They ask for extreme caution with medications used for nasal congestion

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The Spanish Society of Clinical, Family and Community Pharmacy (SEFAC) recommends extreme caution in the dispensing of medicines containing pseudoephedrine, following the decision of the Safety Committee of the European Medicines Agency (EMA), at the request of the French Agency of Medication, to review these drugs - used to relieve nasal congestion in case of cold, flu or rhinitis - for suspected health risks.

This review was originated by the appearance of cases of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome in people who consumed medications containing pseudoephedrine, and which were reported in pharmacovigilance databases and in the medical literature.

Possible measures are currently being evaluated with the aim of restricting the use of these products, mainly indicated as decongestants in catarrhal or allergic processes).

Based on their mechanism of action, medicines containing sympathomimetics such as phenylpropanolamine, phenylephrine or pseudophedrine have a known risk of cardiovascular and cerebrovascular ischemic events (side effects involving ischemia in the heart and brain), including stroke and myocardial infarction.

The medicines available in Spain based on pseudoephedrine include both prescription and non-prescription medicines. Medications with pseudoephedrine that are not subject to medical prescription contain variable amounts in their composition, between 6mg and 240mg, and could be dispensed by the community pharmacist for the symptomatic relief of nasal congestion and runny nose and sinus congestion associated with the common cold, flu and allergic rhinitis for adults and children from 6 years old.

The majority of medicines containing pseudoephedrine have been marketed in Spain for more than 5 years without any reports of cases similar to those registered in France. However, given the expected increase in the prevalence of these symptoms at this time, the severity of the cases that have appeared and the large number of patients who, in routine pharmaceutical practice, present contraindications and precautions with pseudoephedrine, Sefac recommends that pharmacists community members should exercise extreme caution when dispensing it.

Thus, they ask that the patient be advised about the correct dose and the risks of overdose. The maximum limit in taking pseudoephedrine is 120 mg every 12 hours, but they should be excluded in children under 12 years of age, pregnancy and lactation; and on the other hand, verify its contraindication in patients with high blood pressure, hyperthyroidism, coronary heart disease and who are treated with monoamine oxidase inhibitors.

They also advise cautioning its use in patients with glaucoma, prostatic hypertrophy and diabetes since they can aggravate these conditions, and that its use in elderly patients is not advisable or during heat waves.

Also, remember that you should stop treatment and see a doctor if high fever, dizziness, insomnia or nervousness, tachycardia or heart palpitations, nausea, vomiting or persistent abdominal pain appear.


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