Name and composition

Name and composition

10/01/2012

1. Name of the medical

Pradaxa   75 hard capsules
Pradaxa 110 hard capsules
Pradaxa 150 hard capsules

2. Qualitative and quantitativecomposition

Each Pradaxa   75 mg hard capsule contains  75 mg of dabigatran etexilate (as mesilate).
Each Pradaxa 110 mg hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
Each Pradaxa 150 mg hard capsule contains 150 mg of dabigatran etexilate (as mesilate).

Excipients:
Each Pradaxa   75 mg hard capsule contains 2 micrograms sunset yellow (E110).
Each Pradaxa 110 mg hard capsule contains 3 micrograms sunset yellow (E110).
Each Pradaxa 150 mg hard capsule contains 4 micrograms sunset yellow (E110).
For a full list of excipients, see section 6.1.


3. Pharmaceutical form 
 

Pradaxa  75 mg hard capsules have a light blue, opaque cap and cream coloured, opaque body of size 2 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”.

Pradaxa 110 mg hard capsules have a light blue, opaque cap and cream coloured, opaque body of size 1 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”.

Pradaxa 150 mg hard capsules have a light blue, opaque cap and cream coloured, opaque body of size 0 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R150”. 

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