Dabigatran etexilate Alter Genericos 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Alter Generics 150 mg hard capsules EFG

dabigatran etexilate

Read the 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Dabigatran Etexilate Alter Generics is and what it is used for

Dabigatran Etexilate Alter Generics 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 involved in blood clot formation.

Dabigatran etexilate is used in adults for:

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

• treating blood clots in the veins of the legs and lungs and preventing the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran etexilate is used in children for:

• treating blood clots and preventing their recurrence.

2. What you need to know before taking Dabigatrán etexilato Alter Genéricos

Do not take Dabigatrán etexilato Alter Genéricos

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).

• if you have severely reduced kidney function.

• if you are bleeding.

• if you have a disease in an organ of the body that increases the risk of serious bleeding (for example, stomach ulcer, brain injury or hemorrhage, recent brain or eye surgery).

• if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.

• if you are taking medicines to prevent blood clotting (for example, warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, while you have an intravenous or arterial line and receive heparin through this line to keep it open, or while normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.

• if you have severely reduced liver function or 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 heartbeats.

• 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 permanent anticoagulation.

Warnings and precautions

Talk to your doctor before taking this medicine. You may also need to speak with your doctor during treatment with this medicine if you experience symptoms or if you need to undergo a surgical procedure.

Tell your doctor if you have or have had any condition or illness, particularly any of the following:

• if you have a higher risk of bleeding, for example:

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

• if you have had a myocardial infarction or if you have been diagnosed with diseases that increase the risk of myocardial infarction.

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

Take special care with Dabigatrán etexilato Alter Genéricos

• if you need surgery:

In this case, treatment with this medicine should be temporarily stopped due to an increased risk of bleeding during and shortly after a procedure. It is very important that you take this medicine before and after the procedure exactly at the times instructed by your doctor.

• if a procedure involves a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):

• it is very important that you take this medicine before and after the procedure exactly at the times instructed by your doctor.

• inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anesthesia wears off, as urgent medical attention is required.

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

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that causes an increased risk of blood clots), inform your doctor, who will decide whether treatment needs to be adjusted.

Other medicines and Dabigatrán etexilato Alter Genéricos

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. In particular, you must inform your doctor before taking this medicine 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), unless applied only to the skin.
• Medicines to treat abnormal heartbeats (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of this medicine 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 medicine for depression.
• Antidepressant medicines called 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 this medicine on pregnancy and the fetus are unknown. You must not take this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are

a woman of childbearing age, you should avoid becoming pregnant while taking this medicine.

You must not breastfeed while taking this medicine.

Driving and using machines

This medicine has no known effects on the ability to drive or operate machinery.

3. How to take Dabigatran etexilate Alter Generics

Dabigatran etexilate capsules can be used in adults and children over 8 years of age who are able to swallow the capsules whole.

Always follow your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor again.

Take this medicine as recommended for the following conditions:

Prevention of blockage of brain or body blood vessels due to blood clot formation caused by irregular heartbeats, and treatment of blood clots in the legs and lungs, including prevention of recurrence of blood clots in the legs and lungs.

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

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

If you are taking medicines containing verapamil, you should be treated with a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may increase.

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

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

If a medical device (stent) has been implanted in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with this medicine after your doctor has determined that normal blood coagulation control has been achieved. Take this medicine exactly as directed by your doctor.

Treatment of blood clots and prevention of their recurrence in children

This medicine should be taken twice daily, one dose in the morning and one 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 the dose as treatment progresses. Continue taking all other medications unless your doctor tells you to stop any of them.

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

Table 1: Dosing table for Dabigatran etexilate Alter Generics capsules.

Single doses requiring combinations 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 plus one capsule of 150 mg, or
one capsule of 110 mg plus two capsules of 75 mg

220 mg: two capsules of 110 mg

185 mg: one capsule of 75 mg plus one capsule of 110 mg

150 mg: one capsule of 150 mg or two capsules of 75 mg

How to take Dabigatran Etexilate Alter Generics

This medicine can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure it reaches the stomach. Do not break, chew, or empty the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the blister pack

1. Detach one blister through the perforated lines (Figure 1).

2. Carefully peel back the foil and remove the capsule (Figure 2).

3. Do not push the capsules through the blister.
4. Do not remove the blister until you need a capsule.

Switching anticoagulant treatment

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

If you take more Dabigatran Etexilate Alter Generics than you should

Taking too much of this medicine increases the risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at: 91 652 04 20, indicating the medicine and the amount ingested. Specific treatment options are available.

If you forget to take Dabigatran Etexilate Alter Generics

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 scheduled dose. Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran Etexilate Alter Generics

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

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

4. Possible adverse effects

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

This medicine affects blood clotting, so most side effects are related to signs such as bruising or bleeding. Serious or major bleeding may occur, which represent the most severe side effects and, regardless of their location, may become disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.

If you experience any bleeding 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 observation or change your medication.

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

The following is a list of possible side effects, grouped by their frequency.

Prevention of blockage of cerebral or systemic blood vessels due to blood clot formation following abnormal heartbeats.

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

• You may bleed from the nose, stomach or intestines, 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
• Stomach or abdominal pain
• Indigestion
• Frequent loose or soft stools
• Feeling sick

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

• Bleeding
• Bleeding may occur in hemorrhoids, rectum, or brain.
• Bruising
• Coughing up blood or bloody sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting its 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
• Unusual results in liver function laboratory tests

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

• Bleeding may occur in a joint, from a surgical incision, from a wound, from the injection site, or from the site where a venous catheter was inserted
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red bumps due to an allergic reaction
• Decrease in the proportion of blood cells
• Increase in 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 of, or even absence of, white blood cells (which help fight infections)
• Hair loss

In a clinical study, the rate of myocardial infarction with dabigatran 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):

• You may bleed 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 following an injury
• Hemorrhoids may bleed
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood-streaked or blood-tinged sputum
• Allergic reaction
• Sudden change in the skin affecting its 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 sick
• Vomiting
• Stomach or abdominal pain
• Frequent loose or soft stools
• Unusual results in liver function laboratory tests
• Increase in liver enzymes

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

• Bleeding may occur from a surgical incision, from the injection site, from the site where a venous catheter was 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 characterized by raised, itchy, dark red 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 (substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number of, 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 study program, the rate of myocardial infarction with Dabigatran etexilate Alter Generics was higher than with warfarin. The overall incidence was low. No imbalance in the rate of myocardial infarction was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of their recurrence 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 characterized by raised, itchy, dark red bumps due to an allergic reaction
• Sudden change in the skin affecting its color and appearance
• Bruising
• Nosebleeds
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling sick
• Frequent loose or soft stools
• Indigestion
• Hair loss
• Increase in 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 (substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or bloody sputum
• Stomach or abdominal 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 following an injury, from a surgical incision, from the injection site, or from the site where a venous catheter was inserted
• Hemorrhoids may bleed
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Unusual results in liver function laboratory tests

Reporting of adverse effects

If you experience any 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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran etexilate Alter Generics

Keep this medicine out of the 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 month indicated.

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Alter Generics

• The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate), equivalent to 150 mg of dabigatran etexilate.
• The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), indigo carmine (E-132), and hypromellose 2910.

Appearance of the medicine and contents of the pack

Dabigatran etexilate Alter Generics 150 mg are hard capsules with a blue cap and a white to off-white body, size 0, containing off-white to pale yellow pellets.

This medicine is available in packs containing:

10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose aluminum/OPA-AL-PVC perforated blisters.

A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or 2 packs of 50 x 1 hard capsules (100 hard capsules) in single-dose aluminum/OPA-AL-PVC perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

Date of the most recent revision of this leaflet: 08/2025

Other sources of information

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