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Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Open this folder and view contents3. General basis for regulatory assessment
Open this folder and view contents4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the documentAnnex
View the documentAcknowledgements
 

Annex

Model list of drug information (leaflet, product information) for a self-medication product

Various types of information are needed by consumers to ensure the safe, effective and rational use of drugs in self-medication. The advice to the consumer/patient should describe the use of the product without medical supervision and the circumstances when referral for medical advice is necessary. The following list is a sample that should be adjusted to meet the needs and abilities of the consumer. This information will also be of value to health care professionals.

1. International Nonproprietary Name (INN) of each active substance in the product.

2. A brief and simple description of pharmacological effects and mechanism of action.

3. Clinical information:

(a) Indications: whenever appropriate, simple diagnostic criteria should be provided;

(b) Dosage regimen:

• average dose and range for adults and children;

• dosing interval;

• average duration of treatment;

• special situations, e.g. renal, hepatic, cardiac, or nutritional insufficiencies that require either increased or reduced dosage or special precautions.

(c) Contraindications for use;

(d) Precautions and warnings (in relation to pregnancy, lactation, age of patient, etc.);

(e) Adverse effects (quantify by category if possible);

(f) Drug interactions, including the effects of alcohol use.

4. Pharmaceutical information:

(a) Dosage forms;

(b) Strength of dosage form;

(c) Excipients, including substances causing allergic reactions;

(d) Storage conditions and shelf-life (expiry date);

(e) Pack sizes;

(f) Name and address of manufacturer(s).

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