Tuxanuva

Package Leaflet: Information for the Patient

Tuxanuva, 75 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tuxanuva and what is it used for
• 2. Important information before taking Tuxanuva
• 3. How to take Tuxanuva
• 4. Possible side effects
• 5. How to store Tuxanuva
• 6. Contents of the pack and other information

1. What is Tuxanuva and what is it used for

Tuxanuva contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.
Tuxanuva is used in adults to:

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

Tuxanuva is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Tuxanuva

When Not to Take Tuxanuva

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney impairment
• if you are currently bleeding
• if you have a disease of any internal organ that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery)
• if you have an increased tendency to bleed. This can be congenital, of unknown cause, or caused by the use of other medications.
• if you are taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment when heparin is administered to maintain catheter patency in a vein or artery or during restoration of normal heart function using a procedure called catheter ablation for atrial fibrillation

in the event of a heart rhythm disorder procedure (catheter ablation) in atrial fibrillation

• if you have severe liver impairment or liver disease that can lead to death
• if you are taking oral ketoconazole or itraconazole, medications used for fungal infections
• if you are taking oral cyclosporine, a medication to prevent organ rejection
• if you are taking dronedarone, a medication used to treat heart rhythm disorders
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C
• if you have a prosthetic heart valve that requires continuous anticoagulation therapy.

Warnings and Precautions

Before starting Tuxanuva, discuss it with your doctor. If you experienced symptoms or underwent surgery during Tuxanuva treatment, consult your doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently experienced bleeding
• if you have had a surgical biopsy within the last month
• if you have had a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment)
• if you have esophageal or stomach inflammation
• if you have stomach acid reflux into the esophagus
• if you are taking medications that may increase the risk of bleeding. See also "Tuxanuva and other medications" below
• if you are taking anti-inflammatory medications, such as aspirin, ibuprofen, diclofenac
• if you have a heart infection (bacterial endocarditis)
• if you have kidney impairment or are dehydrated (feeling thirsty and producing less urine)
• if you are over 75 years old
• if you are an adult and weigh 50 kg or less
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a heart attack or if you have been diagnosed with conditions that increase the risk of a heart attack.
• if you have liver disease that affects blood test results. In such cases, the use of this medication is not recommended.

When to Exercise Particular Caution When Taking Tuxanuva

• if you need to undergo surgery: In this case, it is necessary to discontinue Tuxanuva temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Tuxanuva before and after surgery exactly as your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or pain relief):
• It is very important to take Tuxanuva before and after surgery exactly as your doctor has instructed.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to see if you may have an increased risk of bleeding.
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Tuxanuva and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or might take.
In particular, before taking Tuxanuva, tell your doctor if you are taking any of the following
medications:

• medications that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin)
• medications used for fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin
• medications used for heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Tuxanuva, depending on the condition for which it was prescribed. See also section 3.
• medications to prevent organ rejection after a transplant (e.g., tacrolimus, cyclosporine)
• a combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C)
• anti-inflammatory and pain medications (e.g., aspirin, ibuprofen, diclofenac)
• St. John's Wort, a herbal remedy used to treat depression
• antidepressant medications called selective serotonin or norepinephrine reuptake inhibitors
• rifampicin or clarithromycin (antibiotics)
• antiviral medications used to treat AIDS (e.g., ritonavir)
• certain medications used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The effect of Tuxanuva on pregnancy and the unborn child is not known. You should not take Tuxanuva during pregnancy unless your doctor considers it necessary.
Women of childbearing age should avoid becoming pregnant while taking Tuxanuva.
Do not breastfeed while taking Tuxanuva.

Driving and Using Machines

Tuxanuva has no or negligible influence on the ability to drive and use machines.

Tuxanuva Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Tuxanuva

Tuxanuva capsules can be used in adults and children aged 8 years or older who can swallow capsules whole. There are other age-appropriate formulations for the treatment of children under 8 years of age.
This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor.

Take Tuxanuva as Follows:

Prevention of blood clots after surgery (hip or knee replacement)
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or if you are 75 years of age or older,
the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Tuxanuva is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medications with reduced kidney functionby more than half should take a reduced dose of 75 mgof Tuxanuva due to increased bleeding risk.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.
After knee replacement surgery
Tuxanuva treatment should be started with a dose of one capsule within 1 to 4 hours after surgery completion. Then, take two capsules once daily for a total of 10 days.
After hip replacement surgery
Tuxanuva treatment should be started with a dose of one capsule within 1 to 4 hours after surgery completion. Then, take two capsules once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Tuxanuva should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of Tuxanuva in milligrams (mg). Doses are based on the patient's weight in kilograms (kg) and age in years.

Table 1: Tuxanuva Dosing Table in Capsule Form

Doses requiring the combination of more than one capsule:
300 mg:
two 150 mg capsules or
four 75 mg capsules
260 mg:
one 110 mg capsule and one 150 mg capsule or
one 110 mg capsule and two 75 mg capsules
220 mg:
two 110 mg capsules
185 mg:
one 75 mg capsule and one 110 mg capsule
150 mg:
one 150 mg capsule or
two 75 mg capsules

How to Take Tuxanuva

Tuxanuva can be taken with or without food. Swallow the capsules whole with a glass of water to help them reach the stomach. Do not crush, 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 and turn the cap
• Immediately after removing a capsule, replace the cap on the bottle and close it tightly.

