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

3x(21+7) film-coated tablets

6x(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.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP:

• 9. SPECIAL STORAGE CONDITIONS

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

Marketing Authorisation Holder: Gedeon Richter Plc.

Gyomroi ut 19–21.

1103 Budapest

Hungary

((RG logo))

• 12. MARKETING AUTHORISATION NUMBER (S)

PL 04854/0132

• 13. BATCH NUMBER

Batch:

• 14. GENERAL CLASSIFICATION FOR SUPPLY poM

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Liladros ED

Place for the pharmacist’s label

• 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} [product code]

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

• 2. NAME OF THE MARKETING AUTHORISATION HOLDER

Gedeon Richter Plc.

((RG emblem))

• 3. EXPIRY DATE

EXP:

• 4. BATCH NUMBER

Batch:

• 5. OTHER