Daxanlo

Package Leaflet: Information for the Patient

Daxanlo, 75 mg, Hard Capsules

Dabigatranum etexilatum

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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Daxanlo and what is it used for

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

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

Daxanlo is used in children to:

• treat blood clots and prevent recurrence of blood clots.

2. Important information before taking Daxanlo

When not to take Daxanlo

• 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 an 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. It may 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 changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function through 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, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication that prevents transplant 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.

Warnings and precautions

Before starting Daxanlo, discuss it with your doctor. If you have experienced symptoms or undergone surgery while taking this medication, 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 esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medications that may increase the risk of bleeding. See also "Daxanlo and other medications" below.
• if you are taking anti-inflammatory medications, such as aspirin, ibuprofen, diclofenac.
• if you have endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing a small amount of dark, concentrated 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 Daxanlo is not recommended.

When to exercise special caution when taking Daxanlo

• if you need to undergo surgery: in such cases, it is necessary to discontinue Daxanlo temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Daxanlo 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 relieve pain):
• it is very important to take Daxanlo 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 while taking Daxanlo, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to determine if you may have an increased risk of bleeding.
• if you have 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.

Daxanlo and other medications

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

• Anticoagulant medications (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medications used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• Medications used to treat 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 Daxanlo, depending on the condition for which it was prescribed. See also section 3.
• Medications that prevent transplant rejection (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 reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medications used to treat AIDS (e.g. ritonavir).
• Certain medications used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Daxanlo on pregnancy and the unborn child is not known. You should not take this medication during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Daxanlo.
Do not breastfeed while taking Daxanlo.

Driving and using machines

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

3. How to take Daxanlo

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

Take Daxanlo as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
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 old 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 Daxanlo is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patients taking medications containing verapamil, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Daxanlo due to the increased risk of bleeding.
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
Start taking Daxanlo with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Start taking Daxanlo with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrence of blood clots in children
Daxanlo should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time each 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 to take all other medications unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of Daxanlo in milligrams (mg).
Doses are based on the patient's weight in kilograms (kg) and age in years.
Table 1: Daxanlo 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 Daxanlo

Daxanlo can be taken with or without food. The capsules should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not break, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters

The following diagram shows how to remove Daxanlo capsules from the blister pack.
To remove a capsule from the blister pack:

• 1. Hold the blister pack by the edges and separate one blister cell from the rest of the pack by gently bending and tearing along the perforation around it.
• 2. Lift the edge of the foil and peel it off completely.
• 3. Push the capsule out onto your hand.
• 4. The capsules should be swallowed whole with a glass of water.
• Do not push the capsules through the blister pack foil.
• Do not peel off the foil until the capsule is needed.

Instructions for opening the container

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

Changing anticoagulant medication

Do not change your anticoagulant medication without receiving detailed instructions from your doctor.

Taking a higher dose of Daxanlo than recommended

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

Missing a dose of Daxanlo

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Daxanlo 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 recurrence of 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 Daxanlo

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

4. Possible side effects

Like all medications, Daxanlo can cause side effects, although not everybody gets them.
Daxanlo 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.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medication.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
The following side effects are grouped by frequency:

• Frequent (may affect up to 1 in 10 people):
• Decreased hemoglobin levels 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, or vagina, or from the urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin, into a joint, due to injury or after surgery
• Hematomas or bruising after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Pus from the wound
• Increased liver enzyme activity
• Jaundice (yellowing of the skin or eyes due to liver or blood disease)

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, from the injection site, or from the catheter site
• Pus from the catheter site, discolored due to the presence of blood
• Coughing up blood or sputum discolored due to the presence of blood
• Decreased platelet count
• Decreased 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)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Nausea
• Difficulty swallowing
• Pus from the wound
• Pus from the surgical wound

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

• Difficulty breathing or wheezing
• Decreased or absent white blood cell count (which helps fight infections)
• Hair loss

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

• Decreased red blood cell count
• Decreased 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
• Hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Nausea
• Hair loss
• Increased liver enzyme activity

Uncommon (may affect up to 1 in 100 people)

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur into the stomach, brain, anus, penis, or vagina, or from the urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or sputum discolored due to the presence of blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice (yellowing of the skin or eyes due to liver or blood disease)

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

• Absent white blood cell count (which helps 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 the surgical site, from the injection site, or from the catheter site
• 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 medication.

5. How to store Daxanlo

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister pack or label on the container after: EXP. The expiry date refers to the last day of the month stated.
Blister pack:
No special storage precautions are required.
Store in the original package to protect from light and moisture.
Container:
No special storage precautions are required.
Store in the original package to protect from light and moisture.
Store the container tightly closed.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Daxanlo contains

• The active substance of Daxanlo is dabigatran etexilate. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients (excipients) are:

capsule contents: tartaric acid (pellets), hypromellose (6 mPa*s), hydroxypropylcellulose (470 mPa*s), and talc;
capsule shell: titanium dioxide (E 171), carrageenan, potassium chloride, hypromellose (type 2910);
ink: shellac, iron oxide black (E 172), potassium hydroxide.

What Daxanlo looks like and contents of the pack

Daxanlo, 75 mg, hard capsules (capsules): The capsule cap is white or almost white, the capsule body is white or almost white, with a black mark "75" printed along the length, approximately 18 mm in length.
The capsule contents are yellowish-white to light yellow pellets.
Daxanlo, 75 mg, hard capsules are available in cartons containing:

• 10 x 1, 30 x 1, 60 x 1, 100 x 1, or bulk packs of 100 (2 packs of 50 x 1) or 180 (3 packs of 60 x 1) hard capsules in perforated, single-dose, peelable blisters.
• 60 hard capsules in a container with a child-resistant cap or 3 containers of 60 hard capsules each with a child-resistant cap.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medication, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of last revision of the leaflet: