Dabigatran etexilate Alter Genericos 110 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran etexilate Alter Generics 110 mg hard capsules EFG

dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this 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 to:

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

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

• treat blood clots in the legs and lungs and to prevent such blood clots from recurring.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent 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 a higher 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 are receiving heparin through this line to keep it open, or while your 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 lead to death.
• 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 lifelong 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 need to undergo a surgical procedure.

Tell your doctor if you have or have had any condition or illness, especially 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 (for example, a bone fracture, head trauma, or any injury requiring surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have gastroesophageal reflux (stomach acid flowing back 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 nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know you have reduced kidney function or 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 around or inside the brain.

• if you have had a myocardial infarction or have been diagnosed with conditions 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 at exactly the times prescribed by your doctor before and after the procedure.

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

  • it is very important that you take this medicine at exactly the times prescribed by your doctor before and after the procedure.
  • inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anesthesia wears off, as urgent medical attention is required.

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

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment adjustment is necessary.

Other medicines and Dabigatrán etexilato Alter Genéricos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 (for example, warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines to treat fungal infections (for example, ketoconazole, itraconazole), unless applied only to the skin.
• Medicines to treat abnormal heart rhythms (for example, 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 this medicine depending on the condition for which it has been prescribed. See section 3.
• Medicines to prevent organ rejection after transplantation (for example, tacrolimus, cyclosporine).
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Nonsteroidal anti-inflammatory drugs and painkillers (for example, 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/AIDS (for example, ritonavir).
• Certain medicines used to treat epilepsy (for example, carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of this medicine on pregnancy and the fetus are unknown. You should not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you must avoid becoming pregnant while taking Dabigatrán etexilato Alter Genéricos.

You must not breastfeed while taking this medicine.

Driving and use of 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.

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Take this medicine as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery

The recommended dose is 220 mg once daily (in 2 capsules of 110 mg).

If your renal function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken in 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (2 capsules of 75 mg).

If you are taking medications containing verapamil and your renal function is reduced by more than half, you should be treated with a reduced dose of dabigatran etexilate 75 mg, because your risk of bleeding may increase.

For both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should begin with 2 capsules once daily.

After knee replacement surgery

You should start treatment with this medicine within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, you should take two capsules once daily for a total of 10 days.

After hip replacement surgery

You should start treatment with this medicine within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, you should take two capsules once daily for a total of 28–35 days.

Prevention of cerebral or systemic vessel blockage due to blood clot formation in patients with abnormal heartbeats, and treatment of blood clots in the leg veins and lungs, including prevention of recurrence of venous 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 medications containing verapamil, you should be treated with a reduced dose of this medicine 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 it becomes necessary to restore normal heart rhythm through a procedure called cardioversion. Take this medicine as directed by your doctor.

If a medical device (stent) has been placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent, you may be treated with this medicine after your doctor has decided that normal blood coagulation control has been achieved. Take this medicine 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 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 daily individual and total 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.

Weight/age combinations	Single dose in mg		Total daily dose in mg
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
26 to less than 31 kg	From 8 to less than 18 years	150		300
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
61 to less than 71 kg	From 8 to less than 18 years	300		600
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 combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule, or
one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

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

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

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. Separate one blister along the perforated lines (Figure 1).

2. Carefully remove the foil and take out the capsule (Figure 2).

3. Do not push the capsules through the blister pack.
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

Prevention of blood clots after knee or hip replacement surgery

Continue with your remaining daily doses at the usual time the following day. Do not take a double dose to make up for the missed dose.

Use in adults: Prevention of blockage in brain or body blood vessels due to blood clots developing after abnormal heartbeats, 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 scheduled dose. Do not take a double 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 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 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 experiences 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 are the most severe side effects; regardless of their location, they 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 possible side effects are listed below, grouped according to their frequency.

Prevention of blood clots after knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells).
• Unusual results in liver function laboratory tests.

