Daxanlo

Patient Information Leaflet

Daxanlo, 75 mg, hard capsules
Dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Daxanlo is and what it is used for
2. What you need to know 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 Daxanlo is and what it is used for

Daxanlo contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.
Daxanlo is used in adults to:

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

Daxanlo is used in children to:

• treat blood clots and to prevent 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 medicine (listed in section 6).
• if the patient has severe kidney function impairment.
• if the patient currently has bleeding.
• if the patient has an internal organ disease that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed, which may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
• if the patient has severe liver function impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has a mechanical heart valve, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Daxanlo, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, consult a doctor.
The patient should inform the doctor if they currently have or have previously had any medical conditions or diseases, especially the following:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding.
• if the patient has undergone a surgical tissue biopsy within the last month.
• if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
• if the patient has inflammation of the oesophagus or stomach.
• if the patient has gastroesophageal reflux (acid reflux into the oesophagus).
• if the patient is taking medicines that may increase the risk of bleeding. See below “Daxanlo and other medicines”.
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection in the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] and/or foamy urine).
• if the patient is over 75 years of age.
• if the patient is an adult weighing 50 kg or less.
• only when used in children: if the child has an infection around or within the brain.
• if the patient has had a heart attack or has conditions increasing the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, Daxanlo is not recommended.

When to exercise special caution when taking Daxanlo

• if the patient needs to undergo surgery: in such cases, temporary discontinuation of Daxanlo is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Daxanlo exactly as directed by the doctor before and after surgery.
• if the surgical procedure requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is very important to take Daxanlo exactly as directed by the doctor before and after surgery.
• the patient must immediately inform the doctor if numbness or weakness in the legs or problems with the bowel or bladder occur after the anaesthesia wears off, as urgent medical care is required.
• if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical evaluation is required. The doctor will assess whether there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed.

Daxanlo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, the patient must inform the doctor before taking Daxanlo if they 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 applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Daxanlo depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine).
• A fixed-dose 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 known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Daxanlo has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Daxanlo.
Breastfeeding is not recommended during treatment with Daxanlo.

Driving and using machines
Daxanlo has no effect or a negligible effect 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 are able to swallow capsules whole.
Other age-appropriate pharmaceutical forms are available for treating children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Take Daxanlo exactly as directed below:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose of Daxanlo is 220 mg once daily (taken as 2 capsules of 110 mg each).
In patients with renal function reduced by more than half or in patients aged 75 years or older,
the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg each).
In patients taking medicines 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 medicines containing verapamil who also have renal function reduced by more than half
should take a reduced dose of 75 mg of Daxanlo due to an increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding at the surgical site.
If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Start taking Daxanlo by taking one capsule within 1 to 4 hours after the end of surgery. Then take two capsules once daily for a total of 10 days.
After hip replacement surgery
Start taking Daxanlo by taking one capsule within 1 to 4 hours after the end of surgery. Then take two capsules once daily for a total of 28 to 35 days.
Treatment and prevention of recurrence of blood clots in children
Daxanlo should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Daxanlo in milligrams (mg).
Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Daxanlo capsules

Single 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 may be taken with or without food. The capsules should be swallowed whole, with a glass of water, to help them pass 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 pictogram illustrates how to remove Daxanlo capsules from the blister pack.
To remove a capsule from the blister:

1. Hold the blister at 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 completely peel it back.
3. Push the capsule out into your hand.
4. Swallow the capsule whole with a glass of water.
   • Do not push the capsules through the blister foil.
   • Do not peel back the foil until the capsule is needed.

Instructions for opening the bottle

• To open the bottle, press down and turn the cap.
• After removing and taking a capsule, immediately close the bottle tightly with the cap.

Switching anticoagulant medication
Do not switch anticoagulant medication without receiving specific instructions from your doctor.

Taking more Daxanlo than recommended
Taking too high a dose of Daxanlo increases the risk of bleeding. If a patient has taken too many Daxanlo capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Daxanlo
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Daxanlo at the usual time the next day. Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain 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 Daxanlo
Daxanlo should be taken as directed by the doctor. Do not stop taking Daxanlo without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if gastrointestinal discomfort occurs after taking Daxanlo.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Daxanlo affects the blood clotting system, so most adverse reactions involve symptoms such as bruising or bleeding.
Serious or severe bleeding may occur, which is the most serious adverse reaction; regardless of location, it may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or if symptoms of excessive bleeding develop (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. The doctor may decide to place the patient under close observation or change the treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, seek immediate medical attention.

The possible adverse reactions listed below are categorized by their frequency of occurrence:

Prevention of blood clots after hip or knee replacement surgery

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

• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding from the nose, stomach or intestines, penis or vagina or urinary tract (including pink or red urine due to presence of blood), from hemorrhoids, rectum, under the skin, into joints, due to injury or after injury or surgical procedure
• Bruising or hematoma occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell fraction
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Discharge from wound (fluid oozing from surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained 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 swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Inflammation of the esophagus and stomach
• Regurgitation of stomach contents into the esophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from wound
• Fluid discharge from surgical wound

Frequency unknown (frequency cannot be determined from available data):

• Difficulty breathing or wheezing
• Decrease in, or even absence of, white blood cells (which help fight infections)
• Hair loss

Treatment and prevention of recurrence of blood clots in children

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

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color and appearance
• Bruising
• Nosebleeds
• Regurgitation of stomach contents into the esophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in white blood cell count (which help fight infections)
• Bleeding into the stomach or intestines, brain, rectum, penis or vagina or urinary tract (including pink or red urine due to presence of blood), or bleeding under the skin
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell fraction
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

Frequency unknown (frequency cannot be determined from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into joints, from wounds, surgical incision sites, injection sites, or intravenous catheter insertion sites
• Bleeding from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the carton, blister, or container label following: EXP. The expiry date refers to the last day of the stated month.
Blister:
No special temperature storage instructions for this medicine.
Store in the original packaging to protect from light and moisture.
Container:
No special temperature storage instructions for this medicine.
Store in the original packaging to protect from light and moisture.
Keep the container tightly closed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Daxanlo contains

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

contents of the capsule: 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);
printing ink: shellac, iron oxide black (E 172), potassium hydroxide.

What Daxanlo looks like and contents of the pack

Daxanlo 75 mg hard capsules: the capsule cap is white or almost white, the body of the capsule is white or almost white, printed longitudinally in black with the characters "75", approximately 18 mm in length.
The contents of the capsule are off-white to pale yellow pellets.

Daxanlo 75 mg hard capsules are available in cardboard packs containing:

• 10 x 1, 30 x 1, 60 x 1, 100 x 1, or multi-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 Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00