Dabigatran SaneXcel
On the Bulgarian pack: Дабигатран SaneXcel 110 mg твърди капсули
Dabigatran SaneXcel 110 mg hard capsules · capsules, hard
- Prescription only
- Blood, clotting and anaemia
- Active substance
- Dabigatran etexilate
- Used in
- Blood, clotting and anaemia
- Made by
- J.J.Bishop Health a.s.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet read the official leaflet for this product. The exact uses and dose are in the leaflet inside the pack. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dabigatran etexilate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors.
Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus.
Dabigatran is metabolized to four different acyl glucuronides and both the glucuronides and dabigatran have similar pharmacological activity.
Dabigatran is eliminated primarily in the urine.
Coadministration of dabigatran with a high-fat meal delays the time to C max by approximately 2 hours but has no effect on the bioavailability of dabigatran; Dabigatran may be administered with or without food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-13
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dabigatran etexilate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF DABIGATRAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including dabigatran, increases the risk of thrombotic events.
- Dabigatran is contraindicated in patients with:.
- Active pathological bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )].
- History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions ( 6.1 )].
- Mechanical prosthetic heart valve [see Warnings and Precautions ( 5.4 )].
The most frequent adverse reactions leading to discontinuation of dabigatran etexilate capsules were bleeding and gastrointestinal events (i.e., dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States10 matching products
European UnionNo exact match for this strength and form
Spain31 matching products
- PRADAXA 110 mg · cápsula dura4 makers
- ANDABRA 110 mg · cápsula dura
- BIGETRA 110 mg · cápsula dura
- DABIDOSE 110 mg · cápsula dura
- DABIGATRAN DR REDDYS 110 mg · cápsula dura
- DABIGATRAN ETEXILATO ACCORD 110 MG · cápsula dura
- DABIGATRAN ETEXILATO ADAMED 110 mg · cápsula dura
- DABIGATRAN ETEXILATO ALTER GENERICOS 110 mg · cápsula dura
Canada2 matching products
Netherlands15 matching products
- Dabigatran etexilaat Accord 110 mg harde capsules 110 mg · capsule, hard
- Dabigatran etexilaat Alembic 110 mg harde capsules 110 mg · capsule, hard
- Dabigatran etexilaat Biocon 110 mg harde capsules 110 mg · capsule, hard
- Dabigatran etexilaat Centrafarm 110 mg 110 mg · capsule, hard
- Dabigatran etexilaat CF 110 mg 110 mg · capsule, hard
- Dabigatran etexilaat Gedeon Richter 110 mg harde capsules 110 mg · capsule, hard
- Dabigatran etexilaat HCS 110 mg harde capsules 110 mg · capsule, hard
- Dabigatran etexilaat Reddy 110 mg harde capsules 110 mg · capsule, hard
SwitzerlandNo exact match for this strength and form
Details
| Made by | J.J.Bishop Health a.s. · Czech Republic |
|---|---|
| Active substance | Dabigatran etexilate |
| Used in | Blood, clotting and anaemia |
| Strength | Dabigatran SaneXcel 110 mg hard capsules |
| Form | capsules, hard |
| Pack sizes | 10 · 30 · 60 · 180 |
| Classification | B01AE07 · Blood, clotting and anaemia |
| Name in the register | Дабигатран SaneXcel 110 mg твърди капсули |
| Reg. no. | 20260135 |
Source: Bulgarian Drug Agency register · 2026-08-01 · not reviewed by a clinician
Източник: Изпълнителна агенция по лекарствата (ИАЛ). The publisher’s terms do not grant reproduction, so text is shortened and linked. Publisher’s terms.
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- capsules, hard3 products
- Dabigatran SaneXcel 75 mg hard capsules
- Dabigatran SaneXcel 110 mg hard capsules
- Dabigatran SaneXcel 150 mg hard capsules
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.