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

• Bleeding from the nose, stomach or intestines, penis, vagina, or urinary tract (including blood in urine turning it pink or red), hemorrhoids, rectum, under the skin, in a joint, or after an injury or procedure.
• Bruising or hematoma formation after a procedure.
• Blood detected in stool by laboratory testing.
• Decrease in the number of red blood cells in the blood.
• Decrease in blood cell proportion.
• Allergic reaction.
• Vomiting.
• Frequent loose or soft stools.
• Feeling unwell.
• Wound discharge (fluid leaking from the surgical wound).
• Increased liver enzymes.
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders.

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

• Bleeding.
• Bleeding may occur in the brain, at a surgical incision site, at the injection site, or at 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-tinged sputum.
• Decrease in the number of platelets in the blood.
• Decrease in the number of red blood cells after surgery.
• 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.
• Sudden change in the skin affecting its color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Reflux of gastric juice into the esophagus.
• Abdominal or stomach pain.
• Indigestion.
• Difficulty swallowing.
• Fluid leaking from a wound.
• Fluid leaking from a wound after surgery.

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.

Prevention of blockage of brain or body vessels due to blood clots after abnormal heartbeats.

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

• Bleeding from the nose, stomach or intestines, penis, vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin.
• Decrease in the number of red blood cells in the blood.
• Abdominal or stomach pain.
• Indigestion.
• Frequent loose or soft stools.
• Feeling unwell.

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

• Bleeding.
• Bleeding may occur in hemorrhoids, rectum, or brain.
• Bruising.
• Coughing up blood or blood-tinged sputum.
• Decrease in the number of platelets in the blood.
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells).
• Allergic reaction.
• Sudden change in the skin affecting its color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Reflux of gastric juice 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, at a surgical incision site, after an injury, at an injection site, or at 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 blood cell proportion.
• 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 study, the rate of myocardial infarction with Dabigatran etexilate Alter Genéricos was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the leg and lung veins, including prevention of recurrence of blood clots in the leg and/or lung veins.

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

• Bleeding from the nose, stomach or intestines, rectum, penis, vagina, or urinary tract (including blood in 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 after an injury.
• Hemorrhoids may bleed.
• Decrease in the number of red blood cells in the blood.
• Bruising.
• Coughing up blood or blood-tinged sputum.
• Allergic reaction.
• Sudden change in the skin affecting its color and appearance.
• Itching.
• Stomach or intestinal ulcer (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Reflux of gastric juice into the esophagus.
• Feeling unwell.
• Vomiting.
• Abdominal or stomach pain.
• Frequent loose or soft stools.
• Unusual results in liver function laboratory tests.
• Increased liver enzymes.

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

• Bleeding may occur from a surgical incision, 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 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 (the substance contained in red blood cells).
• Decrease in blood cell proportion.
• 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 study program, the rate of myocardial infarction with Dabigatran etexilate Alter Genéricos 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 recurrence in children

Common (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 skin affecting its color and appearance.
• Bruising.
• Nosebleeds.
• Reflux of gastric juice into the esophagus.
• Vomiting.
• Feeling unwell.
• Frequent loose or soft 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 intestines, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin.
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells).
• Decrease in blood cell proportion.
• Itching.
• Coughing up blood or blood-tinged sputum.
• Abdominal 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 after an injury, at a surgical incision, at an injection site, or at 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 effects, consult your doctor or pharmacist, even if they are possible side effects 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 after "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 from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Dabigatran etexilate Alter Genericos

• The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 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 product and contents of the container

Dabigatran etexilate Alter Genericos 75 mg are blue hard capsules, size 1, containing pellets ranging from whitish to pale yellow.

This medicine is available in packages containing:

10 x 1, 30 x 1, or 60 x 1 hard capsules in pre-scored unit dose aluminum/OPA-AL-PVC blisters.

A multiple pack 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 pre-scored unit dose aluminum/OPA-AL-PVC 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 review 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 Health Products (AEMPS) http://www.aemps.gob.es