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Elmiron (pentosan polysulfate sodium) – Labelling - G04BX15

Updated on site: 06-Oct-2017

Medication nameElmiron
ATC CodeG04BX15
Substancepentosan polysulfate sodium
Manufacturerbene-Arzneimittel GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BOTTLE

1.NAME OF THE MEDICINAL PRODUCT

elmiron 100°mg hard capsules pentosan polysulfate sodium

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 100 mg of pentosan polysulfate sodium.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

90 hard capsules

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

After first opening: use within 30 days.

9.SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed 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

bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1189/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

ELMIRON

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

elmiron 100°mg hard capsules pentosan polysulfate sodium

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 100°mg of pentosan polysulfate sodium.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

90 hard capsules

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.

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

bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1189/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

ELMIRON

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

elmiron 100°mg hard capsules pentosan polysulfate sodium

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 100 mg of pentosan polysulfate sodium.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

90 hard capsules

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

After first opening: use within 30 days.

Open date: ……………………

9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed 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

bene-Arzneimittel GmbH, PO Box 710269, 81452 Munich, Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1189/001

13. BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

elmiron 100°mg hard capsules pentosan polysulfate sodium

2.NAME OF THE MARKETING AUTHORISATION HOLDER

bene-Arzneimittel GmbH

3.EXPIRY DATE

EXP

4.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

5.OTHER

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