Packaging material appendix for Italy

Packaging material appendix for Italy

Packaging material appendix for Italy Procedure for producing artwork In order to produce the artwork for the company's various packaging materials, the directives for the corresponding standards for family design or hybrid design, where appropriate, must be adhered to at all times. Similarly, this appendix must be consulted, since it specifies the differences - due to legal requirements - that the packaging material for Italy must present with regard to family design or hybrid design content. Packaging material appendix for Italy Introduction This appendix governs the graphic image of the packaging material products to be sold in Italy (except for Kestine 20 mg) and specifies the differences present in the latter with respect to the family design of the packaging material.

Packaging material appendix for Italy Horizontal package (normal retail sales package) Horizontal package model Lower face Lateral face 1 Secondary face (back) Upper face Main face (front) Lateral face 2 Main face Contains the product (brand) name (1); the active ingredient code (2); the active ingredient (3); the package quantity and strength (4), if applicable; the administration (5); and the trademark (6). The Braille corresponding to the product trademark (and dosage if different dosages are marketed) should be included. Secondary face The opposite face to the main face and identical to it except that it contains the reference box for the positioning of the bollino dispensed by the S.S.N. (7) Upper face Contains the composition (8), the product licence number -A.I.C.- (9); and the registered address of the product licence holder (10) and the manufacturing laboratory (11). If there is enough space to do so, the product (brand) name (1); the active ingredient code (2); the active ingredient (3); and package quantity and strength (4), if applicable, should also be included. Lower face Contains information relating to legal category, warnings, storage conditions, etc.... (12). These texts may differ from those featured on the package model shown below (e.g. those relating to storage conditions or dispensing requirements) or may include additional inscriptions according to specific legislation requirements. The sentence La data di scadenza indicata si riferisce al prodotto in confezionamiento integro, correttamente conservato. (13) with an arrow indicating the face on which the expiry date is featured. Lateral faces 1 and 2 One lateral face features the product (brand) name (1); the active ingredient code (2); the active ingredient (3); and the package quantity and strength (4), if applicable. The other lateral face should include the batch marking area, the manufacturing and expiry dates (14).

12 See enclosed leaflet Prescription-only medicine Keep out of the sight and reach of children La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato. 13 Store below 25ºC 4 3 2 1 7 Confezione dispensata dal S.S.N. Composition p... : Product licence holder: 8 * (rinn)... Product licence holder 10 Excipients... c.s. Registered address 9 Product licence number 00.000 Manufacturer: Manufacturing Laboratory Registered address 11 1 2 3 4 5 6 Lote: Mfd.: Exp.: 14 * The text showing the composition (8) should always be in block form, e.g: Composizione Ogni compressa da g 0,158 contiene: Principio attivo: Clebopride malato acido mg 0,68 (pari a clebopride base mg 0,50). Eccipienti: Lattosio; Cellulosa microgranulare; Biossido di silicio; Polivinilpirrolidone; Sodio carbossimetil-amido; Magnesio stearato.

Main face (front) Contains the items already mentioned in the family design version but with the following differences: The presentation is not present. The active ingredient code (followed by the active ingredient itself) should be placed under the product (brand) name at a distance equivalent to 1/2 the height of the text of the code. For the active ingredient code the Frutiger Light typeface, letter size 8 or 9 should be used. It is legally required for the active ingredient to be written in the same typeface and letter size as the product (brand) name. Instead of being written in black, the active ingredient should be featured at 100% of the product identification colour and in general, with a 40% typographic compression. The package quantity and the administration are positioned beneath the product area, aligned with the left-hand margin. The strength is included together with the package quantity. The trademark is positioned aligned with the right-hand margin. 1/2 module Positioning of the items on the main face 1 module X 1/2 X Y 1/2 Y 1/2 module = width of the symbol Secondary face (back) 1/2 module The secondary face is the opposite face to the main face and is identical to it except that it contains the reference box for the positioning of the bollino dispensed by the S.S.N. Remaining faces Below are details of the differences to be found between these faces and the family design version. Lateral face 1 The active ingredient code, the active ingredient (with a 40% typographic compression), and the package quantity and the strength, if applicable, are to be featured under the product (brand) name. These should be placed under the product (brand) name and blocked to the left with it, at a distance equivalent to half the height of the upper case (initial letter) of the product (brand) name. The unit formed by these items should be positioned vertically, from bottom to top, and aligned with the lower left margin. Distance between the items x 1/2x 1/2x Upper Face When there is sufficient space available, the product (brand) name, the active ingredient code, the active ingredient, and the package quantity and the strength may be included, using the same size as that used for lateral face 1. The unit formed by these items should be aligned with the upper left margin. Lower face The lower face should also include the sentence La data di scadenza indicata si riferisce al prodotto in confezionamiento integro, correttamente conservato. using the Frutiger Light typeface, letter size 5 or 6. This sentence is accompanied by an arrow indicating the face on which the expiry date is featured.

