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Granpidam (sildenafil citrate) – Labelling - G04BE03

Updated on site: 07-Oct-2017

Medication nameGranpidam
ATC CodeG04BE03
Substancesildenafil citrate
ManufacturerAccord Healthcare Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Granpidam 20 mg film-coated tablets sildenafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg of sildenafil (as citrate).

3.LIST OF EXCIPIENTS

Contains lactose monohydrate.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

90 tablets

300 tablets

15x1 tablet

90x1 tablet

300x1 tablet

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

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

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/16/1137/001

EU/1/16/1137/002

EU/1/16/1137/003

EU/1/16/1137/004

EU/1/16/1137/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Granpidam 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

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Granpidam 20 mg tablets sildenafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Accord

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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