DABIGATRAN ETEXILATE TEVA 110mg x 60 hard caps
1. NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate Teva 110 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 110 mg dabigatran etexilate (as mesylate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule
Size 1 (approximately 19 mm), light blue opaque cap and light blue opaque body, hard capsule filled with white to yellowish pellets.
4. CLINICAL DATA
4.1 Therapeutic indications
Primary prevention of venous thromboembolic events (VTE) in adult patients undergoing elective total hip replacement or total knee replacement.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as previous stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA class ≥ II); diabetes mellitus; hypertension.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adult patients.
Treatment of PTS and prevention of recurrent PTS in pediatric patients from the time they become able to swallow soft food until under 18 years of age.
For age-appropriate dosage forms, see section 4.2.
4.2 Dosage and administration
Dosage
Dabigatran etexilate Teva capsules can be used in adults and paediatric patients aged 8 years and above who can swallow the capsules whole. The dose indicated in the appropriate dosage table for each formulation should be prescribed based on the child's weight and age.
Other age-appropriate dosage forms are available for the treatment of children under 8 years of age:
⦁ Other dosage forms may be more suitable for use in this population, such as coated granules, which can be used in children under 12 years of age, as soon as the child is able to swallow soft food.
⦁ Other dosage forms, such as powder and solvent for oral solution, should only be used in children under 1 year of age.
Primary prevention of PTS in orthopedic surgery
The recommended doses of dabigatran etexilate and duration of therapy for primary prevention of PTS in orthopedic surgery are shown in Table 1.
Table 1: Recommended doses and duration of therapy for primary prevention of PTS in orthopedic surgery
Starting treatment on the day of surgery
1-4 hours after completion of surgery
Initial maintenance dose
on the first day after surgery
Duration of maintenance dose
Patients after elective knee replacement surgery
one capsule 110 mg dabigatran etexilate
220 mg dabigatran etexilate once daily, taken as 2 capsules of 110 mg
10 days
Patients after elective hip replacement surgery
28-35 days
Dose reduction is recommended.
Patients with moderate renal impairment
impairment (creatinine clearance
(CrCL) 30-50 ml/min)
one capsule 75 mg dabigatran etexilate
150 mg dabigatran etexilate once daily, taken as 2 capsules of 75 mg
10 days (knee replacement) or 28-35 days (hip replacement)
Patients receiving concomitant verapamil*, amiodarone, quinidine
Patients aged 75 years or older
*In patients with moderate renal impairment treated concomitantly with verapamil, see Special Populations.
In both types of surgery, if hemostasis is not assured, the start of treatment should be postponed. If treatment is not started on the day of surgery, it should be started with 2 capsules once daily.
Assessment of renal function before and during treatment with dabigatran etexilate
In all patients and especially in elderly patients (> 75 years), as renal impairment may be commonly observed in this age group:
· Renal function should be assessed by calculating creatinine clearance (CrCL) before starting treatment with dabigatran etexilate to exclude patients with severe renal impairment (i.e. CrCL < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
· Renal function should also be assessed if deterioration of renal function is suspected during treatment (e.g. hypovolemia, dehydration and concomitant use of certain medicinal products).
The method to be used to assess renal function (CrCL in ml/min) is the Cockcroft-Gault method.
Missed dose
It is recommended to continue with the remaining daily doses of dabigatran etexilate at the same time the next day.
A double dose should not be taken to make up for missed individual doses.
Discontinuation of dabigatran etexilate
Treatment with dabigatran etexilate should not be discontinued without medical advice. Patients should be instructed to contact their physician if they develop gastrointestinal symptoms such as dyspepsia (see section 4.8).
Change of treatment
Switching from dabigatran etexilate treatment to a parenteral anticoagulant:
It is recommended to wait 24 hours after the last dose before switching from dabigatran etexilate to a parenteral anticoagulant (see section 4.5).
Switching from parenteral anticoagulant treatment to dabigatran etexilate:
The parenteral anticoagulant should be stopped and dabigatran etexilate should be started 0-2 hours before the next dose of the alternative medication would be due, or at the time of discontinuation in the case of long-term treatment (e.g. intravenous unfractionated heparin (UFH)) (see section 4.5).
Special populations
