BOOTS DECONGESTANT

Adults and children over 12 years:

One tablet if necessary, up to four times daily at intervals of not less than 4 hours.

Children under 12 years:

Not recommended.

Elderly:

There is no need for dosage reduction in the elderly.

Adverse effects may include dry mouth, anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males and skin rashes. Hallucinations have been reported rarely, particularly in children.

Immune system disorders Hypersensitivity reactions, including cross sensitivity that may occur with other sympathomimetics.

Skin and subcutaneous tissue disorders:

Frequency unknown: Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP). 4). 4) Cardiac disorders: Tachycardia, palpitations, cardiac arrhythmias Renal and urinary disorders: Urinary retention in males.

Vascular disorders:

Hypertension Psychiatric disorders: Sleep disturbance, insomnia, restlessness, anxiety, hallucinations (particularly in children). 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.

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 Decongestant 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. 8). 3). Pseudoephedrine should be discontinued, and immediate medical assistance sought 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. Caution is advised in patients with prostatic enlargement. If any of the following occur, this medicine should be stopped: - Hallucinations - Restlessness - Sleep disturbances If symptoms are not controlled by Boots Decongestant Tablets, medical advice should be sought.

Keep all medicines out of the reach of children.

Warning:

Do not exceed the stated dose. This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium free’.

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, or uncontrolled hypertension, severe acute or chronic kidney disease/renal failure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, and phaeochromocytoma.

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