PSEUDOEPHEDRINE

Posology Adults and Children over 12 years 1 tablet every 4 - 6 hours up to 4 times a day. Children under 12 years Not recommended as a smaller dosage is required. Elderly As for adults. Hepatic dysfunction Patients with severe liver impairment should be treated with caution.

Renal Dysfunction Patients with moderate to severe renal impairment should be treated with caution. Method of Administration For oral use.

Clinical Trial Data The safety of pseudoephedrine from clinical trial data is based on data from 6 randomised, placebo-controlled single dose clinical trials and 6 randomised, placebo-controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/infection after a natural cold.

Table 1 includes adverse events from clinical trial and post-marketing experience. Adverse events included from clinical trials are those that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.

Post-marketing Data:

Adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1 below. 4) Psychomotor hyperactivity Somnolence Tremor Eye disorders Ischaemic optic neuropathy Cardiac disorders Dysrhythmias Myocardial infarction/myocardi al ischaemia Palpitations Tachycardia Vascular disorders Hypertension Gastrointestin al disorders Dry mouth Nausea Ischaemic colitis Vomiting Skin and subcutaneous tissue disorders Angioedema Pruritus Rash Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Dysuria Urinary retention (in men in whom prostatic enlargement could have been an important predisposing factor) 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.

Patients experiencing difficulty in urination due to enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment and in occlusive vascular disease.

If any of the following occur, this product should be stopped: • Hallucinations • Restlessness • Sleep disturbances 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 localised 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 Pseudoephedrine 60mg Tablets 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.

Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sough if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.

1. 5). The concomitant use of MAOIs may cause a rise in blood pressure or hypertensive crisis. Diabetes mellitus. Phaeochromocytoma. Hyperthyroidism. Closed angle glaucoma. Severe hypertension or uncontrolled hypertension. Severe acute or chronic kidney disease/renal failure.