Patient leaflet - Rasitrio

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Farma S.p.A.

Via Provinciale Schito 131

IT-80058 Torre Annunziata

Italy

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for t is product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description	Due date
The MAH shall submit the final study report of the ALTITUDE study, including the 1-year safety extension phase covering the results of the active treatment phase relevant to the two different cut-off dates.	31 October 2013

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

Do not store above 30°C.

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/730/001

EU/1/11/730/009

EU/1/11/730/002

EU/1/11/730/010

EU/1/11/730/003

EU/1/11/730/004

EU/1/11/730/011

EU/1/11/730/007

EU/1/11/730/005

EU/1/11/730/006

14 tablets (PVC/PCTFE blisters)

14 tablets (PA/Alu/PVC blisters) z-^

28 tablets (PVC/PCTFE blisters)^

28 tablets (PA/Alu/PVC blisters)

30 tablets (PVC/PCTFE blisters)

56 tablets (PVC/PCTFE blisters)

56 tablets (PA/Al

56 tablets (PVC/F

90 tablets (PVC/P<____________,

98 tablets (PVC/PCTFE blisters)

VC blisters)

FE single-unit-dose blisters)

CTFE blisters)
13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Rasitrio 150 mg/5 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) -WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

Do not store above 30°C.

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

Rasitrio 150 mg/5 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS

Multipack containing 98 (2 packs of 49) tablets. .

Multipack containing 98 (2 packs of 49×1) tablets.

–

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

Do not store above 30°C.

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/730/013

EU/1/11/730/021

EU/1/11/730/014

EU/1/11/730/022

EU/1/11/730/015

EU/1/11/730/016

EU/1/11/730/023

EU/1/11/730/019

EU/1/11/730/017

EU/1/11/730/018

14 tablets (PVC/PCTFE blisters)

14 tablets (PA/Alu/PVC blisters)^

22 (PVC/PCTFE blisters)

28 tablets

28 tablets (PA/Alu/PVC blisters)

30 tablets (PVC/PCTFE blisters)

56 tablets (PVi-P

blisters)

56 tablets (PA/Alu/PVC blisters)

56 tablets (PVC/PCTFE single-unit-dose blisters)

90 tablets (PVC/PCTFE blisters)

98 tablets (PVC/PCTFE blisters)
13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Rasitrio 300 mg/5 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) -WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

Rasitrio 300 mg/5 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS

Multipack containing 98 (2 packs of 49) tablets. .

Multipack containing 98 (2 packs of 49×1) tablets.

–

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

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 25 mg hydrochlorothiazide.

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/730/025

EU/1/11/730/033

EU/1/11/730/026

EU/1/11/730/034

EU/1/11/730/027

EU/1/11/730/028

EU/1/11/730/035

EU/1/11/730/031

EU/1/11/730/029

EU/1/11/730/030

14 tablets (PVC/PCTFE blisters)

14 tablets (PA/Alu/PVC blisters)^

28 tablets (PVC/PCTFE blisters)^

28 tablets (PA/Alu/PVC blisters)

30 tablets (PVC/PCTFE blisters)

56 tablets (PVC/PCTFE blisters)

56 tablets (PA/Al

56 tablets (PVC/i

90 tablets (PVC/P<____________,

98 tablets (PVC/PCTFE blisters)

VC blisters)

FE single-unit-dose blisters)

CTFE blisters)
13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Rasitrio 300 mg/5 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) -WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited Wimblehurst Road

Rasitrio 300 mg/5 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS

Multipack containing 98 (2 packs of 49) tablets. .

Multipack containing 98 (2 packs of 49×1) tablets.

