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LEMSIP MAX COLD AND FLU BLACKCURRANT

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lemsip Max Cold and Flu Blackcurrant

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients

Mg/Sachet

Specification

Paracetamol

1000.00

Ph Eur

Phenylephrine hydrochloride*

12.20

Ph Eur

* Equivalent to phenylephrine (base) 10.0 mg.

Excipient(s) with known effect:
Sucrose
Sodium
Aspartame
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For relief of the symptoms of colds and influenza, including the relief of aches
and pains, sore throat, headache, 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 and children over 12: One sachet dissolved by stirring in hot water and
sweetened to taste.
The dose may be repeated in 4-6 hours as required.

No more than four doses should be taken in 24 hours.
Not to be given to children under 12.
There is no indication that dosage need be modified in the elderly.
Method of Administration:
Oral administration after dissolution in water.

4.3

Contraindications







4.4

Hypersensitivity to paracetamol, phenylephrine or to any of the excipients listed
in section 6.1.
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 (see section 4.5).
Concomitant use of other sympathomimetic decongestants

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 noncirrhotic 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).
Patients with rare hereditary problems of fructose intolerance, glucose- galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Each sachet contains approximately 2.3 g of carbohydrate. Due to its aspartame
content this product should not be given to patients with phenylketonuria.

4.5

Interaction with other medicinal products and other forms of interaction
Paracetamol
The speed 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.
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.

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 preeclampsia.
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage.
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 breast feeding.
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
Lemsip Max Cold & Flu Blackcurrant has no or negligible influence on ability
to drive or use machinery.

4.8

Undesirable effects
Adverse events which have been associated with paracetamol and phenylephrine
hydrochloride 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

Immune System
Disorders
Gastrointestinal
Disorders
Skin and Subcutaneous
Tissue Disorders

Not known

Thrombocytopenia, leucopenia,
pancytopenia, neutropenia,
agranulocytosis1
Hypersensitivity

Not known

Abdominal discomfort, nausea, vomiting

Very rare

Cases of serious skin reactions have been
reported

Not known

Skin rash

Not known

Urinary retention2

Renal and Urinary
Disorders

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
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 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 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, seizures and arrhythmias.
However, smaller amounts of the paracetamol and phenylephrine hydrochloride
combination product would be required to cause paracetamol related liver toxicity
than to cause serious phenylephrine-related toxicity.. Treatment includes 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, 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.
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.
Phenylephrine: 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 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
Sodium citrate,
Citric acid anhydrous,
Blackcurrant flavour,
Aspartame,
Saccharin sodium,
Pulverised sucrose,
Caster sugar,
Ascorbic acid and
Enocyanin

6.2

Incompatibilities
None known.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Store below 25°C in a dry place.

6.5

Nature and contents of container
Heat-sealed laminate sachet of Paper, PE, Aluminium foil and Ionomer
Pack size: 1, 2, 3, 4, 5, 6, 7, 8, 9 and10 sachets.
Not all pack sizes may be marketed

6.6

Special precautions for disposal
No Data Held

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0145

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 March 2004

10

DATE OF REVISION OF THE TEXT
24/10/2016

+ 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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