Daroxomb
Poland
Table of Contents
Package leaflet: Information for the user
Daroxomb, 75 mg, hard capsules
Dabigatranum etexilatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet, as 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 individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Daroxomb is and what it is used for
- Important information before taking Daroxomb
- How to take Daroxomb
- Possible side effects
- How to store Daroxomb
- Contents of the pack and other information
1. What Daroxomb is and what it is used for
Daroxomb 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.
Daroxomb is used in adults to:
- prevent the formation of blood clots in the veins following hip or knee replacement surgery.
Daroxomb is used in children to:
- treat blood clots and to prevent recurrence of blood clots.
2. Important information before taking Daroxomb
When not to take Daroxomb
- 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 is currently experiencing bleeding.
- if the patient has an internal organ disease that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or intracranial hemorrhage, 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.
- 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 an artificial heart valve, which requires continuous use of blood-thinning medicines.
Warnings and precautions
Before starting treatment with Daroxomb, 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 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 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 esophagus or stomach.
- if the patient has gastroesophageal reflux (backflow of stomach acid into the esophagus).
- if the patient is taking medicines that may increase the risk of bleeding. See below “Daroxomb and other medicines”.
- if the patient is taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
- if the patient has an infection of 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 diagnosed to increase the risk of heart attack.
- if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.
When to exercise particular caution when taking Daroxomb
- if the patient needs to undergo surgery: In such cases, temporary discontinuation of Daroxomb is necessary due to increased risk of bleeding during and immediately after surgery. It is very important to take Daroxomb exactly as directed by the doctor before and after surgery.
- if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
- It is very important to take Daroxomb exactly as directed by the doctor before and after surgery.
- The patient should immediately inform the doctor if numbness or weakness in the legs, or problems with bowel or bladder function occur after the anesthesia 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 immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.
Daroxomb and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take. In particular, tell the doctor before taking Daroxomb 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 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 Daroxomb 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-norepinephrine 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 unknown what effect Daroxomb has on pregnancy and the unborn child. This medicine should
not be taken during pregnancy unless the doctor determines it is safe.
Women of childbearing age should avoid becoming pregnant while taking Daroxomb.
Breastfeeding is not recommended during treatment with Daroxomb.
Driving and operating machinery
Daroxomb has no effect or a negligible effect on the ability to drive and operate machinery.
3. How to take Daroxomb
Daroxomb capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are available for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Take Daroxomb exactly as described below:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose of Daroxomb is 220 mg once daily (taken as 2 capsules of 110 mg each).
If kidney function is 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 medications containing amiodarone, quinidine, or verapamil, the recommended dose of Daroxomb is 150 mg once daily (taken as 2 capsules of 75 mg each).
Patients taking medications containing verapamil, who also have reduced kidney function by more than half, should take a reduced dose of Daroxomb of 75 mg due to an increased risk of bleeding.
In both types of surgery, treatment should not be initiated if there is active bleeding at the surgical site. If treatment cannot be started by the day after surgery, it should be initiated at a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Daroxomb should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two capsules should be taken once daily for a total of 10 days.
After hip replacement surgery
Treatment with Daroxomb should begin with one capsule taken 1 to 4 hours after completion of the surgical procedure. Then, two 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
Daroxomb 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 ideally be 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. You should continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Daroxomb in milligrams (mg).
Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Daroxomb capsules
| Body weight and age ranges | Single dose in mg | Total daily dose in mg | |
| Body weight in kg | Age in years | ||
| from 11 to less than 13 kg | from 8 to less than 9 years | 75 | 150 |
| from 13 to less than 16 kg | from 8 to less than 11 years | 110 | 220 |
| from 16 to less than 21 kg | from 8 to less than 14 years | 110 | 220 |
| from 21 to less than 26 kg | from 8 to less than 16 years | 150 | 300 |
| from 26 to less than 31 kg | from 8 to less than 18 years | 150 | 300 |
| from 31 to less than 41 kg | from 8 to less than 18 years | 185 | 370 |
| from 41 to less than 51 kg | from 8 to less than 18 years | 220 | 440 |
| from 51 to less than 61 kg | from 8 to less than 18 years | 260 | 520 |
| from 61 to less than 71 kg | from 8 to less than 18 years | 300 | 600 |
| from 71 to less than 81 kg | from 8 to less than 18 years | 300 | 600 |
| 81 kg or more | from 10 to less than 18 years | 300 | 600 |
Single doses requiring combination of more than one capsule:
300 mg: two capsules of 150 mg or
four capsules of 75 mg
260 mg: one capsule of 110 mg and one capsule of 150 mg or
one capsule of 110 mg and two capsules of 75 mg
220 mg: as two capsules of 110 mg
185 mg: as one capsule of 75 mg and one capsule of 110 mg
150 mg: as one capsule of 150 mg or
two capsules of 75 mg
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 blister packs
The following pictogram illustrates how to remove Daroxomb capsules from the blister pack.
Separate the single dose along the perforated line.
Peel back the protective foil from the blister and remove the capsule.
- Do not push the capsule through the blister foil.
- Do not peel back the foil until the capsule is needed.
Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving specific instructions from your doctor.
Taking more Daroxomb than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.
Missed dose of Daroxomb
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Daroxomb at the usual time on the following 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 Daroxomb
Daroxomb should be taken as directed by the doctor. Do not stop taking this medicine 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 intolerance occurs after taking Daroxomb.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Daroxomb affects the blood clotting system; therefore, most adverse effects are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse effect, and 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 you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.
If you experience a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.
The possible adverse effects listed below are grouped according to 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, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), from hemorrhoids, from the rectum, under the skin, into a joint, due to trauma or following trauma or surgical procedure
- Formation of hematomas or bruising following surgical procedure
- Blood in stool detected in laboratory tests
- Decrease in the number of red blood cells in the blood
- Decrease in blood cell count
- Allergic reaction
- Vomiting
- Frequent passage of loose or watery stools
- Nausea
- Discharge from wound (fluid leakage 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 1,000 people):
- Bleeding
- Bleeding into the brain, from the surgical incision site, from the injection site, or from the site where a venous catheter was inserted
- Blood-tinged discharge from the site where a venous catheter was inserted
- Coughing up blood or blood-stained sputum
- Decrease in the number of platelets in the blood
- Decrease in the number of red blood cells in the blood following surgical procedure
- Severe allergic reaction causing difficulty breathing or dizziness
- Severe allergic reaction causing swelling of the face or throat
- Skin rash consisting 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)
- 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 not known (frequency cannot be estimated 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 the number of red blood cells in the blood
- Decrease in the number of platelets in the blood
- Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
- Sudden change in skin color and appearance
- Formation of hematomas
- Nosebleeds
- Regurgitation of stomach contents into the esophagus (reflux)
- Vomiting
- Nausea
- Frequent passage of loose or watery stools
- Indigestion
- Hair loss
- Increased liver enzyme activity
Uncommon (may occur in up to 1 in 100 people):
- Decrease in the number of white blood cells (which help fight infections)
- Bleeding into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
- Decrease in hemoglobin levels in the blood (a substance in red blood cells)
- Decrease in blood cell count
- 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 not known (frequency cannot be estimated 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 a joint, from a wound, from the surgical incision site, from the injection site, or from the site where a venous catheter was inserted
- Bleeding from hemorrhoids
- Stomach or intestinal ulcer (including esophageal ulceration)
- Abnormal liver function test results
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Daroxomb
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
EXP. The expiry date refers to the last day of the stated month.
Do not store above 30ºC.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Daroxomb contains
- The active substance is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (as mesilate), equivalent to 75 mg of dabigatran etexilate.
- Other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc and hydroxypropylcellulose (100 cps).
- The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171) and hypromellose 2910 (6 cps).
What Daroxomb looks like and contents of the pack
Daroxomb 75 mg is a hard capsule, white to off-white in colour, size 2, filled with off-white to pale yellow pellets.
Daroxomb is available in packages containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose perforated blisters made of
Aluminium/OPA/Aluminium/PVC foil.
Not all pack sizes may be marketed.
Marketing Authorisation 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00