Soluble Cupanol-Co Lemon Flavour
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
4.1 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.
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
4.2 Posology and method of administration
For oral administration.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
Adults
One to two tablets to be taken every four hours if necessary. Do not exceed 8 tablets in 24 hours.
Elderly Patients
Normal adult dose unless there is impaired kidney or liver function.
Paediatric Population
Children aged less than 12 years
Codeine is contraindicated in children below the age of 12 years (see sections 4.3).
Children aged 12 years to 18 years
One to two tablets to be taken every six hours if necessary. Do not exceed 8 tablets in 24 hours.
Codeine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough and cold. (see section 4.4)
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
In children below the age of 12 years for the symptomatic treatment of cough and cold due to an increased risk of developing serious and life-threatening adverse reactions.
Caution should be taken in patients with impaired kidney or liver function.
In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions (see section 4.4)
In women during breastfeeding (see section 4.6)
In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers.
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
CYP2D6 metabolism
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained.
Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opiod toxicity even at common prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
General symptoms of opiod toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal.
Estimates of prevalence of ultra-rapid metabolisers in different populations are summarised below:
|
Population |
Prevalence % |
|
Afri can/Ethi opi an |
29% |
|
African American |
3.4% to 6.5% |
|
Asian |
1.2% to 2% |
|
Caucasian |
3.6% to 6.5% |
|
Greek |
6.0% |
|
Hungarian |
1.9% |
|
Northern European |
1% - 2% |
Post-operative use in children
There have been reports in the published literature that codeine given postoperatively in children after tonsillectomy and /or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
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 Fertility, Pregnancy and lactation
Codeine is contraindicated in women during breastfeeding (see section 4.3)
At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opiod toxicity in the infant, which may be fatal.
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 pg is given i.v. repeated at intervals of 2 -3 minutes if necessary. In children, a dose of 5 - 10 pg per kg of body weight may be given.
5.1 Pharmacodynamic properties
Analgesi c/anti -pyreti c.
Codeine is a centrally acting weak analgesic. Codeine exerts it effect through p opiod receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.
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 8p, 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
MARKETING AUTHORISATION HOLDER
7
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
03/03/2016