An effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (5-fold the plasma exposure level in patients). At doses that were toxic to the mothers (5- to 10-fold the plasma exposure level in patients), a decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits. In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).

In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Capsule fill

• Tartaric acid

• Acacia

• Hypromellose

• Dimeticone 350

• Talc

• Hydroxypropylcellulose

Capsule shell

• Carrageenan

• Potassium Chloride

• Titanium Dioxide

• Indigo Carmine (E132)

• Sunset Yellow (E110)

• Hypromellose

• Water purified

Black printing ink

• Shellac

• N-Butyl alcohol

• Isopropyl alcohol

• Industrial methylated spirit

• Iron oxide black (E172)

• Purified water

• Propylene glycol

6.2 Incompatibilities

 Not applicable.

6.3 Shelf life

 Blister and bottle: 2 years

Once the bottle is opened, the medicinal product must be used within 30 days

6.4 Special precautions for storage

 Blister

Store in the original package in order to protect from moisture

Bottle

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

6.5 Nature and contents of container

 Cartons containing 1, 3, or 6 blister strips (10 x 1, 30 x 1, 60 x 1) in perforated aluminium unit dose blisters. The blister consists of an aluminium lidding foil coated with polyvinylchloride-polyvinylacetate copolymer-acrylate (PVCAC acrylate) in contact with the product and an aluminium bottom foil with polyvinylchloride (PVC) in contact with the product.

Polypropylene bottle with a screw cap containing 60 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

 When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:

• The hard capsules should be taken out of the blister card by peeling off the backing foil.

• The hard capsules should not be pushed through the blister foil.

• The blister foil should only be peeled off, when a hard capsule is required.

When taking a hard capsule out of the bottle, please observe the following instructions:

• The cap opens by pushing and turning.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

 Boehringer Ingelheim International GmbH

D-55216 Ingelheim am Rhein

Germany

8. MARKETING AUTHORISATION NUMBER(S)

 EU/1/08/442/001

EU/1/08/442/002

EU/1/08/442/003

EU/1/08/442/004

9. DATE OF FIRST AUTHORISATION/RENEWAL