This medicine and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis. 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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, including MAO-B inhibitor selegiline. This may also apply to the antibacterial linezolid, which is a reversible, non-selective MAO inhibitor. Metabolism of opioid analgesics is inhibited by cimetidine leading to increased plasma concentration. The following undesirable effects have been reported following use of codeine phosphate or opioid analgesics and may arise following use of this medicine. The frequency of adverse effects cannot be estimated from available data. 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 or in acute alcoholism.

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 codeine is considered essential then great care should be taken in patients taking MAOIs or within 14 days of stopping MAOIs. (See section 4.5).

Read all of this section carefully before you start using Covonia Chesty Cough Sugar-Free Syrup. It includes other information which might be especially important for you. Always use this medicine exactly as described or as your doctor or pharmacist has told you. Warnings: Do not take more medicine than the label tells you to. Do not take with any other cough and cold medicine Anti-arrhythmics: May delay the gastro-intestinal absorption of mexiletine or quinidine (which may also reduce the efficacy of codeine). This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:Codeine should not be used during breastfeeding (see section 4.3). At normal therapeutic doses codeine and its active metabolite 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 a ultra-rapid metaboliser of codeine, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal. The infant itself may be a CYP2D6 ultra-rapid metaboliser. In either case on very rare occasions this may result in symptoms of opioid toxicity in the infant. (See also section 4.4). Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby 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. The opioid analgesics enhance effects of sodium oxybate, used to treat symptoms of narcolepsy and concomitant use should be avoided.

Do not take more medicine than the label tells you to. Do not take with any other cough and cold medicine. The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

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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. Pregnant or breastfeeding: Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby Antimuscarinics: codeine phosphate may increase the risk of antimuscarinic side effects such as dry mouth, urine retention and constipation (but this does not generally apply to antimuscarinics taken by inhalation). Like all medicines, Covonia Chesty Cough Sugar-Free Syrup can have side effects, although these don’t affect everyone Possible CNS excitation or depression (hypertension or hypotension) can occur when opioid analgesics are given with antidepressants such as moclobemide (a reversible MAO-A inhibitor). 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.

Use with caution in the elderly as codeine may contribute to faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and rarely colonic obstruction. Prolonged use could aggravate irritable bowel syndrome. Using the dose recommended, this medicine 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.Patients should be advised not to drive or operate machinery if affected by dizziness or sedation. 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. 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 if more than 2.5 mg/kg (adults and children) has been ingested. o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

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Anti-emetics: 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. 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.