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Ranexa (Latixa) (ranolazine) – Labelling - C01EB18

Updated on site: 09-Oct-2017

Medication nameRanexa (Latixa)
ATC CodeC01EB18
Substanceranolazine
ManufacturerMenarini International Operations Luxembourg S.A. (MIOL)

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Carton containing blister strips or carton containing HDPE bottle and bottle label.

1.NAME OF THE MEDICINAL PRODUCT

Ranexa 375 mg prolonged-release tablets

Ranolazine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 375 mg ranolazine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

60 prolonged-release tablets

100 prolonged-release tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Swallow whole. Do not chew.

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

Menarini International O. L. S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/462/001 60 tablets in blister pack

EU/1/08/462/002 60 tablets in bottle

EU/1/08/462/007 30 tablets in blister pack

EU/1/08/462/008 100 tablets in blister pack

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

Open Here

16.INFORMATION IN BRAILLE

Ranexa 375 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PVDC/Aluminium blisters

1. NAME OF THE MEDICINAL PRODUCT

Ranexa 375 mg prolonged-release tablets

Ranolazine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Menarini International O.L. S.A.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Carton containing blister strips or carton containing HDPE bottle and bottle label.

1. NAME OF THE MEDICINAL PRODUCT

Ranexa 500 mg prolonged-release tablets

Ranolazine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 500 mg ranolazine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

60 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Swallow whole. Do not chew.

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

Menarini International O. L. S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/462/003 60 tablets in blister pack

EU/1/08/462/004 60 tablets in bottle

EU/1/08/462/009 30 tablets in blister pack

EU/1/08/462/010 100 tablets in blister pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

Open Here

16. INFORMATION IN BRAILLE

Ranexa 500 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PVDC/Aluminium blisters

1. NAME OF THE MEDICINAL PRODUCT

Ranexa 500 mg prolonged-release tablets

Ranolazine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Menarini International O.L. S.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

Carton containing blister strips or carton containing HDPE bottle and bottle label.

1. NAME OF THE MEDICINAL PRODUCT

Ranexa 750 mg prolonged-release tablets

Ranolazine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 750 mg ranolazine.

3. LIST OF EXCIPIENTS

Contains colouring agent E102 and lactose; see package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

60 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use.

Swallow whole. Do not chew.

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

Menarini International O. L. S.A.

1, Avenue de la Gare, L-1611 Luxembourg Luxembourg

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/462/005 60 tablets in blister pack

EU/1/08/462/006 60 tablets in bottle

EU/1/08/462/011 30 tablets in blister pack

EU/1/08/462/012 100 tablets in blister pack

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

Open Here

16. INFORMATION IN BRAILLE

Ranexa 750 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

PVC/PVDC/Aluminium blisters

1. NAME OF THE MEDICINAL PRODUCT

Ranexa 750 mg prolonged-release tablets

Ranolazine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Menarini International O.L. S.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PULL OUT

Ranexa® Patient Alert Card

During Ranexa treatment

 

(Carry this card with you at all times)

Do not drink Grapefruit Juice whilst

Information to the patient

taking Ranexa.

Call your doctor if you feel dizzy or

This card contains important safety

sick, become sick or experience any

unexpected symptoms after starting

information you should know before you

Ranexa.

are given Ranexa and during treatment with

 

Ranexa.

Dates of Ranexa treatment:

 

Show this card to any doctor involved

 

in your treatment.

Start………………………

Prior to Ranexa treatment

 

Before taking Ranexa speak to your doctor if

 

you:

See the Ranexa package leaflet for

Have problems with your kidneys

more information.

Have liver problems

Please make sure you have a list of all

Have ever had an abnormal

your other medicines with you at any

electrocardiogram (ECG)

visit to the health care professional.

Are taking medications to treat

 

epilepsy, bacterial or fungal infections,

 

HIV infection, depression or heart

 

rhythm disorders

Patient’s name…………………………..

Are taking the herbal remedy St John’s

Wort

 

Are taking allergy medicines

Doctor’s name…………………………..

Are taking medications to reduce

 

cholesterol

 

Are taking medication to reduce the

Doctor’s phone………………………….

risk of transplanted organ rejection

 

 

 

 

PULL OUT

 

 

Ranexa Patient Alert Card

A dose reduction of Ranexa may be needed in

 

(Information for Health Care Professionals)

combination with:

 

• Moderate CYP3A4 inhibitors

The patient carrying this card is treated

(eg, diltiazem, erythromycin,

with Ranexa for symptomatic angina

fluconazole)

P-gp inhibitors (eg, ciclosporin,

pectoris.

verapamil)

Please refer to the Ranexa SPC prior to

Caution should be exercised when prescribing

prescribing any medications to this patient,

Ranexa to patients:

• Taking certain other drugs mentioned

as there are potential drug interactions

in the product information

which should be taken into consideration.

• With certain other risk factors listed in

the product information

 

Ranexa is contraindicated in patients taking:

Inform the patient about the potential for an

interaction with other prescribed medicinal

• Potent CYP3A4 inhibitors (eg,

products and to contact his/her doctor in case

itraconazole, ketoconazole,

of dizziness, nausea or vomiting.

voriconazol, posaconazol, HIV

 

protease inhibitors, clarithromycin,

Please refer to the Ranexa SPC for further

telithromycin, nefazodone)

recommendations.

• Class Ia (eg, quinidine) or Class III (eg,

 

dofetilide, sotalol) antiarrhythmics

For Medical Information:

other than amiodarone

Freephone: xxxx-xxx-xxxx

 

 

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