Dabigatran etexilate viatris

Package leaflet: Information for the patient

Dabigatran Etexilate Viatris, 75 mg, hard capsules
dabigatran etexilate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dabigatran Etexilate Viatris is and what it is used for
2. What you need to know before taking Dabigatran Etexilate Viatris
3. How to take Dabigatran Etexilate Viatris
4. Possible side effects
5. How to store Dabigatran Etexilate Viatris
6. Contents of the pack and other information

1. What Dabigatran Etexilate Viatris is and what it is used for

Dabigatran Etexilate Viatris contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is involved in blood clotting.
Dabigatran Etexilate Viatris is used in adults to:

• prevent the formation of blood clots in the veins after knee or hip replacement surgery.

Dabigatran Etexilate Viatris is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before using Dabigatran Etexilate Viatris

When not to use Dabigatran Etexilate Viatris

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe impairment of kidney function;
• if the patient is currently experiencing bleeding;
• if the patient has an internal organ disease that increases the risk of major bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent brain or eye surgery);
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines;
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except in the following cases: switching anticoagulant therapy, insertion of a venous or arterial catheter, heparin administration to maintain catheter patency, or restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation;
• if the patient has severe impairment of liver function or liver disease that may lead to death;
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections;
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ;
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders;
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection;
• if the patient has a mechanical heart valve that requires lifelong anticoagulant therapy.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Viatris, discuss this with your doctor.
You should also contact your doctor during treatment with this medicine if symptoms occur or if
the patient requires a surgical procedure.
The patient should inform the doctor if they have or have previously had any medical
conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, for example:
• if the patient has recently experienced bleeding
• if the patient underwent surgical tissue biopsy (biopsy) within the last month
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment)
• if the patient has inflammation of the oesophagus or stomach
• if the patient has regurgitation of stomach contents into the oesophagus (reflux)
• if the patient is taking medicines that may increase the risk of bleeding. See section “Dabigatran Etexilate Viatris with other medicines” below
• if the patient is taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam
• if the patient has an infection in or around the heart (bacterial endocarditis)
• if the patient has kidney dysfunction or dehydration (symptoms include feeling thirsty and passing reduced amounts of dark (concentrated) and/or foamy urine)
• if the patient is over 75 years of age
• if the patient is an adult weighing 50 kg or less
• only when used in children: if the child has an infection around or within the brain
• if the patient has had a heart attack or has conditions increasing the risk of heart attack
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise special caution when using Dabigatran Etexilate Viatris

• if the patient requires surgery: In such cases, temporary discontinuation of Dabigatran Etexilate Viatris will be necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate Viatris exactly as directed by the doctor both before and after surgery.
• if surgery involves insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
• It is very important to take Dabigatran Etexilate Viatris exactly as directed by the doctor both before and after surgery.
• Immediately inform the doctor if, after the anaesthetic wears off, the patient experiences numbness or weakness in the legs or problems with the bowels or bladder, as urgent medical attention is required.
• if the patient falls or injures themselves during treatment, especially if they hit their head. In such cases, seek urgent medical help. The patient may need to be examined by a doctor, as they may be at increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform the doctor, who will decide whether treatment needs to be changed.

Dabigatran Etexilate Viatris with other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has
recently taken, or might take in the future. In particular, before taking Dabigatran Etexilate
Viatris, tell your doctor if the patient is taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are applied only to the skin
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). If the patient is taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a reduced dose of Dabigatran Etexilate Viatris depending on the condition for which it was prescribed. See also section 3.
• medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine)
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection)
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's wort, a herbal remedy used to treat depression
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• rifampicin or clarithromycin (two antibiotics)
• antiviral medicines used to treat AIDS (e.g. ritonavir)
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effect of Dabigatran Etexilate Viatris on pregnancy and the unborn child is unknown. Do not
take this medicine during pregnancy unless your doctor considers it safe. Women of childbearing
potential should avoid becoming pregnant while taking Dabigatran Etexilate Viatris.
Do not breastfeed while taking Dabigatran Etexilate Viatris.

Driving and using machines
Dabigatran Etexilate Viatris has no influence on the ability to drive and use machines.

