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Adrovance (alendronate sodium trihydrate / colecalciferol) – Labelling - M05BB03

Updated on site: 05-Oct-2017

Medication nameAdrovance
ATC CodeM05BB03
Substancealendronate sodium trihydrate / colecalciferol
ManufacturerMerck Sharp

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ADROVANCE 70 mg/2,800 IU

1.NAME OF THE MEDICINAL PRODUCT

ADROVANCE 70 mg/2,800 IU tablets alendronic acid /colecalciferol

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3.).

3.LIST OF EXCIPIENTS

Also contains: lactose and sucrose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

2 tablets

4 tablets

6 tablets

12 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Once weekly.

For oral use.

Take one tablet once a week

Mark the day of the week that best fits your schedule:

MON

TUE

WED

THU

FRI

SAT

SUN

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

Store in the original blister 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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/364/001 (2 tablets)

EU/1/06/364/002 (4 tablets)

EU/1/06/364/003 (6 tablets)

EU/1/06/364/004 (12 tablets)

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ADROVANCE 70 mg

2,800 IU

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ADROVANCE 70 mg/2,800 IU

1. NAME OF THE MEDICINAL PRODUCT

ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol

2.NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ADROVANCE 70 mg/5,600 IU

1. NAME OF THE MEDICINAL PRODUCT

ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3.).

3. LIST OF EXCIPIENTS

Also contains: lactose and sucrose. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

2 tablets

4 tablets

12 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Once weekly.

For oral use.

Take one tablet once a week

Mark the day of the week that best fits your schedule:

MON

TUE

WED

THU

FRI

SAT

SUN

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

Store in the original blister 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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/364/006 (2 tablets)

EU/1/06/364/007 (4 tablets)

EU/1/06/364/008 (12 tablets)

13. BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ADROVANCE 70 mg

5,600 IU

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ADROVANCE 70 mg/5,600 IU

1. NAME OF THE MEDICINAL PRODUCT

ADROVANCE 70 mg/5,600 IU tablets alendronic acid/colecalciferol

2. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR WITHIN THE OUTER PACKAGING (CARTON)

Instruction Card

Important information

How to take ADROVANCE tablets

1.Take one tablet once a week.

2.Choose the day of the week that best fits your schedule. When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not crush or chew the tablet or allow it to dissolve in your mouth) one ADROVANCE tablet with a full glass of water (not mineral water).

3. Continue your morning activities.

You can sit, stand or walk – just stay fully upright. Don’t lie down, eat, drink or take other medicines for at least 30 minutes. Do not lie down until after your first food of the day.

4. Remember

, take ADROVANCE once each week on that same day for as long as your doctor prescribes it.

If you miss a dose, take only one ADROVANCE tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

There is important additional information about how to take ADROVANCE in the package leaflet. Please read it carefully.

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