–

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

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/5 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/730/037

EU/1/11/730/045

EU/1/11/730/038

EU/1/11/730/046

EU/1/11/730/039

EU/1/11/730/040

EU/1/11/730/047

EU/1/11/730/043

EU/1/11/730/041

EU/1/11/730/042

14 tablets (PVC/PCTFE blisters)

14 tablets (PA/Alu/PVC blisters)^

28 tablets (PVC/PCTFE blisters)^

28 tablets (PA/Alu/PVC blisters)

30 tablets (PVC/PCTFE blisters)

56 tablets (PVC/PCTFE blisters)

56 tablets (PA/Al

56 tablets (PVC/i

90 tablets (PVC/P<____________,

98 tablets (PVC/PCTFE blisters)

VC blisters)

FE single-unit-dose blisters)

CTFE blisters)
13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Rasitrio 300 mg/10 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) -WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

Rasitrio 300 mg/10 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS

Multipack containing 98 (2 packs of 49) tablets. .

Multipack containing 98 (2 packs of 49×1) tablets.

–

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

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF SINGLE PACK/CARTON OF UNIT PACK (perforated unit dose blister)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine besylate) and 25 mg hydrochlorothiazide.

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/730/049

EU/1/11/730/057

EU/1/11/730/050

EU/1/11/730/058

EU/1/11/730/051

EU/1/11/730/052

EU/1/11/730/059

EU/1/11/730/055

EU/1/11/730/053

EU/1/11/730/054

14 tablets (PVC/PCTFE blisters)

14 tablets (PA/Alu/PVC blisters)^

28 tablets (PVC/PCTFE blisters)^

28 tablets (PA/Alu/PVC blisters)

30 tablets (PVC/PCTFE blisters)

56 tablets (PVC/PCTFE blisters)

56 tablets (PA/Al

56 tablets (PVC/i

90 tablets (PVC/P<____________,

98 tablets (PVC/PCTFE blisters)

VC blisters)

FE single-unit-dose blisters)

CTFE blisters)
13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Rasitrio 300 mg/10 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INTERMEDIATE CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) -WITHOUT BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE

EXP

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

Rasitrio 300 mg/10 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) – WITH BLUE BOX

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 300 mg aliskiren (as aliskiren hemifumarate), 10 mg amlodipine (as amlodipine

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS (CALENDAR) (PVC/PCTFE OR PA/Alu/PVC)

1. NAME OF THE MEDICINAL PRODUCT

Rasitrio 300 mg/10 mg/25 mg film-coated tablets

Aliskiren/amlodipine/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Package leaflet: information for the user

Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.

What is in this leaflet

What Rasitrio is and what it is used for

What you need to know before you take Rasitrio

How to take Rasitrio

Possible side effects

How to store Rasitrio

Contents of the pack and other information

What Rasitrio is and what it is used for

What Rasitrio is

Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide. All of these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a group of medicines called renin inhibitors. These reduce the amount of angiotensin II the body can make. Angiotensin II causes blood vessels to

tighten, which raises bl vessels to relax; this lo

the amount of angiotensin II allows the blood

Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure. Amlodipine causes blood vessels to dilate and relax; this lowers blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.

Hydrochlorothiazide increases urine output, which also lowers blood pressure.

High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders.

What Rasitrio is used for

Rasitrio is used to treat high blood pressure in adult patients who have their blood pressure already controlled by aliskiren, amlodipine and hydrochlorothiazide taken as separate medicines given at the same time. These patients may thus benefit from taking one tablet containing all three substances.

2. What you need to know before you take Rasitrio

Do not take Rasitrio

– if you are allergic to aliskiren, to amlodipine, to other dihydropyridine-derived medicines

(known as calcium channel blockers), to hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, do not take Rasitrio and ask your doctor for advice.

– if you have experienced the following forms of angioedema (difficulties in breathing or

swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): – angioedema when taking aliskiren,

– hereditary angioedema,
– angioedema without any known cause.

– if you are more than 3 months pregnant. (It is also better to avoid Rasitrio in early pregnancy –

see Pregnancy section).

