Danengo

Package Leaflet: Information for the Patient

Danengo, 110 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. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this package leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Danengo and What is it Used For
• 2. Important Information Before Taking Danengo
• 3. How to Take Danengo
• 4. Possible Side Effects
• 5. How to Store Danengo
• 6. Contents of the Package and Other Information

1. What is Danengo and What is it Used For

Danengo 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.
Danengo is used in adults to:

• prevent blood clots in the veins after hip or knee replacement surgery.
• prevent blood clots in the brain (stroke) and other blood vessels in the patient's 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 and prevent blood clots in the legs and lungs.

Danengo is used in children to:

• treat and prevent blood clots.

2. Important Information Before Taking Danengo

When Not to Take Danengo

• 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 condition that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This can 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 catheter into a vein or artery, when heparin is administered to maintain catheter 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 can 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 mechanical heart valve that requires continuous anticoagulation.

Warnings and Precautions

Before starting Danengo, 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 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 severe injury (e.g., 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 "Danengo and Other Medications" below.
• if the patient is taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
• if the patient has endocarditis (bacterial infection of the heart).
• if the patient has decreased kidney function or is dehydrated (feeling thirsty and producing less urine).
• 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 pediatric use: 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 the patient has liver disease affecting blood test results. In such cases, the use of Danengo is not recommended.

When to Exercise Particular Caution When Taking Danengo

• if the patient needs to undergo surgery: in such cases, it is necessary to temporarily discontinue Danengo due to the increased risk of bleeding during and after surgery. It is very important to take Danengo before and after surgery exactly as prescribed by the doctor.
• 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 Danengo before and after surgery exactly as prescribed by the doctor.
• the patient should immediately inform the doctor if they experience numbness or weakness in the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient falls or injures themselves while taking the medication, especially if they hit their head. The patient 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 antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Danengo and Other Medications

Tell the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take. In particular, before taking Danengo, tell the doctor if the patient is taking any of the followingmedications:

• blood thinners (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).
• for patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Danengo, depending on the condition for which Danengo 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 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 Danengo on pregnancy and the unborn child is not known. Danengo should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Danengo.
During Danengo treatment, breastfeeding should be avoided.

Driving and Using Machines

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

3. How to Take Danengo

Danengo can be used in adults and children aged 8 years or older who can swallow 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 prescribed by the doctor. In case of doubts, consult the doctor.

Take Danengo 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 in patients 75 years of age 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 Danengo is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patients taking medications containing verapamilwith reduced kidney functionof more than half should take a reduced dose of Danengo of 75 mgdue to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once daily.
After knee replacement surgery
Danengo treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Danengo treatment should be started with a dose of 1 capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once daily for a total of 28 to 35 days.
Prevention of blood clots in the brain and body due to irregular heart rhythm and treatment of blood clots in the legs and lungs and prevention of recurrent blood clots in the legs and lungs
The recommended dose is 300 mgtaken as 1 capsule of 150 mg twice daily.
In patients 80 years of age or older, the recommended dose of Danengo is 220 mgtaken as 1 capsule of 110 mg twice daily.
Patients taking medications containing verapamilshould receive a reduced dose of Danengo of 220 mgtaken as 1 capsule of 110 mg twice dailydue to the increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as 1 capsule of 110 mg twice daily.
Danengo treatment can be continued if the patient needs to restore normal heart rhythm using a procedure called cardioversion. Danengo should be taken as prescribed 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 Danengo treatment after the doctor has confirmed that blood clotting is under control. Danengo should be taken as prescribed by the doctor.
Treatment of blood clots and prevention of recurrent blood clots in children
Danengo 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 advises otherwise.
Table 1 shows the single and total daily doses of Danengo in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Danengo Dosing Table in Capsule Form
Doses requiring the combination of more than one capsule:
300 mg:
2 capsules of 150 mg each or
4 capsules of 75 mg each
260 mg:
1 capsule of 110 mg and 1 capsule of 150 mg or
1 capsule of 110 mg and 2 capsules of 75 mg each
220 mg:
2 capsules of 110 mg each
185 mg:
1 capsule of 75 mg and 1 capsule of 110 mg
150 mg:
1 capsule of 150 mg or
2 capsules of 75 mg each

How to Take Danengo

Danengo 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 Danengo capsules from a 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 back 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 a capsule and taking a dose, immediately close the container tightly with the cap.

Changing Anticoagulant Medication

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

Taking a Higher Than Recommended Dose of Danengo

Taking too much Danengo increases the risk of bleeding. If the patient has taken too many Danengo capsules, they should immediately contact a doctor. Specific treatments are available.

Missing a Dose of Danengo

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Danengo 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 due to irregular heart rhythm and treatment of blood clots in the legs and lungs and prevention of recurrent blood clots in the legs and lungs
Use in children: Treatment of blood clots and prevention of recurrent blood clots
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 Danengo Treatment

Danengo should be taken as prescribed by the doctor. Do not stop taking Danengo without consulting the doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Consult the doctor if the patient experiences indigestion after taking Danengo.
In case of any further doubts about the use of this medication, consult the doctor or pharmacist.

