Galcodine Linctus

1. Name Of The Medicinal Product

Galcodine Linctus

Care Codeine 15mg/5ml Oral Solution Sugar Free

2. Qualitative And Quantitative Composition

Codeine phosphate 15mg (Per 5ml Dose)

For excipients, see 6.1

3. Pharmaceutical Form

Oral Liquid

A viscous orange coloured liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Codeine is indicated in adults for the relief of an unproductive dry cough.

4.2 Posology And Method Of Administration

For oral administration.

Adult:

One 5ml spoonful four times daily.

Elderly:

Should be used with caution; a reduced dose is recommended.

Paediatric population

Codeine should not be used for the treatment of children under the age of 18 years.

4.3 Contraindications

Suspected opiate abuse, known hypersensitivity to codeine or any of the other ingredients.

Liver or respiratory failure or comatose patients.

In patients with raised intracranial pressure or head injury.

During an acute asthma attack.

4.4 Special Warnings And Precautions For Use

Galcodine should be used with caution in patients with renal and hepatic impairment, patients suffering from asthma or other respiratory disorders, or patients with a history of asthma, hypotension, shock, myasthenia gravis, cardiac arrhythmias, acute abdomen, gallstones, prostatic hypertrophy, obstructive or inflammatory bowel disorders, diseases of the biliary tract, and convulsive disorders.

Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions. If the use of dihydrocodeine is considered essential then great care should be taken in patients taking MAOIs or within 14 days of stopping MAOIs. (See section 4.5).

Use with caution in the elderly as codeine may contribute to faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and rarely colonic obstruction.

A reduced dose is recommended in elderly or debilitated patients, in hepatic and renal impairment (but avoid if severe), in hypothyroidism, and in adrenocortical insufficiency. Repeated use of opioid analgesics is associated with the development of psychological and physical dependence; although this is rarely a problem with therapeutic use, caution is advised if prescribing for patients with a history of drug dependence.

Galcodine and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.

If symptoms persist consult your doctor.

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.

The leaflet will state in the “Pregnancy and breast-feeding” subsection of section 2 “Before taking your medicine”:

Usually it is safe to take Galcodine while breast-feeding as the levels of the active ingredient 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 Interaction With Other Medicinal Products And Other Forms Of Interaction

As an opioid analgesic, codeine phosphate may potentiate the effects of tranquillisers such as barbiturates, anaesthetics, anxiolytics and hypnotics, sedatives and alcohol.

Possible CNS excitation or depression (hypertension or hypotension) can occur when opioid analgesics are given with antidepressants such as moclobemide. The sedative effects of codeine can possibly be increased when given with tricyclic antidepressants, with anxiolytics or hypnotics, or with sedating antihistamines. Antipsychotic medicines can enhance hypotensive and sedative effects when opioid analgesics are given with antipsychotics.

Monoamine oxidase inhibitors: MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.

Anti-emetic: The reduction in intestinal motility caused by codeine may delay the absorption or antagonise the gastrointestinal effects of other drugs e.g. metoclopramide and domperidone.

Metabolism of opioid analgesics is inhibited by cimetidine leading to increased plasma concentration.

Anti-arrhythmic: May delay the gastro-intestinal absorption of mexiletine or quinidine.

Opioid analgesics should be avoided when ciprofloxacin is to be used for antibacterial surgical prophylaxis as concomitant use can lead to decreased plasma concentration of ciprofloxacin. The opioid analgesics enhance effects of sodium oxybate, used to treat symptoms of narcolepsy and concomitant use should be avoided.

4.6 Pregnancy And Lactation

The product should be avoided during pregnancy unless considered necessary by the physician and should be avoided during the first trimester. Opioid administration in the third trimester may cause respiratory depression in the newborn, withdrawal effects in neonates of dependent mothers, gastric stasis and risk of inhalation pneumonia in the mother during labour.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and are 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

Using the dose recommended, Galcodine Linctus is not considered to be a hazard. Nevertheless, use of codeine at higher doses or in more sensitive individuals may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.

4.8 Undesirable Effects

The following undesirable effects have been reported following use of codeine phosphate or opioid analgesics and may arise following use of Galcodine Linctus. The frequency of adverse effects cannot be estimated from available data.

Psychiatric disorders: hallucinations, dysphoria, mood changes

Nervous system disorders: dizziness, drowsiness, seizures, addiction, tolerance, headache, vertigo, malaise

Eye disorders: miosis

Cardiac disorders: palpitations, bradychardia, tachycardia

Vascular disorders: postural hypotension, hypothermia, facial flushing

Gastrointestinal disorders: nausea, vomiting, constipation, abdominal pain, anorexia, pancreatitis, dry mouth

Hepatobiliary disorders: biliary spasm

Skin and subcutaneous tissue disorders: rashes, urticaria, pruritis, sweating

Musculoskeletal and connective tissue disorders: muscle fasciculation

Renal and urinary disorders: difficulty with micturition, ureteric spasm

Reproductive system and breast disorders: decreased libido or potency.

4.9 Overdose

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

RO5D A04 - Cough suppressants, excl. combinations with expectorants - opium alkaloids and derivatives

Galcodine contains codeine phosphate which is an opiate with analgesic, anti-diarrhoeal and cough suppressant activities.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid monohydrate

Sodium hydroxybenzoate

Ethanol 96%

Sunset yellow FCF (E110)

Saccharin sodium

Blanose cellulose gum (7HOF)

Menthol

Condensed milk flavour (F12516)

Orange flavour (17.40.7040)

Glycerol

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Two years from the date of manufacture.

6.4 Special Precautions For Storage

Store in a cool place.

6.5 Nature And Contents Of Container

Amber HDPE 2 litre Winchester with a polypropylene cap.

200ml Amber glass bottle with a white 28mm child-resistant tamper evident cap with EPE/Saranex Liner.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Thornton & Ross Ltd.

Linthwaite

Huddersfield

HD7 5QH, United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0099

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th July 2002

10. Date Of Revision Of The Text

23/03/2011