Following a decision by the Safety Committee of the European Medicines Agency (EMA), and at the request of the French Medicines Agency, the Spanish Society of Clinical, Family and Community Pharmacy (SEFAC) recommends that extra caution be exercised when formulating medicines containing pseudoephedrine, reviewing these products for the relief of colds , flu or rhinitis, and whether medications for nasal congestion pose questionable health risks.
This review arises from cases of reversible posterior encephalopathy syndrome and reversible cerebral vasoconstriction syndrome in persons taking medications containing pseudoephedrine, which have been reported in pharmacovigilance databases and in the medical literature.
Possible measures to limit the use of these products, primarily as decongestants in catarrhal or allergic processes, are currently being evaluated.
Based on their mechanism of action, medications containing sympathomimetics such as phenylpropanolamine, phenylephrine, or pseudoephedrine are known to carry a risk of cardiovascular ischemic events (side effects involving ischemia in the heart and brain), including stroke and Myocardial infarction.
Pseudoephedrine-based medicines available in Spain include prescription and over-the-counter medicines. Prescription-free pseudoephedrine medicines are available in varying amounts from 6 mg to 240 mg and can be dispensed by community pharmacists for the relief of congestion, runny nose and sinus congestion associated with the common cold, flu and in adults and Allergic rhinitis in children over 6 years of age.
Most medicines containing pseudoephedrine have been on the market in Spain for more than 5 years, and there have not been any reported cases similar to those registered in France. However, given the current expected increase in the prevalence of these symptoms, the severity of the cases that have emerged, and the large number of patients presenting with pseudoephedrine contraindications and precautions in routine pharmaceutical practice, Sefac recommends that members of the pharmacist community should exercise extreme caution when dispensing.
Therefore, they require patients to understand the correct dosage and the risk of overdose. The maximum limit for taking pseudoephedrine is 120 mg every 12 hours, but children under 12 years old, pregnancy and lactation should be excluded; on the other hand, its contraindications are verified in patients with hypertension, hyperthyroidism, coronary heart disease and patients receiving monoamine oxidase inhibitors. disease.
They also recommend use with caution in patients with glaucoma, prostatic hypertrophy and diabetes, as they can aggravate these conditions, and do not recommend its use in older patients or during heat waves.
Also, remember that you should stop treatment and see your doctor if you develop high fever, dizziness, insomnia or nervousness, tachycardia or palpitations, nausea, vomiting, or persistent abdominal pain.
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