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CODEINE LINCTUS BP

Active substance(s): CODEINE PHOSPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Codeine Linctus BP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml dose contains: Codeine Phosphate BP 15 mg

3.

PHARMACEUTICAL FORM Oral solution.

4 4.1.

CLINICAL PARTICULARS 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.

Contra-indications Respiratory depression, hypersensitivity to codeine, obstructive airways disease, liver disease.

4.4

Special warnings and precautions for 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. 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 in the Pregnancy and breast-feeding subsection of section 2 Before taking your medicine: Usually it is safe to take Codeine Linctus while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

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 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 metabolites 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 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.

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

5.1.

Pharmacodynamic properties Codeine is an analgesic with uses similar to that of morphine but is much less potent as an analgesic and has only mild sedative effects.

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 Chloroform 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 25C. 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 & Co (Druggists) Ltd Gifford House Slaidbum Crescent Southport Merseyside PR9 9AL United Kingdom

8.

MARKETING AUTHORISATION NUMBER PL 03105/0063

9. DATE OF AUTHORISATION

FIRST

AUTHORISATION/RENEWAL

OF

THE

21st May 1998 / 15th December 1998

10

DATE OF REVISION OF THE TEXT
13/09/2012

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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.

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