DABIGATRAN ETEXILATE STADAFARMA 75 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Dabigatran etexilate Stadafarma 75 mg hard capsules EFG

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Dabigatran etexilate Stadafarma and what is it 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. Package contents and additional information

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

This medication contains the active substance dabigatran etexilate and belongs to a group of medications 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 knee or hip replacement surgery.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Stadafarma

Do not take Dabigatran etexilate Stadafarma

• if you are allergic to dabigatran etexilate or any of the other components of this medication (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medications.
• if you are taking medications to prevent blood clot formation (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching to anticoagulant treatment, 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 through 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, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medication used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Consult your doctor before starting to take Dabigatran etexilate Stadafarma. During treatment with this medication, 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:
• • if you have recently experienced bleeding.
  • if you have undergone surgical tissue removal (biopsy) in the last month.
  • if you have suffered a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have problems with gastric juice reflux in the esophagus.
  • if you are taking medications that may increase the risk of bleeding. See "Other medications and Dabigatran etexilate Stadafarma" below.
  • if you are using anti-inflammatory medications such as diclofenac, ibuprofen, or piroxicam.
  • if you have a heart infection (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-colored urine).
  • if you are over 75 years old.
  • if you are an adult patient and weigh 50 kg or less.
  • only if used in children: if the child has a brain infection or around the brain.

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

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

Be especially careful withDabigatran 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 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):

• Tell your doctor immediately if you experience numbness or weakness in your legs or intestinal 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 clot formation), inform your doctor to decide if it may be necessary to modify the treatment.

Other medications andDabigatran etexilate Stadafarma

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, you must inform your doctor before takingdabigatran etexilateif you are taking any of the following medications:

• Medications to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medications for the treatment of fungal infections (e.g., ketoconazole, itraconazole), except if only applied to the skin
• Medications used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are using medications containing amiodarone, quinidine, or verapamil, your doctor may indicate that you use a reduced dose of dabigatran etexilate depending on the disease for which it was prescribed. See section 3.
• Medications for the prevention of organ rejection after a transplant (e.g., tacrolimus, cyclosporine)
• A combination product of glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal remedy for depression
• Antidepressant medications called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medications for HIV (e.g., ritonavir)
• Certain medications 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 medication if you are pregnant unless your doctor indicates that 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 Stadafarma

Dabigatran etexilate 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 suitable for the treatment of children under 8 years.

Follow your doctor's instructions for administration of this medication exactly. If you are in doubt, consult your doctor again.

Takedabigatran etexilateas recommended for the following situations

Prevention of blood clot formation after knee or hip replacement surgery

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

If your kidney function is reducedby 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 using 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 using medications containing verapamil and your kidney function is reducedby 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 replacement surgery

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 replacement surgery

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.

Treatment of blood clots and prevention of new blood clot formation 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 to 12 hours as possible.

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

Single dose of dabigatran etexilate to be administered twice a day in milligrams (mg) based on the patient's weight in kilograms (kg) and age in years:

How to takeDabigatran 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 the blister packs

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

Separate a single blister pack from the strip of blister packs through the perforated line.

Remove the rear foil and extract the capsule.

• Do not press the capsules through the blister pack foil.
• Do not remove the blister pack foil until the capsule is needed.

Changing anticoagulant treatment

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

If you take moreDabigatran etexilate Stadafarmathan you should

Taking too much dabigatran etexilate or increasing the dose increases the risk of bleeding. 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 of dabigatran etexilate ingested. Specific treatment options are available.

If you forget to takeDabigatran etexilate Stadafarma

Prevention of blood clot formation after knee or hip replacement surgery

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 missed doses.

Treatment of blood clots and prevention of new blood clot formation in children

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

A missed 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 missed doses.

If you interrupt treatment withDabigatran etexilate Stadafarma

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with dabigatran etexilate without consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is interrupted 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.

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

Prevention of blood clot formation after knee or hip arthroplasty

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

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

• Bleeding may be from the nose, in the stomach or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), from hemorrhoids, from the rectum, under the skin, from a joint, or after an injury or surgery
• 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 like vomiting
• Wound suppuration (secretion of fluid from a surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may be 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
• Bloody suppuration at the site of a catheter in a vein
• Coughing up blood or sputum with blood spots
• 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 ulcer in the esophagus)
• 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

Treatment of blood clots and prevention of blood clot formation 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
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may be in the stomach or intestine, in the brain, in the rectum, from the penis/vagina or 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 spots
• 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 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 be in a joint or wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may be from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• 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 it directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Stadafarma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the box or blister after "CAD". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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6. Package Contents and Additional Information

Composition of Dabigatran Etexilate Stadafarma

• The active ingredient is dabigatran. Each hard capsule contains 75 mg dabigatran etexilate (in the form of mesilate).
• The other ingredients are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), and hypromellose.

Appearance of the Product and Package Contents

Dabigatran Etexilate Stadafarma 75 mg are hard capsules, white to off-white in color, size 2, containing white to pale yellow pellets.

Dabigatran Etexilate Stadafarma is available in packages containing 1 x 10, 3 x 10, or 6 x 10 hard capsules in perforated aluminum/OPA-ALU-PVC blisters.

Only some package 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 Agustin 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 Last Revision of this ProspectusJune 2023

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/