3. How to take Dabigatran Etexilate Viatris

Dabigatran Etexilate Viatris capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. There are other age-appropriate formulations available for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Dabigatran Etexilate Viatris should be taken according to the following recommendations for the
following medical conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg each).
If kidney function is reduced by more than half or if the patient is 75 years of age or older,
the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).
If the patient is taking medications containing amiodarone, quinidine, or verapamil, the recommended
dose is 150 mg once daily (taken as 2 capsules of 75 mg each).
If the patient is taking medications containing verapamil and has reduced kidney function by more than
half, a reduced dose of 75 mg of Dabigatran Etexilate Viatris should be used, as the risk of bleeding may be increased.
For both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be started on the day following surgery, it should be initiated with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran Etexilate Viatris should begin 1–4 hours after completion of surgery, taking one capsule. Then, two capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran Etexilate Viatris should begin 1–4 hours after completion of surgery, taking one capsule. Then, two capsules should be taken once daily for a total of 28–35 days.
Treatment and prevention of recurrence of blood clots in children
Dabigatran Etexilate Viatris should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the appropriate dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Dabigatran Etexilate Viatris in milligrams (mg). Doses are based on body weight in kilograms (kg) and patient age in years.
Table 1: Dosing table for Dabigatran Etexilate Viatris capsules

Single doses requiring combination of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule plus two 75 mg capsules
220 mg: as two 110 mg capsules
185 mg: as one 75 mg capsule plus one 110 mg capsule
150 mg: as one 150 mg capsule or
two 75 mg capsules

How to take Dabigatran Etexilate Viatris
Dabigatran Etexilate Viatris can be taken with food or independently of meals. The capsule should be swallowed whole, with a glass of water, to ensure it reaches the stomach. Do not break, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening the bottle

• To open the bottle, press down and turn the cap.
• After removing a capsule and taking the dose, immediately close the bottle tightly with the cap.

Changing anticoagulant therapy
Do not change anticoagulant treatment without receiving specific instructions from your doctor.

Taking more Dabigatran Etexilate Viatris than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatment options are available.

Missed dose of Dabigatran Etexilate Viatris

Prevention of blood clots after knee or hip replacement surgery
Continue taking the remaining daily doses of Dabigatran Etexilate Viatris at the usual time on the next day. Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
Do not take a missed dose if less than 6 hours remain before the next scheduled dose. If a dose is missed, do not take a double dose to make up for it.

Stopping Dabigatran Etexilate Viatris
Take Dabigatran Etexilate Viatris exactly as prescribed. Do not stop taking the medicine without consulting your doctor first, as stopping treatment too early may increase the risk of developing a blood clot. Contact your doctor if you experience gastrointestinal discomfort after taking Dabigatran Etexilate Viatris.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Dabigatran Etexilate Viatris affects blood clotting, so most adverse reactions are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which represent the most serious adverse reactions and, regardless of location, may lead to disability, life-threatening situations, or even death. In some cases, these bleedings may not be visible.
If any bleeding occurs that does not stop spontaneously, or if symptoms of excessive bleeding occur (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor the patient or change the treatment.
Inform your doctor immediately if a serious allergic reaction occurs causing difficulty in breathing or dizziness.
The possible adverse reactions listed below are grouped according to their frequency of occurrence.

Prevention of blood clots after surgery (knee or hip replacement)
Common (may affect up to 1 in 10 people):

• decrease in haemoglobin levels in blood (a substance contained in red blood cells)
• abnormal laboratory test results assessing liver function.

Uncommon (may affect up to 1 in 100 people):

• bleeding from nose, stomach or intestines, from penis or vagina, or urinary tract (including blood in urine, which turns urine pink or red), from haemorrhoids, from rectum, under the skin, into joints, due to injury or after injury, or following a surgical procedure
• formation of haematomas or bruising after surgery
• blood detected in stool in laboratory tests
• decrease in number of red blood cells in blood
• decrease in number of blood cells
• allergic reaction
• vomiting
• frequent loose or watery stools
• nausea
• wound discharge (fluid leakage from surgical wound)
• increased liver enzyme activity
• yellowing of skin or whites of eyes caused by problems with liver or blood.

