Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Teofarma S.R.L., Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Opiate addiction, mental clouding, disturbances of the breathing centre and respiratory function, head injuries and conditions in which intracerebral pressure is elevated (at high doses), hypotension and hypovolaemia.
Do not give Paracodin to children below the age of 6 years.
Do not give to patients who are receiving monoamine oxidase inhibitors or who have received these within the previous 14 days.
As dihydrocodeine may bring about histamine release, Paracodin should not be given during an attack of asthma and it should be administered with care to persons liable to such attacks.
This medicine contains 2 mg benzoic acid in each 20-drop dose Dosage should be reduced in the elderly, in hypothyroidism, in chronic hepatic disease and in renal insufficiency. Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms such as restlessness and irritability, once the drug is stopped.
Patients with pre-existing seizure disorders should be observed with caution when prescribed this product.
Patients should take Paracodin until a relief in the cough and for no longer than the maximum of 7 days for children (6-12 years).
Dihydrocodeine is a semi-synthetic analogue of codeine. There are similarities between the metabolism of codeine and dihydrocodeine in the formation of (O-demethylated) metabolites catalysed by CYP2D6. There are genetic differences in the expression of the CYP2D6 enzyme. For codeine, this results in a risk of lack of efficacy in poor metabolisers and a risk of opioid toxicity in patients who are ultra rapid metabolisers. The clinical implications of CYP2D6 genetic polymorphisms have not been sufficiently elucidated for dihydrocodeine (see section 5.2).
As with all other drugs acting on the central nervous system, the consumption of alcohol should be avoided under Paracodin therapy.
Paracodin should not be administered to patients who are receiving monoamine oxidase inhibitors or who have received these within the previous 14 days.
As occurs for other opoids, the effects of DHC on the central nervous system may be enhanced by other drugs acting on the central nervous system such as:
Cimetidine and other drugs (e.g. quinidine, fluoxetine) may inhibit hepatic metabolism of dihydrocodeine but no change of the clinical effects of dihydrocodeine have been noted.
All narcotic analgesics can cross the placenta and are also excreted in breast milk. They should not be used during pregnancy or lactation unless considered essential by the physician.
Paracodin Tablets may induce drowsiness. Patients receiving Paracodin Tablets should not drive or operate machinery unless it has been shown not to affect physical or mental ability.
At the usual recommended doses the most frequent side effects are nausea and constipation and less frequently headache and dizziness.
Psychiatric disorders: Confusion, euphoria.
Nervous system disorders: Dizziness, headache, vertigo or drowsiness.
Eye disorders: Miosis, visual disturbances.
Respiratory, thoracic and mediastinal disorders: Dyspnea, respiratory depression may occur at larger doses. Laringeal edema has been reported very rarely.
Gastrointestinal disorders: Nausea, vomiting, gastrointestinal complaints and constipation.
Cardiovascular disorders: Bradycardia, hypotension, palpitations, facial flushing.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus. Angioedema (Quinke’s edema).
Renal and urinary disorders: Urinary retention.
General disorders and administration site conditions: Fatigue.
Reporting 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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