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Tadalafil Lilly (tadalafil) – Labelling - G04BE08

Updated on site: 10-Oct-2017

Medication nameTadalafil Lilly
ATC CodeG04BE08
Substancetadalafil
ManufacturerEli Lilly Nederland B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 2.5 mg film-coated tablets tadalafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg tadalafil

3.LIST OF EXCIPIENTS

lactose

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

How to take Tadalafil Lilly once-a-day

1.Start with the pill from the blister pack that corresponds with the day you start taking Tadalafil Lilly.

2.Take Tadalafil Lilly with water every day at approximately the same time, either with or without food.

3. When taken once a day, Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Always take Tadalafil Lilly exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with Tadalafil Lilly.

You should not take Tadalafil Lilly more than once a day. If you take more than you should, tell your doctor.

Read the package leaflet before use.

Once daily. For 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/1/17/1177/001

13.BATCH NUMBER

Lot.

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

tadalafil lilly 2.5 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 5 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg tadalafil

3. LIST OF EXCIPIENTS

lactose

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

84 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

How to take Tadalafil Lilly once-a-day

1.Start with the pill from the blister pack that corresponds with the day you start taking Tadalafil Lilly.

2.Take Tadalafil Lilly with water every day at approximately the same time, either with or without food.

3. When taken once a day for erectile dysfunction, Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

• Always take Tadalafil Lilly exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with Tadalafil Lilly.

You should not take Tadalafil Lilly more than once a day. If you take more than you should, tell your doctor.

Read the package leaflet before use.

Once daily. For 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 25°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/1/17/1177/002-004

13. BATCH NUMBER

Lot.

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tadalafil lilly 5 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 10 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg tadalafil

3. LIST OF EXCIPIENTS

lactose

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

4 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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/1/17/1177/005

13. BATCH NUMBER

Lot.

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tadalafil lilly 10 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 20 mg film-coated tablets tadalafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg tadalafil

3. LIST OF EXCIPIENTS

lactose

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 film-coated tablets

4 film-coated tablets

8 film-coated tablets

12 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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/1/17/1177/006-009

13. BATCH NUMBER

Lot.

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

tadalafil lilly 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

Tadalafil Lilly 2.5 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

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 5 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

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 10 mg tablets tadalafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Tadalafil Lilly 20 mg tablets tadalafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Lilly

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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