– if you have serious liver problems.
– if you have serious kidney problems.
– if you have problems to produce urine (anuria).
– if the level of potassium in your blood is too low despite treatment.
– if the level of sodium in your blood is too low.
– if the level of calcium in your blood is too high.
– if you have gout (uric acid crystals in the joints).
– if you are taking any of the following medicines:

ciclosporin (a medicine used in transplantation t conditions, e.g. rheumatoid arthritis or atopic d itraconazole (a medicine used to treat fungal

nt organ rejection or for other titis), ctions),

– quinidine (a medicine used to correct heart rhythm).

if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure:

– an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

– if you have a very low blood pressure.
– if you are suffering from shock, including cardiogenic shock.
– if you have a narrowing of the aortic heart valve (aortic stenosis).
– if you have heart failure after an acute heart attack.

If any of the above applies to you, do not take Rasitrio and talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Rasitrio:

– if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce).
– if you have already experienced angioedema (difficulties in breathing, or swallowing, or

swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking Rasitrio and contact your doctor.

– if you suffer from heart problems.
– if you are on a low-salt diet.
– if your urine flow has decreased markedly for 24 hours or more and/or if you have serious

kidney problems (e.g. require dialysis), including if you have had a kidney transplant or a narrowing or blockage of the arteries that supply blood to your kidney.

– if you have impaired kidney function, your doctor will carefully consider whether Rasitrio is

suitable for you and may wish to monitor you carefully.

– if you suffer from liver problems (impaired liver function).
– if you have diabetes (high level of sugar in your blood).
– if you have a high level of cholesterol or triglycerides in your blood.
– if you suffer from a disease called lupus erythematosus (also called “lupus” or “SLE”).

if you suffer from allergy or asthma.

if you are taking either of the following classes of medicines used to treat high blood pressure:

– an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

if you are 65 years of age or older (see section Elderly (age 65 years or older) below).

if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, restlessness, muscle pain or cramps, weakness, low blood pressure, reduced urine output, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Rasitrio).

if you experience skin reactions such as rash after sun exposure.

if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Rasitrio. This can lead to permanent vision impairment, if not treated.

if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body.

You must tell your doctor if you think you are (or might become) pregnant. Rasitrio is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section).

Children and adolescents

is not recommended.

The use of Rasitrio in children and adolescents up to 18 years

Elderly

You should tell your doctor if you are 65 years of age or older because you may be more susceptible to side effects related to low blood pressure (see section 4 on possible side effects). Your doctor will carefully consider whether Rasitrio is suitable for you. If you are 75 years of age or older, your doctor may wish to monitor your blood pressure more frequently.

In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.

Other medicines and Rasitrio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

t take Rasitrio and talk to your doctor if you are taking any of the following medicines: ciclosporin (a medicine used in transplantation to prevent organ rejection and also in other conditions, e.g. rheumatoid arthritis or atopic dermatitis).

itraconazole (a medicine used to treat fungal infections).

quinidine (a medicine used to correct heart rhythm).

one of the following classes of medicines used to treat high blood pressure if you have diabetes mellitus or impaired kidney function:

– an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

Tell your doctor if you are using the following medicines:

– medicines or substances that increase the amount of potassium in your blood. These include

potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

– medicines that may reduce the amount of potassium in your blood, such as diuretics (water

tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.

– medicines to reduce blood pressure, including methyldopa.
– medicines to increase blood pressure, such as noradrenaline or adrenaline.
– medicines that may induce “torsades de pointes ” (irregular heart beat), such as antiarrhythmics

(medicines used to treat heart problems) and some antipsychotics.

– ketonazole, a medicine used to treat fungal infections.
– verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat

angina pectoris.

– clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections.
– amiodarone, a medicine used to treat abnormal heart rhythms.
– atorvastatin, a medicine used to treat high cholesterol.
– furosemide or torasemide, medicines belonging to the type known as diuretics, which are used

to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling).

– medicines that may reduce the amount of sodium in your blood, such as antidepressants,

antipsychotics, antiepileptics (carbamazepine).