Changing Treatment During Tuxanuva Use

Do not change the dose of the medication or treatment without receiving detailed instructions from your doctor.

Taking More Than the Recommended Dose of Tuxanuva

Taking too much of this medication increases the risk of bleeding. If you have taken too many Tuxanuva capsules, contact your doctor immediately. Specific treatments are available.

Missing a Dose of Tuxanuva

Prevention of blood clots after surgery (hip or knee replacement)
Continue taking the missed daily dose of Tuxanuva at the same time the next day. Do not take a double dose to make up for the missed dose.
Treatment of blood clots and prevention of recurrent blood clots in children
A missed dose can be taken up to 6 hours before the next scheduled dose. If there are less than 6 hours until the next scheduled dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Tuxanuva Treatment

Tuxanuva should be taken as instructed by your doctor. Do not stop taking this medication without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Tuxanuva.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Tuxanuva can cause side effects, although not everybody gets them.

Serious Side Effects

Tuxanuva affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.
Severe or massive bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of the location.
In some cases, these bleedings may not be visible.

• In the event of bleeding that does not stop on its own or signs of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), seek medical attention immediately. Your doctor may decide to monitor you closely or change your medication.
• In the event of a severe allergic reaction that can cause difficulty breathing or dizziness, seek medical attention immediately.

Other Side Effects

Other possible side effects are listed below by frequency of occurrence.
Prevention of blood clots after surgery (hip or knee replacement)
Common(may affect up to 1 in 10 people):

• decrease in hemoglobin in the blood (a substance in red blood cells)
• abnormal liver function test results. Uncommon(may affect up to 1 in 100 people):
• bleeding may occur from the nose, stomach, intestines, penis/vagina, or urinary tract (including urine discoloration due to blood), from hematomas, from the rectum, or under the skin, or after injury or surgery
• formation of hematomas or bruising after surgery
• blood in the stool as detected by laboratory tests
• decrease in red blood cell count
• decrease in red blood cell percentage
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion
• increased liver enzyme activity
• jaundice (yellowing of the skin or eyes due to liver or blood disease). Rare(may affect up to 1 in 1,000 people):
• bleeding
• bleeding into the brain, from the surgical site, injection site, or catheter insertion site
• blood-tinged secretion from the catheter insertion site
• coughing up blood or blood-tinged sputum
• decrease in platelet count
• decrease in red blood cell count after surgery
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing facial or throat swelling
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin color and appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophageal and stomach inflammation
• acid reflux from the stomach into the esophagus
• abdominal or stomach pain
• indigestion
• difficulty swallowing
• wound secretion
• wound secretion after surgery.

Unknown(frequency cannot be estimated from the available data):

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

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

• decrease in red blood cell count
• decrease in platelet count
• skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• sudden change in skin color and appearance
• formation of hematomas
• nosebleeds
• acid reflux from the stomach into the esophagus
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increased liver enzyme activity. Uncommon(may affect up to 1 in 100 people):
• decrease in white blood cell count (which help fight infections)
• bleeding may occur into the stomach, brain, rectum, penis/vagina, or urinary tract (including urine discoloration due to blood), or under the skin

or bleeding after injury or surgery

• decrease in hemoglobin in the blood (a substance in red blood cells)
• decrease in red blood cell percentage
• itching
• coughing up blood or blood-tinged sputum
• abdominal or stomach pain
• esophageal and stomach inflammation
• allergic reaction
• difficulty swallowing
• jaundice (yellowing of the skin or eyes due to liver or blood disease).

Unknown(frequency cannot be estimated from the available data):

• absence of white blood cells (which help fight infections)
• severe allergic reaction causing difficulty breathing or dizziness
• severe allergic reaction causing facial or throat swelling
• difficulty breathing or wheezing
• bleeding
• bleeding into the joint, wound, surgical site, injection site, or catheter insertion site
• bleeding from hematomas
• stomach or intestinal ulcers (including esophageal ulcers)
• abnormal liver function test results.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Tuxanuva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Blister:
Store in a temperature not exceeding 30°C.
Bottle:
Store in a temperature not exceeding 30°C. Store in the outer 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. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tuxanuva Contains

• The active substance is dabigatran etexilate. Each hard capsule contains dabigatran etexilate in the form of dabigatran etexilate mesylate, equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid (in the form of pellets), hypromellose (2910), talc, hydroxypropylcellulose (353 cps - 658 cps), croscarmellose sodium, and magnesium stearate. Capsule shell: titanium dioxide and hypromellose. Black ink for printing: shellac, propylene glycol (E 1520), iron oxide black (E 172), and potassium hydroxide.

What Tuxanuva Looks Like and Contents of the Pack

Tuxanuva 75 mg is a hard capsule, size "2" (17.5 mm ± 0.4 mm), with a white opaque cap with the imprint "MD" and a white opaque body with the imprint "75", printed with black ink, containing a mixture of pellets that are white to light yellow in color and granules that are light yellow in color.
Tuxanuva 75 mg is available in blisters of OPA/Aluminum/PE + desiccant/Aluminum/PE, in cardboard boxes containing 10, 30, or 60 hard capsules.
Tuxanuva 75 mg is also available in PP bottles with a capacity of 120 mL or 150 mL with a child-resistant closure and a desiccant in the form of silica gel, containing 60 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA3000 Paola
Malta
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Stada Poland Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Phone: +48 22 737 79 20

Date of Last Revision of the Leaflet: