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Adcirca (Tadalafil Lilly) (tadalafil) – Labelling - G04BE08

Updated on site: 05-Oct-2017

Medication nameAdcirca (Tadalafil Lilly)
ATC CodeG04BE08
Substancetadalafil
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

ADCIRCA 20 mg film-coated tablets tadalafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 20 mg tadalafil

3.LIST OF EXCIPIENTS

lactose

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

56 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from moisture. Do not store above 30°C.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/476/005-006

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ADCIRCA 20 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

ADCIRCA 20 mg tablets tadalafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Mon, Tue, Wed, Thu, Fri, Sat, Sun.

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