Erectile Dysfunction LEVITRA Identifying genuine products of Bayer HealthCare. Product presentation, packaging design, and selected security features

Transcription

1 Erectile Dysfunction LEVITRA Identifying genuine products of Bayer HealthCare Product presentation, packaging design, and selected security features LEVITRA brochure Status: July 2013/Version

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3 Erectile Dysfunction LEVITRA Erectile Dysfunction LEVITRA Identifying genuine products of Bayer HealthCare LEVITRA brochure Status: July 2013 Version:

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5 Erectile Dysfunction LEVITRA 6 Protecting against counterfeits 7 LEVITRA film-coated and orodispersible tablets 8 How can I identify genuine packages of film-coated tablets? 10 How can I identify genuine blister packs of film-coated tablets? 12 How can I identify genuine packages of orodispersible tablets? 14 How can I identify genuine pull-out blister packs of orodispersible tablets? 16 How can I identify genuine LEVITRA pill bottles? 18 How can I identify counterfeit products? 20 Recognizing fake and pseudo-generic products LEVITRA brochure Status: July 2013 Version:

6 Protecting against counterfeits In general, medicines in Germany are pharmacy-only (i.e. patients can buy them only in pharmacies). In addition, many medicines may only be handed out by the pharmacist on presentation of a doctor s prescription. This will be indicated on the package ( pharmacy-only or prescription-only ). The pharmacy where patients buy their medicines is thus the primary place of trust. Germany can be rightly proud of the safety and quality of its medicine supplies. How can I protect myself against counterfeit products? In the case of suspect pharmaceuticals, patients should always consult their doctor or pharmacist, particularly if they think that the product has had different effects from the ones they are used to or if there seems to be something wrong with the packaging. Patients should only purchase medicines from suppliers to whom they can entrust their health to! Patients should not trust suppliers who break the law, for example, by marketing drug products in contravention of legal regulations, in particular outside legal retail channels. by selling so-called generic products that infringe intellectual property rights (for example, marketing generic vardenafil that is allegedly of a quality comparable with LEVITRA in Europe). For this reason: Avoid purchasing pharmacy-only medicinal products from private individuals, whether over the internet, from acquaintances who bring back apparently genuine products from abroad, or in establishments such as discos, body-building studios, etc. Avoid offers for prescription-only medicinal products that circumvent the regulations requiring a doctor s prescription. Avoid products in packaging that is incomplete or not correctly configured for retail in Germany. (In case of doubt, consult your physician or pharmacist.) Identify reputable internet pharmacies before purchasing drug products online. obtain any medication you may need on vacation before you travel abroad. Patients should ensure that they are wellinformed before purchasing medicinal products online. Patients who buy products when they are abroad should ensure that the source they are buying from is trustworthy. They would do best to create a personal first-aid kit before leaving home, with the advice of a doctor or pharmacist. 6

7 LEVITRA film-coated and orodispersible tablets Erectile Dysfunction LEVITRA LEVITRA : packaging with security features Bayer HealthCare protects its product LEVITRA (active ingredient: vardenafil) worldwide by means of various security features. The following pages will show which features genuine products must display (page 7 17). Most of them are visible to the naked eye and it would be extremely difficult to reproduce all of them. Please note that the depictions may not apply to parallel imports. The LEVITRA film-coated tablet is sold worldwide in three dosages of 5 mg, 10 mg, and 20 mg. German packaging is different from packaging in other countries. The new LEVITRA orodispersible tablet is sold worldwide but only in a 10 mg dosage. In the USA and Canada, the LEVITRA orodispersible tablet is sold under the name of STAXYN. The LEVITRA film-coated tablet is sold in the USA in pill bottles, in dosages of 2.5 mg, 5 mg, 10 mg, and 20 mg. LEVITRA brochure Status: July 2013 Version:

8 How can I identify genuine packages of film-coated tablets? Identifying characteristics of the packaging of LEVITRA film-coated tablets The following images and texts describe identifying characteristics of the German packaging of LEVITRA film-coated tablets. The packages may look different in other countries. As an example, a non-european package bearing the flame symbol is shown at the bottom of page 9. A Dosage of the LEVITRA film-coated tablet Dosages of the active ingredient vardenafil in the LEVITRA film-coated tablet in Europe are 5 mg, 10 mg, and 20 mg. The dosage is displayed at the top right of the front of every package. A B Embossed elements The brand name LEVITRA and a Braille inscription are tangibly embossed on the box. B C C Number of tablets The LEVITRA film-coated tablets are sold in Europe in packages of 2, 4, 8, and 12 tablets. The number of tablets is printed in violet on the front of the package. A dosage of 5 mg is printed in white within a violet frame. If the dosage is higher than 5 mg, it is all printed in violet. The displayed number is made up of smaller numbers, repeated continuously in microprinting, which become visible to the human eye with the help of a magnifying glass. 8

