SOLUBLE CUPANOL-CO LEMON FLAVOUR

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Soluble Cupanol-Co Lemon Flavour

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Soluble Cupanol-Co Lemon Flavour contain:
Paracetamol BP 500mg
Codeine Phosphate BP 8mg

3

PHARMACEUTICAL FORM

Effervescent Tablets

4

CLINICAL PARTICULARS

4.1
Therapeutic indications
For the relief of mild to moderate pain including headache, migraine, neuralgia,
toothache, sore throat, muscular and periods pains.
The symptomatic relief of influenza, feverishness and colds.

4.2
Posology and method of administration
For oral administration.
Adults, the Elderly and Children Aged Over 12 Years
One to two tablets to be taken every four hours if necessary. Do not exceed 8 tablets
in 24 hours.
Children 6-12 years
Half to one tablet to be taken every four hours if necessary. Do not exceed 4 tablets in
24 hours.
Not suitable for children under 6 years.
Elderly Patients
Normal adult dose unless there is impaired kidney or liver function.

Directions
The tablets must be dissolved in half a glass of water (100). The tablets dissolve more
quickly in warm water, or if stirred.

4.3
Contraindications
Caution should be taken in patients with impaired kidney or liver function. Each
tablet contains 430.1 mg (18.7 mmols) of Na+. This sodium should be taken into
account when prescribing for patients on a sodium restricted diet. Hypersensitivity to
Paracetamol and/or other constituents.

4.4
Special warnings and precautions for use
Do not exceed the recommended dose. This product contains Paracetamol. If
symptoms persist for more than 3 days, consult your doctor. If you are pregnant or
breastfeeding consult your doctor before taking this preparation. Keep out of the
reach of children. Care is advised in the administration of Paracetamol to patients
with severe renal or severe hepatic impairment and in those with non-cirrhotic
alcoholic liver disease. The hazards of overdose are greater in those with alcoholic
liver disease.
Labelling: "Immediate medical advice should be sought in the event of an overdose,
even if you feel well". "Do not take with any other paracetamol-containing products".
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
Interaction with other medicinal products and other forms of interaction
(i) Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase
the hepatotoxicity of Paracetamol, particularly after an overdose.
(ii) Chloramphenicol - Paracetamol may increase the half-life of Chloramphenicol.
(iii) Cholestyramine - may reduce absorption of Paracetamol.
(iv) Metoclopramide, Domperidone - may potentiate the effect of Paracetamol.
(v) Warfarin & other coumarins - The anticoagulant effect may be enhanced by
prolonged regular use or Paracetamol with increased bleeding.

4.6
Pregnancy and lactation
There is inadequate evidence for the safety of codeine in pregnancy. Epidemiological
studies in human pregnancy have shown no effects due to Paracetamol used in the
recommended dosage. Both substances have been used for many years without
apparent ill consequences and animal studies have not shown any hazard. However,
these tablets should be avoided in pregnancy unless considered essential by the

physician. Paracetamol has been detected in breast milk, although it is estimated that
less than 0.1% of the material dose appears in 100ml of breast milk. Codeine has also
been shown to be excreted in breast milk, although the quantity was not determined.
Available published data do not contraindicate breastfeeding.

4.7
Effects on ability to drive and use machines
Codeine can occasionally cause drowsiness. If affected the patient should not drive or
operate machinery.

4.8
Undesirable effects
If given in therapeutic doses side effects are very rare. Hypersensitivity including
skin rashes and other allergic reactions may occur occasionally. There have been
reports of blood dyscrasias including thrombocytopenia and agranulocytosis, and of
acute pancreatitis. Most reports of adverse reactions to Paracetamol relate to overdose
with the drug. Codeine can cause constipation, nausea, drowsiness and confusion.

4.9
Overdose
Symptoms due to Paracetamol in the first 24 hours are pallor, nausea, vomiting,
anorexia and abdominal pain. Liver damage may become apparent after 12 to 48
hours. 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 have been reported.
Liver damage is likely 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.
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 four hours should undergo gastric lavage.
Administration of oral Methionine or intravenous N-acetylcysteine which may have a
beneficial effect up to at least 48 hours after the overdose may be required. General
supportive measures must be available.
Due to codeine - respiratory depression and hypotension with circulatory failure and
deepening coma. Convulsion may occur in infants and children.
Treatment: Naloxone Hydrochloride - 400 µg is given i.v. repeated at intervals of 2 3 minutes if necessary. In children, a dose of 5 - 10 µg per kg of body weight may be
given.

5

PHARMACOLOGICAL PROPERTIES

5.1
Pharmacodynamic properties
Analgesic/anti-pyretic.

5.2
Pharmacokinetic properties
None stated.

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

6

PHARMACEUTICAL PARTICULARS

6.1
List of excipients
Sodium Bicarbonate
Sodium Carbonate (Anhydrous)
Sodium Cyclamate 1968
Sodium Saccharin
Citric Acid Anhydrous
Polyethylene Glycol Powder 6000
Povidone
Lemon F-O-L 610406E

6.2
Incompatibilities
None stated.

6.3
Shelf life
Two years.

6.4
Special precautions for storage
Store in a cool dry place.

6.5
Nature and contents of container
Strip pack using PPFM laminate, constructed of: 40gsm MGBK paper / l2gsm LDPE
8μ aluminium foil / 23gsm LDPE. Strips are packed into a carton containing either
10, 12, 16, 24, 30, 36, 50, 56, 100, or 112 tablets.

6.6
Special precautions for disposal
Non stated

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU

8

MARKETING AUTHORISATION NUMBER(S)

PL 16431/0055

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/03/2009

10

DATE OF REVISION OF THE TEXT
19/10/2012

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
(web3)