Packaging material appendix for Italy Vertical package (normal retail sales package) Vertical package model Upper face Lateral face 1 Secondary face (back) Lateral face 2 Main face (front) Lower face Main face Contains the product (brand) name (1); the active ingredient code (2); the active ingredient (3); the package quantity and strength (4), if applicable; the administration (5); and the trademark (6). The Braille corresponding to the product trademark (and dosage if different dosages are marketed) should be included. Secondary face The opposite face to the main face and identical to it. Upper face Features the product (brand) name (1); the active ingredient code (2); the active ingredient (3); and the package quantity and the strength (4), if applicable. Lower face Features the batch marking area, the manufacturing and expiry dates (14). Lateral face 1 Features the product (brand) name (1); the active ingredient code (2); the active ingredient (3); the package quantity and strength (4), if applicable; the texts relating to the legal category, warnings, storage conditions, etc... (12). These texts may differ from those featured on the package model shown below (e.g. those relating to storage conditions or dispensing requirements) or may include additional inscriptions according to specific legislation requirements. This face also includes the reference box for the positioning of the bollino dispensed by the S.S.N. (7) and the sentence La data di scadenza indicata si riferisce al prodotto in confezionamiento integro, correttamente conservato. (13) with an arrow indicating the face on which the expiry date is featured. Lateral face 2 Features the product (brand) name (1); the active ingredient code (2), the active ingredient (3); the package quantity and strength (4), if applicable; the composition (8); the product licence number -A.I.C.- (9); the product licence holder s registered address (10) and the manufacturing laboratory s registered address (11).

1 2 3 4 5 6 Composition p...: (rinn)... Excipients... c.s. Product licence number 00.000 4 3 2 1 8 * 9 Product licence holder: Product licence holder Registered address Manufacturer: Manufacturing Laboratory Registered address 10 11 Exp.: Mfd.: Batch: 14 See enclosed leaflet Prescription-only medicine Keep out of the sight and reach of children Store below 25ºC Confezione dispensata dal S.S.N. La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato. 1 2 3 4 12 7 13 * The text showing the composition (8) should always be in block form, e.g.: Composizione Ogni compressa da g 0,158 contiene: Principio attivo: Clebopride malato acido mg 0,68 (pari a clebopride base mg 0,50). Eccipienti: Lattosio; Cellulosa microgranulare; Biossido di silicio; Polivinilpirrolidone; Sodio carbossimetil-amido; Magnesio stearato.

Main face (front) Contains the items already mentioned in the family design version but with the following differences: The presentation is not present. The active ingredient code (followed by the active ingredient itself) should be placed under the product (brand) name at a distance equivalent to 1/2 the height of the text of the code. For the active ingredient code the Frutiger Light typeface, letter size 8 or 9 should be used. It is legally required for the active ingredient to be written in the same typeface and letter size as the product (brand) name. Instead of being written in black, the active ingredient should be featured at 100% of the product identification colour and in general, with a 40% typographic compression. The strength is included together with the package quantity. 1/4 module 1/4 module A 1/2 A Positioning of the items on the main face 1/2 module Active ingred. Secondary face (back) The secondary face is the opposite face to the main face and is identical to it. Remaining Faces Below are details of the differences to be found between these faces and the family design version. Lateral faces 1 and 2 1/4 module = width of the symbol 1/2 module Distance between the items The active ingredient code, the active ingredient, and the package quantity and the strength, if applicable, are to be featured under the product (brand) name. These should be placed under the product (brand) name and blocked to the left with it, at a distance equivalent to half the height of the upper case (initial letter) of the product (brand) name. The unit formed by these items should be aligned with the left margin and the upper part blocked with the prolongation of the upper part of the product (brand) name located on the main face. Lateral face 1 should also include the reference box for the positioning of the bollino dispensed by the S.S.N. Following on from this the sentence La data di scadenza indicata si riferisce al prodotto in confezionamiento integro, correttamente conservato. should be featured using the Frutiger Light typeface, letter size 5 or 6. This sentence is accompanied by a black, 0.25 mm thick arrow indicating the face on which the expiry date is written. Upper face x 1/2x The active ingredient code, the active ingredient, and the package quantity and the strength, if applicable, are to be featured under the product (brand) name. 1/2x Additional Specifications Reference box for the bollino dispensed by the S.S.N. This reference box measures 25 x 40 mm with a 0.25 thick black line and features the inscription Confezione dispensata dal S.S.N., also in black, centred inside the box and using the Frutiger Light typeface, letter size 7. Confezione dispensata dal S.S.N.

