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LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 100 MG / 12.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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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.

  • 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 {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.>

  • 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 ~