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
 

PHENYLEPHRINE HYDROCHLORIDE

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

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
 

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

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.
 

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.

4.9 Overdose
PARACETAMOL

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

a) is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

or

b) Regularly consumes ethanol in excess of recommended amounts.

or

c) 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

Immedi