Packaging material appendix for Italy Free sample packs The free sample pack is the same as the normal retail sales package except that: the secondary face carries the inscription Campione ridotto per medici. Vietata la vendita written over the bollino. This text is printed in red (Pantone 185) using the Frutiger Bold typeface with letter size 8 or 9. It is positioned transversally (15º) in the centre of the box containing the information relating to the bollino. For the free sample packs the smallest package quantity should always be used.

Horizontal free sample package model 12 See enclosed leaflet Prescription-only medicine Keep out of the sight and reach of children La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato. 13 Store below 25ºC 4 3 2 1 7 Campione ridotto per medici. Vietata la vendita. Composition p... : Product licence holder: 8 * (rinn)... Product licence holder 10 Excipients... c.s. Registered address 9 Product licence number 00.000 Manufacturer: Manufacturing Laboratory Registered address 11 1 2 3 4 5 6 Lote: Mfd.: Exp.: 14

Vertical free sample package model 1 2 3 4 5 6 Composition p...: (rinn)... Excipients... c.s. Product licence number 00.000 4 3 2 1 8 * 9 Product licence holder: Product licence holder Registered address Manufacturer: Manufacturing Laboratory Registered address 10 11 Exp.: Mfd.: Batch: 14 See enclosed leaflet Prescription-only medicine Keep out of the sight and reach of children Store below 25ºC Campione ridotto per medici. Vietata la vendita. La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato. 1 2 3 4 12 7 13

Packaging material appendix for Italy Labelling (normal retail sales package) Contains the items already mentioned in the family design version but with the following differences: The active ingredient code (followed by the active ingredient itself) should be placed under the product (brand) name at a distance equivalent to 1/2 the height of the text of the code. For the active ingredient code the Frutiger Light typeface, letter size 7, 8 or 9 should be used. It is legally required for the active ingredient to be written in the same typeface and letter size as the product (brand) name. Instead of being written in black, the active ingredient should be featured at 100% of the product identification colour and in general, with a 40% typographic compression. The strength is included together with the package quantity. The trademark is positioned on the right-hand side. Composition p...: (rinn)... Excipients... c.s. Keep out of the sight and reach of children Batch: Mfd.: Exp.: Front Back If there is no back face, the information should be distributed over the only available face. Composition p...: (rinn)... Excipients... c.s. Keep out of the sight and reach of children Batch: Mfd.: Exp.:

Packaging material appendix for Italy Labelling for foil blister packs (normal retail sales package) Contains the following differences with respect to the family design version: The presentation is not present. The strength is included together with the active ingredient.

Packaging material appendix for Italy Labelling for foil blister packs (free sample package) The free sample blister pack is the same as the normal retail sales pack except that it also carries the inscription: Campione ridotto per medici. Vietata la vendita. This text is printed in red (Pantone 185) using the Frutiger Bold typeface with letter sizes 5,6,7,8 or 9. It is positioned transversally (15º) in the centre of the blister and printed over the texts in black. Campione ridotto per medici. Vietata la vendita.

