7

Fertility
There are no available data regarding the effects of the active ingredients on fertility.
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

Frequency

Adverse Events

Blood and Lymphatic
System Disorders

Not known

Thrombocytopenia, leucopenia,
pancytopenia, neutropenia, agranulocytosis1

Immune System Disorders

Not known

Hypersensitivity

Psychiatric Disorders

Not known

Insomnia, restlessness, nervousness, delirium

Gastrointestinal
Disorders
Skin and Subcutaneous
Tissue Disorders

Not known

Epigastric discomfort, nausea, vomiting

Very rare

Cases of serious skin reactions have been
reported
Skin rash

Not known
Renal and Urinary
Disorders

Not known

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

4.9

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.
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
5.1.

Pharmacological Properties
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 mainly 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 from 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, 1-methylxanthine 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

PHARMACEUTICAL PARTICULARS

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
Do not store above 25°C. Store in original package.

6.5

Nature and contents of container
250 micron opaque uPVC blister with foil/paper laminate, 35 gsm paper/9 micron soft-temper
foil and heat-seal coated, contained in an outer cardboard carton.
Pack sizes: 4, 6, 8, 10, 12, 14 and 16 capsules. Not all pack sizes may be marketed.

6.6.

Special precautions for disposal and other handling

7.

MARKETING AUTHORISATION HOLDER

No special requirements for disposal.

Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS
United Kingdom

8.

MARKETING AUTHORISATION NUMBER

PL 00063/0104.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/03/2009

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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