RELONCHEM CODEINE LINCTUS

4). Adults and the elderly: 5 – 10 ml three to four times a day. Dosage should be reduced in elderly or debilitated patients. 3). 4). Bell’s Healthcare Codeine Linctus 15 mg per 5 ml Oral Solution should not be used longer than necessary.

Gastrointestinal side effects: constipation is not uncommon; loss of appetite; flushing of face might occasionally occur; respiratory depression may be experienced; sputum retention may occur particularly in patients with chronic bronchitis and bronchiectasis.

4) General disorders and administration site conditions: Uncommon: drug withdrawal syndrome Hepatobiliary disorders Not known : sphincter of Oddi dysfunction Drug dependence Repeated use of Bell’s Healthcare Codeine Linctus 15 mg per 5 ml Oral Solution can lead to drug dependence, even at therapeutic doses.

4). Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Geriatric patients should be supervised while on this medication, and consideration of reduced dosage should be based on response. Codeine should only be used with caution in patients with kidney or liver impairment. Care should be taken in patients with asthma, hypothyroidism, and in patients with a history of drug abuse.

Tolerance and dependency may occur with prolonged use. CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic therapeutic effect will not be obtained.

Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.

These patients convert codeine into morphine rapidly resulting in higher-than-expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation, and lack of appetite.

In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. 9% Northern European 1%-2% Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.

These factors may worsen symptoms of morphine toxicity. Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Bell’s Healthcare Codeine Linctus 15 mg per 5 ml Oral Solution.

1 • Ventilatory failure condition may be exacerbated. 6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers • In children below the age of 12 years due to an increased risk of developing serious and life threatening adverse reactions.