– rifampicin, a medicine used to prevent or treat infections.
– St. John’s wort (hypericum perforatum) , a herbal medicine used to elevate mood.
– pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective

cyclooxygenase-2 inhibitors (Cox-2 inhibitors) (used especially in the patients over 65 years old).

– diltiazem, a medicine used to treat heart problems.
– ritonavir, a medicine used to treat viral infection.
– lithium (a medicine used to treat some types of depression).
– some laxatives.
– medicines for the treatment of gout, such as allopurinol.
– digoxin or other digitalis glycosides (medicines used to treat heart problems).
– vitamin D and calcium salts.
– one of the following classes of medicines used to treat high blood pressure:

– an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensi

medicines used medicines for t

n II receptor blocker” such as valsartan, telmisartan, irbesartan etc. ntrol heart rhythm.

treatment of diabetes (oral agents such as metformin or insulins).

medicines that may increase blood sugar level, such as beta blockers and diazoxide. steroids.

cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide. arthritis medicines.

medicines used to treat oesophageal ulceration and inflammation (e.g. carbenoxolone).

muscle relaxants (medicines to relax the muscles which are used during operations).

amantadine (a medicine used to treat Parkinson’s disease, also used to treat or prevent certain illnesses caused by viruses).

anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as an aid to anaesthesia).

cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood).

alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures).

iodine contrast media (agents used for imaging examinations).

Your doctor may need to change your dose and/or take other precautions if you are taking one of the following medicines:

– furosemide or torasemide, medicines belonging to the type known as diuretics, which are used

to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling).

– some medicines used to treat infections, such as ketoconazole, amphotericin or penicillin G.

Rasitrio with food and drink

You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine with grapefruit juice.

Due to hydrochlorothiazide contained in Rasitrio, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.

Pregnancy

Do not take this medicine if you are pregnant (see section Do not take Rasitrio). If you become pregnant while taking this medicine stop taking it immediately and talk to your doctor. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking Rasitrio before you become pregnant and will advise you to take another medicine instead of Rasitrio. Rasitrio is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Rasitrio is not

recommended for mothers who are you if you wish to breast-feed.

ur doctor may choose another treatment for

Driving and using machines

This medicine may make you feel dizzy and drowsy. If you experience this symptom, do not drive or use tools or machines.

Always take this medicine exactly as your doctor has told you and do not exceed the recommended dose. Check with your doctor or pharmacist if you are not sure.

The usual dose of Rasitrio is one tablet a day.

Method of administration

Swallow the tablet whole with some water. You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine together with grapefruit juice.

If you take more Rasitrio than you should

If you have accidentally taken too many Rasitrio tablets, talk to a doctor immediately. You may require medical attention.

If you forget to take Rasitrio

If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time. If it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

Do not stop taking this medicine , even if you are feeling well (unless your doctor tells you to do so). People who have high blood pressure often do not notice any signs of the problem. Many may feel quite normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appointments with the doctor even if you are feeling well.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects reported for Rasitrio are: Common (may affect up to 1 in 10 people) dizziness

low blood pressure

swelling of hands, ankles and feet (peripheral oedema).

Tell your doctor immediately if you experience the following at the beginning of your treatment: Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasitrio. Patients 65 years of age or older are more susceptible to side effects related to low blood pressure. In clinical trials low blood pressure occurred more frequently in patients taking Rasitrio than those taking only dual combinations of aliskiren/amlodipine, aliskiren/hydrochlorothiazide or amlodipine/hydrochlorothiazide (see section 2).

The following, possibly serious, side effects have been reported with medicines containing aliskiren, amlodipine or hydrochlorothiazide alone.

Aliskiren

Some side effects can be serious

not known):

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following occur, tell your doctor straight away:

Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,

difficulty breathing, dizziness.

Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (signs of liver disorder).

Possible side effects

Common (may affect up to 1 in 10 people)

diarrhoea

joint pain (arthralgia)

high level of potassium in the blood dizziness.