9 Erectile Dysfunction LEVITRA D Uncoated area The entire surface of the LEVITRA folding box is coated, except for the LEVITRA lettering on the white part of the box. This can be seen when the box is tilted to the appropriate angle under a light source. Example of a 10 mg package F D E E Variable data Variable data (batch number, expiry date) are printed on one side flap of every folding box. The batch number is a combination of letters and digits. The expiry date has two digits showing the month and four digits showing the year. Package with variable data F Blue box* On the back of the LEVITRA folding box, there is a colored frame (blue box) which may contain (varying) countryspecific texts and symbols. *Used only in the EU, Norway, and Iceland. Folding boxes bearing the flame symbol are sold outside the EU. LEVITRA brochure Status: July 2013 Version:

10 How can I identify genuine blister packs of film-coated tablets? Identifying characteristics of LEVITRA film-coated tablet blisters The following images and texts describe identifying characteristics of the German LEVITRA film-coated tablet blister. The printed texts can appear in different positions. They may look different in other countries. The examples shown at the bottom of the page are earlier versions of the blister packs. A Variable data Variable data (batch number, expiry date) are printed on every blister. The batch number is a combination of letters and digits. The expiry date has two digits showing the month and four digits showing the year. A A Old blister variations that may still be available commercially, but are no longer manufactured. 10

11 Erectile Dysfunction LEVITRA B B Variable colors The word LEVITRA and the flame symbol are repeated in a special color parallel to the shorter edge of the blister. The blister is moved (or, more precisely, when the light falls on it from a different angle), the color changes from violet to green or vice versa. C D D The word LEVITRA The word LEVITRA has been placed on the inside surface of the transparent plastic film. For this reason, it does not look flat, but follows the shape of the deformed blister foil and moves with it. C Bayer cross on the aluminum foil Light and dark Bayer crosses are continuously embossed in the aluminum foil of every blister of film-coated tablets. LEVITRA brochure Status: July 2013 Version:

12 How can I identify genuine packages of orodispersible tablets? Identifying characteristics of the packaging of LEVITRA orodispersible tablets The following images and texts describe identifying characteristics of the German packaging of LEVITRA package of orodispersible tablets. The package may look different in other countries. Page 13, for example, shows a package of STAXYN TM with the flame symbol that is available only in the USA and Canada. A Dosage of the LEVITRA orodispersible tablet LEVITRA orodispersible tablets are sold worldwide but only in the dosage of 10 mg of the active ingredient vardenafil. The dosage is always displayed at the top right of the front package. B Embossed elements The brand name LEVITRA and a Braille inscription are tangibly embossed on the box. A B C C Number of tablets LEVITRA orodispersible tablets are sold worldwide in packages of 2, 4, and 8 tablets. The number of tablets is printed in violet on the front of the package. The displayed number is made up of smaller numbers, repeated continuously in microprinting, which are visible to the human eye with the help of a magnifying glass. 12

13 Erectile Dysfunction LEVITRA D Uncoated area The entire surface of the LEVITRA folding box is coated, except for the LEVITRA lettering on the white part of the box. This can be seen when the box is tilted to the appropriate angle under a light source. F D E E Variable data Variable data (batch number, expiry date) are printed on one side flap of the package. The batch number is a combination of letters and digits. The expiry date has two digits showing the month and four digits showing the year. F Blue box On the back of the LEVITRA folding box, there is a colored frame (blue box) which may contain (varying) countryspecific texts and symbols. Package with variable data In the USA and Canada, the orodispersible tablet is sold under the product name STAXYN. LEVITRA brochure Status: July 2013 Version:

14 How can I identify genuine pull-out blister packs of orodispersible tablets? Identifying characteristics of the LEVITRA pull-out blister pack of orodispersible tablets The following images and texts describe identifying characteristics of a European LEVITRA pull-out blister pack of orodispersible tablets. It is part of the LEVITRA package of orodispersible tablets and may look different in other countries. For example, a STAXYN TM pull-out blister pack of orodispersible tablets bearing the flame symbol, sold only in the USA and Canada, is shown at the bottom of page 15. A Embossed elements The product name LEVITRA is tangibly embossed on the black box. A B B Using the LEVITRA pull-out blister pack When the orange flap with the arrow is pulled, the blister emerges from the opposite side of the package. B C C Embossed elements The word LEVITRA and the flame symbol are continuously embossed in diagonal lines on the aluminum foil of every blister of orodispersible tablets. 14

