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Farmacovigilancia

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HUMAN-USE MEDICINES PHARMACOVIGILANCE

This section presents the necessary information for users to notify to the Spanish Service of Pharmacovigilance (SEFV-H) adverse reactions to medicines that have been observed.

Information presented below is a summary of what is said on the informative website on Pharmacovigilance of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS).

PHARMACOVIGILANCE: WHICH EFFECT SHOULD I NOTIFY AND HOW ? 

Pharmacovigilance consists on the collection of information about adverse effects (ADR: Adverse Drug Reactions) which medicines for human use can produce.

In Spain there is a pharmacovigilance system for medicines for human use called Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano (SEFV-H), whose purpose is to gather the cases in which adverse drug reactions are suspected of, both those identified by health professionals or by citizens. 

An adverse effect or reaction, is a non-expected or not-desired response to a drug. Adverse reactions to medicines may arise both during the treatment or after its completion, and it can happen that until a lot of people use it for an extended period of time, these adverse effects are not detected. 

For that reason it is very important that patients inform a doctor, pharmacist or other health professional about these effects, or that they notify them directly to the  AEMPS using an electronic form (it is a notification, not a complaints mechanism). Anyone can notify it.

If you suffer a symptom that you think that may be a side effect, the first thing to do is to read the patient information leaflet (PIL) to check if it is included within the known reactions. The notification to your doctor or pharmacist of the possible adverse reaction of which you suspect is recommended. And you can also notify it from the  website of the AEMPS, on the following link: https://www.notificaram.es/ 

Before making the notification, please read carefully the section of the AEMPS "How to fill the form".
Suspicions of medicines with or without prescription, incluiding phytotherapy, must be notified, particularly in the following cases:
  • They are not mentioned on the PIL.
  • They have caused you severe problems which interfere with your nomal activity.
  • They are linked to new medicines. 
  • They occur if you are taking more than one medicine, and they can be the cause of an interaction between them, or with any food.
  • If they occur as a result of an involuntary mistake in the prescription, dispensation or intake of the medication (e.g. a confusion with the dose of a medicine or with its name).

You may inform us of the adverse reactions you notice after acquiring any product at Farmacia Campoamor or Farmacia Campoamor Online, by using our CONTACT FORM (select Pharmacovigilance), calling us to 965320584 or sending an email to: farmacovigilancia@farmaciacampoamor.com