WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Pradaxa 110mg contains the same active ingredient as the 150mg capsule —
dabigatran etexilate — and is used for the same indications: prevention of
stroke in non-valvular atrial fibrillation (AF), treatment and prevention of
deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of blood
clots after hip or knee replacement surgery.
The 110mg dose is prescribed when a lower anticoagulant exposure is
appropriate to balance the risk of blood clots against the risk of bleeding.
Your doctor will choose 110mg over 150mg if you are aged 80 or over, have
reduced kidney function (creatinine clearance of 30–50 mL/min), are taking
verapamil (a heart or blood pressure medicine), or are assessed as having a
high bleeding risk.
3. HOW TO TAKE THIS MEDICINE
For atrial fibrillation: 110mg twice daily — one capsule morning and one
evening, approximately 12 hours apart. For DVT/PE treatment: 150mg twice daily
after initial heparin for most patients, but 110mg may be used if bleeding risk
is higher.
For post-surgical VTE prevention after hip replacement: 220mg once daily
(two 110mg capsules as a single dose) or 150mg once daily. Take with a full
glass of water, with or without food. Swallow capsules whole — do not open or
chew.
All the same storage rules apply to the 110mg capsule as to the 150mg
capsule — keep in the original blister pack and only remove immediately before
taking. Do not use a pill organiser or dosette box. The capsule contents are
highly moisture-sensitive.
⚠ PATIENT TIP: If you have been changed from
warfarin to Pradaxa 110mg, do not start Pradaxa until your INR has fallen below
2.0 — your anticoagulation clinic or doctor will advise the exact timing.
Starting too soon, while warfarin is still active, increases bleeding risk
significantly.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Very common |
Gastrointestinal
symptoms (nausea, heartburn, indigestion, diarrhoea), minor bruising, pink or
orange-tinged urine. These are the same as the 150mg capsule, though the
overall anticoagulant effect and associated bleeding risk is modestly lower
at this dose. |
|
Common |
Significant internal
or external bleeding (dark stools, vomiting blood, prolonged bleeding).
Stroke symptoms (sudden severe headache, weakness, slurred speech). Allergic
reactions. |
5. WHO SHOULD NOT TAKE THIS MEDICINE
Pradaxa must not be taken by people with active or significant bleeding,
or with a mechanical heart valve (where warfarin is still required). It must
not be used in patients with severe kidney disease (creatinine clearance below
30 mL/min) — the drug accumulates to dangerous levels.
It is not recommended during pregnancy or breastfeeding. Tell your doctor
about all your medicines and medical conditions before starting.
⚠ BLEEDING RISK: All anticoagulants increase the
risk of bleeding. Report any unusual or prolonged bleeding to your doctor. Seek
emergency care for signs of internal bleeding — including very dark or tarry
stools, vomiting blood, or a sudden severe headache. Before any surgical
procedure, dental work, or invasive test, tell the healthcare provider you are
taking Pradaxa — it may need to be temporarily stopped.
⚠ KIDNEY FUNCTION IS CRITICAL: Dabigatran is
largely cleared by the kidneys. Kidney function (creatinine clearance or eGFR)
must be checked before starting and at least once a year during treatment. As
kidney function declines with age or illness, dabigatran can accumulate —
increasing bleeding risk significantly. Dose adjustment or switching to an
alternative may be needed.
⚠ KEEP IN ORIGINAL BLISTER PACK: Do not transfer
capsules to a pill organiser, dosette box, or any other container. The capsule
contents are highly moisture-sensitive and will degrade rapidly outside the
original packaging. This is one of the most important storage instructions for
Pradaxa.
6. MEDICINES THAT INTERACT WITH THIS TREATMENT
Idarucizumab (Praxbind) is the specific reversal agent for dabigatran —
it rapidly reverses the anticoagulant effect in emergency situations such as
life-threatening bleeding or emergency surgery. Strong P-glycoprotein
inhibitors (ketoconazole, cyclosporin, dronedarone, clarithromycin)
significantly increase dabigatran levels — use with caution or avoid.
Strong P-glycoprotein inducers (rifampicin, St. John's Wort,
carbamazepine) reduce dabigatran levels, risking inadequate anticoagulation.
Combining dabigatran with other anticoagulants, antiplatelet agents (aspirin,
clopidogrel), or NSAIDs (ibuprofen) significantly increases bleeding risk.
Always tell all healthcare providers — including dentists — that you are taking
Pradaxa.
7. HOW TO STORE THIS MEDICINE
Store below 30°C. Keep in the original blister pack — extremely
moisture-sensitive. Do not remove from blister until immediately before taking.
Once the bottle or blister is opened, use within 4 months. Keep out of reach of
children.
8. PRESCRIPTION REQUIREMENT
|
Field |
Details |
|
Status |
Prescription Only
Medicine (POM) |
9. GUIDANCE FOR PATIENTS & CAREGIVERS
Take one capsule in the morning and one in the evening, roughly 12 hours
apart, with a full glass of water. Food or milk can help if you experience
nausea or heartburn. Always take capsules directly from the blister pack —
never use a pill organiser. Before any surgery, dental extraction, or medical
procedure, let the provider know you take Pradaxa well in advance — it may need
to be stopped temporarily.
Carry an anticoagulant alert card (available from your pharmacist). If
you notice any unusual bleeding — including blood in urine, dark stools,
vomiting blood, or bleeding that won't stop — seek medical attention promptly.
A specific reversal agent (idarucizumab) is available in hospital if serious
bleeding occurs.
10. PHARMACIST & PRESCRIBER NOTES
|
Field |
Details |
|
Clinical Dispensing
Notes |
110mg is the dose for:
age ≥80; CrCl 30–50 mL/min; concomitant verapamil; or elevated bleeding risk
as assessed by prescriber. Confirm renal function (CrCl) at dispensing.
Annual renal monitoring minimum — more frequent in elderly or if intercurrent
illness affects kidney function. CrCl <30 mL/min: dabigatran
contraindicated at any dose — switch to alternative anticoagulant. Same
moisture-sensitive storage counselling as 150mg — no compliance aids.
Verapamil interaction: 110mg BD is the specifically recommended dose when
verapamil is co-prescribed. All P-glycoprotein inhibitor/inducer
interactions, bleeding risk counselling, anticoagulant alert card provision,
and peri-procedural interruption guidance from entry 151 apply. |
11. FREQUENTLY ASKED QUESTIONS
Q: Do I still need to keep it in the blister pack?
Yes — absolutely. The moisture-sensitivity and storage requirements are
exactly the same for the 110mg capsule as for the 150mg capsule. Remove each
capsule from the blister only immediately before taking it, and never use a
pill organiser.
Q: How do I switch from warfarin to Pradaxa 110mg?
Your anticoagulation team or doctor will guide the timing. Generally,
Pradaxa is started when the INR (warfarin monitoring test) has fallen to below
2.0. Never start Pradaxa while the INR is still in the therapeutic range
without clear guidance from your doctor.
Q: Does taking it with verapamil mean I need a lower dose?
Yes — verapamil inhibits a transport protein called P-glycoprotein that
helps clear dabigatran from the body. This means dabigatran levels rise when
verapamil is taken at the same time. The 110mg dose is specifically chosen in
this situation to compensate for this effect and prevent excessive
anticoagulation.
Q: Will my kidneys be monitored while on this medicine?
Yes — kidney function checks (eGFR or creatinine clearance) should be
done at least once a year, and more often if you are elderly or unwell. If
kidney function falls below a certain level (CrCl <30 mL/min), dabigatran
must be stopped and an alternative anticoagulant considered.