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There is no medicine without side effects. Nor are anticatarrhals, despite the fact that most of them are sold without a prescription, without risks, as the Spanish Agency for Medicines and Health Products (Aemps) recalled in December with pseudoephedrine, for which it has established new limitations on use in patients with severe hypertension and kidney disease.

Precisely, promoting correct self-medication with medicines for flu and cold is one of the concerns of the Ministry of Health of Andalusia. To this end, Carlos García Collado, Deputy Director General of Pharmacy and Benefits, explains that his department is preparing materials, available on the website of the Andalusian Health Service, aimed at citizens.

"Medicines do not cure these diseases, but are aimed at alleviating the symptoms, so it is necessary to assess the benefit/risk balance of their use," says García Collado. It points out that it is necessary to go beyond their overall efficacy and safety and take into consideration each specific patient, according to the contraindications, warnings and limitations of use of the drugs.

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Europe Monitors Frenadol, Gelocatil with Pseudoephedrine and Other Flu Drugs After Cases of Brain Damage

  • Written by: C. G. LUCIO | EFE Madrid | The Hague

Europe Monitors Frenadol, Gelocatil with Pseudoephedrine and Other Flu Drugs After Cases of Brain Damage

As with any other drug, "the use of these drugs must be governed by rational use. They should be used following the recommendations of the healthcare professional, since not only their specific indication must be assessed, but also the general condition of the patient," agrees Gonzalo Aparicio, general director of Benefits and Pharmacy of La Rioja.

For Natalia Rilla, from the Patient Safety Committee of the Spanish Society of Primary Care Pharmacists (Sefap), "the main mistake is not consulting a qualified health professional, such as the pharmacist and, instead, following the instructions of friends or family".

The arsenal of anti-colds is wide and varied in their composition, since they are part of the prescription of these analgesic and anti-inflammatory products, antihistamines, vasoconstrictors (such as pseudoephedrine and phenylephrine for nasal congestion), expectorants and cough suppressants, Rilla explains.


When advising on the choice of the best medication for each person, the pharmacist states that the patient's symptoms and characteristics, comorbidities and underlying treatment must be taken into account, and the dosage and duration of treatment must be reported. "The most vulnerable populations are children, due to the need to adjust doses, and frail and polymedicated patients," he says.

Many of these medications have contraindications, such as cardiovascular disease, hyperthyroidism, diabetes, benign prostatic hypertrophy, and angle-closure glaucoma. They may also be contraindicated in patients being treated with drugs such as monoamine oxidase inhibitor (MAOI) antidepressants.

The Sefap spokeswoman indicates that in family doctors' consultations, the most frequent thing is to recommend the use of analgesics and antipyretics, such as paracetamol and ibuprofen, and non-pharmacological measures, such as adequate water intake and rest.

In the presence of coughing, he clarifies that "the patient must be explained that it is the natural mechanism of expulsion of secretions, so its suppression could lead to an obstruction of the airway. However, when the cough is non-productive and prevents sleep, cough suppressants may be prescribed."

"In the field of Primary Care, in general, there is a prudent use of medications in these processes, although it is very important to continue insisting on avoiding the prescription of antibiotics," warns Rilla.

From pharmacies, "one of the key points that is highlighted in the approach to colds and flu is that antibiotics are not effective in treating them; they should not be used, and even less so as self-medication," adds Carlos Fernández Moriano, head of Scientific Dissemination at the General Council of Colleges of Pharmacists.

"The fact that most cold medicines can be purchased without a prescription reinforces the role of the pharmacist in ensuring proper use," notes the Council's expert. The expert understands that it is necessary to stress "the importance of respecting the indicated doses and the duration of treatment, both with oral medications and with nasal decongestants".

Pseudoephedrine and phenylephrine

In Europe, the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA) has just concluded a review on the safety of pseudoephedrine and its association with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction (RCVS), potentially serious and fatal adverse effects.

As a result of its report and in order to avoid these risks, the Aemps points out that it should be avoided in patients with uncontrolled or severe hypertension or with severe kidney disease (acute or chronic) or kidney failure. Meanwhile, in the United States, the FDA has warned that the efficacy of phenylephrine would not be superior to a placebo.

