Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT

 Pradaxa 75 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Excipients: Each hard capsule contains 2 micrograms sunset yellow (E110).

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Hard capsule

Imprinted capsules with 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”.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications

 Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

4.2 Posology and method of administration

 Posology

Prevention of Venous Thromboembolism (VTE)

Patients following elective knee replacement surgery

The recommended dose of Pradaxa is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1–4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.

Patients following elective hip replacement surgery

The recommended dose of Pradaxa is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1–4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.

For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.

Renal impairment

Treatment with Pradaxa in patients with severe renal impairment (creatinine clearance (CrCL) < 30 ml/min) is contraindicated (see section 4.3).

In patients with moderate renal impairment (CrCL 30-50 ml/min), there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see sections 4.4 and 5.1).

Concomitant use of Pradaxa with strong P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil

Dosing should be reduced to 150 mg taken o