Summary of Product Characteristics Updated 09-Jul-2018 | THE BOOTS COMPANY PLC
|Active ingredient||% w/v|
|Paracetamol Ph Eur Pseudoephedrine Hydrochloride BP Pholcodine Ph Eur||3.333 0.200 0.033|
PholcodineShould be used with caution by patients with liver or renal disease. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma or are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.Do not take with any other cough and cold medicine.Use of pholcodine with alcohol or other CNS depressants may increase the effects of the CNS and cause toxicity in relatively smaller doses.
PseudoephedrineIf any of the following occur, this medicine should be stoppedHallucinationsRestlessnessSleep disturbancesCaution in moderate to severe renal impairment.
Severe Skin reactions:
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicne should be discontinued and appropriate measures taken if needed.
ParacetamolShould be given with caution to patients with impaired renal or hepatic function. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.Contains paracetamol.Warning: Do not exceed the stated dose.Do not use this product for longer than 5 days unless your doctor agrees.If symptoms persist consult your doctor.Do not take with any other paracetamol-containing products.Label:Immediate medical advice should be sought in the event of an overdose, even if you feel well.Leaflet or combined Label/Leaflet:Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.May be harmful to people on a low sodium diet. (Sodium)Warning: this product contains 4.8% by volume of ethanol.Each 30ml dose contains up to 1.16g of alcohol.Harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. May modify or increase the effect of other medicines. (Alcohol)This medicinal product contains 42.75g of sucrose.When taken according to the dosage recommendations each 30ml dose supplies up to 5.34g of sucrose.Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. (Sucrose)This medicinal product contains 14.37g of glucose.When taken according to the dosage recommendations each dose supplies up to 1.8g of glucose. (Glucose)Harmful in high doses. Can cause headache, upset stomach and diarrhoea. (Glycerin)
PholcodineNot to be used in patients taking MAOIs or within 14 days of stopping treatment.Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
PseudoephedrineMAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.Moclobemide: risk of hypertensive crisis.Antihypertensives: (including adrenergic neurone blockers, diuretics & beta-blockers): this medicine may block the hypotensive effects.Cardiac glycosides: increased risk of dysrhythmias.Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.Oxytocin: risk of hypertension.Enhances effects of anticholinergic drugs (such as TCAs).
ParacetamolThe speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
ParacetamolImmune system disorders: Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.Blood and lymphatic system disorders: Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Skin and subcutaneous tissue disorders: very rare cases of serious skin reactions have been reported.
PholcodineThe following side effects may be associated with the use of pholcodine: Gastrointestinal disorders: Gastrointestinal disturbances (nausea and constipation), vomiting, diarrhoea, upset stomach, epigastric pain.Immune system disorders: Hypersensitivity reactions and anaphylaxis.Nervous system disorders: Occasional drowsiness, dizziness, excitation, confusion.Respiratory, thorasic and mediastinal disorders: Sputum retention.Skin and subcutaneous tissue disorders: Skin reactions including rash.
PseudoephedrineCardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.Ear and labyrinth disorders: Tinnitus.Eye disorders: Blurred vision.Gastrointestinal disorders: nausea and/or vomiting, anorexia.General disorders and administration site conditions: Irritability.Immune system disorders: Hypersensitivity reactions including cross-sensitivity that may occur with other sympathomimetics.Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.Psychiatric disorders: Sleep disturbance, nightmares.Renal and urinary disorders: Difficulty in micturition including urinary retention.Skin and subcutaneous tissue disorders: Skin reactions including rash, sweating. Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP) - frequency unknown.Vascular disorders: Hypertension.Harmful in high doses. Can cause headache, stomach upset and diarrhoea. (Glycerin) 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
PholcodineIt is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In cases of severe poisoning the specific narcotic antagonist nalaxone may be used.
Information for children:Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.Other symptoms of overdosage may include headache, tachycardia, urinary retention, hallucinations, coma, hyperreflexia, tremor, hypertension and arrhythmias.
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