15 Erectile Dysfunction LEVITRA E D D D D Variable data on the LEVITRA pull-out blister pack Variable data (batch number, expiry date) are printed on the aluminum foil and on the package of every pull-out blister pack. The batch number is a combination of letters and digits. The expiry date has two digits showing the month and four digits showing the year. The details on the foil must match those on the box, as shown in the image. E Variable data on the outer folding box The first batch number shown on the outer folding box is the batch number of the package as distributed commercially. In the USA and Canada, the blister displays an embossed flame symbol instead of the word LEVITRA. LEVITRA brochure Status: July 2013 Version:

16 How can I identify genuine LEVITRA pill bottles? The US packaging In the USA, LEVITRA is sold in four different dosages and is usually available in plastic bottles. Furthermore, and in contrast to many other countries, it is common practice and quite legal for patients to obtain individual tablets from their pharmacist. In Germany, such bottles may not be given to patients. Any patient who is offered such a bottle should refuse to touch it. A A The LEVITRA pill bottle Every genuine LEVITRA pill bottle is white with an orange screwcap. It contains 30 tablets when first sold. Every LEVITRA pill bottle has an adhesive label which displays the flame symbol, the product name, and the number of tablets contained in the bottle. C B B Dosage of the LEVITRA film-coated tablet In the USA, the dosages of the active ingredient vardenafil are 2.5 mg, 5 mg, 10 mg, and 20 mg. The dosages are displayed in different colors on the right, below the flame symbol on the front of every pill bottle. C Microprinting Every adhesive label displays the characteristic orange LEVITRA microprinting, which extends over the entire width of the label. 16

17 Erectile Dysfunction LEVITRA D Patient information leaflet The patient information leaflet is attached to the back of the bottle. F Aluminum seal Every single LEVITRA bottle is sealed. The aluminum foil displays the Bayer cross and the word Bayer. D F E E Label Variable data are imprinted on the black part of the label. Old package variation: On the bottle (left), variable data are printed in a grey area; on the aluminum seal (right) the flame symbol and the word LEVITRA are shown. LEVITRA brochure Status: July 2013 Version:

18 How can I identify counterfeit products? Counterfeits The products shown here and on the following pages are either not registered anywhere in the world or, at least, not registered in Europe, but they are available to patients in Europe over the internet and are used by European consumers. Many patients in Germany who order this kind of product are not aware of, or ignore, the fact that by doing so, they are not only endangering their health but may also be breaking the law. We strongly advise you not to take these drugs! LEVITRA packages and/or blisters with the batch number BXB8551 are always counterfeits! 18

19 Erectile Dysfunction LEVITRA These packages and the tablets are counterfeit No genuine LEVITRA pill bottle is sold by Bayer in a folding box. No genuine LEVITRA pill bottle is sold by Bayer with a white screwcap. No genuine LEVITRA pill bottle is sold by Bayer with a white label. No genuine LEVITRA product is sold by Bayer with 100 mg of vardenafil per tablet. No genuine LEVITRA product with the following batch numbers is sold by Bayer: K K K K K81 Genuine LEVITRA tablets by Bayer are not supplied loosely or in a plastic bag. LEVITRA brochure Status: July 2013 Version:

20 Recognizing fake and pseudo-generic products We strongly advise you not to take these drugs! 20

21 Erectile Dysfunction LEVITRA We strongly advise you not to take these drugs! LEVITRA brochure Status: July 2013 Version:

22 Further addresses and links European Alliance for Access to Safe Medicines (EAASM) Internet: National Association of Boards of Pharmacy (NABP) 1600 Feehanville Drive Mount Prospect, IL USA Phone: Fax: Internet: World Health Organization (WHO) Avenue Appia Geneva 27 Switzerland Phone: Fax: Internet: European Federation of Pharmaceutical Industries and Associations (EFPIA) Leopold Plaza Building Rue du Trône Brussels Belgium Phone: Fax: Internet:

23 Erectile Dysfunction LEVITRA LEVITRA brochure Status: July 2013 Version:

24 Bayer Pharma AG Packaging Technology Building D Leverkusen, Germany