Packaging material appendix for Italy Patient Information sheet The patient information sheet features some differences with respect to the family design version. The typefaces and letter sizes to be used are as follows: Product (brand) name (1): Frutiger Bold, letter size 20. code (2) Frutiger Light, letter size 9 and active ingredient (3) Frutiger Bold with the same letter size as those used for the product (brand) name and with a 40% typographic compression. Main text (4) consisting of: - Section headings: these should be numbered in the upper case, using Frutiger Bold, letter size 8. - Subsections: Frutiger Bold, letter size 8, in lower case. - Highlighted texts: Frutiger Light, letter size 8. - Remaining text: Frutiger Light, letter size 8. The lead between lines for all the main text should be at least 8.5. If the texts are too long for the patient information sheet format, they may be compressed by a maximum of 25%. trademark (5) (height of the symbol 8 mm). Code and version (6): Frutiger Light, letter size 5. Details of the differences regarding the positioning of the main items on the patient information sheet are described below: The product (brand) name (1) are to be placed starting from the upper left-hand margin. The active ingredient code (2) and the active ingredient (3) are to be placed on the second line and third lines respectively, below the product (brand) name (1), and blocked to the left.

Patient information sheet model 1 2 3 Name 4 COMPOSIZIONE compresse: ogni compressa da 0,158 g contiene: Principio attivo: clebopride malato acido mg 0,68 (pari a clebopride base mg 0,50). Eccipienti: Lattosio, Cellulosa microgranulare, Biossido di silicio, Polivinilpirrolidone, Sodio carbossimetilamido, Magnesio stearato. fiale: ogni fiala da ml 2 contiene: Principio attivo: clebopride malato acido mg 1,36 (pari a clebopride base mg 1,0). Eccipienti: Sorbitolo, Acqua per preparazioni iniettabili. sciroppo: ogni ml contiene: Principio attivo: clebopride malato acido mg 0,136 (pari a clebopride base mg 0,10). Eccipienti: Sorbitolo soluzione, Glicol propilenico, Acido benzoico, Aroma di lampone, Acqua depurata. FORMA FARMACEUTICA E CONTENUTO 30 compresse da g 0,150 flacone sciroppo da 120 ml 6 fiale da ml 2 CATEGORIA FARMACOTERAPEUTICA Motilex è un preparato ad attività procinetica, cioè in grado di regolarizzare il transito gastrointestinale nelle condizioni caratterizzate da scarsa attività motoria di questo apparato. Motilex è inoltre in grado di controllare il vomito di qualsiasi origine e natura. TITOLARE DELL'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO Laboratori Guidotti S.p.A., Via Livornese, 897 - PISA - La Vettola su licenza, S.A. - Spagna Concessionario per la vendita S.p.A. - Milano PRODUTTORE Compresse: - prodotto da: Laboratori Guidotti S.p.A. - Via Trieste, 40 Pisa A. Menarini Industrie Sud - Via Campo di Pile - L'Aquila - controllato da: Laboratori Guidotti S.p.A. - Via Trieste, 40 Pisa Dompé S.p.A. - Via Campo di Pile - L Aquila A. Menarini Industrie Farmaceutiche Riunite S.r.l. - Via Sette Santi, 3 - Firenze Fiale: A. Menarini Industrie Farmaceutiche Riunite S.r.l. - Via Sette Santi, 3 - Firenze Sciroppo: - prodotto da: Laboratori Guidotti S.p.A. - Via Trieste, 40 Pisa Berlin Chemie AG - Berliner Str. 50 - Rheinsberg 16831 - Berlino - Germania - controllato da:laboratori Guidotti S.p.A. - Via Trieste, 40 Pisa Berlin Chemie AG - Glienicker Weg 125, 12489 - Berlino - Germania A. Menarini Industrie Farmaceutiche Riunite S.r.l. - Via Sette Santi, 3 - Firenze INDICAZIONI TERAPEUTICHE Discinesie gastroduodenali. Nausea e vomito di genesi organica o funzionale. Aerofagia e meteorismo. Disturbi digestivi psicosomatici. Coadiuvante nella terapia della malattia ulcerosa gastroduodenale. Disturbi digestivi da stasi gastrica. Sindrome da reflusso gastroesofageo. Vomito da chemioterapia antineoplastica. Colonpatie funzionali. Esplorazione radiologica del tratto gastrointestinale. 4 SCADENZA E NORME DI CONSERVAZIONE Per la data di scadenza si rimanda a quella riportata sulla confezione. Attenzione: non utilizzare il medicinale dopo la data di scadenza indicata sulla confezione. Conservare il medicinale in luogo asciutto. DATA ULTIMA APPROVAZIONE DEL MINISTERO DELLA SANITÀ: Ottobre 2002 TENERE FUORI DALLA PORTATA DEI BAMBINI 5 00000000 6