Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking DABIGATRAN VIATRIS?
DABIGATRAN VIATRIS contains the active ingredient dabigatran etexilate (as mesilate).
DABIGATRAN VIATRIS is taken to prevent the formation of blood clots.
2. What should I know before I take DABIGATRAN VIATRIS?
Do not take if you have ever had an allergic reaction to dabigatran etexilate mesilate
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take DABIGATRAN VIATRIS? in the full CMI.
3. What if I am taking other medicines?
4. How do I take DABIGATRAN VIATRIS?
Your doctor will tell you how much of this medicine you should take.
5. What should I know while taking DABIGATRAN VIATRIS?
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Things you should do
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Tell your doctor if you fall or injure yourself during treatment, especially if you
hit your head, please seek urgent medical attention.
Remind any doctor, dentist or pharmacist you visit that you are taking DABIGATRAN
VIATRIS, especially if you are going to have surgery.
Tell your doctor if you become pregnant while taking DABIGATRAN VIATRIS.
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Things you should not do
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Do not stop taking your medicine or lower the dosage without checking with your doctor.
Do not give DABIGATRAN VIATRIS to anyone else, even if they have the same condition
as you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how DABIGATRAN
VIATRIS affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your capsules in the original container until it is time to take them.
Store your medicine in a cool dry place below 25°C.
Keep your medicine where children cannot reach it.
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6. Are there any side effects?
The
most common side effects are bruising, nosebleed, rash, diarrhoea, indigestion, feeling sick, swollen
joints, sore nasal passages and throat, discomfort when swallowing, hair loss, fever,
severe chills, mouth ulcers.
Serious side effects: long or excessive bleeding, exceptional weakness, dizziness and looking pale, chest
pain or being short of breath, swelling of hands, ankles and feet, red or dark brown
urine, red or black bowel motions.
This is not a complete list of all possible side effects. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
dabigatran etexilate (as mesilate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking DABIGATRAN VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking DABIGATRAN VIATRIS.
Where to find information in this leaflet:
1. Why am I taking DABIGATRAN VIATRIS?
DABIGATRAN VIATRIS contains the active ingredient dabigatran etexilate (
as mesilate
). After oral use, dabigatran etexilate is rapidly converted in the body to its active
form dabigatran. DABIGATRAN VIATRIS belongs to a group of medicines called anticoagulants.
Some people refer to anticoagulant medicines as "blood thinners".
Dabigatran works by inhibiting a specific protein in the blood, called thrombin. Thrombin
contributes to the formation of blood clots. Dabigatran prevents the formation of
blood clots.
DABIGATRAN VIATRIS has been prescribed to you for one of the following uses:
to prevent the formation of blood clots in the veins after knee or hip replacement
surgery in adults
to reduce the risk of brain (stroke) and/or other body vessel obstruction by blood
clot formation in adults with an abnormal heartbeat rhythm called non-valvular atrial
fibrillation
to treat blood clots in the veins of your legs and lungs and to prevent blood clots
from re-occurring in the veins of your legs and/or lungs.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I take DABIGATRAN VIATRIS?
Warnings
Do not take DABIGATRAN VIATRIS if:
you are allergic to dabigatran etexilate, or any of the ingredients listed at the
end of this leaflet. Some of the symptoms of an allergic reaction may include:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or troubled breathing.
Always check the ingredients to make sure you can take this medicine.
you are currently bleeding.
you have severely reduced kidney function (your doctor will know how to determine
your kidney function).
you have an increased tendency of bleeding complications (this may be inherited, of
unknown cause or due to other medicines).
you have a medical condition which increases your risk of serious bleeding, such as
recent brain or spinal injury, and cancer.
you have active stomach ulcers or have experienced stomach bleeding in the past year,
unless the cause has been permanently eliminated, e.g. by surgery.
you have a history of bleeding in the head, eyes, spine, abdomen and joints.
you have an indwelling spinal or epidural catheter, and during the first two hours
after their removal (your doctor will know about the kind of catheters and precautionary
measures).
you have liver problems or liver disease.
you are currently taking oral ketoconazole or itraconazole, medicines used to treat
fungal infections.
you are taking dronedarone, a medicine used to treat abnormal heartbeat.
you are taking ciclosporin or tacrolimus, medicines used to prevent organ rejection
after transplantation.
you are taking glecaprevir/pibrentasvir, a combination medicine used to treat hepatitis
C infection.
you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban
or heparin), except when changing anticoagulant treatment, while having a venous or
arterial line and you get heparin through this line to keep it open or while your
heartbeat is being restored to normal by a procedure called catheter ablation for
atrial fibrillation.
you have a prosthetic heart valve.