4. Possible Side Effects

Like all medications, Danengo can cause side effects, although not everybody gets them.
Danengo affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding.
Severe or massive bleeding can 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.
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), immediately contact a doctor. The doctor may decide to closely monitor the patient or change the medication.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, immediately contact a doctor.
Side effects are listed below by frequency of occurrence:

• Frequent (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

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

• bleeding that may occur from the nose, into the stomach or intestines, from the penis or vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• formation of hematomas or bruising after surgery
• blood in the stool as detected by laboratory tests
• decrease in red blood cell count
• decrease in hematocrit
• allergic reaction
• vomiting
• diarrhea
• nausea
• wound secretion (oozing from the surgical wound)
• increase in liver enzyme activity
• jaundice (yellowing of the skin or eyes) due to liver or blood disease

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

• bleeding
• bleeding into the brain, from the surgical site, from the injection site, or from the catheter insertion site
• bleeding from the catheter insertion site into a vein
• coughing up blood or sputum stained with blood
• decrease in platelet count
• decrease in red blood cell count after surgery
• severe allergic reaction causing breathing difficulties 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
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease

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

• breathing difficulties or wheezing
• decrease in white blood cell count (which helps fight infections)
• hair loss

Prevention of blood clots in the brain and body due to irregular heart rhythm
Frequent (may occur in up to 1 in 10 people):

• bleeding that may occur from the nose, into the stomach or intestines, from the penis or vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• decrease in red blood cell count
• abdominal pain or stomach pain
• indigestion
• diarrhea
• nausea

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

• bleeding
• bleeding from hematomas or from the anus
• bleeding into the brain
• formation of hematomas
• coughing up blood or sputum stained with blood
• decrease in platelet count
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease
• vomiting
• breathing difficulties or wheezing
• increase in liver enzyme activity

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

• bleeding from the surgical site, from the injection site, or from the catheter insertion site into a vein
• severe allergic reaction causing breathing difficulties 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
• decrease in hematocrit
• increase in liver enzyme activity
• jaundice (yellowing of the skin or eyes) due to liver or blood disease

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

• breathing difficulties or wheezing
• decrease in white blood cell count (which helps fight infections)
• hair loss

Treatment of blood clots in the legs and lungs and prevention of recurrent blood clots in the legs and lungs
Frequent (may occur in up to 1 in 10 people):

• bleeding that may occur from the nose, into the stomach or intestines, from the anus, from the penis or vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• indigestion

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

• bleeding
• bleeding into a joint or due to injury
• bleeding from hematomas
• decrease in red blood cell count
• formation of hematomas
• coughing up blood or sputum stained with blood
• allergic reaction
• sudden change in skin color or appearance
• itching
• stomach or intestinal ulcer (including esophageal ulceration)
• esophagitis or gastritis
• gastroesophageal reflux disease
• nausea
• vomiting
• abdominal pain or stomach pain
• diarrhea
• increase in liver enzyme activity

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

• bleeding from the surgical site, from the injection site, or from the catheter insertion site into a vein or bleeding into the brain
• decrease in platelet count
• severe allergic reaction causing breathing difficulties 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):

• breathing difficulties or wheezing
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in hematocrit
• decrease in white blood cell count (which helps fight infections)
• jaundice (yellowing of the skin or 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 small.
Treatment of blood clots and prevention of recurrent blood clots in children
Frequent (may occur in up to 1 in 10 people):

• decrease in red blood cell count
• decrease in 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
• nasal bleeding
• gastroesophageal reflux disease
• vomiting
• nausea
• diarrhea
• indigestion
• hair loss
• increase in liver enzyme activity

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

• decrease in white blood cell count (which helps fight infections)
• bleeding into the stomach or intestines, into the brain, from the anus, from the penis or vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• decrease in hemoglobin levels in the blood (a substance in red blood cells)
• decrease in hematocrit
• itching
• coughing up blood or sputum stained with 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):

• absence of white blood cells (which help fight infections)
• severe allergic reaction causing breathing difficulties or dizziness
• severe allergic reaction causing facial or throat swelling
• breathing difficulties or wheezing
• bleeding
• bleeding into a joint, from a wound, from the surgical site, from the injection site, or from the catheter insertion site into a vein
• bleeding from hematomas
• stomach or intestinal ulcer (including esophageal ulceration)
• abnormal liver function test results

Reporting Side Effects

If side effects occur, including any not listed in this package leaflet, inform the 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 gather more information on the safety of this medication.

5. How to Store Danengo

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister or label on the container after: EXP. The expiration date refers to the last day of the month stated.
Blister pack:
No special storage temperature instructions.
Store in the original packaging to protect from light and moisture.
Container:
No special storage temperature instructions.
Store in the original packaging to protect from light and moisture.
Store the container tightly closed.
Medications should not be disposed of via wastewater or household waste. Ask the 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 Danengo Contains

• The active substance of Danengo is dabigatran etexilate. Each hard capsule contains 110 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); printing ink: shellac, iron oxide black (E 172), potassium hydroxide.

What Danengo Looks Like and Contents of the Package

Danengo, 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.
Danengo, 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 with a child-resistant cap, each containing 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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 Package Leaflet: