BOOTS DECONGESTANT Tablet Ref.[7059] Active ingredients: Pseudoephedrine

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.

Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).

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'.

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Beta-blockers: this medicine may block the hypotensive effects.

Cardiac glycosides: (such as digoxin) increased risk of dysrhythmias.

Anticholinergic drugs: (such as tricyclic antidepressants) enhanced effects.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin: risk of hypertension.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Pregnancy

There are limited amount of data on the use of pseudoephedrine in pregnant women. The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital obstruction of small intestine). Due to the vasoconstrictive properties of pseudoephedrine, it may induce a reduction in uteroplacental circulation.

Pseudoephedrine is not recommended in pregnancy.

Breast-feeding

Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to the breastfed infant. Irritability and disturbed sleep have been reported in breastfed infants. Pseudoephedrine may suppress lactation.

No adverse effects known.

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).

Gastrointestinal Disorders:

Nausea, vomiting, dry mouth.

Frequency unknown: Ischaemic colitis.

Eye disorders:

Frequency unknown: Ischaemic optic neuropathy.

Nervous system disorders:

Headache, dizziness, tremor.

Frequency unknown: Posterior reversible encephalopathy syndrome (PRES) (see section 4.4). Reversible cerebral vasoconstriction syndrome (RCVS) (see section 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. 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.

None are known.