BOOTS COLD AND FLU RELIEF HOT BLACKCURRANT

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Cold and Flu Relief Hot Blackcurrant

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Paracetamol Fine crystals EP

650

Ascorbic Acid Fine powder EP

3

Quantity/Dose Unit (mg)

50

PHARMACEUTICAL FORM
Granular Powder

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of colds and influenza and to provide extra vitamin C
during such infections.

4.2

Posology and method of administration
For oral administration, following solution in hot water.
Adults And Children Over 12 Years: The contents of the sachet dissolved in freshly
boiled water to be taken at bedtime and repeat 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.
Elderly: There is no need for dosage reduction in the elderly.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Severe liver disease or kidney damage.

4.4

Special warnings and precautions for use
Label:
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.
Caution in patients with impaired liver or kidney function.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver
disease.
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 advice.
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
Contains Paracetamol.
Do not take this product for more than three days without consulting your doctor.
Do not take with any other paracetamol-containing products.

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 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 effects due to
paracetamol used in the recommended dosage, but patients must 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
No adverse effects stated.

4.8

Undesirable effects
Side effects are usually rare and mild and may occasionally 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.

4.9

Overdose
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Thereafter, 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, 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 10g 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.

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 and any patient who has
ingested around 7.5g or more of paracetamol in the preceding 4 hours should
undergo gastric lavage. Administration of oral methionine or intravenous Nacetylcysteine, which may have a beneficial effect up to at least 48 hours after
the overdose, may be required. General supportive measures must be
available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma
concentrations occurring about 30 mins 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 done dependent.
Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely
distributed in the body tissues. Ascorbic acid is reversibly oxidised to dehydro
ascorbic acid; some is metabolised to ascorbate-2-sulphate which is inactive and
oxalic acid which is excreted in the urine. Ascorbic acid crosses the placenta and is
distributed into the breast milk.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Pulverised sugar
Castor sugar
Light Magnesium carbonate
Sodium saccharin recryst (76% saccharin)
Dried maize starch pdr
Anhydrous citric acid gran
Blackcurrant flavour 213 IFF
Anthocyanin
Sodium citrate

6.2

Incompatibilities
None stated

6.3

Shelf life
36 months

6.4

Special precautions for storage
None

6.5

Nature and contents of container
Heat sealed paper/aluminium foil/polythene sachets/ contained in a cardboard carton.
Pack size: 5 or 10 sachets.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
The Boots Company Plc
1 Thane Road West
Nottingham NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0218

9

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

10

DATE OF REVISION OF THE TEXT
03/03/2009

Expand view ⇕

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.

Hide
(web2)