Daroxomb

Package Leaflet: Information for the Patient

Daroxomb, 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, 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Daroxomb and what is it used for

Daroxomb 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.
Daroxomb is used in adults to:

• prevent 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 a heart valve problem and at least one additional risk factor.
• treat blood clots in the legs and lungs and prevent the recurrence of blood clots in the legs and lungs.

Daroxomb is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Daroxomb

When Not to Take Daroxomb

Warnings and Precautions

Before starting to take Daroxomb, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with 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:

• 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 the patient has been diagnosed with conditions that increase the risk of a heart attack.

When to Exercise Particular Caution When Taking Daroxomb

• It is very important to take Daroxomb before and after surgery exactly as the 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.

Daroxomb 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, you should
tell your doctor before taking Daroxomb if you are taking any of the following
medications:

• Medications that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless these medications 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 reduced dose of Daroxomb, depending on the condition for which the medication 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 Daroxomb 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 Daroxomb.
You should not breastfeed while taking Daroxomb.

Driving and Using Machines

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

3. How to Take Daroxomb

Daroxomb capsules 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, consult your doctor.

Take Daroxomb Exactly 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 legs and lungs, as well as prevention of the recurrence of blood clots in the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
For patients aged 80 years or older, the recommended dose of Daroxomb is 220 mg taken as one 110 mg capsule twice a day.
Patients taking medications containing verapamilshould receive a reduced dose of Daroxomb to 220 mg taken as one 110 mg capsule twice a daydue to the possible increased risk of bleeding.
For patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice a day.
Treatment can be continued if the patient needs to restore normal heart function through a procedure called cardioversion or through a procedure called catheter ablation in atrial fibrillation. Daroxomb should be taken exactly as the doctor has instructed.
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 Daroxomb after the doctor has confirmed that adequate blood clotting control has been achieved. Daroxomb should be taken exactly as the doctor has instructed.
Treatment of blood clots and prevention of the recurrence of blood clots in children
Daroxomb should be taken twice a day,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 Daroxomb in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Daroxomb Capsule Dosing Table

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 Daroxomb

Daroxomb 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 the Blister Pack

The following diagram shows how to remove Daroxomb capsules from the blister pack.

Remove a single dose from the blister pack along the perforated line.

Peel off the foil covering the blister pack and remove the capsule.

• Do not push the capsules through the blister pack foil.
• Do not peel off the foil until the capsule is needed.

Changing Anticoagulant Medication

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

Taking More Than the Recommended Dose of Daroxomb

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

Missing a Dose of Daroxomb

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 Treatment with Daroxomb

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

4. Possible Side Effects

Like all medications, Daroxomb can cause side effects, although not everybody gets them.
Daroxomb affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Major or severe bleeding can 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.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), you should contact your doctor immediately. The doctor may decide to closely monitor you or change your medication.
In case of a severe allergic reaction that can cause difficulty breathing or dizziness, you should contact your doctor immediately.
The following side effects are grouped 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

• Frequent (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
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Nausea
• Diarrhea

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

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Hematoma formation
• Coughing up blood or sputum stained 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
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal and stomach inflammation
• Acid reflux from the stomach into the esophagus
• 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 injection site, or from a catheter insertion site
• 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 red blood cell count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss
• Unknown frequency (frequency cannot be estimated from the available data):
• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)

Treatment of blood clots in the legs and lungs and prevention of the recurrence of blood clots in 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/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Nausea

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 stained with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal and stomach inflammation
• Acid reflux from the stomach into the esophagus
• Vomiting
• Abdominal pain or stomach pain
• Diarrhea
• Abnormal liver function test results
• Increased liver enzyme activity
• Unknown frequency (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)
• Yellowing 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.

Treatment of blood clots and prevention of the 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
• Hematoma formation
• Nosebleeds
• Acid reflux from the stomach into the esophagus
• Vomiting
• Nausea
• Diarrhea
• 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 or intestines, into 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
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum stained with blood
• Abdominal pain or stomach pain
• Esophageal and stomach inflammation
• Unknown frequency (frequency cannot be estimated from the available data):
• Decreased 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 a surgical wound, from an injection site, or from a catheter insertion 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 package 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:
Jerozolimskie Avenue 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 or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Daroxomb

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton or blister pack after: EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medications should not be disposed of via wastewater. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Daroxomb Contains

• The active substance of Daroxomb is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesylate) which corresponds to 150 mg of dabigatran etexilate.
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15cps), dimethicone 350, talc, and hydroxypropylcellulose (100 cps).
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E 132), and hypromellose 2910 (6 cps).

What Daroxomb Looks Like and Contents of the Pack

Daroxomb 150 mg is a hard capsule with a blue cap and a white to off-white body, size 0, filled with pellets that are white to off-white to pale yellow in color.
Daroxomb is available in packs containing
10 x 1, 30 x 1, or 60 x 1 hard capsule in perforated unit dose blisters of Aluminum/OPA/Aluminum/PVC.
A multipack containing 3 packs of 60 x 1 hard capsule (180 hard capsules)
or a multipack containing 2 packs of 50 x 1 hard capsule (100 hard capsules) in perforated unit dose blisters of Aluminum/OPA/Aluminum/PVC.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Galenicum Health, S.L.U.
Sant Gabriel 50
08950 Esplugues de Llobregat, Barcelona
Spain
SAG Manufacturing S.L.U.
Carretera Nacional 1 Km 36
28750 San Agustin de Guadalix,
Madrid
Spain

For Further Information on This Medication, Please Contact the Representative of the Marketing Authorization Holder in Poland:

Zentiva Poland Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
phone: +48 22 375 92 00

Date of Last Revision of the Package Leaflet: