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Vizarsin (sildenafil) – Labelling - G04BE03

Updated on site: 10-Oct-2017

Medication nameVizarsin
ATC CodeG04BE03
Substancesildenafil
ManufacturerKrka, d.d., Novo mesto

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg film-coated tablets

Sildenafil

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.

3.LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet

4 x 1 film-coated tablet

8 x 1 film-coated tablet

12 x 1 film-coated 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/001

4 x 1 film-coated tablet: EU/1/09/551/002

8 x 1 film-coated tablet: EU/1/09/551/003

12 x 1 film-coated tablet: EU/1/09/551/004

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 25 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

Vizarsin 25 mg film-coated tablets

Sildenafil

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg film-coated tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet

4 x 1 film-coated tablet

8 x 1 film-coated tablet

12 x 1 film-coated 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/005

4 x 1 film-coated tablet: EU/1/09/551/006

8 x 1 film-coated tablet: EU/1/09/551/007

12 x 1 film-coated tablet: EU/1/09/551/008

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 50 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

Vizarsin 50 mg film-coated tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg film-coated tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 film-coated tablet

4 x 1 film-coated tablet

8 x 1 film-coated tablet

12 x 1 film-coated 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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/009

4 x 1 film-coated tablet: EU/1/09/551/010

8 x 1 film-coated tablet: EU/1/09/551/011

12 x 1 film-coated tablet: EU/1/09/551/012

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 100 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

Vizarsin 100 mg film-coated tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 25 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 orodispersible tablet

2 x 1 orodispersible tablet

4 x 1 orodispersible tablet

8 x 1 orodispersible tablet

12 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Dissolve in the mouth.

for 1 tablet per blister:

I/.II

H14jçJ I

I

 

for 4 tablets per blister:

I'K{i:p2j

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel the foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/013

2 x 1 orodispersible tablet: EU/1/09/551/014

4 x 1 orodispersible tablet: EU/1/09/551/015

8 x 1 orodispersible tablet: EU/1/09/551/016

12 x 1 orodispersible tablet: EU/1/09/551/017

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Vizarsin 25 mg orodispersible tablets

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 for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.BEND AND TEAR

2.PEEL

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 orodispersible tablet

2 x 1 orodispersible tablet

4 x 1 orodispersible tablet

8 x 1 orodispersible tablet

12 x 1 orodispersible tablet

24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Dissolve in the mouth.

for 1 tablet per blister:

I/*H LJ4

iii UI

for 4 tablets per blister:

'I'

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel the foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/018

2 x 1 orodispersible tablet: EU/1/09/551/019

4 x 1 orodispersible tablet: EU/1/09/551/020

8 x 1 orodispersible tablet: EU/1/09/551/021

12 x 1 orodispersible tablet: EU/1/09/551/022

24 x 1 orodispersible tablet: EU/1/09/551/028

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 50 mg orodispersible tablets

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 for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.BEND AND TEAR

2.PEEL

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 orodispersible tablet

2 x 1 orodispersible tablet

4 x 1 orodispersible tablet

8 x 1 orodispersible tablet

12 x 1 orodispersible tablet

24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Dissolve in the mouth.

for 1 tablet per blister:

I/*H LJ4

iii UI

for 4 tablets per blister:

'I'

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel the foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/023

2 x 1 orodispersible tablet: EU/1/09/551/024

4 x 1 orodispersible tablet: EU/1/09/551/025

8 x 1 orodispersible tablet: EU/1/09/551/026

12 x 1 orodispersible tablet: EU/1/09/551/027

24 x 1 orodispersible tablet: EU/1/09/551/029

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 100 mg orodispersible tablets

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 for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.BEND AND TEAR

2.PEEL

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for trilingual packaging
1. NAME OF THE MEDICINAL PRODUCT
Vizarsin 25 mg orodispersible tablets Sildenafil
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each orodispersible tablet contains 25 mg sildenafil.
3. LIST OF EXCIPIENTS
Contains aspartame (E951) and peppermint oil (sorbitol (E420)). See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
for 1 tablet per blister:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ii51

U

 

 

 

 

 

 

 

 

I I!

 

 

 

/*I I, LJ4

 

 

for 4 tablets per blister:

 

 

 

 

 

 

 

 

 

1.

Hold the blister at the edges and separate one blister cell from the rest of the blister by gently

 

 

 

 

 

 

 

'I'

 

 

tearing along the perforations around it.

2.

Pull up the edge of the foil and peel the foil off completely.

3.

Tip the tablet onto your hand and place it on the tongue.

4.

Dissolve in the mouth.

 

 

 

 

 

 

 

 

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/013

2 x 1 orodispersible tablet: EU/1/09/551/014

4 x 1 orodispersible tablet: EU/1/09/551/015

8 x 1 orodispersible tablet: EU/1/09/551/016

12 x 1 orodispersible tablet: EU/1/09/551/017

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 25 mg orodispersible tablets

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 for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.Tear

2.Peel

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 orodispersible tablet

2 x 1 orodispersible tablet

4 x 1 orodispersible tablet

8 x 1 orodispersible tablet

12 x 1 orodispersible tablet

24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

 

 

 

 

 

 

 

 

 

 

for 1 tablet per blister:

 

r

 

I

I I'\/r

' /c

I 1I

 

LiJ4

.p9k fl\\ U

 

I

 

 

 

 

 

for 4 tablets per blister:

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel the foil off completely.

3.Tip the tablet onto your hand and place it on the tongue.

4.Dissolve in the mouth.

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/018

2 x 1 orodispersible tablet: EU/1/09/551/019

4 x 1 orodispersible tablet: EU/1/09/551/020

8 x 1 orodispersible tablet: EU/1/09/551/021

12 x 1 orodispersible tablet: EU/1/09/551/022

24 x 1 orodispersible tablet: EU/1/09/551/028

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 50 mg orodispersible tablets

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 for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.Tear

2.Peel

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets

Sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

1 orodispersible tablet

2 x 1 orodispersible tablet

4 x 1 orodispersible tablet

8 x 1 orodispersible tablet

12 x 1 orodispersible tablet

24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

 

 

 

 

 

 

 

 

 

for 1 tablet per blister:

 

r

I

I I'\/r

' /c

I 1I

LiJ4

.p9k fl\\ U

I

 

 

 

 

 

for 4 tablets per blister:

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel the foil off completely.

3.Tip the tablet onto your hand and place it on the tongue.

4.Dissolve in the mouth.

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

Do not store above 30 C.

Store in the original package in order to protect from moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/023

2 x 1 orodispersible tablet: EU/1/09/551/024

4 x 1 orodispersible tablet: EU/1/09/551/025

8 x 1 orodispersible tablet: EU/1/09/551/026

12 x 1 orodispersible tablet: EU/1/09/551/027

24 x 1 orodispersible tablet: EU/1/09/551/029

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 100 mg orodispersible tablets

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 for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets

Sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

1.Tear

2.Peel

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