Health

Alert: Flogo-ROSA® drug should not be taken

06/24/2016

This article was translated by an automatic translation system, and was therefore not reviewed by people.

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Anvisa issued a health warning about the risk of ingestion of Flogo-ROSA® medicine (benzydamine hydrochloride), especially in children. Accidental ingestion of high doses of Flogo-ROSA® can cause agitation, anxiety, hallucinations and seizures.

By: Ascom - Anvisa

The Flogo-ROSA® intended for the use of vaginal washes and should not be swallowed. This is an anti-inflammatory drug for the treatment of acute vulvovaginitis (inflammation of the vulvar and vaginal tissue) associated with symptoms of pain, burning, itching and runny inflammatory disease and cervical of any type or origin. The Flogo-Rose can also be indicated as an aid in the treatment of ringworm and sexually transmitted disease caused by a parasite, as a preventive pre- and postoperative vaginal surgery, and intimate hygiene postpartum.

According to the Pharmacovigilance Management Anvisa, the alert want to call attention to a misuse of product problem that has been reported to the Agency. Some people ingested the drug or gave children orally, rather than just use it in place as it is in the label directions for use. The packaging itself the drug warns that Flogo-Rose should not be swallowed. The problem may originate in self-medication and insufficient medical advice of doctor to prescribe or pharmacist to dispense the medicine emphasizes Marcia Gonçalves, Pharmacovigilance Manager.

Upon monitoring the risk of drug use were observed several cases of accidental ingestion of Flogo-ROSA® medicine for children and adults by the São Paulo Monitoring Centre (CVS-SP) and the Toxicological Assistance Center of São Paulo ( CEATOX-SP).

At the time, Anvisa determined the company Aché the development of a Risk Minimization Plan, which foresaw the change in packaging with the inclusion of figures and phrases that say "no drink". The effectiveness of this plan has been since then monitored by Anvisa and the owner of the product registration.

What Anvisa recommends?

Here are some important guidelines to patients undergoing treatment with Flogo-ROSA®:

* The use of the drug should only be performed UNDER MEDICAL PRESCRIPTION.

* Ask your doctor how to use the product before the treatment;

* In case of accidental ingestion, seek immediate medical advice or an emergency room, stating the amount ingested, the time of ingestion and symptoms. If possible take the container or package leaflet.

* If you need more guidance on how to proceed in situations of poisoning, call the nearest Poison Service Center. The following link tells the contact of Brazilian centers: http://www.cvs.saude.sp.gov.br/procura_det.asp?procura_id=6

* Adopt in your house measures to prevent accidental ingestion of drugs and the occurrence of poisoning. Keep the medicine out of the reach of children. For this, it is recommended to store the product in high places. If someone else watch your children for a period of the day, passing on these guidelines to the caregiver.

* Anvisa calls on citizens to report cases related to improperly use the Flogo-ROSA®. This notification can be performed through the Adverse Event Reporting Form for the Citizen, the Anvisa portal: (http://www.anvisa.gov.br/hotsite/notivisa/formularios.htm). The notification of patients can also be performed free of charge by the Anvisa Meets - 0800-642-9782 or by the Ombudsman.

* For health professionals, Anvisa provides the Notivisa system for the realization of reports of adverse events: (http://www.anvisa.gov.br/hotsite/notivisa/formularios.htm).

Here's the full text of Health Alert.

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Source: Anvisa

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This article was translated by an automatic translation system, and was therefore not reviewed by people.

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