1. Name Of The Medicinal Product
Pholcodine Linctus BP.
2. Qualitative And Quantitative Composition
Pholcodine BP 5.0mg/5ml.
For excipients, see 6.1.
3. Pharmaceutical Form
Oral solution.
A deep orange/ red viscous liquid with an odour of chloroform.
4. Clinical Particulars
4.1 Therapeutic Indications
For relief of the symptoms of dry or irritating coughs.
4.2 Posology And Method Of Administration
Oral use
Recommended Doses
Adults and children over 12 years: 5-10ml.
The elderly: Use with caution, not exceeding the recommended adult dose.
Dosage Schedule
The dosage may be repeated after 4 hours if required but not more than 4 doses in any 24 hours.
4.3 Contraindications
Contraindicated in patients with hypersensitivity to any of the ingredients; and in cases of liver disease.
It should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma.
Pholcodine should be avoided in patients being treated with monoamine oxidase inhibitors or within 2 weeks of cessation of their use.
Children under 12 years of age.
4.4 Special Warnings And Precautions For Use
Keep all medicines away from children.
Do not exceed the stated dose.
Not advisable for persistent or productive coughs and in chronic bronchitis or bronchiectasis because of the risk of sputum retention.
Pholcodine should be used with caution in patients with renal impairment or a history of asthma.
If symptoms persist consult your doctor.
Do not give to children under 12 years.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
When taken with alcohol the effects of CNS depression may be potentiated. May cause delayed absorption of mexiletine and potentiation of the effects of hypnotics and anxiolytics.
When used with monoamine oxidase inhibitors, pholcodine may cause CNS excitation and hypertension. The effects can occur up to two weeks after stopping MAOI'S.
Domperidone and metoclopramide have the opposing effects on gastro-intestinal activity, to pholcodine.
4.6 Pregnancy And Lactation
Safety of this product in pregnancy has not been established. All drugs should be avoided if possible during pregnancy, especially during the first trimester.
4.7 Effects On Ability To Drive And Use Machines
Using the dose recommended, pholocodine linctus is not considered to be a hazard, however, the use of pholcodine may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.
4.8 Undesirable Effects
May cause drowsiness, dizziness and nausea.
Constipation is occasionally encountered.
Immune system disorders: hypersensitivity reactions, anaphylaxis
4.9 Overdose
Restlessness, excitement, ataxia, nausea, drowsiness, and respiratory depression may occur after large doses. A toxic dose in children is said to be about 200mg.
Treatment consists of emptying the stomach by aspiration and lavage. Otherwise treatment should be symptomatic and supportive.
Treatment of acute poisoning should include a trial of naloxone. It should not be repeated unless there is a clinically effective response.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
R05D A08 – Cough suppressants, excl. combinations with expectorants -opium alkaloids and derivatives.
Pholcodine is a cough suppressant with mild sedative but little analgesic action. Its depressant effects on the respiration are less than those of morphine. It has been suggested that it produces its major effect on the patient's subjective reactions to the cough, rather than on the frequency and intensity of coughing. Opioids act as agonists, interacting with stereospecific and saturable binding sites or receptors in the brain and other tissues.
5.2 Pharmacokinetic Properties
Opioids are readily absorbed from the gastro-intestinal tract. Pholcodine may relieve local irritation of the respiratory tract for about 4 - 5 hours after oral administration.
Pathways of metabolism include hydrolysis followed by conjugation, as well as the more common N-dealkylation.
5.3 Preclinical Safety Data
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Chloroform
Ethanol (96%)
Citric acid monohydrate (granular)
Purified water
Amaranth solution (E123)
Quinoline yellow solution compound (Containing quinoline yellow (E104), yellow dye sunset (E110), chloroform, ethanol and glycerol)
Syrup
6.2 Incompatibilities
No major incompatibilities known.
6.3 Shelf Life
200ml: 24 months unopened.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
200ml: Glass bottle with plastic cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 12965/0030
9. Date Of First Authorisation/Renewal Of The Authorisation
25 October 1993
10. Date Of Revision Of The Text
15/03/2010
No comments:
Post a Comment