WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Pradaxa contains dabigatran etexilate, an oral anticoagulant — a medicine
that prevents blood clots from forming or growing. It works by directly
blocking a clotting protein called thrombin, which plays a central role in the
blood's clotting process. Unlike older anticoagulants such as warfarin,
dabigatran does not require routine monitoring blood tests (like INR checks)
because its effect is predictable and consistent.
It is prescribed for: prevention of stroke and systemic embolism (blood
clots travelling to the brain or other organs) in adults with non-valvular
atrial fibrillation (AF) — an irregular heart rhythm that increases stroke
risk; treatment and prevention of recurrence of deep vein thrombosis (DVT — a
blood clot in the leg) and pulmonary embolism (PE — a blood clot in the lungs);
and prevention of venous thromboembolism (VTE) following hip or knee
replacement surgery.
The 150mg capsule is the standard full treatment dose for most patients.
The 110mg capsule is used for those at higher bleeding risk (older adults,
reduced kidney function, or those on certain medicines).
3. HOW TO TAKE THIS MEDICINE
For atrial fibrillation (stroke prevention): 150mg twice daily — one
capsule in the morning and one in the evening, approximately 12 hours apart.
For DVT/PE treatment: 150mg twice daily after an initial 5–10 days of
injectable anticoagulant (heparin).
For post-surgical VTE prevention: 220mg once daily or 150mg once daily
depending on the surgery and risk factors. Take capsules with or without food.
Swallow whole with a full glass of water — do not open, crush, or chew the
capsules, as this alters the absorption pattern.
If you miss a dose: for twice-daily dosing, take the missed dose as soon
as you remember on the same day — but if it is within 6 hours of your next
scheduled dose, skip the missed dose and continue as normal. Never take two
doses at the same time to make up for a missed one. This is important because
skipping a dose increases clot risk, but doubling up increases bleeding risk.
⚠ PATIENT TIP: Store Pradaxa capsules in the
original blister pack and only remove each capsule immediately before taking
it. The capsule contents are highly moisture-sensitive and degrade rapidly when
exposed to air and humidity. Do not transfer them to a pill organiser or loose
container — always take directly from the blister strip.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Common |
Gastrointestinal
symptoms — nausea, indigestion, heartburn, abdominal pain, diarrhoea
(reported by up to 35% of patients; taking with food or milk helps). Minor
bruising. Small amounts of blood in urine (may appear slightly pink or orange
— usually harmless but worth reporting). |
|
Less Common |
Anaemia, raised liver
enzymes on blood tests, skin rash |
|
Serious — Seek Urgent
Medical Help |
Significant bleeding:
coughing up blood, vomiting blood or material that looks like coffee grounds,
blood in stools (dark/tarry or bright red), unusually heavy or prolonged
bleeding from cuts, heavy menstrual bleeding, nosebleeds that won't stop.
Signs of bleeding into the brain (stroke): sudden severe headache, weakness
or numbness of face/arm/leg, slurred speech, vision changes — seek emergency
care immediately. Allergic reaction: rash, facial swelling, difficulty
breathing. |
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 |
Counsel on
moisture-sensitive blister storage — this is critical and unique to
dabigatran. Do not dispense in compliance aids or dosette boxes. Renal
function (CrCl or eGFR) must be confirmed before dispensing — contraindicated
in CrCl <30 mL/min; use 110mg dose in CrCl 30–50 mL/min or high bleeding
risk. Annual renal function monitoring — more frequent if elderly or
intercurrent illness. Dose: 150mg BD standard; 110mg BD for age ≥80, CrCl
30–50, concomitant verapamil, or high bleeding risk. P-glycoprotein interaction
screening (ketoconazole, ciclosporin, dronedarone, clarithromycin). Bleeding
risk assessment with co-prescribed antiplatelets or NSAIDs. GI side effect
counselling — with food or milk reduces symptoms. Anticoagulant alert card
provision. Reversal agent: idarucizumab (Praxbind) — confirm hospital
formulary availability. Peri-procedural interruption guidance: stop 24–48 hrs
(normal renal function) or 48–96 hrs (CrCl 30–50) before elective procedure. |
11. FREQUENTLY ASKED QUESTIONS
Q: Why don't I need INR blood tests like warfarin patients do?
Warfarin's effect varies between people and is affected by many foods,
medicines, and other factors — so regular INR blood tests are needed to make
sure it's working at a safe level. Dabigatran works predictably at a given dose
regardless of food or most medicines, so routine monitoring isn't necessary.
However, kidney function tests are still needed periodically, as your kidneys
clear dabigatran from the body.
Q: What if I get indigestion or heartburn?
Gastrointestinal symptoms are the most common side effect of dabigatran.
Taking the capsule with food or a glass of milk can significantly help. Some
patients find switching to a slightly different time of day or taking a proton
pump inhibitor (like omeprazole) useful — discuss this with your doctor or
pharmacist.
Q: What should I do if I have surgery or a dental procedure?
Tell the surgeon, anaesthetist, or dentist well in advance that you take
Pradaxa. It will usually need to be stopped 24 to 48 hours (or longer if your
kidneys are less efficient) before any procedure, and restarted afterwards when
bleeding risk has settled. Never stop it without guidance — but also never have
an invasive procedure without telling the team.
Q: Is there an antidote if I bleed seriously?
Yes — idarucizumab (brand name Praxbind) is a specific reversal agent for
dabigatran. It rapidly and completely reverses the anticoagulant effect and is
available in hospital emergency settings. This is one advantage dabigatran has
over some older blood thinners.
Q: What are the signs of dangerous bleeding?
Dark or tarry black stools (digested blood), vomiting bright red blood or
material like coffee grounds, coughing up blood, unusually heavy or prolonged
bleeding from a cut, sudden severe headache, or any weakness or speech problem
— all of these need urgent medical attention. Call emergency services or go to
A&E immediately.