Patient leaflet - Tremapecil 150 mg / 37.5 mg / 200 mg

1. NAME OF THE MEDICINAL PRODUCT

Tremapecil 50 mg/12.5 mg/200 mg film-coated tablets

Tremapecil 75 mg/18.75 mg/200 mg film-coated tablets
Tremapecil 100 mg/25 mg/200 mg film-coated tablets
Tremapecil 125 mg/31.25 mg/200 mg film-coated tablets
Tremapecil 150 mg/37.5 mg/200 mg film-coated tablets
Tremapecil 200 mg/50 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of
entacapone.
Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

30 film-coated tablets

100 film-coated tablets

130 film-coated tablets

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:

Should be used within 6 months after first opening.

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

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

Tremapecil 50 mg/12.5 mg/200 mg - PL 20075/0421

Tremapecil 75 mg/18.75 mg/200 mg - PL 20075/0422
Tremapecil 100 mg/25 mg/200 mg - PL 20075/0417
Tremapecil 125 mg/31.25 mg/200 mg - PL 20075/0419
Tremapecil 150 mg/37.5 mg/200 mg - PL 20075/0418
Tremapecil 200 mg/50 mg/200 mg - PL 20075/0420

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

POM

15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE

Tremapecil #50 /12.5 /200 mg film-coated tablets

Tremapecil #75 /18.75 /200 mg film-coated tablets
Tremapecil #100 /25 /200 mg film-coated tablets
Tremapecil #125 /31.25 /200 mg film-coated tablets
Tremapecil #150 /37.5 /200 mg film-coated tablets
Tremapecil #200 /50 /200 mg film-coated tablets

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

{LABEL FOR BOTTLE}

1. NAME OF THE MEDICINAL PRODUCT