Daxanlo

Package Leaflet: Information for the Patient

Daxanlo, 110 mg, Hard Capsules

Dabigatranum etexilatum

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

• Keep this package 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.

Table of Contents of the Package 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.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat 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.

Daxanlo is used in children to:

• treat blood clots and prevent the 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 medicines.
• if you are taking anticoagulant medicines (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 maintain catheter patency or when restoring 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 cyclosporine, 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.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting treatment with Daxanlo, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment, 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 experienced bleeding.
• if you have undergone 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 "Daxanlo and other medicines" below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing less urine, dark and concentrated or foamy 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 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 Daxanlo is not recommended.

When to exercise special caution when taking Daxanlo

• if you need to undergo surgery: in this case, it is necessary to temporarily discontinue Daxanlo 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 reduce 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 intestines 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 immediately seek medical attention. 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.

Daxanlo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. In particular, tell your doctor before taking Daxanlo 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 they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil).
• For patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Daxanlo, depending on the condition for which Daxanlo was prescribed to the patient. See section 3.
• Medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• 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 (both 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 Daxanlo on pregnancy and the unborn child is not known. You should not take Daxanlo 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 medicine 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
The recommended dose is 220 mg once a day(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 a day(taken as 2 capsules of 75 mg each).
For patients taking medicines containing amiodarone, quinidine or verapamil, the recommended dose of Daxanlo is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking medicines containing verapamilwith reduced kidney function by more than half should take a reduced dose of Daxanlo to 75 mgdue 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 a day.
After knee replacement surgery
Take Daxanlo starting with one capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once a day for a total of 10 days.
After hip replacement surgery
Take Daxanlo starting with one capsule within 1 to 4 hours after the end of surgery. Then take 2 capsules once a day for a total of 28 to 35 days.
Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function, 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 mgtaken as one 150 mg capsule twice a day.
For patients 80 years old or older, the recommended dose of Daxanlo is 220 mgtaken as one 110 mg capsule twice a day.
Patients taking medicines containing verapamilshould receive a reduced dose of Daxanlo to 220 mgtaken as one 110 mg capsule twice a daydue to the increased risk of bleeding.
For patients with potentially increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as one 110 mg capsule twice a day.
Daxanlo can be continued if the patient needs to restore normal heart function using a procedure called cardioversion. Take Daxanlo 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 treatment with Daxanlo after the doctor has determined that adequate blood clotting control has been achieved. Take Daxanlo as instructed by your doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Take Daxanlo twice a day, 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 medicines unless your doctor instructs you to stop taking them.
Table 1 shows the single and total daily doses of Daxanlo in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Daxanlo 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 Daxanlo

Daxanlo can be taken with or without food. Swallow the capsules whole with a glass of water to facilitate passage into the stomach. Do not crush, 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 blister 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. Swallow the capsules 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 medicine

Do not change your anticoagulant medicine 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
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.
Use in adults: Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function, 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
Use in children: Treatment of blood clots and prevention of recurrence of blood clots
You can take the missed dose 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 treatment with Daxanlo

Daxanlo should be taken as instructed by your doctor. 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 indigestion after taking Daxanlo.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 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 medicine.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are listed below 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, into the stomach or intestines, from the penis or vagina or urinary tract (including urine discoloration to pink or red due to the presence of blood), or bleeding under the skin
• Formation of 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
• Wound exudate (oozing of fluid from the surgical wound)
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, from the injection site or from the catheter insertion site into a vein
• Exudate from the catheter insertion site into a vein, discolored with blood
• Coughing up blood or sputum discolored with 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 or appearance
• Itching
• Ulcer of the stomach or intestines (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Belly pain or stomach pain
• Indigestion
• Difficulty swallowing
• Exudate from the wound or surgical wound

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

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

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function
Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, into the stomach or intestines, from the penis or vagina or urinary tract (including urine discoloration to pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Belly pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from the hematomas or from the rectum or into the brain
• Formation of hematomas
• Coughing up blood or sputum discolored with blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Ulcer of the stomach or intestines (including esophageal ulceration)
• 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 the joint, from the surgical site, from the injection site or from the catheter insertion site into a vein or bleeding into the brain
• 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
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

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

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
Frequent (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 or vagina or urinary tract (including urine discoloration to 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 the joint or due to injury
• Bleeding may occur from the hematomas
• Decreased 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
• Ulcer of the stomach or intestines (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Belly pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical site, from the injection site or from the catheter insertion site into a vein or bleeding into the brain
• Decreased 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

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

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• 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 events was low. No difference in the number of heart attacks was observed in patients treated with dabigatran compared to patients who received placebo.
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 or appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• 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 or intestines, into the brain, from the rectum, from the penis or vagina or urinary tract (including urine discoloration to pink or red 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 with blood
• Belly 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

Frequency 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 the joint, from the wound, from the surgical site, from the injection site or from the catheter insertion site into a vein
• Bleeding may occur from the hematomas
• Ulcer of the stomach or intestines (including esophageal ulceration)
• 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 Monitoring of the 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 Daxanlo

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 and blister or container label after EXP. The expiry date refers to the last day of the month.
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.
Keep the container tightly closed.
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 Daxanlo contains

• The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are: capsule contents: tartaric acid (pellets), hypromellose (6 mPa*s), hydroxypropylcellulose (470 mPa*s) and talc; capsule shell: titanium dioxide (E 171), indigo carmine (E 132), 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, 110 mg, hard capsules (capsules): The capsule cap is blue, the capsule body is blue, with a black mark printed along the length "110", approximately 19 mm in length.
The capsule contents are yellowish-white to light yellow pellets.
Daxanlo, 110 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 blister packs.
• 60 hard capsules in a container with a child-resistant cap or 3 containers of 60 hard capsules 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 medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
phone: +48 22 573 75 00

Date of last revision of the package leaflet: