Dabigatran etexilate Combix 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Combix 150 mg hard capsules EFG

dabigatran etexilate

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dabigatran etexilate Combix is and what it is used for
2. What you need to know before taking Dabigatran etexilate Combix
3. How to take Dabigatran etexilate Combix
4. Possible adverse effects
5. How to store Dabigatran etexilate Combix
6. Contents of the pack and other information

1. What Dabigatrán etexilato Combix is and what it is used for

Dabigatrán etexilato Combix contains the active substance dabigatrán etexilato and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatrán etexilato Combix is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treat blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatrán etexilato Combix is used in children to:

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

2. What you need to know before taking Dabigatrán etexilato Combix

Do not take Dabigatrán etexilato Combix

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you currently have bleeding.
• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely impaired or you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting to take Dabigatrán etexilato Combix. You may also need to talk to your doctor during treatment with this medicine if you experience any symptoms or if you need to undergo surgery.

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

• If you have an increased risk of bleeding, for example:

  • if you have recently had bleeding.
  • if you have undergone surgical tissue removal (biopsy) within the last month.
  • if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
  • if you have inflammation of the oesophagus or stomach.
  • if you have problems with gastric juice reflux into the oesophagus.
  • if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Combix” below.
  • if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
  • if you have an infection in the heart (bacterial endocarditis).
  • if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine).
  • if you are over 75 years old.
  • if you are an adult patient and weigh 50 kg or less.
  • only if used in children: if the child has an infection in or around the brain.

• If you have had a heart attack or have been diagnosed with diseases that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

Take special care with Dabigatrán etexilato Combix

• If you need to undergo surgery:

In this case, Dabigatrán etexilato Combix should be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important that you take Dabigatrán etexilato Combix before and after surgery exactly as directed by your doctor.

• If surgery requires the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):

  • It is very important that you take Dabigatrán etexilato Combix before and after surgery exactly as directed by your doctor.
  • Inform your doctor immediately if you experience numbness or weakness in the legs or intestinal or bladder problems after the anaesthesia wears off, as this situation requires urgent attention.

• If you fall or get injured during treatment, especially if you hit your head. Seek urgent medical help. You may need to be examined by a doctor, as you may be at increased risk of bleeding.

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Dabigatrán etexilato Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. In particular, you must tell your doctor before taking Dabigatrán etexilato Combix if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for the treatment of fungal infections (e.g., ketoconazole, itraconazol), except if applied only to the skin
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatrán etexilato Combix depending on the condition for which it has been prescribed. See also section 3.

• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine)
• A combination product of 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 remedy for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Certain antiepileptic medicines (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects of Dabigatrán etexilato Combix on pregnancy and the unborn child are unknown. You should not use this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant while being treated with Dabigatrán etexilato Combix.

Breastfeeding is not recommended during treatment with Dabigatrán etexilato Combix.

Driving and using machines

Dabigatrán etexilato Combix has no known effects on the ability to drive or use machines.

3. How to take Dabigatran etexilate Combix

Dabigatran etexilate Combix capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms available according to age for the treatment of children under 8 years of age.

Always follow exactly the dosing instructions for this medicine given by your doctor. If you are unsure, consult your doctor again.

Take Dabigatran etexilate Combix as recommended for the following conditions:

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of such clots

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

If you are 80 years of age or older, the recommended dose is 220 mg administered as one 110 mg capsule twice daily.

If you are taking medicines containing verapamil, you will be prescribed a reduced dose of Dabigatran etexilate Combix of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg administered as one 110 mg capsule twice daily.

You may continue taking this medicine if a procedure called cardioversion is performed to restore your normal heart rhythm. Take Dabigatran etexilate Combix exactly as directed by your doctor.

If you have received a medical device (vascular stent) placed in a blood vessel during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Dabigatran etexilate Combix once your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Combix exactly as directed by your doctor.

Treatment of blood clots and prevention of recurrence in children

Dabigatran etexilate Combix should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.

Table 1 shows the single doses and total daily doses of Dabigatran etexilate Combix in milligrams (mg). The doses are based on patient weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Combix capsules

Single doses requiring combinations of more than one capsule

How to take Dabigatran etexilate Combix

Dabigatran etexilate Combix capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.

Dabigatran etexilate Combix can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Changing anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabigatran etexilate Combix than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dabigatran etexilate Combix

Prevention of blood clots after knee or hip replacement surgery: Take the remaining daily doses of Dabigatran etexilate Combix at the usual time on the following day.

Do not take a double dose to make up for missed doses.

Use in adults: Prevention of cerebral or systemic vascular obstruction due to blood clot formation associated with irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs.

Use in children: Treatment of blood clots and prevention of their recurrence.

A missed dose may be taken up to 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for missed doses.

If you stop taking Dabigatran etexilate Combix

Take Dabigatran etexilate Combix exactly as prescribed by your doctor. Do not stop treatment with this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Combix.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Dabigatran etexilate Combix acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or serious bleeding episodes may occur, which represent the most severe adverse effects and, regardless of their location, may lead to disability, may be potentially life-threatening, or even result in death. In some cases, this bleeding may not be apparent.

If you experience any bleeding episode that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you closely or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of stroke or systemic embolism due to blood clots caused by irregular heartbeat

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in the urine turning it pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach ache
• Indigestion
• Frequent loose or watery stools
• Feeling nauseous

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting color and appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function tests

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

• Bleeding may occur in a joint, at a surgical incision site, in a wound, at the injection site, or at the site where a venous catheter is inserted
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of leukocytes (which help fight infections)
• Hair loss

In a clinical trial, the rate of heart attacks with Dabigatran etexilate Combix was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in the urine turning it pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur in a joint or wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or watery stools
• Abnormal liver function tests
• Increased liver enzymes

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

• Bleeding may occur at a surgical incision site, at an injection site, at the site where a venous catheter is inserted, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of leukocytes (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders
• Hair loss

In the clinical trial program, the rate of heart attacks with Dabigatran etexilate Combix was higher than with warfarina. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

Frequent (may affect 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 with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in the skin affecting color and appearance
• Bruising
• Nasal bleeding
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of leukocytes (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine turning it pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach ache
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Absence of leukocytes (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 may occur in a joint or wound, at a surgical incision site, at an injection site, or at the site where a venous catheter is inserted
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran etexilate Combix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after "EXP". The expiry date refers to the last day of the month indicated.

Aluminum – Aluminum (oPA/Al/PVC//Al blister): Do not store above 30°C.

Aluminum with desiccant coating – Aluminum (OPA/Al/PE//PE/Al/LDPE): No special storage conditions required.

Bottles: Do not store above 30°C. Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Combix

• The active substance is dabigatran. Each hard capsule contains dabigatran etexilate mesilate equivalent to 150 mg of dabigatran etexilate.

The other components are:

• Capsule contents: tartaric acid, hypromellose, hydroxypropylcellulose, talc.
• Capsule shell: indigo carmine, carrageenan, potassium chloride, titanium dioxide, hypromellose.

Nature of the product and contents of the container

Hard capsules approximately 22.0 mm long, with a light blue, opaque cap and a white, opaque body, size “0”, filled with whitish to yellowish granules.

The capsules are stored in blisters made of aluminum with desiccant cover – aluminum (OPA/Al/PE//PE/Al/LDPE) and aluminum – aluminum (oPA/Al/PVC//Al blister), or in white plastic bottles with silica gel desiccant in the cap (PP).

Pack sizes:

Blister packs containing: 10, 10x1 (single-dose blister), 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100 or 180 hard capsules.

Bottles containing: 60 or 100 hard capsules.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Laboratorios Liconsa S.A. Avenida Miralcampo 7 Poligono Industrial Miralcampo 19200, Azuqueca De Henares Guadalajara Spain

Date of the most recent revision of this leaflet:

March 2026