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Actelsar HCT (telmisartan / hydrochlorothiazide) – Labelling - C09DA07

Updated on site: 05-Oct-2017

Medication nameActelsar HCT
ATC CodeC09DA07
Substancetelmisartan / hydrochlorothiazide
ManufacturerActavis Group hf

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/Al blister

1.NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Tablet

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/043

EU/1/13/817/001

EU/1/13/817/042

EU/1/13/817/002

EU/1/13/817/003

EU/1/13/817/004

EU/1/13/817/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Actelsar HCT 40 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/PVC/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

28 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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 30ºC

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/006

EU/1/13/817/007

EU/1/13/817/008

EU/1/13/817/009

EU/1/13/817/010

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 40 mg/12.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2.NAME OF THE MARKETING AUTHORISATION HOLDER

[Actavis logo]

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/011

EU/1/13/817/012

EU/1/13/817/013

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 40 mg/12.5 mg

PARTICULARS TO APPEAR ON THE INNER PACKAGING

Label for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

[Actavis logo]

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/011

EU/1/13/817/012

EU/1/13/817/013

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/Al blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/014

EU/1/13/817/015

EU/1/13/817/044

EU/1/13/817/016

EU/1/13/817/017

EU/1/13/817/018

EU/1/13/817/019

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/PVC/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

14 tablets

28 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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 30ºC

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/020

EU/1/13/817/021

EU/1/13/817/022

EU/1/13/817/023

EU/1/13/817/024

EU/1/13/817/025

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/12.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

[Actavis logo]

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/026

EU/1/13/817/027

EU/1/13/817/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/12.5 mg

PARTICULARS TO APPEAR ON THE INNER PACKAGING

Label for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

[Actavis logo]

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/026

EU/1/13/817/027

EU/1/13/817/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/Al blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

14 tablets

28 tablets

30 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/045

EU/1/13/817/029

EU/1/13/817/046

EU/1/13/817/030

EU/1/13/817/031

EU/1/13/817/032

EU/1/13/817/033

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for Al/PVC/PVDC blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

28 tablets

56 tablets

84 tablets

90 tablets

98 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 ANDREACH 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 30ºC

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/034

EU/1/13/817/035

EU/1/13/817/036

EU/1/13/817/037

EU/1/13/817/038

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

[Actavis logo]

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Carton for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

Actavis Group PTC ehf. 220 Hafnarfjörður Iceland

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/039

EU/1/13/817/040

EU/1/13/817/041

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Actelsar HCT 80 mg/25 mg

PARTICULARS TO APPEAR ON THE INNER PACKAGING

Label for HDPE tablet container

1. NAME OF THE MEDICINAL PRODUCT

Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

30 tablets

90 tablets

250 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

Contains desiccant, do not eat.

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

[Actavis logo]

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/817/039

EU/1/13/817/040

EU/1/13/817/041

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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