BOOTS COLD RELIEF (LEMON)
Active substance(s): ASCORBIC ACID / PARACETAMOL / ASCORBIC ACID / PARACETAMOL / ASCORBIC ACID / PARACETAMOL
Name of the Medicinal Product
Boots Cold Relief (Lemon) or Boots Hot Lemon Cold Relief or Boots Cold
Relief Hot Lemon or Boots Cold and Flu Relief Hot Lemon or Value Health
Cold Relief Powders Lemon.
Qualitative and Quantitative Composition
Paracetamol fine cryst EP
Ascorbic Acid fine PDR EP
Powder for oral solution
For the symptomatic relief of colds and influenza
Posology and Method of Administration
Adults and children over 12 years:
The contents of the sachet dissolved in hot water to be taken at bedtime and
repeated every four hours during the day if necessary up to a maximum of 4
doses in 24 hours.
Children under 12 years:
Not to be given without medical advice.
There is no need for dosage reduction in the elderly.
Hypersensitivity to any of the ingredients. Severe liver disease or kidney
Special Warnings and Precautions for Use
Caution in patients with impaired liver or kidney function.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver
Do not take more than 4 doses in 24 hours.
Do not exceed the stated dose.
Children under 12 years should not be given this medicine without medical
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
Do not take this product for more than three days without consulting your
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even
if you feel well.
Leaflet or combined label/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.
Interactions with other Medicaments and other forms of Interaction
The speed of absorption of paracetamol may be increased by metaclopramide
or domperidone and absorption reduced by cholestyramine.
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.
Pregnancy and Lactation
Epidemiological studies in human pregnancy have shown no effects due to
paracetamol when 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.
Effects on Ability to Drive and Use Machines
Very rare cases of serious skin reactions have been reported.
Side effects are usually mild and may include skin rashes and other allergic reactions
There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis,
but these were not necessarily causally related to 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).
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 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 odema 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.
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 the 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) but
results should not delay initiation of treatment beyond 8 hours after ingestion, as 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 of hospital.
Paracetamol is a peripherally acting analgesic with antipyretic properties.
Ascorbic acid is a source of vitamin c which may be beneficial during
infection when vitamin c levels are believed to fall.
Paracetamol is readily absorbed from the gastrointestinal tract with peak
plasma concentrations occurring about 30 minutes to 2 hours after ingestion.
Paracetamol is metabolised in the liver and excreted in the urine mainly as the
glucuronide and sulphate conjugates with about 10% as glutathione
conjugates. Less than 5% is excreted as unchanged paracetamol. The
elimination half life varies from about 1 to 4 hours. Plasma protein binding is
negligible at usual therapeutic concentrations, although this is dose-dependent.
Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely
distributed in the body tissues. Ascorbic acid is reversibly oxidised to dehyro
ascorbic acid; some is metabolised to ascorbate-2- sulphate which is inactive
and oxalic acid which are excrete in the urine. Ascorbic acid crosses the
placenta and is distributed in to breast milk.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.
List of excipients
B-Carotene 1% cws (roche)
Lemon flavour for cold relief
Pulverised sugar BSC
Castor sugar BSC 043
Sodium saccharin recryst
Maize starch pdr
Anhydrous citric acid gran
Sodium citrate fine gran
Special Precautions for Storage
Nature and Contents of Container
Heat sealed paper/aluminium foil/polythene sachets in a cardboard carton.
Pack sizes: 5, 10.
Instruction for Use/Handling
MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Trading as: Value Health
Marketing Authorization Number
Date of First Authorisation/Renewal of Authorisation
First authorisation: 24 March 1988
Last renewal: 28 July 1993
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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