Packaging material appendix for Italy

Packaging material

appendix for Italy

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

This appendix governs the graphic image of the packaging material Almirall 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

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 Almirall 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).

Horizontal package model

Upper face Lower face Secondary face (back) Lateral face 1 Lateral face 2 Main face (front)

Packaging material appendix for Italy

The text showing the composition (8) should always be in block form, e.g:

*

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.

Composition p... :

Active ingredient (rINN) .... Excipients ... c.s.

Product licence number 00.000

Product licence holder: Product licence holder Registered address

Manufacturer:

Manufacturing Laboratory Registered address

See enclosed leaflet Prescription-only medicine

Keep out of the sight and reach of children Store below 25ºC

La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato.

Package quantity strength Administration

Package quantity strength

Administration

Lote: Mfd.:

Exp.:

Confezione dispensata dal S.S.N.

Name

Active ingr

edient

Name

Active ingredient

Name

Active ingredient

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 Almirall trademark is positioned aligned with the right-hand margin.

Secondary face (back)

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.

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.

Distance between the items x

1/2x

Name

®

A00 FA00

Active ingredient

Package quantity strength

1/2x

Name

A00 FA00

Active ingredient

Package quantity strength

Administration 1/2 module 1/2 module 1/2 module Y 1/2Y

= width of the symbol

1/2X X

1 module

Positioning of the items on the main 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 Almirall 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).

Vertical package model

Lateral face 1 Main face (front) Lateral face 2 Secondary face (back) Upper face Lower face

Packaging material appendix for Italy

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.

*

Composition p...: Active ingr

edient (rINN)...

Excipients ... c.s. Product licence number 00.000 Product licence holder: Product licence holder Register

ed addr

ess

Manufactur

e

r:

Manufacturing Laboratory Register

ed addr ess Batch: Mfd.: Exp.: Package quantity str ength Administration Package quantity str ength Administration

See enclosed leaflet Prescription-only medicine Keep out of the sight and r

each of childr e n Stor e below 25ºC

Confezione dispensata dal S.S.N.

La data di scadenza indicata si riferisce al pr

odotto in confezionamento integr

o, corr ettamente conservato.

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

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.

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

Name

Package quantity strength

Administration 1/2 module 1/4 module 1/4 module 1/4 module 1/2 module

= width of the symbol

Almirall

Positioning of the items on the main face

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

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.

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.

A00 FA00

Active ingred.

A 1/2A

Confezione dispensata dal S.S.N.

Distance between the items x

1/2x

Name

®

A00 FA00

Active ingredient

Package quantity strength

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.

Packaging material appendix for Italy

Horizontal free sample package model

Active ingredient (rINN) .... Excipients ... c.s.

Product licence number 00.000

Product licence holder: Product licence holder Registered address

Manufacturer:

Manufacturing Laboratory Registered address

See enclosed leaflet Prescription-only medicine

Keep out of the sight and reach of children Store below 25ºC

La data di scadenza indicata si riferisce al prodotto in confezionamento integro, correttamente conservato.

Package quantity strength Administration

Package quantity strength

Administration Lote: Mfd.: Exp.:

Name

Active ingr

edient

Name

Active ingredient

Name

Active ingredient

Vertical free sample package model

Campione ridotto per medici. V ietata la vendita.

Composition p...: Active ingr

edient (rINN)...

Excipients ... c.s. Product licence number 00.000 Product licence holder: Product licence holder Register

ed addr

ess

Manufactur

e

r:

Manufacturing Laboratory Register

ed addr ess Batch: Mfd.: Exp.: Package quantity str ength Administration Package quantity str ength Administration

See enclosed leaflet Prescription-only medicine Keep out of the sight and r

each of childr e n Stor e below 25ºC

La data di scadenza indicata si riferisce al pr

odotto in confezionamento integr

o, corr ettamente conservato.

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

Name

Active ingr

edient

Front Back

If there is no back face, the information should be distributed over the only available face.

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 Almirall trademark is positioned on the right-hand side.

Packaging material appendix for Italy

Labelling (normal retail sales package)

Package quantity strength

Administration

Batch:

Mfd.:

Exp.:

Composition p ...:

Active ingredient (rINN) ... Excipients ... c.s.

Keep out of the sight and reach of children

Name

Active ingredient

Name

Active ingredient

Package quantity strength

Administration

Composition p ...:

Active ingredient (rINN) ... Excipients ... c.s.

Keep out of the sight and reach of children

Name

A00 FA00

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.

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Packaging material appendix for Italy

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.

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall

Name

Act. ingredient, Strength

Administration

Almirall Campione ridotto per medici. V

ietata la vendita.

Packaging material appendix for Italy

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.

Active ingredient 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%.

Almirall 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.

Packaging material appendix for Italy

Name

A00 FA00

Active ingredient

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 Almirall, S.A. - Spagna

Concessionario per la vendita Almirall 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.

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

00000000

Almirall

Patient information sheet model

1 2 3 4 5 4 6