Uncommon (may affect up to 1 in 100 people)

skin rash (this may also be a sign of allergic reactions or angioedema – see “Rare” side effects

below)

kidney problems including acute renal failure (severely decreased urine output)
swelling of hands, ankles or feet (peripheral oedema)
severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions – red skin,

blistering of the lips, eyes or mouth, skin peeling, fever)

low blood pressure
palpitations
cough
itching, itchy rash (urticaria)
increased liver enzymes.

Rare (may affect up to 1 in 1,000 people)

severe allergic reaction (anaphylactic reaction)
allergic reactions (hypersensitivity)
angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash,

itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness)

increased level of creatinine in the blood
red skin (erythema).

Amlodipine

In patients taking amlodipine alone, the following have been reported:

Common (may affect up to 1 in 10 people)

sleepiness

dizziness

headache (especially at the beginning of treatment) hot flushes

abdominal pain

nausea

ankle swelling

swelling

tiredness

palpitations (awareness of your heart beat).

Uncommon (may affect up to 1 in 100 people)

insomnia
mood changes (including anxiety)
depression
trembling
disturbed sense of taste
sudden, temporary loss of consciousness
decreased skin sensitivity
tingling or numbness

vision disorder (inc ringing noise in ear low blood pressure breathlessness

ng double vision)

runny nose

vomiting

stomach discomfort after meal

altered bowel habits (including diarrhoea and constipation)

dry mouth

hair loss

purple skin patches

skin discolouration

excessive sweating

itching; rash

generalised rash

joint pain

muscle pain

muscle cramps

back pain

urination disorders

urination at night
frequent urination
impotence
breast enlargement in men
chest pain
weakness
pain
feeling unwell
weight increase
weight decrease.

Rare (may affect up to 1 in 1,000 people)

confusion.

low level of white blood cells and blood platelets

allergic reaction with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness

high level of sugar in the blood

increased muscle stiffness and inability to stretch

sensation of numbness or tingling with sensation of burning in fingers and toes

heart attack

irregular heart beat

inflammation of blood vessels

cough

severe upper stomach pain

inflammation of the gastric lining

bleeding, tender or enlarged gums

inflammation of the liver

, or swelling of the face, hands and feet,

ng and peeling, blistering of lips, eyes or mouth; dry skin, rash,

liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine abnormal liver function test angioedema (difficulties in eyes, lips and/or tongue) skin reaction with skin redd itchy rash skin rash with flaking or peeling; rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever

swelling mainly of the face and throat

increased sensitivity of the skin to sun.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following have been reported, however the frequency cannot be estimated from the available data:

Very common (may affect more than 1 in 10 people)

low level of potassium in the blood
increase of lipids in the blood.

Common (may affect up to 1 in 10 people)

high level of uric acid in the blood
low level of magnesium in the blood
low level of sodium in the blood
dizziness, fainting on standing up
reduced appetite
nausea and vomiting
itchy rash and other types of rash
inability to achieve or maintain erection.

Rare (may affect up to 1 in 1,000 people)

low level of blood platelets (sometimes with bleeding or bruising underneath the skin) high level of calcium in the blood

high level of sugar in the blood

worsening of the diabetic metabolic state

sad mood (depression)
sleep disturbances
dizziness
headache
tingling or numbness
vision disorder
irregular heart beat
abdominal discomfort
constipation
diarrhoea
liver disorders which can occur together with yellow skin and eyes
increased sensitivity of skin to the sun
sugar in the urine.

Very rare (may affect up to 1 in 10,000 people)

fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood

cells)

pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia)
rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress

including pneumonitis and pulmonary oedema)

severe upper stomach pain (pancreatitis)
facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling,

fever (toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data)

weakness
bruising and frequent infections (aplastic anaemia)
decrease in vision or pain in your eyes due to high pressure (possible signs of acute-angle

closure glaucoma)

severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling,

fever (erythema multiforme)

muscle spasm
severely decreased urine output (possible signs of renal disorder or renal failure), weakness

(asthenia)

fever.

