Tolura (telmisartan) – Labelling - C09CA07

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON/BOX

1.NAME OF THE MEDICINAL PRODUCT

Tolura 20 mg tablets

telmisartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan.

3.LIST OF EXCIPIENTS

Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Do not store above 30°C.

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

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)

14 tablets: EU/1/10/632/001

28 tablets: EU/1/10/632/002

30 tablets: EU/1/10/632/003

56 tablets: EU/1/10/632/004

84 tablets: EU/1/10/632/005

90 tablets: EU/1/10/632/006

98 tablets: EU/1/10/632/007

100 tablets: EU/1/10/632/022

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Tolura 20 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER/OPA/Al/PVC Al

1. NAME OF THE MEDICINAL PRODUCT

Tolura 20 mg tablets

telmisartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Only on blisters containing 7 tablets

MON

TUE

WED

THU

FRI

SAT

SUN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON/BOX

1. NAME OF THE MEDICINAL PRODUCT

Tolura 40 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Do not store above 30°C.

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

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)

14 tablets: EU/1/10/632/008

28 tablets: EU/1/10/632/009

30 tablets: EU/1/10/632/010

56 tablets: EU/1/10/632/011

84 tablets: EU/1/10/632/012

90 tablets: EU/1/10/632/013

98 tablets: EU/1/10/632/014

100 tablets: EU/1/10/632/023

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tolura 40 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER/OPA/Al/PVC Al

1. NAME OF THE MEDICINAL PRODUCT

Tolura 40 mg tablets

telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Only on blisters containing 7 tablets

MON

TUE

WED

THU

FRI

SAT

SUN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON/BOX

1. NAME OF THE MEDICINAL PRODUCT

Tolura 80 mg tablets

telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 tablets

100 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before 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

Do not store above 30°C.

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

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)

14 tablets: EU/1/10/632/015

28 tablets: EU/1/10/632/016

30 tablets: EU/1/10/632/017

56 tablets: EU/1/10/632/018

84 tablets: EU/1/10/632/019

90 tablets: EU/1/10/632/020

98 tablets: EU/1/10/632/021

100 tablets: EU/1/10/632/024

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Tolura 80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER/OPA/Al/PVC Al

1. NAME OF THE MEDICINAL PRODUCT

Tolura 80 mg tablets

telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Only on blisters containing 7 tablets

MON

TUE

WED

THU

FRI

SAT

SUN