- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Codeine Linctus BP
2. Qualitative and quantitative composition
Each 5 ml of Codeine Linctus BP contains 15 mg of Codeine Phosphate BP.
3. Pharmaceutical form
Clear yellow, lemon flavoured syrup.
4. Clinical particulars
4.1 Therapeutic indications
Recommended as an anti-tussive for a non productive cough by oral administration.
4.2 Posology and method of administration
The usual dosage for adults is 5 to 10 ml, 3 to 4 times daily. Dosage should be reduced in elderly or debilitated patients.
Hypersensitivity to Codeine.Liver disease: drug may accumulate.Ventilatory failure condition may be exacerbated. 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
Geriatric patients should be supervised while on this medication, and consideration of reduced dosage should be based on response. Codeine should only be used with caution in patients with kidney or liver impairment. Care should be taken in patients with asthma, hypothyroidism, and in patients with a history of drug abuse. Tolerance and dependency may occur with prolonged use.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 adequate analgesic effects 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. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Sunset Yellow may cause allergic reactions.This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
|African American||3.4% to 6.5%|
|Asian||1.2% to 2%|
|Caucasian||3.6% to 6.5%|
4.5 Interaction with other medicinal products and other forms of interaction
CNS depressants, anticholinergics, hydroxyzine and methadone concurrent use of these medicines may result in potentiation of effects and hypotensive effects and CNS depressant effects may be increased; levallorphan is a morphine antagonist; the respiratory effects of neuromuscular blocking agents may be addictive to the central respiratory effects of the opioid analgesics; metoclopramide and codeine have opposing effects on gastro intestinal activity; codeine causes delayed absorption of mexiletine; the effects of hypnotics and sedatives may be potentiated by codeine; hypertensive crisis may be caused by concurrent use of codeine and monoamine oxidase inhibitors.
4.6 Fertility, pregnancy and lactation
Risk benefit must be considered before using codeine during pregnancy. Codeine crosses the placenta and is excreted in small amounts in breast milk. Regular use during pregnancy may cause physical dependency in the foetus, depression of neonatal respiration, withdrawal effects in the neonate. Teratogenic effects in humans have not been documented but controlled studies have not been done. There is a risk of gastric stasis in the mother during labour which may lead to inhalation pneumonia.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 ultra-rapid 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. If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
4.7 Effects on ability to drive and use machines
Codeine may cause drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive • Do not drive until you know how the medicine affects you • It is an offence to drive while under the influence of this medicine • However, you would not be committing an offence (called 'statutory defence') if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely
4.8 Undesirable effects
Gastrointestinal side effects, constipation is not uncommon; loss of appetite; flushing of face might occasionally occur; respiratory depression may be experienced; sputum retention may occur particularly in patients with chronic bronchitis and bronchiectasis.
Reporting of suspected adverse reactionsReporting 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.
In cases of overdosage supportive therapy is recommended. Gastric lavage should be carried out and a saline purgative may then be given to reduce absorption from gastro intestinal tract. Symptomatic treatment of respiratory embarrassment should be given. If respiration is seriously depressed intravenous naloxone HCl may be required.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Morphine derivative. Antitussive suppresses the cough reflex by a direct central action, probably in the medulla or pons. Codeine is a centrally acting weak analgesic. Codeine exerts it's effect through µ 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
Protein binding is very low.Half life from 2.5 to 4 hours.Duration of action approximately 4 hours.Onset of action after oral administration is 30 to 45 minutes.Excretion is primarily renal with 5 to 15% of the drug excreted unchanged.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Sodium Benzoate (E211)Citric Acid Monohydrate Saccharin Sodium (E954)Sunset Yellow (E110) Sorbitol Solution 70% (E420)Purified Water (to volume)Orange FlavourCarboxymethylcellulose 7H3SFX Propylene Glycol
6.3 Shelf life
|High density polyethylene Bottles:||36 months|
|Amber glass Bottles:||36 months|
6.4 Special precautions for storage
Do not store above 25°C. Protect from light.
6.5 Nature and contents of container
Pharmaceutical Grade III Amber Glass Bottles with CRC caps: 100 ml, 125 ml and 200 mlHigh Density Polyethylene Bottles: 2000 ml and 1000 ml
6.6 Special precautions for disposal and other handling
As for all medicines no special warnings.
7. Marketing authorisation holder
Pinewood Laboratories Ltd.,Ballymacarbry, Clonmel,Co. Tipperary, Ireland.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
30/08/1998 / 20/11/2003
10. Date of revision of the text
Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
+ 353 52 6136311
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