If any of these affect you severely, tell your doctor. You may need to stop Rasitrio.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Rasitrio

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.

The expiry date refers to the last day of that month.

Do not store above 30°C.

Store Rasitrio tablets in the original package in order to protect from moisture and light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These

es will help protect the environment.

6. Contents of the pack and other i

What Rasitrio contains

– Each Rasitrio 150 mg/5 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as

hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide. The other ingredients are cellulose microcrystalline, crospovidone, povidone, magnesium stearate, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).

What Rasitrio looks like and contents of the pack

– Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets are violet white, oval tablets, with “YIY”

debossed on one side and “NVR” on the other.

Rasitrio is available in packs containing 14, 28, 56, 98 tablets in calendar blisters.

It is also available in multi-packs of 98 tablets (2 packs of 49) in calendar blisters.

Rasitrio is available in packs containing 30 or 90 tablets in blisters.

Rasitrio is available in packs containing 56×1 tablet in perforated unit dose blister.

It is also available in multi-packs of 98×1 tablet (2 packs of 49×1) in perforated unit dose blister.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito 131

I-80058 Torre Annunziata/NA

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

Novartis Pharma Services Inc.

Tel: +370 5 269 16 50

Etnrapua

Novartis Pharma Services Inc.

Ten.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Magyarország

Novartis Hungária Kft. Pharma

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

Novartis Pharma Services Inc.

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

EXÀàôa

Novartis (Hellas) A.E.B.E.

Tql: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

Portugal

Novartis Farma – Produtos Farmacéuticos, S.A.

Tel: +351 21 000 8600

Romania

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Island

Vistor hf.

Simi: +354 535 7000

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Knnpoç

Novartis Pharma Services Inc.

Tql: +357 22 690 690

Latvija

Novartis Pharma Services Inc.

Tel: +371 67 887 070

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the E

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ropean Medicines Agency website:

Package leaflet: information for the user

Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets Aliskiren/amlodipine/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.

What is in this leaflet

What Rasitrio is and what it is used for

What you need to know before you take Rasitrio

How to take Rasitrio

Possible side effects

How to store Rasitrio

Contents of the pack and other information

What Rasitrio is and what it is used for

What Rasitrio is

Rasitrio contains three active substances, called aliskiren, amlodipine and hydrochlorothiazide. All of these substances help to control high blood pressure (hypertension).

Aliskiren is a substance that belongs to a group of medicines called renin inhibitors. These reduce the amount of angiotensin II the body can make. Angiotensin II causes blood vessels to

tighten, which raises bl vessels to relax; this lo

the amount of angiotensin II allows the blood

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.

Hydrochlorothiazide increases urine output, which also lowers blood pressure.

What Rasitrio is used for

2. What you need to know before you take Rasitrio

Do not take Rasitrio

– if you are allergic to aliskiren, to amlodipine, to other dihydropyridine-derived medicines

– if you have experienced the following forms of angioedema (difficulties in breathing or

swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): – angioedema when taking aliskiren,

– hereditary angioedema,
– angioedema without any known cause.

– if you are more than 3 months pregnant. (It is also better to avoid Rasitrio in early pregnancy –

see Pregnancy section).

– if you have serious liver problems.
– if you have serious kidney problems.
– if you have problems to produce urine (anuria).
– if the level of potassium in your blood is too low despite treatment.
– if the level of sodium in your blood is too low.
– if the level of calcium in your blood is too high.
– if you have gout (uric acid crystals in the joints).
– if you are taking any of the following medicines:

ciclosporin (a medicine used in transplantation t conditions, e.g. rheumatoid arthritis or atopic d itraconazole (a medicine used to treat fungal

nt organ rejection or for other titis), ctions),

quinidine (a medicine used to correct hea

hythm).

nction and you are treated with either of the

if you have diabetes mellitus or impaired ki following classes of medicines used to treat – an “angiotensin converting enzyme in

high blood pressure:

hibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

– if you have a very low blood pressure.
– if you are suffering from shock, including cardiogenic shock.
– if you have a narrowing of the aortic heart valve (aortic stenosis).
– if you have heart failure after an acute heart attack.

