Dabigatran etexilate Stadafarma 150 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Dabigatran etexilate Stadafarma 150 mg hard capsules EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult 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 effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Dabigatran etexilate Stadafarma is and what it is used for

This medicine contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatran etexilate 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.

Dabigatran etexilate is used in children to:

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

2. What you need to know before starting to take Dabigatran etexilate Stadafarma

Do not take Dabigatran etexilate Stadafarma

• 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 are currently experiencing bleeding.
• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, cerebral injury or hemorrhage, 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 medications to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter through which heparin is administered 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 Dabigatran etexilate Stadafarma. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are scheduled for 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 esophagus or stomach.
  • if you have gastroesophageal reflux disease (acid reflux into the esophagus).
  • if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran etexilate Stadafarma” 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 weighing 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 conditions that increase the risk of heart attack.

• If you have a liver disease associated with changes in blood tests. Use of this medicine is not recommended in such cases.

Take special care with Dabigatran etexilate Stadafarma

• If you need to undergo surgery:

In this case, dabigatran etexilate should be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate before and after surgery exactly at the times specified by your doctor.

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

  • It is very important that you take dabigatran etexilate before and after surgery exactly at the times specified by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after anesthesia wears off, as this situation requires urgent medical attention.

• If you fall or are 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 have an 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 Dabigatran etexilate Stadafarma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking dabigatran etexilate 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 to treat fungal infections (e.g., ketoconazole, itraconazole), except when 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 take a reduced dose of dabigatran etexilate depending on the condition for which it has been prescribed. See section 3.
• Medicines 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 known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g., ritonavir)
• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects of dabigatran etexilate on pregnancy and the fetus are unknown. You must not use this medicine during pregnancy unless your doctor tells you it is safe. If you are of childbearing age, you should avoid becoming pregnant while being treated with dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive or use machines.

3. How to take Dabigatran etexilate Stadafarma

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

Always follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Take dabigatran etexilate as recommended for the following conditions:

Prevention of systemic or cerebral vascular blockage 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 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 of dabigatran etexilate is 220 mg administered as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you should be prescribed a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, as 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 of dabigatran etexilate administered as one 110 mg capsule twice daily.

You may continue taking dabigatran etexilate if it is necessary to restore your normal heart rhythm through a procedure called cardioversion or through a catheter ablation procedure for atrial fibrillation. Take dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) implanted in a blood vessel to keep it open during a procedure known as percutaneous coronary intervention with stent placement, you may receive treatment with dabigatran etexilate once your doctor has determined that normal blood coagulation control has been achieved. Take dabigatran etexilate exactly as directed by your doctor.

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

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

The recommended dose depends on age and body weight. 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 taking any of them.

Single dose of dabigatran etexilate to be administered twice daily in milligrams (mg) according to body weight in kilograms (kg) and patient age in years:

Weight [kg]	Age in years
	From 8 to <9	From 9 to <10	From 10 to <11	From 11 to <12	From 12 to <13	From 13 to <14	From 14 to <15	From 15 to <16	From 16 to <17	From 17 to <18
>81		300 mg in two 150 mg capsules or four 75 mg capsules
From 71 to <81
From 61 to <71
From 51 to <61	260 mg in one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules
From 41 to <51	220 mg in two 110 mg capsules
From 31 to <41	185 mg in one 75 mg capsule plus one 110 mg capsule
From 26 to <31	150 mg in one 150 mg capsule or two 75 mg capsules
From 21 to <26
From 16 to <21	One capsule of 110 mg
From 13 to <16
From 11 to <13	One capsule of 75 mg

Means that no dosage recommendations can be made

How to take Dabigatran etexilate Stadafarma

Dabigatran etexilate can be taken with or without food. The capsule should 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.

Instructions for opening blister packs

The following images illustrate how to remove Dabigatran etexilate Stadafarma capsules from the blister pack:

Separate an individual blister from the strip along the perforated line.

Peel back the backing foil and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the foil until the capsule is needed.

Instructions for the bottle

• Press and twist to open.
• After removing the capsule, replace the cap on the bottle and close the bottle tightly immediately after taking your dose.

Switching anticoagulant treatment

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

If you take more Dabigatran etexilate Stadafarma than you should

Taking too much dabigatran etexilate increases the risk of bleeding. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medication and the amount of dabigatran etexilate ingested. Specific treatment options are available.

If you forget to take Dabigatran etexilate Stadafarma

A missed dose can 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 forgotten doses.

If you stop taking Dabigatran etexilate Stadafarma

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

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 acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding.

Major or severe bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, this bleeding may not be evident.

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 keep you under close monitoring 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 listed below, grouped according to their frequency of occurrence.

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm

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 urine that turns urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid 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 blood-streaked sputum
• 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 physical 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, wound, 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 number or even absence of white blood cells (which help fight infections)
• Hair loss

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

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/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 urine that turns urine 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 blood-streaked sputum
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including throat ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid 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, injection site, venous catheter insertion site, 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 number or even absence of white blood cells (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 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 physical appearance
• Bruising
• Nosebleed
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in urine that turns urine 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 blood-streaked 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, caused by liver or blood disorders

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 may occur in a joint or wound, surgical incision, injection site, or venous catheter insertion site
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormal liver function tests

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Stadafarma

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

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

Blister pack: Do not store above 30°C. Keep in the original packaging to protect from moisture.

Bottle: Do not store above 30°C. Keep in the original packaging to protect from moisture. After opening, the medicine should be used within 4 months. Keep the bottle tightly closed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Stadafarma

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose, and indigo carmine (E-132).

Appearance of the medicinal product and contents of the pack

Dabigatran Etexilate Stadafarma 150 mg are hard capsules with a blue cap and a white or whitish body, size 0, containing whitish to pale yellow pellets.

Dabigatran Etexilate Stadafarma is available in packs containing 1 x 10, 3 x 10 or 6 x 10 hard capsules, a multiple pack containing 3 packs of 1 x 60 hard capsules (180 hard capsules) or a multiple pack containing 2 packs of 1 x 50 hard capsules (100 hard capsules) in perforated aluminum/OPA-ALU-PVC blisters.

This medicine is also available in high-density polyethylene (plastic) bottles containing 60 hard capsules, with a child-resistant screw cap and an integrated desiccant sealed with a fiber seal.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S. L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 – Barcelona

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustín de Guadalix,

Madrid

Spain

or

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

or

Pharmadox Healthcare Limited

Kkw46 Kordin Industrial Park, Paola, PLA 3000,

Malta

Date of the most recent review of this leaflet: February 2026

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/