In patients with moderate renal impairment and concomitantly treated with dabigatran etexilate and verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered (see sections 4.4 and 4.5).

Elderly

In elderly patients (> 75 years) 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).

Hepatic impairment

Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in clinical trials investigating the VTE prevention following elective hip or knee replacement surgery. No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population (see sections 4.4 and 5.2).

Weight

There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology. Given the available clinical and kinetic data no adjustment is necessary (see section 5.2), but close clinical surveillance is recommended (see section 4.4).

Gender

Given the available clinical and kinetic data, no dose adjustment is necessary (see section 5.2).

Switching

Pradaxa treatment to parenteral anticoagulant

It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).

Parenteral anticoagulants to Pradaxa

Dabigatran etexilate should be given 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)) (see section 4.5).

Paediatric population

There is no relevant use of Pradaxa in the paediatric population in the indication: primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Pradaxa is not recommended for use in patients below 18 years due to lack of data on safety and efficacy.

Missed dose

It is recommended to continue with the remaining daily doses of dabigatran etexilate at the same time of the next day.

No double dose should be taken to make up for missed individual doses.

Method of administration

Pradaxa should be swallowed as a whole with water, with or without food.

Patients should be instructed not to open the capsule as this may increase the risk of bleeding (see sections 5.2 and 6.6).

4.3 Contraindications

 • Hypersensitivity to the active substance or to any of the excipients

• Patients with severe renal impairment (CrCL < 30 ml/min)

• Active clinically significant bleeding

• Organic lesion at risk of bleeding

• Spontaneous or pharmacological impairment of haemostasis

• Hepatic impairment or liver disease expected to have any impact on survival

• Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole and tacrolimus (see section 4.5)

4.4 Special warnings and precautions for use

 Hepatic impairment

Patients wi