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Telmisartan Teva (telmisartan) – Labelling - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Teva
ATC CodeC09CA07
Substancetelmisartan
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of peelable blisters

1.NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 20 mg tablets telmisartan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan

3.LIST OF EXCIPIENTS

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

4.PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

1.Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it

2.Carefully peel off the top paper layer

3.Push the tablet through the exposed foil

4.Put the tablet in your mouth and swallow with water or a suitable liquid

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/001

14x1 tablets

EU/1/09/610/002

28x1 tablets

EU/1/09/610/003

30x1 tablets

EU/1/09/610/004

40x1 tablets

EU/1/09/610/005

56x1 tablets

EU/1/09/610/006

60x1 tablets

EU/1/09/610/007

84x1 tablets

EU/1/09/610/008

90x1 tablets

EU/1/09/610/009

98x1 tablets

EU/1/09/610/010

100x1 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Telmisartan Teva 20 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of blisters

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 20 mg tablets telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg telmisartan

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/031

14x1 tablets

EU/1/09/610/032

28x1 tablets

EU/1/09/610/033

30x1 tablets

EU/1/09/610/034

40x1 tablets

EU/1/09/610/035

56x1 tablets

EU/1/09/610/036

60x1 tablets

EU/1/09/610/037

84x1 tablets

EU/1/09/610/038

90x1 tablets

EU/1/09/610/039

98x1 tablets

EU/1/09/610/040

100x1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Teva 20 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of peelable blisters

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 40 mg tablets telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

1.Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it

2.Carefully peel off the top paper layer

3.Push the tablet through the exposed foil

4.Put the tablet in your mouth and swallow with water or a suitable liquid

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/011

14x1 tablets

EU/1/09/610/012

28x1 tablets

EU/1/09/610/013

30x1 tablets

EU/1/09/610/014

40x1 tablets

EU/1/09/610/015

56x1 tablets

EU/1/09/610/016

60x1 tablets

EU/1/09/610/017

84x1 tablets

EU/1/09/610/018

90x1 tablets

EU/1/09/610/019

98x1 tablets

EU/1/09/610/020

100x1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Teva 40 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of blisters

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 40 mg tablets telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 tablets

30 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/041

14x1 tablets

EU/1/09/610/042

28x1 tablets

EU/1/09/610/043

30x1 tablets

EU/1/09/610/044

40x1 tablets

EU/1/09/610/045

56x1 tablets

EU/1/09/610/046

60x1 tablets

EU/1/09/610/047

84x1 tablets

EU/1/09/610/048

90x1 tablets

EU/1/09/610/049

98x1 tablets

EU/1/09/610/050

100x1 tablets

EU/1/09/610/061

30 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Teva 40 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of peelable blisters

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 80 mg tablets telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

1.Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it

2.Carefully peel off the top paper layer

3.Push the tablet through the exposed foil

4.Put the tablet in your mouth and swallow with water or a suitable liquid

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/021

14x1 tablets

EU/1/09/610/022

28x1 tablets

EU/1/09/610/023

30x1 tablets

EU/1/09/610/024

40x1 tablets

EU/1/09/610/025

56x1 tablets

EU/1/09/610/026

60x1 tablets

EU/1/09/610/027

84x1 tablets

EU/1/09/610/028

90x1 tablets

EU/1/09/610/029

98x1 tablets

EU/1/09/610/030

100x1 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Teva 80 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of blisters

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 80 mg tablets telmisartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan

3. LIST OF EXCIPIENTS

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

4. PHARMACEUTICAL FORM AND CONTENTS

14x1 tablets

28x1 tablets

30x1 tablets

40x1 tablets

56x1 tablets

60x1 tablets

84x1 tablets

90x1 tablets

98x1 tablets

100x1 tablets

30 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

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

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/610/051

14x1 tablets

EU/1/09/610/052

28x1 tablets

EU/1/09/610/053

30x1 tablets

EU/1/09/610/054

40x1 tablets

EU/1/09/610/055

56x1 tablets

EU/1/09/610/056

60x1 tablets

EU/1/09/610/057

84x1 tablets

EU/1/09/610/058

90x1 tablets

EU/1/09/610/059

98x1 tablets

EU/1/09/610/060

100x1 tablets

EU/1/09/610/062

30 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Telmisartan Teva 80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Telmisartan Teva 20 mg tablets telmisartan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

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

Telmisartan Teva 40 mg tablets telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

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

Telmisartan Teva 80 mg tablets telmisartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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