Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse. Very rare cases of serious skin reactions have been reported with paracetamol.
Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with paracetamol, codeine, buclizine hydrochloride, or the combinations of paracetamol/codeine or paracetamol/codeine/buclizine hydrochloride are listed below by System Organ Class (SOC).
The frequencies are defined according to the following convention:
Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1,000 and <1/100); Rare (≥1/10,000 and <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data). ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence is unavailable, frequency category is listed as ‘Not known’.
4) Very common Headache5,6 Very Common Somnolence1,2,5 Common Dizziness1,2,5,6 Nervous system disorders Not known Psychomotor skills impaired5 Eye disorders Not known Vision blurred5 Vascular disorders Very common Flushing6 Not known Bronchospasm2 Not known Dyspnoea6 Respiratory, thoracic and mediastinal disorders Not known Increased viscosity of bronchial secretion5 Not known Respiratory depression2 Very common Nausea1,2 Common Constipation1,2 Common Dry mouth1,2,5 Common Vomiting1,2 Not known Abdominal pain6 Not known Dyspepsia2 Not known Gastrointestinal disorder5 Gastrointestinal disorders Not known Pancreatitis acute2 (in patients with a history of cholecystectomy) Hepatobiliary disorders Not known Liver injury3,8 Common Hyperhidrosis1,2 Uncommon Rash3,5 Not known Angioedema5,6 Not known Dermatitis2 Not known Erythema5 Not known Fixed eruption3 Not known Pruritus2,6 Skin and subcutaneous tissue disorders Not known Urticaria2,3,5 Not known Dysuria2,5 Renal and urinary disorders Not known Nephropathy toxic3 General disorders and administration site conditions Uncommon Drug withdrawal syndrome2 Investigations Not known Transaminases increased7 Metabolism and nutrition disorders Not known High anion gap metabolic acidosis 1 Adverse events reported by ≥1% of codeine/paracetamol treated subjects in 27 randomised placebo-controlled trials 2 Associated with codeine 3 Associated with paracetamol 4 Reported following paracetamol use, but not necessarily causally related to the drug 5 Associated with buclizine 6Associated with paracetamol / codeine combination 7Low level transaminase elevations may occur in some patients taking therapeutic doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.
8Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year. Other known ADRs that occur with codeine include: anorexia, antidiuretic effect, hypothermia, malaise, muscle fasciculation, and seizures.
4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.