What Pradaxa contains
The active substance is dabigatran, which is administered in the form of 75 mg or 110 mg dabigatran etexilate given as mesilate.
The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and
hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, sunset yellow, hypromellose and purified water.
The black printing ink contains shellac, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, iron oxide black, purified water and propylene glycol.
What Pradaxa looks like and contents of the pack
Pradaxa is a hard capsule.
Pradaxa 75 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body. The Boehringer Ingelheim logo is printed on the cap and ?R75? on the body of the capsule.
Pradaxa 110 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body. The Boehringer Ingelheim logo is printed on the cap and ?R110? on the body of the capsule.
Pradaxa 75 mg and 110 mg hard capsules are available in packs containing 10 x 1, 30 x 1, 60 x 1capsules in aluminium perforated unit dose blisters.
Pradaxa 75 mg and 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien SCS. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11 LuxembourgLuxemburg SCS. Boehringer Ingelheim Comm.V. TélTel 32 2 773 33 11
359 2 958 79 98 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel 36 1 299 8900
eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600
Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 88 Nederland Boehringer Ingelheim b.v. Tel 31 0 800 22 55 889
Deutschland Boehringer Ingelheim Pharma GmbH Co. KG Tel 49 0 800 77 90 900 Norge Boehringer Ingelheim Norway KS Tlf 47 66 76 13 00
Österreich Boehringer Ingelheim RCV GmbH Co KG Tel 43 1 80 105-0 Eesti Boehringer Ingelheim Pharma GmbH Eesti Filiaal Tel 372 60 80 940
Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Polska Boehringer Ingelheim Sp.zo.o. Tel 48 22 699 0 699
España Boehringer Ingelheim España S.A. Tel 34 93 404 51 00 Portugal Boehringer Ingelheim, Lda. Tel 351 21 313 53 00
France Boehringer Ingelheim France S.A.S. Tél 33 3 26 50 45 33 România Boehringer Ingelheim RCV GmbH Co KG Viena - Sucursala Bucuresti Tel 40 21 330 99 63
Ireland Boehringer Ingelheim Ireland Ltd. Tel 353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH Co KG, podrunica Ljubljana Tel 386 1 586 40 00
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH Co KG, organizaná zloka Tel 421 2 5810 1211
Italia Boehringer Ingelheim Italia S.p.A. Tel 39 02 5355 1 SuomiFinland Boehringer Ingelheim Finland Ky PuhTel 358 10 3102 800
Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Sverige Boehringer Ingelheim AB Tel 46 8 721 21 00
United Kingdom Boehringer Ingelheim Ltd. Tel 44 1344 424 600 Latvija Boehringer Ingelheim Pharma GmbH Prstvniecba Latvij Tel 371 67 240 068
Lietuva
Boehringer Ingelheim Pharma Ges mbH
Atstovyb- Lietuvoje
Tel: +370 37 473922
This leaflet was last approved in XX/YYYY