- phenylephrine hydrochloride
This information is intended for use by health professionals
Adults and children 12 years and overOne 20 ml measured dose (or four 5 ml spoonfuls). Repeat every four hours as necessary. Do not exceed four doses per 24 hours.Not to be given to children under 12 years except on medical advice. ElderlyThe normal adult dose may be taken.Do not take continuously for more than 5 days without medical advice
Special label warningsDo not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.Immediate medical advice should be sought in the event of an overdose, even if you feel well.Contains ethanol, glycerol, sorbitol and Sunset Yellow, see leaflet for further information.
Special leaflet warningsImmediate 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.This medicinal product contains 19% v/v ethanol (alcohol) i.e. 3.8 ml per 20 ml dose, equivalent to 76 ml beer or 31.6 ml wine.Harmful for those suffering from alcoholism.To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.Glycerol may cause headache, stomach upset and diarrhoea. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains sorbitol 4.7 g per dose, a source of 1.175 g fructose.Sunset Yellow (E110) may cause allergic reactions.
|Monoamine oxidase inhibitors (including moclobemide)||Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).|
|Sympathomimetic amines||Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.|
|Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)||Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.|
|Tricyclic antidepressants (e.g. amitriptyline)||May increase the risk of cardiovascular side effects with phenylephrine.|
|Ergot alkaloids (ergotamine and methylsergide)||Increased risk of ergotism|
|Digoxin and cardiac glycosides||Increase the risk of irregular heartbeat or heart attack|
|Body System||Undesirable effect|
|Blood and lymphatic system disorders||Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol|
|Immune system disorders||Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis|
|Respiratory, thoracic and mediastinal disorders||Bronchospasm*|
|Hepatobiliary disorders||Hepatic dysfunction|
|Gastrointestinal disorders||Acute pancreatitis|
|Body System||Undesirable effect|
|Psychiatric disorders||Nervousness, irritability, restlessness, and excitability|
|Nervous system disorders||Headache, dizziness, insomnia|
|Cardiac disorders||Increased blood pressure|
|Gastrointestinal disorders||Nausea, Vomiting, diarrhoea|
|Eye disorders||Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma|
|Cardiac disorders||Tachycardia, palpitations|
|Skin and subcutaneous disorders||Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions including cross- sensitivity with other sympathomimetics may occur.|
|Renal and urinary disorders||Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.|
GuaifenesinThe frequency of these events is unknown but considered likely to be rare.
|Body system||Undesirable effect|
|Immune system disorders||Allergic reactions, angioedema, anaphylactic reactions|
|Respiratory, thoracic and mediastinal disorders||Dyspnoea*|
|Gastrointestinal disorders||Nausea, vomiting, abdominal discomfort,|
|Skin and subcutaneous disorders||Rash, urticaria|
ParacetamolLiver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).Risk factors: If the patienta, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.Orb, Regularly consumes ethanol in excess of recommended amounts. Orc, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.Symptoms:Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.Management:Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour.Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post- ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Symptoms and signsPhenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions.Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
TreatmentTreatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
Symptoms and signsVery large doses of guaifenesin cause nausea and vomiting.
TreatmentVomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.
980 Great West Road, Brentford, Middlesex, TW8 9GS
0800 783 8881
0800 783 8881