Codeine Linctus Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codeine Linctus Bell’s Healthcare 15 mg per 5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains:
Codeine Phosphate BP 15 mg
Each 5 ml solution contains Sucrose 4g
Each 5 ml solution contains 2 vol% ethanol (alcohol)
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral solution.
4 CLINICAL PARTICULARS
4.1. Therapeutic indications
Codeine linctus is indicated for a dry or painful cough.
4.2. Posology and method of administration
Adults and the elderly:
5 - 10 ml three to four times a day.
Children:
Not recommended
4.3 Contraindications
• Respiratory depression
• Hypersensitivity to codeine
• Obstructive airways disease
• Liver disease.
• In women during breastfeeding (see section 4.6)
• In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers
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 opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
|
Population |
Prevalence % |
|
African/Ethiopian |
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% |
Not recommended for use in patients with acute asthma.
It should only be used with caution in those patients with renal or hepatic impairment and in those with a history of drug abuse.
Caution is advised when using this product in the elderly.
The leaflet will state, under “Pregnancy and breast-feeding”:
Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine
It contains 4 of sucrose per 5ml. To be taken into account in people with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains 2% vol% ethanol (alcohol) i.e. up to 156 mg per 10 ml dose, equivalent to 4 ml of beer or 1.6 ml of wine per 10 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups such as patient with liver disease or epilepsy.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
Codeine exhibits interactions common to all narcotic analgesics.
It delays the absorption of mexiletine and potentiates the actions of hypnotics and anxiolytics. In conjunction with MAOIs it may cause CNS excitation and hypertension. Codeine antagonises the effects of domperidone and metoclopramide.
4.6 Fertility, pregnancy and lactation
Pregnancy
As with all medications caution should be exercised during pregnancy, especially
in the third trimester when codeine may depress respiration in the neonate. Breastfeeding
Codeine should not be used during breastfeeding (see section 4.3).
At normal therapeutic doses codeine and its active metabolite 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 ultrarapid metaboliser of codeine, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.
4.7. Effects on ability to drive and use machines
Codeine produces sedation, therefore, treatment may impair ability to drive and use machines.
4.8 Undesirable effects
Side effects include tolerance and dependence, dizziness, nausea and constipation.
In therapeutic doses, codeine is much less liable than morphine to produce adverse effects.
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.yellowcard.mhra.gov.uk.
4.9. Overdose
Symptoms are:
Respiratory depression, dry mouth, sweating and facial flushing. High doses of codeine may produce sedation or excitement, and in children convulsions may occur. Respiratory depression may be reversed with naloxone using one of the following dose regimens:
Intravenous injection
Adults:
0.8 - 2 mg repeated at intervals of two to three minutes to a maximum of 10mg.
Children:
10 micrograms/kg and, if no response, subsequent doses of 100 micrograms/kg.
Subcutaneous or Intramuscular Injection
As for intravenous injection but only if the intravenous route is not feasible. The onset of action is slower with subcutaneous or intramuscular injection.
Continuous Intravenous Infusion
2 mg diluted in 500 ml of intravenous infusion solution at a rate adjusted according to the patients response.
5 PHARMACOLOGICAL PROPERTIES
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Codeine is a centrally acting weak analgesic. Codeine exerts it’s effect through p opioid 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
Codeine is well absorbed after oral administration. It is metabolised in the liver to morphine and norcodeine which are both excreted in the urine, partly as conjugates with glucuronic acid. Most of the excretion products appear in the urine within 6 hours and up to 86% of the dose is excreted in 24 hours. About 70% of the dose is excreted as free codeine, 10% as free and conjugated morphine and a further 10% as free or conjugated norcodeine. Only traces are found in the faeces.
5.3.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anhydrous Citric Acid BP Sunset yellow E110 Quinoline yellow E104 Glycerol BP Invert Syrup BP Benzoic Acid BP Propylene Glycol BP Ethanol 90% BP Terpeneless Lemon Oil BP Sucrose BP
Methyl Hydroxybenzoate Sodium BP Purified Water BP
6.2. Incompatibilities
None known.
6.3. Shelf Life
Three years.
6.4. Special Precautions for Storage
Do not store above 25°C.
Protect from light.
6.5 Nature and contents of container
100 ml, 200 ml and 500 ml glass bottles, child resistant cap with EPE liner. Not all packs may be marketed.
6.6. Instructions for Use, Handling and Disposal
None.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons and Co (Druggists) Ltd [Trading Style - Bell’s Healthcare] Gifford House,
Slaidburn Crescent Southport Merseyside PR9 9AL
8. MARKETING AUTHORISATION NUMBER
PL 03105/0063
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21st May 1998 / 15th December 1998
10 DATE OF REVISION OF THE TEXT
28/07/2016