Patient leaflet - LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 100 MG / 12.5 MG FILM-COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT
/…/ 100 mg/25 mg film-coated tablets
Losartan potassium/hydrochlorothiazide
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each /…/ 50 mg/12.5 mg tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Each /./ 100 mg/12.5 mg tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Each /./ 100 mg/25 mg tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Film-coated tablets [Blister:]
10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 film-coated tablets [For 50 mg/12.5 mg and 100 mg/25 mg film-coated tablets only :]
[Container:]
100, 250 or 500 film-coated tablets [For 100 mg/12.5 mg film-coated tablets only :]
[Container:]
100 or 300 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
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
[For 100 mg/12.5 mg film-coated tablets only :]
[Container:]
Shelf life after opening: 6 months
9. SPECIAL STORAGE CONDITIONS
[Blister:]
Store below 25°C.
[Tablet container:] Store below 30°C.
[For 100 mg/12.5 mg film-coated tablets only :]
Store below 30°C and store in the original packaging in order to protect from moisture.
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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and Address}
<{tel}>
<{fax}>
<{e-mail}>
12. MARKETING AUTHORISATION NUMBER(S)
13. BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
<Medicinal product subject to medical prescription.>
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15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
/…/ 100 mg/25 mg
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
| 1. NAME OF THE MEDICINAL PRODUCT
/…/ 50 mg/12.5 mg film-coated tablets /…/ 100 mg/12.5 mg film-coated tablets
/…/ 100 mg/25 mg film-coated tablets
Losartan potassium/hydrochlorothiazide
2. NAME OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
{Name}
3. EXPIRY DATE
EXP
| 4. BATCH NUMBER
Lot
| 5. OTHER ~