1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
(a) for the identification of the medicinal product:
- the name of the medicinal product, followed by the common name if the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product,
- a full statement of the active substances and excipients expressed qualitatively and a statement of the active substances expressed quantitatively, using their common names, in the case of each presentation of the medicinal product,
- the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product,
- the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,
- the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer;
(b) the therapeutic indications;
(c) list of information which is necessary before taking the medicinal product:
- contra-indications,
- appropriate precautions for use,
- forms of interaction with other medicinal products and other forms of interaction
(e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product,
- special warnings;
this list must:
- take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),
- mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,
- detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 65;
(d) the necessary and usual instructions for proper use, in particular:
- the dosage,
- the method and, if necessary, route of administration,
- the frequency of administration, specifying if necessary, the appropriate time at which the medicinal product may or must be administered,
and, as appropriate, depending on the nature of the product:
- the duration of treatment, where it should be limited,
- the action to be taken in the case of an overdose (e.g., symptoms, emergency procedures),
- the course of action to take when one or more doses have not been taken,
- indication, if necessary, of the risk of withdrawal effects;
(e) a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist;
(f) a reference to the expiry date indicated on the label, with:
- a warning against using the product after this date,
- where appropriate, special storage precautions,
- if necessary, a warning against certain visible signs of deterioration;
(g) the date on which the package leaflet was last revised.
2. Notwithstanding paragraph 1(b), the authority competent may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient.