Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON/BOX
1.NAME OF THE MEDICINAL PRODUCT
Tolura 20 mg tablets
telmisartan
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg telmisartan.
3.LIST OF EXCIPIENTS
Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.
4.PHARMACEUTICAL FORM AND CONTENTS
14 tablets
28 tablets
30 tablets
56 tablets
84 tablets
90 tablets
98 tablets
100 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

9.SPECIAL STORAGE CONDITIONS
Do not store above 30°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
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
12.MARKETING AUTHORISATION NUMBER(S)
14 tablets: EU/1/10/632/001
28 tablets: EU/1/10/632/002
30 tablets: EU/1/10/632/003
56 tablets: EU/1/10/632/004
84 tablets: EU/1/10/632/005
90 tablets: EU/1/10/632/006
98 tablets: EU/1/10/632/007
100 tablets: EU/1/10/632/022
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Tolura 20 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS
BLISTER/OPA/Al/PVC Al
1. NAME OF THE MEDICINAL PRODUCT
Tolura 20 mg tablets
telmisartan
2.NAME OF THE MARKETING AUTHORISATION HOLDER
KRKA
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER
Only on blisters containing 7 tablets
MON
TUE
WED
THU
FRI
SAT
SUN
- Kinzalkomb - telmisartan / hydrochlorothiazide
- Telmisartan teva - telmisartan
- Telmisartan actavis - telmisartan
- Micardis - telmisartan
- Actelsar hct - telmisartan / hydrochlorothiazide
Prescription drugs listed. Substance: "Telmisartan"

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON/BOX
1. NAME OF THE MEDICINAL PRODUCT
Tolura 40 mg tablets
telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 40 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
14 tablets
28 tablets
30 tablets
56 tablets
84 tablets
90 tablets
98 tablets
100 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

9. SPECIAL STORAGE CONDITIONS
Do not store above 30°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
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
12. MARKETING AUTHORISATION NUMBER(S)
14 tablets: EU/1/10/632/008
28 tablets: EU/1/10/632/009
30 tablets: EU/1/10/632/010
56 tablets: EU/1/10/632/011
84 tablets: EU/1/10/632/012
90 tablets: EU/1/10/632/013
98 tablets: EU/1/10/632/014
100 tablets: EU/1/10/632/023
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Tolura 40 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS
BLISTER/OPA/Al/PVC Al
1. NAME OF THE MEDICINAL PRODUCT
Tolura 40 mg tablets
telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
KRKA
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Only on blisters containing 7 tablets
MON
TUE
WED
THU
FRI
SAT
SUN
- Pritor - C09CA07
- Micardis - C09CA07
- Kinzalmono (telmisartan boehringer ingelheim pharma kg) - C09CA07
- Telmisartan teva - C09CA07
- Telmisartan actavis - C09CA07
Prescription drugs listed. ATC Code: "C09CA07"

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON/BOX
1. NAME OF THE MEDICINAL PRODUCT
Tolura 80 mg tablets
telmisartan
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 80 mg telmisartan.
3. LIST OF EXCIPIENTS
Contains lactose monohydrate and sorbitol (E420). Read the package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
14 tablets
28 tablets
30 tablets
56 tablets
84 tablets
90 tablets
98 tablets
100 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

9. SPECIAL STORAGE CONDITIONS
Do not store above 30°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
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
12. MARKETING AUTHORISATION NUMBER(S)
14 tablets: EU/1/10/632/015
28 tablets: EU/1/10/632/016
30 tablets: EU/1/10/632/017
56 tablets: EU/1/10/632/018
84 tablets: EU/1/10/632/019
90 tablets: EU/1/10/632/020
98 tablets: EU/1/10/632/021
100 tablets: EU/1/10/632/024
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Tolura 80 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS
BLISTER/OPA/Al/PVC Al
1. NAME OF THE MEDICINAL PRODUCT
Tolura 80 mg tablets
telmisartan
2. NAME OF THE MARKETING AUTHORISATION HOLDER
KRKA
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Only on blisters containing 7 tablets
MON
TUE
WED
THU
FRI
SAT
SUN
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