Rare (may affect up to 1 in 1000 people):

• bleeding
• bleeding in the brain, from surgical incision site, from injection site, or from site of intravenous catheter insertion
• blood-tinged discharge from intravenous catheter insertion site
• coughing up blood or blood-tinged sputum
• decrease in platelet count
• decrease in number of red blood cells in blood after surgery
• severe allergic reaction causing difficulty in breathing or dizziness
• severe allergic reaction causing swelling of face or throat
• skin rash consisting of dark red, raised, itchy lumps due to allergic reaction
• sudden change in skin colour and appearance
• itching
• stomach or intestinal ulcer (including oesophageal ulceration)
• inflammation of oesophagus and stomach
• regurgitation of stomach contents into oesophagus (reflux)
• abdominal pain or stomach pain
• indigestion
• difficulty swallowing
• fluid leakage from wound
• fluid leakage from surgical wound.

Frequency not known (frequency cannot be estimated from available data):

• difficulty breathing or wheezing
• decrease in number or even absence of white blood cells (which help fight infections)
• hair loss.

Treatment and prevention of recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

• decrease in number of red blood cells in blood
• decrease in platelet count
• skin rash consisting of dark red, raised, itchy lumps due to allergic reaction
• sudden change in skin colour and appearance
• formation of haematomas
• nosebleeds
• regurgitation of stomach contents into oesophagus (reflux)
• vomiting
• nausea
• frequent loose or watery stools
• indigestion
• hair loss
• increased liver enzyme activity.

Uncommon (may affect up to 1 in 100 people):

• decrease in number of white blood cells (which help fight infections)
• bleeding into stomach or intestines, into brain, from rectum,
  from penis or vagina or urinary tract (including blood in urine, which turns urine pink or red), or bleeding under the skin
• decrease in haemoglobin levels in blood (a substance contained in red blood cells)
• decrease in number of blood cells
• itching
• coughing up blood or blood-tinged sputum
• abdominal pain or stomach pain
• inflammation of oesophagus and stomach
• allergic reaction
• difficulty swallowing
• yellowing of skin or whites of eyes caused by problems with liver or blood.

Frequency not known (frequency cannot be estimated from available data):

• absence of white blood cells (which help fight infections)
• severe allergic reaction causing difficulty in breathing or dizziness
• severe allergic reaction causing swelling of face or throat
• difficulty breathing or wheezing
• bleeding
• bleeding into joints or following trauma, from surgical incision site, injection site, or intravenous catheter insertion site
• bleeding from haemorrhoids
• stomach or intestinal ulcer (including oesophageal ulceration)
• abnormal laboratory test results assessing liver function.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Dabigatran Etexilate Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle
after: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Dabigatran Etexilate Viatris contains

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate in the form of mesilate, equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid (pellets), hydroxypropyl cellulose, talc, and hypromellose (type 2910).
• The capsule shell contains titanium dioxide (E 171) and hypromellose.
• The printing ink contains shellac, propylene glycol, concentrated ammonium hydroxide, black iron oxide (E 172), and potassium hydroxide.

What Dabigatran Etexilate Viatris looks like and contents of the pack
Dabigatran Etexilate Viatris 75 mg is a hard capsule approximately 19 mm in length, with a white, opaque cap and a white, opaque body, filled with pellets ranging in colour from light yellow to yellowish. It is printed with "VTRS" above "DC75" in black ink on both the cap and body.
Dabigatran Etexilate Viatris is available in packs containing 10, 30 or 60 capsules in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Dabigatran Etexilate Viatris is also available in packs containing single-dose perforated blisters of OPA/Aluminium/PVC/Aluminium containing 10 x 1, 30 x 1 or 60 x 1 capsules, in a cardboard box.
Dabigatran Etexilate Viatris is also available in cardboard packs containing 100 or 180 capsules in HDPE bottles with a child-resistant PP screw cap and aluminium seal. The bottle also contains a desiccant (silica gel).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer/Importer
Mylan Hungary Kft.
Mylan Utca 1
Komárom 2900
Hungary
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg 61352
Germany

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel.: +48 22 546 64 00

This medicinal product is authorised in the European Economic Area countries under the following names: