Summary of Product Characteristics Updated 03-Oct-2019 | Thornton & Ross Ltd
Active Ingredient:
Pseudoephedrine hydrochloride BP 60.0mg (Per Tablet).For full list of excipients, see section 6.1Severe 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 product should be discontinued and appropriate measures taken if needed.
Ischaemic colitis
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Immune system disorders:
Hypersensitivity reactions cross-sensitivity may occur with other sympathomimetics.Psychiatric disorders:
Hallucinations (particularly in children), insomnia, sleep disturbances, anxiety, restlessness, irritability, excitability, psychotic disorder has occurred rarely following misuse of pseudoephedrine.Nervous system disorders:
Headache, tremor, dry mouth.Eye disorders:
Angle-closure glaucoma.Cardiac disorders:
Tachycardia, palpitations, arrhythmia.Vascular disorders:
Hypertension, impaired circulation to the extremities.Gastrointestinal disorders:
Nausea, vomiting, ischaemic colitis.Skin and subcutaneous tissue disorders:
Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP). Fixed drug eruption in the form of erythematous nodular patches, rash.
Renal and urinary disorders:
Urinary retention.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.
25/09/2019
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