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LEMSIP COLD CONGESTION & FLU RELIEF 500 MG/6.1 MG CAPSULES

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

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SUMMARY OF PRODUCT CHARACTERISTICS
1.

NAME OF THE MEDICINAL PRODUCT
Lemsip Cold, Congestion & Flu Relief 500 mg/6.1 mg Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient

mg/Capsule

Paracetamol

500

Phenylephrine Hydrochloride

6.1

For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Capsule, hard.
Dark blue/light blue hard gelatin capsules containing the drug product, an off-white
powder.

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, nasal congestion and lowering of
temperature.

4.2

Posology and method of administration
For oral use.
Swallow whole with water. Do not chew.
Adults and Children over 16 years
2 capsules to be taken every 4 to 6 hours, as required. Do not take more than 8
capsules in 24 hours.
Not recommended for children under 16 years of age.
Note: Does not contain a sleep aid.

4.3 Contraindications
PARACETAMOL
Hypersensitivity to paracetamol or any of the other constituents.
PHENYLEPHRINE HYDROCHLORIDE
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.

4.4

Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal
or severe hepatic impairment. The hazards of overdose are greater in those with
non-cirrhotic alcoholic liver disease.
Use with caution in patients with Raynaud’s Phenomenon and diabetes mellitus.

Patients should be advised not to take other paracetamol-containing products
concurrently.
Phenylephrine
Phenylephrine should be used with care in patients with diabetes mellitus, closed
angle glaucoma and prostatic enlargement.
The following warnings will appear on the pack:CONTAINS PARACETAMOL
-

If symptoms persist consult your doctor.
Do not exceed the stated dose.
Keep all medicines out of the reach and sight of children.
Do not take with any other paracetamol-containing products.

The Label shall say:
Immediate medical advice should be sought in the event of an overdose, even if
you feel well.
The Leaflet shall say:
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.

4.5

If you are pregnant or being prescribed medicine by your doctor, seek your
doctor’s advice before taking this product.
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 colestyramine.
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.
Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates,
monoamine oxidase inhibitors and tricyclic antidepressants, may increase the
hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in
patients currently receiving or within two weeks of stopping therapy with
monoamine oxidase inhibitors because of a risk of hypertensive crisis.

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

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.
Available published data do not contraindicate breast feeding.

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.
4.7

Effects on ability to drive and use machines
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
Immune System
Disorders
Gastrointestinal
Disorders
Skin and Subcutaneous
Tissue Disorders

Not known
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:
www.mhra.gov.uk/yellowcard

4.9

Overdose
PARACETAMOL
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, 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 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 British National Formulary (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 National Poisons Information Service (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, 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

PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group:

Other analgesics and antipyretics &

Other cold combination preparations
ATC code:

N02BE51

PARACETAMOL
Analgesic:
The mechanism of analgesic action has not been fully determined. Paracetamol may act
predominantly by inhibiting a prostaglandin synthesis in the central nervous system
(CNS) and to a lesser extent through a peripheral action by blocking pain-impulse
generation. The peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain
receptors to mechanical or chemical stimulation.
Antipyretic:
Paracetamol probably produces antipyresis by acting on the hypothalamic heat-regulating
centre to produce peripheral vasodilation resulting in increased blood flow through the
skin, sweating and heat loss. The central action probably involves inhibition of
prostaglandin synthesis in the hypothalamus.
PHENYLEPHRINE HYDROCHLORIDE
Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of
the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling
associated with inflammation of the mucous membranes lining the nasal and sinus
passages. This allows the free drainage of the sinusoidal fluid from the sinuses.
In addition to reducing mucosal lining swelling, decongestants also suppress the
production of mucus, therefore preventing a build up of fluid within the cavities which
could otherwise lead to pressure and pain.

5.2 Pharmacokinetic properties
PARACETAMOL
Absorption and Fate
Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma
concentrations occurring between 10 and 120 minutes after oral administration. It is
metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate

conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination halflife varies from about 1 to 4 hours.
Plasma-protein binding is negligible at usual therapeutic concentrations but increases
with increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by
mixed-function oxidases in the liver and which is usually detoxified by conjugation with
liver glutathione may accumulate following paracetamol overdose and cause liver
damage.

PHENYLEPHRINE HYDROCHLORIDE
Absorption and Fate
Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to
irregular absorption and first-pass metabolism by monoamine oxidase in the gut and
liver.

5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to that already
covered in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize Starch
Croscarmellose Sodium
Sodium Laurilsulfate
Magnesium Stearate
Talc
Gelatin
Titanium Dioxide

E171

Erythrosine

E127

Indigo Carmine

E132

6.2 Incompatibilities
None known.

6.1

Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
Blister packs of white opaque 250 micron PVC/30 micron hard temper pyramidal
aluminium foil, heat-seal coated, contained in an outer cardboard carton.
or
Blister packs of white opaque 250 micron PVC/9 micron Aluminium Foil
laminated to
35 g/m2 paper, contained in an outer cardboard carton.
Pack sizes: 8, 10 or 16 capsules.
6.6 Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL

8

MARKETING AUTHORISATION NUMBER(S)
PL 12063/0072

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/11/2007

10

DATE OF REVISION OF THE TEXT
14/03/2017

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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