If any of the above applies to you, do not take Rasitrio and talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Rasitrio:

– if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to

increase the amount of urine you produce).

– if you have already experienced angioedema (difficulties in breathing, or swallowing, or

swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking Rasitrio and contact your doctor.

– if you suffer from heart problems.
– if you are on a low-salt diet.
– if your urine flow has decreased markedly for 24 hours or more and/or if you have serious

kidney problems (e.g. require dialysis), including if you have had a kidney transplant or a narrowing or blockage of the arteries that supply blood to your kidney.

– if you have impaired kidney function, your doctor will carefully consider whether Rasitrio is

suitable for you and may wish to monitor you carefully.

– if you suffer from liver problems (impaired liver function).
– if you have diabetes (high level of sugar in your blood).
– if you have a high level of cholesterol or triglycerides in your blood.
– if you suffer from a disease called lupus erythematosus (also called “lupus” or “SLE”).

if you suffer from allergy or asthma.

if you are taking either of the following classes of medicines used to treat high blood pressure: – an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

if you are 65 years of age or older (see section Elderly (age 65 years or older) below). if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, restlessness, muscle pain or cramps, weakness, low blood pressure, reduced urine output, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Rasitrio).

if you experience skin reactions such as rash after sun exposure.

if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body.

Children and adolescents

is not recommended.

The use of Rasitrio in children and adolescents up to 18 years

Elderly

In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.

Other medicines and Rasitrio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Rasitrio and talk to your doctor if you are taking any of the following medicines:

– ciclosporin (a medicine used in transplantation to prevent organ rejection and also in other

conditions, e.g. rheumatoid arthritis or atopic dermatitis).

– itraconazole (a medicine used to treat fungal infections).
– quinidine (a medicine used to correct heart rhythm).
– one of the following classes of medicines used to treat high blood pressure if you have diabetes

mellitus or impaired kidney function:

– an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

– an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

Tell your doctor if you are using the following medicines:

– medicines or substances that increase the amount of potassium in your blood. These include

potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

– medicines that may reduce the amount of potassium in your blood, such as diuretics (water

tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.

– medicines to reduce blood pressure, including methyldopa.
– medicines to increase blood pressure, such as noradrenaline or adrenaline.
– medicines that may induce “torsades de pointes ” (irregular heart beat), such as antiarrhythmics

(medicines used to treat heart problems) and some antipsychotics.

– ketonazole, a medicine used to treat fungal infections.
– verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat

angina pectoris.

– clarithromycin, telithromycin, erythromycin which are antibiotics used to treat infections.
– amiodarone, a medicine used to treat abnormal heart rhythms.
– atorvastatin, a medicine used to treat high cholesterol.
– furosemide or torasemide, medicines belonging to the type known as diuretics, which are used

to increase the amount of urine you produce and are also used to treat a certain kind of heart problem (heart failure) or oedema (swelling).

– medicines that may reduce the amount of sodium in your blood, such as antidepressants,

antipsychotics, antiepileptics (carbamazepine).

– rifampicin, a medicine used to prevent or treat infections.
– St. John’s wort (hypericum perforatum) , a herbal medicine used to elevate mood.
– pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective

cyclooxygenase-2 inhibitors (Cox-2 inhibitors) (used especially in the patients over 65 years old).

– diltiazem, a medicine used to treat heart problems.
– ritonavir, a medicine used to treat viral infection.
– lithium (a medicine used to treat some types of depression).
– some laxatives.
– medicines for the treatment of gout, such as allopurinol.
– digoxin or other digitalis glycosides (medicines used to treat heart problems).
– vitamin D and calcium salts.
– one of the following classes of medicines used to treat high blood pressure: