VALUE HEALTH COLD RELIEF POWDERS LEMON

Active substance: PARACETAMOL

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Summary of Product Characteristics
1.

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.

2.

Qualitative and Quantitative Composition
Paracetamol fine cryst EP
Ascorbic Acid fine PDR EP

3.

650mg
50mg

Pharmaceutical Form
Powder for oral solution

4.

Clinical Particulars

4.1.

Therapeutic Indications
For the symptomatic relief of colds and influenza

4.2.

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.

4.3.

Contra-indications
Hypersensitivity to any of the ingredients. Severe liver disease or kidney
damage.

4.4.

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
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.
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.

4.5.

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.

4.6.

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.

4.7.

Effects on Ability to Drive and Use Machines
None stated

4.8.

Undesirable Effects
Side-effects are usually mild and may include skin rashes and other allergic
reactions occasionally.
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. 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 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 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 7.5 g 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 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.

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
B-Carotene 1% cws (roche)
Lemon flavour for cold relief
Pulverised sugar BSC
Magnesium carbonate
Castor sugar BSC 043
Sodium saccharin recryst
Maize starch pdr

Anhydrous citric acid gran
Sodium citrate fine gran

6.2

Incompatibilities
None

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 in a cardboard carton.
Pack sizes: 5, 10.

6.6

Instruction for Use/Handling
None

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
Trading as: Value Health

8.

Marketing Authorization Number
PL 00014/5213R

9.

Date of First Authorisation/Renewal of Authorisation
First authorisation: 24 March 1988
Last renewal: 28 July 1993

10

DATE OF REVISION OF THE TEXT
04/04/2006

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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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