Do not start DABIGATRAN VIATRIS and verapamil treatment at the same time.
Do not start verapamil if you are currently taking DABIGATRAN VIATRIS and have just
undergone major orthopaedic surgery.
Do not take this medicine if you are pregnant or breastfeeding.
It may affect your developing baby if you take it during pregnancy and the active
ingredient in DABIGATRAN VIATRIS passes into breast milk.
Do not take this medicine after the expiry date printed on the box or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal. If you
use this medicine after the expiry date has passed, it may not work as well.
Check with your doctor if you:
are pregnant, intend to become pregnant, breastfeeding or intend to breastfeed. DABIGATRAN
VIATRIS should not be used during pregnancy and is not recommended in women who are
breastfeeding.
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
have any other medical conditions, e.g.:
have had a heart attack or if you have been diagnosed with conditions that increase
the risk to develop a heart attack
have reduced liver function, life- threatening liver disease or increased liver enzymes.
have an increased bleeding risk, as could be the case in the following situations:
if you are older than 75 years, your doctor may prescribe a lower dose of DABIGATRAN
VIATRIS
if you know you have reduced kidney function, or you are suffering from dehydration
(symptoms include feeling thirsty and passing reduced amounts of dark-coloured urine)
if you have been recently bleeding
if you have any problems with your blood
if you have had a recent tissue sampling (biopsy)
if you have cancer
if you have had a serious injury (e.g. a bone fracture, head injury or any injury
requiring treatment)
if you are suffering from an inflammation of the food pipe (oesophagus) or stomach
if you have problems with reflux of gastric juice into the food pipe (oesophagus)
if you are receiving medicines which could increase the risk of bleeding, such as
clopidogrel and warfarin
if you are taking anti-inflammatory medicines such as diclofenac
if you are suffering from an infection of the heart (bacterial endocarditis).
have a disease called antiphospholipid syndrome (a disorder of the immune system that
causes an increased risk of blood clots).
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not take this medicine if you are pregnant. It may affect your developing baby
if you take it during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breastfeed if you are taking this medicine. The active ingredient in DABIGATRAN
VIATRIS passes into breast milk.
Children and adolescent
Do not give this medicine to a child or adolescent under 18 years old.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DABIGATRAN VIATRIS and affect how it works.
These include:
aspirin, salicylates or other NSAID (anti-inflammatory) medicines
medicines used to thin your blood (such as warfarin, unfractionated heparins, heparin
derivatives (fondaparinux and desirudin), low molecular weight heparins (enoxaparin),
clopidogrel, tirofiban, bivalirudin, prasugrel, ticagrelor, eptifibatide, ticlopidine,
dextran, sulfinpyrazone, rivaroxaban and apixaban)
amiodarone, dronedarone, medicines used to treat irregular heartbeats
verapamil, a calcium channel blocker used to treat high blood pressure and angina
quinidine, a medicine used to treat malaria and irregular heartbeats
clarithromycin or rifampicin, medicines used to treat infections
lopinavir, nelfinavir, ritonavir, tipranavir or saquinavir, medicines used to treat
HIV infections
ciclosporin or tacrolimus, medicines used to help the body's immune system
glecaprevir/pibrentasvir, a combination medicine used to treat hepatitis C infection
selective serotonin re-uptake inhibitors (SSRI) (e.g. citalopram, escitalopram, fluoxetine),
selective serotonin norepinephrine re-uptake inhibitors (SNRI) (e.g. duloxetine, venlafaxine,
desvenlafaxine), medicines used to treat mood disorders
herbal medicines derived from St John's wort (Hypericum perforatum)
carbamazepine, a medicine used to treat fits or convulsions
medicines used to treat reflux and stomach ulcers (such as pantoprazole and ranitidine).
These medicines may be affected by DABIGATRAN VIATRIS or may affect how well it works.
You may need different amounts of your medicines, change the timing of your medicine-taking
routine or take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking DABIGATRAN VIATRIS.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DABIGATRAN VIATRIS.
4. How do I take DABIGATRAN VIATRIS?
How much to take
AFTER KNEE AND HIP REPLACEMENT SURGERY
The recommended dose of DABIGATRAN VIATRIS is 220 mg (2 capsules of 110 mg) taken
as a single dose once daily.
Patients with moderately reduced kidney function (e.g. over 75 years) or patients
taking certain medicines may have an increased risk of bleeding. The doctor may prescribe
the lower dose of 150 mg once daily, taken as 2 capsules of DABIGATRAN VIATRIS 75
mg.
Treatment with DABIGATRAN VIATRIS should be started within 1 - 4 hours of completed
surgery, taking a single capsule of 110 mg and continuing with 2 capsules of 110 mg
once daily for a total of 10 days (after knee replacement surgery) or for a total
of 28 - 35 days (after hip replacement surgery).
If, within 4 hours after surgery, post-operative bleedings can still be observed,
initiation of treatment should be delayed. If treatment is not started on the day
of surgery then treatment should be initiated with 2 capsules of 110 mg once daily.
Follow the initiation instructions given to you by your doctor carefully.
FOR STROKE PREVENTION IN PATIENTS WITH ATRIAL FIBRILLATION
The recommended dose of DABIGATRAN VIATRIS is 300 mg taken as 1 capsule of 150 mg
in the morning and 1 capsule of 150 mg in the evening.
Patients over 75 years should take a lower dose of 220 mg, taken as 1 capsule of 110
mg in the morning and 1 capsule of 110 mg in the evening.
Patients with an increased risk of major bleeding (as determined by your doctor) should
take a lower dose of 220 mg, taken as 1 capsule of 110 mg in the morning and 1 capsule
of 110 mg in the evening.
FOR THE TREATMENT OF BLOOD CLOTS AND PREVENTION OF BLOOD CLOTS RE-OCCURRING IN THE
VEINS OF YOUR LEGS AND/OR LUNGS
The recommended dose of DABIGATRAN VIATRIS is 300 mg taken as 1 capsule of 150 mg
twice a day following treatment with an injectable blood thinner for at least 5 days.
To prevent blood clots re-occurring, continue on 1 capsule of 150 mg twice a day.
Patients over 75 years should take a lower dose of 220 mg, taken as 1 capsule of 110
mg in the morning and 1 capsule of 110 mg in the evening. To prevent blood clots re-
occurring, continue on 1 capsule of 110 mg twice a day.
Patients with an increased risk of major bleeding (as determined by your doctor) should
take a lower dose of 220 mg, taken as 1 capsule of 110 mg in the morning and 1 capsule
of 110 mg in the evening. To prevent blood clots re-occurring, continue on 1 capsule
of 110 mg twice a day.
Your doctor will decide how long you need to be on this treatment for.
Follow the instructions provided and take DABIGATRAN VIATRIS until your doctor tells
you to stop.
When to take DABIGATRAN VIATRIS
DABIGATRAN VIATRIS should be taken at about the same time each day.
Taking your capsules at the same time each day will have the best effect. It will
also help you remember when to take it. It does not matter if you take this medicine
with or without food.
How to take DABIGATRAN VIATRIS
Swallow the capsules whole with a full glass of water.
DO NOT CHEW OR OPEN THE CAPSULE. DO NOT SPRINKLE THE PELLETS ON FOOD OR MIX WITH LIQUIDS.
This may cause an overdose of DABIGATRAN VIATRIS and increase the risk of bleeding.
Capsules should always be stored in the original container and should be taken immediately,
or its effectiveness may be reduced.
If additional capsules are inadvertently exposed to air, they should not be used and
should be discarded.
Capsules should not be removed from the original container and repackaged in dose
administration aids such as dosette boxes, tablet organisers or weekly medication
packs.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
DABIGATRAN VIATRIS will continue to be prescribed while there is a risk of excessive
clotting.
AFTER KNEE REPLACEMENT SURGERY:
This will usually be for a period of 10 days.
AFTER HIP REPLACEMENT SURGERY:
This will usually be for a period of 28 - 35 days.
It is important to keep taking your medicine even if you feel well.
If you stop taking DABIGATRAN VIATRIS before your doctor tells you to stop, you are
at risk of developing a blood clot in a vein of your leg which can move to the lungs
and be life-threatening.
Tell your doctor immediately or go to Emergency at your nearest hospital if you notice
swelling of the leg or cough and shortness of breath.
These could be signs of a blood clot.
Tell your doctor if you intend stopping treatment earlier.
FOR STROKE PREVENTION IN PATIENTS WITH ATRIAL FIBRILLATION:
It is important to keep taking your medicine even if you feel well.
If you stop taking DABIGATRAN VIATRIS before your doctor tells you to stop, you are
at risk of developing a blood clot. This can lead to serious health problems such
as strokes.
FOR TREATMENT AND PREVENTION OF BLOOD CLOTS RE-OCCURRING IN THE VEINS OF YOUR LEGS
AND LUNGS:
It is important to keep taking your medicine even if you feel well.
If you stop taking DABIGATRAN VIATRIS before your doctor tells you to stop, you are
at risk of developing a blood clot. This can lead to serious health problems if those
clots stop blood flowing normally.
If you forget to take DABIGATRAN VIATRIS
After knee and hip replacement surgery continue with your remaining daily doses of
DABIGATRAN VIATRIS at the same time of the next day. Do not take a double dose to make up for the dose you missed.
For stroke prevention in patients with atrial fibrillation a forgotten dose of DABIGATRAN
VIATRIS can still be taken up to 6 hours prior to the next dose.
A missed dose should be omitted if the remaining time is less than 6 hours prior to
the next dose. Do not take a double dose to make up for the dose you missed.
For the treatment and prevention of blood clots re-occurring in the veins of your
legs and lungs a forgotten dose of DABIGATRAN VIATRIS can still be taken up to 6 hours
prior to the next dose.
A missed dose should be omitted if the remaining time is less than 6 hours prior to
the next dose. Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you take too much DABIGATRAN VIATRIS
If you think that you have taken too much DABIGATRAN VIATRIS, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much DABIGATRAN VIATRIS you may have bleeding. Blood may be seen in
stools or urine. Abnormal bruising may also be experienced.
5. What should I know while taking DABIGATRAN VIATRIS ?
Things you should do
Tell all doctors, dentist and pharmacists who are treating you that you are taking
DABIGATRAN VIATRIS.
Tell your doctor if, for any reason, you have not taken DABIGATRAN VIATRIS exactly
as prescribed. Otherwise, your doctor may think that it was not effective and change
your treatment unnecessarily.
If you are going to have surgery, including dental surgery, tell your doctor or dentist
that you are taking DABIGATRAN VIATRIS.
Your doctor may decide to temporarily stop your treatment with DABIGATRAN VIATRIS.
Call your doctor straight away if you:
become pregnant while taking DABIGATRAN VIATRIS
fall or injure yourself during treatment, especially if you hit your head, please
seek urgent medical attention. You may need to be checked by a doctor, as you may
be at increased risk of bleeding.
Things you should not do
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DABIGATRAN
VIATRIS affects you.
Driving or operating machinery should be avoided for a period of time after orthopaedic
surgery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your capsules in the original container until it is time to take them. If you
take them out of the container they may not keep well.
Store below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
If your doctor tells you to stop taking DABIGATRAN VIATRIS or it has passed its expiry
date, ask your pharmacist what to do with any that is left over.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DABIGATRAN VIATRIS contains
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Active ingredient
(main ingredient)
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Dabigatran etexilate (as mesilate)
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Other ingredients
(inactive ingredients)
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Capsule fill:
tartaric acid
hypromellose
purified talc
hyprolose
HPMC capsule shell:
titanium dioxide
hypromellose
DABIGATRAN VIATRIS 110 mg and 150 mg also include Brilliant Blue FCF.
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Potential allergens
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Sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What DABIGATRAN VIATRIS looks like
DABIGATRAN VIATRIS 75 mg capsule is size 1, white opaque cap and white opaque body,
hard hypromellose capsule filled with light yellow to yellowish pellets, imprinted
axially with VTRS over DC75 on both cap and body in black ink (AUST R 442634).
DABIGATRAN VIATRIS 110 mg capsule is size 1, powder blue opaque cap and powder blue
opaque body, hard hypromellose capsule filled with light yellow to yellowish pellets,
imprinted axially with VTRS over DC110 on both cap and body in black ink (AUST R 442630).
DABIGATRAN VIATRIS 150 mg capsule is size 0, powder blue opaque cap and white opaque
body, hard hypromellose capsule filled with light yellow to yellowish pellets, imprinted
axially with VTRS over DC150 on both cap and body in black ink (AUST R 442632).
DABIGATRAN VIATRIS capsules are supplied in blister pack of 60 capsules.
Not all strengths, pack sizes and/or pack types may be available.
Who distributes DABIGATRAN VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2025.
DABIGATRAN VIATRIS_cmi\Apr25/00