Liladros ED 0.02 mg / 3 mg film-coated tablets – patient leaflet, side effects, dosage

1. NAME OF THE MEDICINAL PRODUCT

Liladros ED 0.02 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

21 white or almost white film-coated tablets:

Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.

7 green placebo (inactive) film-coated tablets:

The film-coated tablet does not contain active substances.

3. LIST OF EXCIPIENTS

The white or almost white film-coated tablets also contain lactose monohydrate and lecithin (soya). The green placebo film-coated tablets also contain lactose and sunset yellow. See the package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

21+7 film-coated tablets

3×(21+7) film-coated tablets

6×(21+7) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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.

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

EXP:

1. 9. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C. Store in the original package in order to protect from light.

1. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
2. 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

((RG logo))

1. 12. MARKETING AUTHORISATION NUMBER (S)

PL 04854/0132

1. 13. BATCH NUMBER

Batch:

1. 14. GENERAL CLASSIFICATION FOR SUPPLY

POM

1. 15. INSTRUCTIONS ON USE
2. 16. INFORMATION IN BRAILLE

Liladros ED

1. 17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

1. 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} [product code]

Place for the pharmacist’s label

SN: {number} [serial number]

NN: {number} [national reimbursement number or other national number identifying the medicinal product]

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister

1.NAME OF THE MEDICINAL PRODUCT

Liladros ED 0.02 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone

1. 2. NAME OF THE MARKETING AUTHORISATION HOLDER

Gedeon Richter Plc.

((RG emblem))

1. 3. EXPIRY DATE

EXP:

1. 4. BATCH NUMBER

Batch:

1. 5. OTHER

Start

1 → 2 → 3 ….. → 28