DABIGATRAN ETEXILATE LICONSA 110 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Dabigatran etexilate Liconsa110 mg hard capsules EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Dabigatran etexilate Liconsa 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 the formation of blood clots.

Dabigatran etexilate is used in adults to:

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

• 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 blood clots from forming again in the veins of your legs and lungs.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent blood clots from forming again.

2. What you need to know before you take Dabigatran etexilate Liconsa

Do not take Dabigatran etexilate Liconsa

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be inherited, 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 having a venous or arterial catheter and being administered heparin 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 reduced or you have a life-threatening liver disease.
• 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 a transplant.
• if you are taking dronedarone, a medicine used to treat irregular heartbeat.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take this medicine. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

Tell your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• • only if used in children: if the child has an infection in the brain or around it.

• 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.

Be careful with Dabigatran etexilate Liconsa

• If you need to undergo surgery:

In this case, dabigatran etexilate must be temporarily stopped 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 indicated by your doctor.

• If surgery requires the placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia or for pain relief):
• • It is very important that you take dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the end of anesthesia, as this situation requires urgent attention.

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have an increased risk of bleeding.

• If you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor so that they can decide if it is necessary to modify treatment.

Other medicines and Dabigatran etexilate Liconsa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must tell 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 for the treatment of fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin.
• Medicines used to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil).

If you are using medicines that contain amiodarone, quinidine, or verapamil, your doctor may indicate that you should use a reduced dose of dabigatran etexilate depending on the disease for which it was prescribed. See section 3.

• Medicines for the prevention of organ rejection after a transplant (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 selective serotonin and norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV (e.g. ritonavir).
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of dabigatran etexilate on pregnancy and the fetus are unknown. You should not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant during treatment 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 and use machines.

3. How to take Dabigatran etexilate Liconsa

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Take Dabigatran etexilate Liconsa as recommended for the following situations:

Prevention of blood clot formation after knee or hip arthroplasty

The recommended dose is 220 mg once a day(administered in the form of 2 capsules of 110 mg).

If your renal function is decreasedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

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

If you are taking medications containing verapamil and your renal function is decreasedby more than half, you should be indicated a reduced dose of dabigatran etexilate of 75 mgbecause your risk of bleeding may increase.

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

After knee arthroplasty

You should start treatment with dabigatran etexilate 1-4 hours after the operation, taking a single capsule. Then, 2 capsules should be taken once a day for a total of 10 days.

After hip arthroplasty

You should start treatment with dabigatran etexilate 1-4 hours after the operation, taking a single capsule. Then, 2 capsules should be taken once a day for a total of 28-35 days.

Prevention of cerebral or systemic vascular obstruction by blood clot formation developed 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

The recommended dose is 300 mg administered in the form of one 150 mg capsule twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered in the form of one 110 mg capsule twice a day.

If you are using medications containing verapamil, you should be indicated a reduced dose of dabigatran etexilate of 220 mg taken in the form of one 110 mg capsule twice a day, as your risk of bleeding may increase.

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

You can continue taking this medication if it is necessary to restore your normal heartbeat through a procedure called cardioversion. Take dabigatran etexilate as your doctor has indicated.

If you have been fitted with a medical device (vascular endoprosthesis) in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis placement, you may receive treatment with dabigatran etexilate once your doctor has decided that normal blood coagulation control has been achieved. Take dabigatran etexilate as your doctor has indicated.

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

Dabigatran etexilate should be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The administration 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. It is possible that your doctor will adjust the dose during treatment. Continue using all other medications unless your doctor tells you to stop using any.

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

Table 1:Dosing table for dabigatran etexilate capsules

Doses that require combinations of more than one capsule:

How to take Dabigatran etexilate Liconsa

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

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.

Changing anticoagulant treatment

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

If you take more Dabigatran etexilate Liconsa than you should

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

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

If you forget to take Dabigatran etexilate Liconsa

Prevention of blood clot formation after knee or hip arthroplasty

Take the remaining daily doses of dabigatran etexilate at the same time the next day.

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

Use in adults: Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal 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 recurrence of blood clots.

A forgotten dose can be taken up to 6 hours before the next dose.

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

If you interrupt treatment with Dabigatran etexilate Liconsa

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which are the most serious adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

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

Possible adverse effects are listed below, grouped according to their frequency of occurrence.

Prevention of blood clot formation after knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Anomalies in liver function tests

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

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina, or from the urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Formation of hematomas or bruising after surgery
• Detection of blood in stool in a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Feeling sick
• Wound suppuration (discharge of fluid from a surgical wound)
• Increased liver enzymes
• Yellowish discoloration of the skin or the whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Sanguineous suppuration of the site of a catheter in a vein
• Coughing up blood or sputum with blood stains
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain 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 the number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal heart rhythm

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

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina, or from the urinary tract (including blood in the urine that stains the 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 sick

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

• Bleeding
• Bleeding may occur from hemorrhoids, the rectum, or the brain
• Formation of hematomas
• Coughing up blood or sputum with blood stains
• 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 skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests

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

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowish discoloration of the skin or the whites of the eyes, caused by liver or blood problems

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

• Difficulty breathing or wheezing
• Decrease in the 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 the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs

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

• Bleeding may occur from the nose, stomach, or intestine, from the rectum, from the penis/vagina, or from the urinary tract (including blood in the urine that stains the 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 in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood stains
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling sick
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Anomalies in liver function tests
• Increased liver enzymes

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

• Bleeding may occur at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by 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 white blood cells (which help fight infections)
• Yellowish discoloration of the skin or the whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarin. The overall incidence was low. No imbalance was observed in the rate of heart attacks 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, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling sick
• 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, from the brain, from the rectum, from the penis/vagina, or from the urinary tract (including blood in the urine that stains the 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 sputum with blood stains
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowish discoloration of the skin or the whites of the eyes, caused by liver or blood problems

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Anomalies in 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Liconsa

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

Do not use this medicine after the expiration date that appears on the box, blister, or bottle after "EXP". The expiration date is the last day of the month indicated.

Aluminum - Aluminum (orPA/Al/PVC//Al blister): Do not store at a temperature above 30°C.

Aluminum with desiccant cover - Aluminum (OPA/Al/PE//PE/Al/LDPE blister): This medicine does not require special storage conditions.

Bottle: Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through the drains or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dabigatran Etexilate Liconsa

• The active ingredient is dabigatran etexilate. Each capsule contains dabigatran etexilate mesilate equivalent to 110 mg of dabigatran etexilate.

The other components are:

• Capsule content: tartaric acid pellets, hypromellose, hydroxypropylcellulose, and talc.
• Capsule coating: indigo carmine (E132), carrageenan, potassium chloride, titanium dioxide (E171), and hypromellose.

Appearance of the Product and Package Contents

Capsules approximately 19 mm in size with a light blue opaque cap and a light blue opaque body of size "1", filled with white to yellowish granules.

The capsules are stored in Aluminum with desiccant cover - Aluminum (OPA/Al/PE//PE/Al/LDPE blister) and Aluminum - Aluminum (orPA/Al/PVC//Al blister) or in a white plastic bottle with a desiccant silica gel in the cap (PP).

Package sizes:

Packages with blisters contain: 10, 10x1 (precut unit dose blister), 30, 30x1 (precut unit dose blister), 60, 60x1 (precut unit dose blister), 100, or 180 hard capsules.

The bottles contain: 100 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Liconsa, S.A.

C/Dulcinea S/N,

28805, Alcalá de Henares, Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7

Poligono Industrial Miralcampo

19200 Azuqueca De Henares

Guadalajara

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: June 2024

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