Daxanlo

Package Leaflet: Information for the Patient

Daxanlo, 150 mg, Hard Capsules

Dabigatran Etexilate

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their 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 Package 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 medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.

Daxanlo 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 type of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem 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 the patient is allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
• if the patient has severe kidney impairment.
• if the patient is currently bleeding.
• if the patient has 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 the patient has an increased tendency to bleed. This may be inherited, of unknown cause, or caused by the use of other medications.
• if the patient is taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a venous catheter or arterial line when heparin is administered to maintain its patency or when restoring normal heart rhythm using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medication used to prevent organ rejection.
• if the patient is taking dronedarone, a medication used to treat heart rhythm disorders.
• if the patient is taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if the patient has a prosthetic heart valve that requires continuous anticoagulation therapy.

Warnings and Precautions

Before starting Daxanlo, discuss it with your doctor or pharmacist. If you have experienced symptoms or undergone surgery during treatment, consult your doctor.

The patient should inform their doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding.
• if the patient has undergone surgical biopsy within the last month.
• if the patient has had a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medications that may increase the risk of bleeding. See "Daxanlo and Other Medications" below.
• if the patient is taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
• if the patient has an infection of the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing less urine, which is darker and more concentrated).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 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 heart attack or if the patient has been diagnosed with conditions that increase the risk of heart attack.
• if the patient has liver disease that affects blood test results. In such cases, the use of Daxanlo is not recommended.

When to Exercise Particular Caution When Taking Daxanlo

• if the patient needs 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 the 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 Daxanlo before and after surgery exactly as the doctor has instructed.

• the patient should immediately inform their doctor if they experience numbness or weakness in their lower limbs or problems with their intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient falls or injures themselves during treatment, especially if they hit their head. They should immediately seek medical attention. The doctor will examine the patient to determine if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

Daxanlo and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

In particular, 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, acetylsalicylic acid).
• 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 verapamil, the doctor may recommend a lower dose of Daxanlo, depending on the condition for which it was prescribed. See section 3.
• Medications used to prevent organ rejection (e.g., tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal medication 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. Daxanlo should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Daxanlo.

Do not breastfeed while taking Daxanlo.

Driving and Operating Machinery

Daxanlo has no or negligible influence on the ability to drive and operate machinery.

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 the doctor has instructed. In case of doubts, consult a doctor.

Take Daxanlo 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, as well as prevention of the 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.

In patients aged 80 years or older, the recommended dose of Daxanlo is 220 mg taken as one 110 mg capsule twice daily.

Patients taking medications containing verapamil should receive a reduced dose of Daxanlo, 220 mg taken as one 110 mg capsule twice daily, due to the possible increased risk of bleeding.

In patients with potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice daily.

Daxanlo can be continued if the patient needs to restore normal heart rhythm using a procedure called cardioversion or catheter ablation in atrial fibrillation. Daxanlo should be taken as instructed by the 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 Daxanlo treatment after the doctor has confirmed that adequate blood coagulation control has been achieved. Daxanlo should be taken as instructed by the doctor.

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 every day. The interval between doses should be approximately 12 hours.

The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medications should be continued, unless the doctor instructs otherwise.

Table 1 shows the single and total daily doses of Daxanlo in milligrams (mg). The doses depend 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. They should not be broken, chewed, or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Instructions for Opening Blister Packs

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. 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 More Than the Recommended Dose of Daxanlo

Taking more than the recommended dose of Daxanlo increases the risk of bleeding. If you have taken more Daxanlo capsules than recommended, contact your doctor immediately. There are specific treatments available.

Missing a Dose of Daxanlo

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 a missed dose.

Stopping Daxanlo Treatment

Daxanlo should be taken as instructed by the doctor. Do not stop taking Daxanlo 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 Daxanlo.

In case of any further doubts about the use of this medication, consult a 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 bleeding occurs that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling) occur, seek medical attention immediately. The doctor may decide to closely monitor the patient or change the medication.

If a severe allergic reaction occurs that may cause difficulty breathing or dizziness, seek medical attention immediately.

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 or vagina, or from the urinary tract (including urine that is pink or red due to the presence of blood), or bleeding under the skin.
• Decreased red blood cell count.
• Abdominal 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 hematomas, the rectum, or the brain.
• Hematoma formation.
• Coughing up blood or sputum that is blood-stained.
• Decreased platelet count.
• Decreased hemoglobin levels in the blood (a substance in red blood cells).
• Allergic reaction.
• Sudden change in skin color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Esophagitis and 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 surgical wound, from an injury, from an injection site, or from a catheter insertion site.
• Severe allergic reaction that may cause difficulty breathing or dizziness.
• Severe allergic reaction that may cause swelling of the face or throat.
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction.
• Decreased red blood cell count.
• 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.

In clinical trials, the number of heart attacks in patients taking dabigatran etexilate was higher than in those taking warfarin. The overall number of events was small.

Treatment of blood clots in the veins of the legs and lungs, as well as prevention of the 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 or vagina, or from the urinary tract (including urine that is 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.
• Decreased red blood cell count.
• Hematoma formation.
• Coughing up blood or sputum that is blood-stained.
• Allergic reaction.
• Sudden change in skin color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Esophagitis and gastritis.
• Gastroesophageal reflux disease.
• Nausea.
• Vomiting.
• Abdominal 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 a surgical wound, from an injection site, or from a catheter insertion site, or bleeding into the brain.
• Decreased platelet count.
• Severe allergic reaction that may cause difficulty breathing or dizziness.
• Severe allergic reaction that may cause swelling of the face or throat.
• 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 red blood cell count.
• 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 those 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 those who received placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children.

Common (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.
• Hematoma formation.
• 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 from the urinary tract (including urine that is 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 red blood cell count.
• Itching.
• Coughing up blood or sputum that is blood-stained.
• Abdominal pain or stomach pain.
• Esophagitis and 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 that may cause difficulty breathing or dizziness.
• Severe allergic reaction that may cause swelling of the face or throat.
• Difficulty breathing or wheezing.
• Bleeding.
• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site.
• Bleeding may occur from hematomas.
• Stomach or intestinal ulcer (including esophageal ulceration).
• Abnormal liver function test results.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product 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.

Reporting side effects will help to gather 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 or container label after EXP. The expiry date refers to the last day of the month stated.

Blister pack:

No special storage instructions.

Store in the original package to protect from light and moisture.

Container:

No special storage instructions.

Store in the original package to protect from light and moisture.

Keep 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 Package and Other Information

What Daxanlo Contains

• The active substance of Daxanlo is dabigatran etexilate. Each hard capsule contains 150 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), 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 Package

Daxanlo, 150 mg, hard capsules (capsules): The capsule cap is blue, the capsule body is white or almost white, with a black mark printed along the length "150", approximately 24 mm in length.

The capsule contents are yellowish-white to light yellow pellets.

Daxanlo, 150 mg, hard capsules are available in cartons containing:

• 10 x 1, 30 x 1, 60 x 1, 100 x 1, or bulk packages of 100 (2 packages of 50 x 1) or 180 (3 packages 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.

For more information about 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 Package Leaflet: