DANENGO 75 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Danengo, 75 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Danengo and what is it used for
4. Important information before taking Danengo
   1. When not to take Danengo
   2. Warnings and precautions
   3. When to be particularly careful when taking Danengo
   4. Danengo and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Danengo
   1. Danengo should be taken as follows:
   2. How to take Danengo
   3. Instructions for opening blisters
   4. Instructions for opening the container
   5. Changing anticoagulant medicine
   6. Taking a higher dose of Danengo than recommended
   7. Missing a dose of Danengo
   8. Stopping Danengo treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Danengo
8. Contents of the pack and other information
   1. What Danengo contains
   2. What Danengo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Danengo, 75 mg, hard capsules

Dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 medicines called anticoagulants. Its action is to block the substance in the body responsible for the formation of blood clots.
Danengo is used in adults to:

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

Danengo is used in children to:

• treat blood clots and prevent recurrence of 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 medicine (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. It may be congenital, of unknown cause or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function 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, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent transplant rejection.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if the patient has been fitted with an artificial heart valve that requires continuous anticoagulation.

Warnings and precautions

Before starting to take Danengo, discuss it with your doctor. If symptoms occurred during treatment with this medicine or the patient underwent surgery, consult a 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 had bleeding.
• if the patient has had a 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 medicines that may increase the risk of bleeding. See also "Danengo and other medicines" below.
• if the patient is taking anti-inflammatory medicines, such as acetylsalicylic acid, ibuprofen, diclofenac.
• if the patient has endocarditis (bacterial infection of the heart).
• if the patient has decreased kidney function or is dehydrated (feeling thirsty and passing less dark (concentrated) and/or foamy 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 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.
• if the patient has liver disease that affects blood test results. In such cases, the use of Danengo is not recommended.

When to be particularly careful when taking Danengo

• if the patient needs to undergo surgery: in such cases, it is necessary to 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 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 to reduce pain):
• it is very important to take Danengo before and after surgery exactly as the doctor has instructed.
• the doctor should be informed immediately if the patient experiences numbness or weakness of the lower limbs or bowel or bladder problems after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. Medical attention should be sought immediately. The doctor will examine the patient to see 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 medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken or might take. In particular,
before taking Danengo, tell your doctor if the patient is 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 they are used only on 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 Danengo, depending on the condition for which the medicine was prescribed. See also section 3.
• Medicines used to prevent transplant rejection (e.g. tacrolimus, cyclosporine).
• A combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• 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 called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Danengo on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Danengo.
During treatment with Danengo, 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 the capsules whole.
There are other age-appropriate pharmaceutical forms for the treatment of children under 8 years of age.
This medicine should always be taken exactly as the doctor has instructed. If in doubt, consult a doctor.

Danengo should be taken 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 medicines 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 verapamil-containing medicines, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Danengo due 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 one 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 one 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.
Treatment of blood clots and prevention of recurrence of 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. All other medicines should be continued, unless the doctor advises to stop taking any of them.
Table 1 shows the single and total daily doses of Danengo in milligrams (mg).
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:
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. They should not be broken, chewed or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters

The following diagram shows how to remove Danengo capsules from the blister.
To remove a capsule from the blister:

• 1. Hold the blister by the edges and separate one cell from the rest of the blister 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 foil.
• Do not tear 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, the container should be tightly closed with the cap immediately.

Changing anticoagulant medicine

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

Taking a higher dose of Danengo than recommended

Taking too much Danengo increases the risk of bleeding. If the patient has taken too many Danengo capsules, they should contact their doctor immediately. 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.
Treatment of blood clots and prevention of recurrence of blood clots in children.
A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours before 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 exactly as the doctor has instructed. Do not stop taking Danengo without consulting your doctor first, as the risk of blood clots may be higher if treatment is stopped too early. Contact your doctor if you experience nausea after taking Danengo.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, 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. In some cases, these bleedings may not be visible.
If bleeding occurs that does not stop by itself, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), contact your doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
If a serious allergic reaction occurs, which can cause difficulty breathing or dizziness, contact your doctor immediately.
Possible side effects listed below are grouped by frequency of occurrence:

• Frequent (may affect up to 1 in 10 people):
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, stomach or intestines, penis or vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin, into a joint, due to injury or after surgery
• Formation of hematomas or bruising after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Presence of wound exudate
• Increased liver enzyme activity
• Jaundice or yellowing of the skin and whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, injection site, or catheter site
• Blood-tinged exudate from the catheter site
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased red blood cell count after surgery
• 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
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Nausea
• Difficulty swallowing
• Wound exudate
• Wound exudate after surgery

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

• Difficulty breathing or wheezing
• Decreased or absent white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots and prevention of 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 and appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• 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, brain, anus, penis or vagina, or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing of the skin and whites of the eyes due to liver or blood disease

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

• Absent 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, surgical site, injection site, or catheter site
• 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 leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medicine.

5. How to store Danengo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or label on the container after: EXP. The expiry date refers to the last day of the month stated.
Blister:
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.
Store the container tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 75 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), 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, 75 mg, hard capsules (capsules): The capsule cap is white or almost white, the capsule body is white or almost white, with a black mark "75" printed along the length, approximately 18 mm long.
The capsule contents are yellowish-white to light yellow pellets.
Danengo, 75 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 blisters.
• 60 hard capsules in a container with a child-resistant cap or 3 containers of 60 hard capsules with child-resistant caps.

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 medicine, 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 leaflet: