paracetamol + pseudoephedrine hydrochloride: clinical use

Prescribing considerations

• Confirm that both congestion and pain or fever require treatment.
• Check for duplicate paracetamol, oral or topical decongestants, and interacting medicines.
• Assess cardiovascular, renal, hepatic, endocrine, ophthalmic and urinary risk factors.
• Product-specific licensed ages and indications differ; use the relevant SmPC and pack.

Contraindications and cautions

• Hypersensitivity to either active substance or an excipient.
• Cardiovascular disease or hypertension, including severe or uncontrolled hypertension.
• Severe acute or chronic kidney disease or renal failure.
• Diabetes mellitus, phaeochromocytoma, hyperthyroidism and closed-angle glaucoma.
• Concurrent sympathomimetic decongestants, beta-blockers, monoamine oxidase inhibitors or recently discontinued monoamine oxidase inhibitors.
• Below the product-specific licensed minimum age.

Monitoring

• Review blood pressure and cardiovascular status when clinically relevant.
• Stop and assess urgently for thunderclap headache, acute neurological symptoms or visual disturbance suggestive of PRES or RCVS.
• Suspected overdose requires immediate assessment even when early symptoms are absent.

Clinical pharmacology

Pseudoephedrine has direct and indirect sympathomimetic activity, producing vasoconstriction in swollen upper-airway mucosa. Paracetamol provides analgesic and antipyretic effects with little anti-inflammatory activity.

Formulation and product differences

• Both selected products are oral tablets, but licensed indications and minimum ages differ.
• The products contain different proportions of the active ingredients.
• The Boots product is described as essentially sodium-free; excipients and pack sizes differ.

Tablet

Route: Oral

Strengths: 500 mg + 30 mg