Prospect

Prospect of the "Puchera de Riaza", the first known pharmaceutical prospect of Spain that accompanied the medicine, signed by Dr Frutos Sanz Agudo.

A prospect is the written information addressed to the consumer or user, which accompanies the medication. For the preparation of this document, certain standards must be followed, drawn up by the European Medicines Agency (EMA) of the European Union.

The prospectus includes:^{[citation required]}

• Identification of the medication
  • Denomination of medication (active principle or commercial name)
  • Full qualitative composition in active and emerging principles
  • Pharmaceutical form and weight content, volume, or take-off unit
  • Pharmacotherapeutic category, or type of activity, in terms easily understandable to the consumer or user
  • Identification of the holder of the medical authorization of the medication.
• Therapeutic indicators
• Listing of necessary information prior to taking the medication
  • Contraindications
  • Proper employment precautions
  • Drug interactions or other types (e.g. alcohol, tobacco or food) that may affect the action of the drug
  • Special warnings, when necessary take into account:
  • The particular situation of certain categories of users (children, pregnant women or during breastfeeding, elderly, athletes, people with certain specific pathologies)
  • Possible effects of treatment on the ability to drive a vehicle or manipulate certain machines
  • Excipients with known action or effect, whose knowledge is important for effective and safe use of the medication
• Instructions necessary and usual for good use, in particular:
  • Posology
  • Pharmaceutical form and, if necessary, drug administration (intravenous, intramuscular, intravesical, etc.)
  • Frequency of administration (or taking), specifying, if necessary, the time at which the medication should or may be given (especially in relation to meals)
  • If necessary, when the nature of the medication requires it:
  • Duration of treatment, when limited
  • Measures to be taken in case of overdose (e.g. symptoms, emergency treatment)
  • Attitude to be taken if one or more doses have been omitted
  • Indication, if necessary, of the risk of withdrawal syndrome
  • Instructions, if necessary, for the extemporaneous preparation of the medication, for the purpose of proper administration
• Description of adverse reactions that may be observed during the normal use of the medication and, where appropriate, measures to be taken. The consumer will be expressly informed that he or she should communicate to his or her doctor or pharmacist or nurse any adverse reaction that was not described in the prospect.
• Reference to the expiration date in the container:
  • A warning not to exceed this date
  • If applicable, special conservation precautions.
  • In your case, a warning regarding certain signs visible to the deterioration.
  • For extemporaneous preparations, the conditions of conservation for the reconstituted suspension and its validity period, either at room temperature or in refrigerator (of 4 to 8 °C).
• Date of last review of the prospect
• At the end of the text, and duly separated from it, additional warnings may appear, such as Medicines should be kept out of reach of children.