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LEMSIP PARACETAMOL 500MG LEMON FLAVOUR TABLETS

Active substance(s): PARACETAMOL DC 96% / PARACETAMOL DC 96% / PARACETAMOL DC 96%

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lemsip Paracetamol 500mg Lemon Flavour Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol.
Excipients:
Each tablet contains 38 mg of aspartame.
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Tablet.
Convex pale yellow oval shaped tablet with lemon odour and flavour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For relief of symptoms of colds and influenza, including the relief of aches and
pains, sore throat, headache and lowering of temperature.

4.2

Posology and method of administration

Adults (16 years and over): Two tablets every 4-6 hours to a maximum of four
doses in any 24 hours.
Do not exceed eight tablets in any 24 hours.
Children 12-15 years: One tablet every 4-6 hours to a maximum of four doses
in any 24 hours.
Do not exceed four tablets in any 24 hours.
Swallow whole with water. Do not chew.
OR
Oral administration after dissolution in water.
Adults 16 years and over: Two tablets dissolved by stirring in half a mug of
hot, not boiling water and sweetened to taste.
Dose may be repeated in 4-6 hours. No more than four doses (eight tablets)
should be taken in 24 hours.
Children 12 – 15 years: One tablet dissolved by stirring in half a mug of hot,
not boiling water and sweetened to taste.
Dose may be repeated in 4-6 hours to a maximum of four doses in any 24
hours. Do not exceed four doses (four tablets)
Once prepared the drink should be taken as soon as possible and should not be
stored.
Not recommended for children under 12 years of age.

4.3

Contraindications
Paracetamol : Hypersensitivity to paracetamol or any other constituents

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.
Label: Immediate medical advice should be sought in the event of an
overdose, even if you feel well.
Leaflet: 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 no exceed the stated dose. Keep out of the reach and sight of children.
Contains paracetamol (panel). If symptoms persist consult your doctor. If you
are pregnant or are being prescribed medicine by your doctor, seek their
advice before taking this product. Do not take with any other paracetamolcontaining products.
Due to its aspartame content this medicinal product should not be given to
patients with phenylketonuria.

4.5

Interaction with other medicinal products and other forms of interaction
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.

4.6

Pregnancy and lactation
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.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Adverse effects of paracetamol are rare, but hypersensitivity including skin
rash may occur. There have been a few reports of blood dyscrasias including

thrombocytopenia and agranulocytosis, but these were not necessarily causally
related to paracetamol.

4.9

Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g or more
of paracetamol. Ingestion of 5 g 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, primadone, 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.
Sumptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Liver damage may become apparent
12-48 hours after ingestion. Abnormalities of glucose metabolism and
metabolic acidosis may occur. In severe poisoning, hepatic failure may
progress to encephalopathy, coma and death. Acute renal failure with acute
tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported. Liver damage is
possible in adults who have taken 10 g or more of paracetamol. It is
considered that excess quantities of a toxic metabolite (usually adequately
detoxified by glutathione when normal doses of paracetamol are ingested)
become irreversibly bound to liver tissue.
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
or organ damage. Management should be in accordance with established
treatment guidelines.
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 Nacetylcysteine, 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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code
N02BE51 – paracetamol, combinations excluding 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.

5.2

Pharmacokinetic properties
Paracetamol: Paracetamol is absorbed readily after taking the product and is
detected in the plasma within 5 minutes or oral dosing. The pharmacokinetic
model shows faster absorption seen over the first 30 minutes for the product
compared to a standard does of two paracetamol tablets, however, the overall
extent of absorption of both products remains the same. Actual mean plasma
levels at each time point show the time to achieve a level of 5 µg/ml is less
than 14 minutes, compared to 22 minutes for standard paracetamol tablets; the
speed to achieve 10 µg/ml being 19 minutes versus 30 minutes.
The median time to maximum plasma concentration (tmax) was 35 minutes
which was the same as a standard dose of two tablets of 500 mg paracetamol.
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.

5.3

Preclinical safety data
There are no findings of relevance to the prescriber other than those already
mentioned elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Microcrystalline cellulose
Crospovidone
Citric acid
Aspartame
Quinoline yellow
Lemon flavour
Magnesium stearate
Povidone
Pre-gelatinised maize starch

6.2

Incompatibilities
None known

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
Tablets are packed in blister trays of cold-form aluminium base and peelable
paper/aluminium laminate lidding.
Pack sizes: 6 tablets and 12 tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0554

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/06/2010

10

DATE OF REVISION OF THE TEXT
04/06/2010

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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