Europe warns of new risks of pseudoephedrine and US concludes that oral phenylephrine is a placebo

There are alternatives to these two compounds, Fernández Moriano points out. If nasal congestion, associated with processes such as flu or allergies, is very bothersome, "you can resort to other decongestant drugs, which are used mainly locally in the nasal mucosa, such as tramazoline, naphazoline, oxymetazoline and xylometazoline. It is also common to combine it with other drugs, such as antihistamines, such as chlorphenamine, analgesics or anti-inflammatories, such as paracetamol, ibuprofen, aspirin, and even cough suppressants such as dextromethorphan or codeine."


Knowing the most common mistakes made in self-medication with cold medicines can help avoid them. Fernández Moriano warns that it is common to use nasal decongestants for longer than indicated, "which is usually three days maximum", which increases the risk of a rebound effect.

Combining several active ingredients in a single medicine increases the risk of problems. "It may be convenient, but each case must be assessed, because a single specific drug may be more appropriate to treat the predominant or most annoying symptom and avoid taking other non-essential ones," says Fernández Moriano.

In addition, with these compound drugs it is easier to incur duplications, warns Arantza Viamonte, from the CIM of the COF of Navarra: "Especially if paracetamol and anti-flu drugs that contain it are used, which leads to a high consumption of doses".

There are more errors in dosing, "both too much and too little," says Viamonte. While acknowledging that overdosing is more of a concern, "up to 32% of users use lower doses and are therefore ineffective."

Although the use of anticatarrhals is not recommended in children, "it is something that seems to be systematically violated, even in primary care consultations." The expert recalls that a study published in Anales de Pediatría in 2016 concluded that there is a high percentage of prescriptions of anticatarrhals in children under 14 years of age, and that 85% of these prescriptions are considered inadequate. "It should not be forgotten that it is the third most frequently reported group of drugs in childhood drug poisonings," he points out.

María José Calvo, Deputy Director General of Pharmacy and Medical Devices in Madrid, understands that reviews of the safety of medicines, such as the one that pseudoephedrine is currently going through in Europe, "are the order of the day, which shows that the pharmacovigilance system works and allows the most appropriate decisions to be made to ensure patient safety".

In the case of medicines for the symptomatic treatment of respiratory infections, which are not subject to medical prescription and are included in self-care, he understands that "it is very important to report any adverse effects that are suspected, through the corresponding pharmacovigilance systems".

Doctor's Consultation

Common colds in people without chronic pathologies are usually not of major importance. "Adequate health education should facilitate patients' self-management of the disease," says José Tomás Gómez Sáez, coordinator of the Respiratory Working Group of the Spanish Society of Primary Care Physicians (Semergen).

"Another clinical situation is patients with immunodeficiencies, chronic respiratory pathologies or elderly patients. The appearance of influenza leads to an increase in mortality and hospital admission in these patients," warns the Semergen expert.

It is also necessary to take into account if there are warning symptoms that require a referral to a doctor, including persistent fever, changes in the color of the expectoration or respiratory distress. "The role of community pharmacy in these cases is essential."

The annual turnover of cold medicines stands at 521,000 million euros, more than double the 232,000 million in 2021, when covid-19 was wreaking havoc.

Frenadol is the leading brand in sales, and the formula of Frenadol Complex, with up to five active ingredients (ascorbic acid, caffeine, chlorpheniramine, dextromethorphan and paracetamol), the one that generates the most revenue in Spanish pharmacies, followed closely by acetylcysteine (present in 50 presentations of medicines, but with Fluimucil as the leading brand).

Oxymetazoline (the active ingredient in Respibien) completes the podium of the most successful drugs in Spain to combat cold and flu symptoms such as nasal congestion.

This segment of medicines sold in pharmacies, dominated by over-the-counter presentations, continues to attract the interest of laboratories, which in 2023 have launched new products such as Farinstop, Ivilgrip Expectorant, Ivilgrip Night and Normogrip Antitussive.

  • Pharmacology
  • Influenza