Section 12: Notice

The package leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their doctor, pharmacist or any other health professional or directly to the regional pharmacovigilance centre, and specifying the various reporting methods available to them. It also includes, in order, the following information:

1° For the identification of the medicinal product or product:

a) The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, the name of the recipient ("infants", "children" or "adults"), as well as the common name when it contains only one active substance and its name is an invented name;

b) The pharmacotherapeutic category or type of activity in terms that are easy for the patient to understand;

2° The therapeutic indications;

3° A list of information required before taking the medicinal product relating to contra-indications, precautions for use, drug interactions and other interactions likely to affect the action of the medicinal product and special warnings. This list must :

a) Take account of the particular situation of the following categories of user: children, pregnant or breast-feeding women, the elderly, persons with certain specific pathologies;

b) Mention, where appropriate, the possible effects of treatment on the ability to drive a vehicle or use certain machines;

c) Include a list of excipients, knowledge of which is necessary for the safe and effective use of the medicinal product or product;

4° The instructions necessary for proper use, in particular :

a) Dosage ;

b) The method and, if necessary, the route of administration;

c) The frequency of administration, specifying, if necessary, the time at which the medicinal product or product may or must be administered, and, where appropriate, depending on the nature of the product ;

d) Duration of treatment;

e) What to do in the event of an overdose;

f) What to do if one or more doses are missed;

g) Mention, if necessary, of the risk of withdrawal syndrome;

h) A recommendation to consult a doctor or pharmacist for any clarification or advice relating to the use of the product;

5° A description of the adverse reactions that may be observed during normal use of the medicinal product or product and, where appropriate, the action to be taken;

6° A reference to the expiry date shown on the outer packaging, with :

a) A warning not to exceed this date;

b) Where appropriate, special storage precautions;

c) If applicable, a warning in the event of visible signs of deterioration;

d) The complete qualitative composition in active substances and excipients and the quantitative composition in active substances, using the common names for each presentation of the medicinal product or product;

e) The pharmaceutical form and content by weight, by volume, or in units of administration, for each presentation of the medicinal product;

f) The name and address of the marketing authorisation holder and, where appropriate, of the company exploiting the medicinal product or product;

g) The name and address of the manufacturer;

7° Where the medicinal product is authorised in accordance with articles R. 5121-51 et seq. under different names in the States concerned, a list of the names authorised in each of these States;

8° The date on which the package leaflet was last revised.

For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, the package leaflet must, in addition to the information mentioned above, include the statement: "This medicinal product is subject to additional monitoring". This statement is preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 and followed by an explanatory sentence determined by the European Commission.

For radiopharmaceutical preparations, the package leaflet must also mention the precautions to be taken by the user and the patient during preparation and administration of the product and the special precautions for disposal of the packaging and its unused contents.

In addition to the company's distinctive sign, the leaflet may include signs or pictograms explaining some of the above information, as well as other information compatible with the summary of product characteristics. This information must be useful for patients and must not be promotional in nature.