- 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.
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 partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. 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 indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.Sunset Yellow may cause allergic reactions.This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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 or lactation. 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.At normal therapeutic doses codeine 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 codeine may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.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.
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.
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.
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
Medical Information e-mail
+353 52 6186000
Medical Information Direct Line
+44 1978 661 261
Medical Information Fax
+44 1978 661 702