Danengo

Package Leaflet: Information for the Patient

Danengo, 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.
• 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 you experience any side effects, including those not listed in this package leaflet, inform your 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 pack 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 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 heart valve problems and at least one additional risk factor.
• treat blood clots in the legs and lungs and prevent repeated formation of blood clots in the legs and lungs.

Danengo is used in children to:

• treat blood clots and prevent repeated blood clots.

2. Important information before taking Danengo

When Not to Take Danengo

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney impairment.
• if you are currently bleeding.
• if you have a condition that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. This can be inherited, of unknown cause, or due to the use of other medications.
• if you are taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a venous or arterial catheter, or when heparin is administered to maintain catheter patency or restore normal heart function through a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver impairment or liver disease that can lead to death.
• if you are taking oral ketoconazole or itraconazole, medications used for fungal infections.
• if you are taking oral cyclosporine, a medication that prevents organ rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have a mechanical heart valve that requires continuous anticoagulation.

Warnings and Precautions

Before starting Danengo, discuss it with your doctor or pharmacist. 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 had a 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 medications that may increase the risk of bleeding. See "Danengo and other medications" below.
• if you are taking anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
• if you have an infection of the heart (bacterial endocarditis).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing a reduced amount of dark, concentrated 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 heart attack or if you have been diagnosed with conditions that increase the risk of heart attack.
• if you have 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 you need to undergo surgery: in such cases, it is necessary to discontinue Danengo temporarily due to the increased risk of bleeding during and after surgery. It is very important to take Danengo before and after surgery exactly as your doctor has advised.
• if surgery 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 Danengo before and after surgery exactly as your doctor has advised.

• 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 determine if there is 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.

Danengo 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 must tell your doctor before taking Danengo 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 for 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 lower dose of Danengo, depending on the condition for which it was prescribed. See section 3.
• Medications that 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 Danengo on pregnancy and the unborn child is not known. You should not take Danengo during pregnancy unless your doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Danengo.

Do not breastfeed while taking Danengo.

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 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 advised. If you are unsure, consult your doctor.

How to Take Danengo

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 legs and lungs and prevention of repeated formation of blood clots in the legs and lungs.

The recommended dose is 300 mg taken as one 150 mg capsule twice daily.

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

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

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

Treatment of blood clots and prevention of repeated 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 body weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. You should continue to take all other medications unless your doctor advises you to stop taking them.

Table 1 shows the single and total daily doses of Danengo in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.

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 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. Do not break, chew, or empty the pellets 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 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 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 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 Danengo

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

Missing a Dose of Danengo

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 Danengo Treatment

Danengo should be taken exactly as your doctor has advised. Do not stop taking Danengo 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 Danengo.

If you have any further doubts about the use of this medication, consult your 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 heavy bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location, and in some cases, these bleeds 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 medication.

If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, 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 abnormal heart function.

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 urinary tract (including urine discolored pink or red due to blood presence), 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 brain.
• Hematoma formation.
• 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.
• Stomach or intestinal ulcers (including esophageal ulcers).
• 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 a joint, from a surgical wound, or from an injection site or 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 white blood cell count.
• Increased liver enzyme activity.
• Jaundice or yellowing 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 hemoglobin levels in the blood (a substance in red blood cells).
• Decreased red blood cell count.
• Decreased white blood cell count (which help fight infections).
• Jaundice or 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 small.

Treatment of blood clots in the legs and lungs and prevention of repeated formation of blood clots in 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 urinary tract (including urine discolored pink or red due to blood presence), 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 discolored with blood.
• Allergic reaction.
• Sudden change in skin color or appearance.
• Itching.
• Stomach or intestinal ulcers (including esophageal ulcers).
• Esophagitis or 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, injection site, or catheter insertion site, or bleeding from 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 red blood cell count.
• Decreased white blood cell count (which help fight infections).
• Jaundice or 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. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

Treatment of blood clots and prevention of repeated 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 or 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 help fight infections).
• Bleeding may occur into the stomach or intestines, brain, rectum, penis or vagina, or urinary tract (including urine discolored pink or red due to blood presence), 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 discolored with blood.
• Abdominal pain or stomach pain.
• Esophagitis or gastritis.
• Allergic reaction.
• Difficulty swallowing.
• Jaundice or yellowing 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 a joint, from a wound, surgical wound, injection site, or 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, 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, Tel.: +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 medication.

5. How to Store Danengo

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 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.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Danengo Contains

• The active substance of Danengo 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 Danengo Looks Like and Contents of the Pack

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

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

Danengo, 150 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

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

Manufacturer

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