Dabigatran Viatris

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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.
For more information, see Section 1. Why am I taking DABIGATRAN VIATRIS? in the full CMI.

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?

Some medicines may interfere with DABIGATRAN VIATRIS and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take DABIGATRAN VIATRIS?

Your doctor will tell you how much of this medicine you should take.
More instructions can be found in Section 4. How do I take DABIGATRAN VIATRIS? in the full CMI.

5. What should I know while taking DABIGATRAN VIATRIS?

Things you should do
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.
Things you should not do
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DABIGATRAN VIATRIS affects you.
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.
Store your medicine in a cool dry place below 25°C.
Keep your medicine where children cannot reach it.
For more information, see Section 5. What should I know while taking DABIGATRAN VIATRIS? in the full CMI.

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

Less serious side effects
What to do
Bleeding related
bruising
nosebleed
Digestive tract/Gastrointestinal related
diarrhoea
discomfort when swallowing
feeling sick
indigestion
stomach ache
Infection related
frequent infections such as fever, severe chills, sore throat or mouth ulcers (signs of lack of white blood cells).
sore nasal passages and throat
Joint related
painful, swollen joints
Skin related
itchy skin
rash
hair loss
Respiratory related
cough
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
Bleeding related
long or excessive bleeding
red or dark brown urine
red or black bowel motions
General disorders
exceptional weakness
swelling of hands, ankles and feet
chest pain or being short of breath
Haematological/Blood related
Anaemia (signs may include tiredness, headaches, dizziness and looking pale)
Urinary tract related
symptoms related to a condition called anticoagulant-related nephropathy: blood in urine, reduced urine output, swelling of the legs, ankles and feet, increased time for blood to clot (high INR test values), heavy bleeding.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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

Active ingredient
(main ingredient)
Dabigatran etexilate (as mesilate)
Other ingredients
(inactive ingredients)
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.
Potential allergens
Sulfites
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

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