Tuxanuva

Package Leaflet: Information for the Patient

Tuxanuva, 150 mg, Hard Capsules

Dabigatran Etexilate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 is to block a substance in the body that is responsible for the formation of blood clots.
Tuxanuva is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by heart valve problems and at least one additional risk factor
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

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 into the brain, recent brain or eye surgery)
• if you have an increased tendency to bleed. This may be congenital, of unknown cause or caused by the use of other medicines.

if you are taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment when heparin is given to maintain catheter patency in a vein or artery or during restoration of normal heart function using a procedure called catheter ablation in atrial fibrillation

• if you have severe liver impairment or liver disease that may lead to death
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections
• if you are taking oral cyclosporin, a medicine used to prevent organ rejection
• if you are taking dronedarone, a medicine used to treat heart rhythm disorders
• if you are taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection
• if you have a prosthetic heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Tuxanuva, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with Tuxanuva, consult your doctor.
You should inform your doctorif you 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 had 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 esophagitis or gastritis
• if you have gastroesophageal reflux disease
• if you are taking medicines that may increase the risk of bleeding. See below "Tuxanuva and other medicines"
• if you are taking anti-inflammatory medicines, such as diclofenac, ibuprofen, piroxicam
• if you have an infection of the heart (bacterial endocarditis)
• if you have kidney impairment or are dehydrated (feeling thirsty and passing less urine than usual)
• 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 history of myocardial infarction or if the patient has been diagnosed with conditions that increase the risk of myocardial infarction.
• if you have liver disease that affects blood test results. In this case, the use of this medicine is not recommended.

When to be particularly careful 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 to reduce pain):

• 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 medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, as well as any medicines you plan to take.
In particular, you must
tell your doctor before taking Tuxanuva if you are 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 these medicines are used only on the skin
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Tuxanuva, depending on the condition for which the medicine was prescribed. See section 3.
• medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporin)
• 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 medicine used to treat depression
• antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors
• rifampicin or clarithromycin (antibiotics)
• antiviral medicines used to treat AIDS (e.g. ritonavir)
• certain medicines 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 child, ask your doctor or pharmacist for advice before taking this medicine.
The use of Tuxanuva in pregnancy is not recommended. Women of childbearing potential 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 in the brain and body, by preventing the formation of clots that occur during irregular heart rhythm and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
For patients aged 80 years or olderthe recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patient taking medicines containing verapamilshould receive reduced dose Tuxanuva treatment of 220 mg taken as one 110 mg capsule twice dailydue to the potential increased risk of bleeding.
For patients with potentially increased risk of bleedingthe doctor may recommend Tuxanuva treatment of 220 mg taken as one 110 mg capsule twice daily.
Treatment can be continued if the patient needs to be restored to normal heart function using a procedure called cardioversion or using a procedure called catheter ablation in atrial fibrillation. Tuxanuva should be taken as instructed by your doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive Tuxanuva treatment after the doctor has confirmed that adequate anticoagulation control has been achieved. Tuxanuva should be taken as instructed by your doctor.
Treatment of blood clots and prevention of recurrence of 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. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued unless the doctor instructs otherwise.
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 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. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. They should not be broken, chewed or the pellets emptied 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 the bottle tightly.

Changing treatment during Tuxanuva use

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

Taking more Tuxanuva than prescribed

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

Missing a dose of Tuxanuva

A missed dose can be taken up to 6 hours before the next scheduled dose.
If it is less than 6 hours before the next scheduled dose, do not take the missed dose. Do not take a double dose to make up for a missed dose.

Stopping Tuxanuva treatment

Tuxanuva should be taken as instructed by your doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped too early. Contact your doctor if you experience indigestion after taking Tuxanuva.
If you have any further questions on the use of this medicine, 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.
Major or severe 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, and in some cases may not be visible.

• In case of bleeding that does not stop by itself, or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), contact your doctor immediately. Your doctor may decide to closely monitor you or change your medicine.
• In case of a severe allergic reaction that may cause difficulty breathing or dizziness, contact your doctor immediately.

Other side effects

Other possible side effects are listed below by frequency of occurrence.
Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heart rhythm

Common(may affect up to 1 in 10 people):

• bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood) or bleeding under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• indigestion
• diarrhea
• nausea

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

• bleeding
• bleeding may occur from hematomas, from the rectum or into the brain
• formation of hematomas
• coughing up blood or sputum discolored with blood
• decrease in platelet count
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis or gastritis
• gastroesophageal reflux disease
• vomiting
• difficulty swallowing
• abnormal liver function test results

Rare(may affect up to 1 in 1,000 people):

• bleeding may occur into a joint, from a wound, from a surgical incision site, from an injection site or from a catheter insertion site into a vein
• 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
• decrease in red blood cell count
• increase in liver enzyme activity
• jaundice of the skin or whites of the eyes due to liver or blood disease

Not known(frequency cannot be estimated from the available data):

• difficulty breathing or wheezing
• decrease in white blood cell count (which help fight infections)
• hair loss

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in patients taking warfarin. The overall number of occurrences was small.
Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

Common(may affect up to 1 in 10 people):

• bleeding may occur from the nose, into the stomach or intestines, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• indigestion

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

• bleeding
• bleeding may occur into a joint or due to injury
• bleeding may occur from hematomas
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or sputum discolored with blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcers (including esophageal ulcers)
• esophagitis or gastritis
• gastroesophageal reflux disease
• nausea
• vomiting
• abdominal pain or stomach pain
• diarrhea
• abnormal liver function test results
• increase in liver enzyme activity

Rare(may affect up to 1 in 1,000 people):

• bleeding may occur from a surgical incision site, from an injection site or from a catheter insertion site into a vein or from the brain
• decrease in platelet count
• 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
• difficulty swallowing

Not known(frequency cannot be estimated from the available data):

• difficulty breathing or wheezing
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in red blood cell count
• decrease in white blood cell count (which help fight infections)
• jaundice of the skin or whites of the eyes due to liver or blood disease
• hair loss

Treatment of blood clots and prevention of recurrence of 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 or appearance
• formation of hematomas
• nosebleeds
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increase in 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 or intestines, from the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in red blood cell count
• itching
• coughing up blood or sputum discolored with blood
• abdominal pain or stomach pain
• esophagitis or gastritis
• allergic reaction
• difficulty swallowing
• jaundice of the skin or whites of the eyes due to liver or blood disease

Not known(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 may occur into a joint, from a wound, from a surgical incision site, from an injection site or from a catheter insertion site into a vein
• bleeding may occur from hematomas
• stomach or intestinal ulcers (including esophageal ulcers)
• abnormal liver function test results

Reporting side effects

If you experience any side effects, including those 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

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. These measures 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 150 mg 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 150 mg is a hard capsule, size "0" (21.5 mm ± 0.4 mm), with a white opaque cap with the imprint "MD" and a white opaque body with the imprint "150", printed with black ink, containing a mixture of pellets that are white to light yellow and granules that are light yellow.
Tuxanuva 150 mg is available in blisters of OPA/Aluminum/PE + desiccant/Aluminum/PE, in cardboard boxes containing 10, 30 or 60 hard capsules.
Tuxanuva 150 mg is also available in PP bottles 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, please 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: