DABIDOSE 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Dabidose 150 mg Hard Capsules EFG

dabigatran etexilate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dabidose and what is it used for
2. What you need to know before taking Dabidose
3. How to take Dabidose
4. Possible side effects
5. Storage of Dabidose
6. Package contents and further information

1. What is Dabidose and what is it used for

Dabidoseis a medication that contains the active ingredient 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.

Dabidoseis used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.
• treat blood clots in the veins of your legs and lungs and to prevent blood clots from forming again in the veins of your legs and lungs.

2. What you need to know before taking Dabidose

Do not take Dabidose

• if you are allergic to dabigatran etexilate or any of the other ingredients 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 clotting (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment or while having a venous or arterial catheter and being administered heparin through this catheter to keep it open or while your normal heartbeat is being restored through a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or you have a liver disease that can be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking cyclosporine, a medication used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medication used to treat abnormal heartbeat.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medication 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 Dabidose. During treatment with Dabidose, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery. Inform your doctor if 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 Dabidose" 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 impaired 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 weigh 50 kg or less.
• 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 Dabidose is not recommended in this case.

Be careful with Dabidose

• If you need to undergo surgery: In this case, Dabidose should be temporarily discontinued due to an increased risk of bleeding during and after surgery. It is very important that you take Dabidose before and after surgery exactly at the times indicated by your doctor.
• If a surgical procedure 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 Dabidose before and after surgery exactly at the times indicated by your doctor.
• Inform 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.

Children and Adolescents

Dabidose should not be used in children and adolescents under 18 years of age.

Other Medications and Dabidose

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. In particular, you must inform your doctor before taking Dabidose if you are taking any of the following medications:

• Medications used 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 to treat abnormal heartbeat (e.g., amiodarone, dronedarone, quinidine, verapamil) If you are using medications containing verapamil, your doctor will indicate that you should use a reduced dose of Dabidose. 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)
• Medications for the treatment of epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and Breastfeeding

The effects of Dabidose on pregnancy and the fetus are unknown. You should not use Dabidose 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 Dabidose.

Breastfeeding is not recommended during treatment with Dabidose.

Driving and Using Machines

Dabidose has no known effects on the ability to drive and use machines.

Dabidose contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to Take Dabidose

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

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

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

If you are using medications containing verapamil, you will be indicated to use a reduced dose of Dabidose of 220 mg, taken in the form of a 110 mg capsule twice a day, as your risk of bleeding may increase.

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

You can continue taking Dabidose if it is necessary to restore your normal heartbeat through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take Dabidose exactly as your doctor has indicated.

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

How to Take Dabidose

Dabidose 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.

Follow these instructions to remove Dabidose capsules from their blister:

The following images illustrate how to remove Dabidose capsules from the blister

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

• • peel off the backing of the blister and remove the capsule.
• do not push the capsules through the blister backing.
• do not peel off the blister backing until the capsule is needed.

Follow these instructions to remove Dabidose capsules from their bottle:

• press and turn to open
• after removing the capsule, put the cap back on the bottle and close it immediately after taking your dose.

Changing Anticoagulant Treatment

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

If you take more Dabidose than you should

If you take more Dabidose than recommended, you may have an increased risk of bleeding.

Inform your doctor immediately if you take a dose higher than the prescribed dose of Dabidose. There are specific treatment options available. In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dabidose

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 Dabidose

Take Dabidose exactly as prescribed. Do not interrupt your treatment without consulting your doctor first. Interrupting treatment with Dabidose may increase the risk of developing a blood clot if treatment is interrupted too soon. Contact your doctor if you experience indigestion after taking this medication.

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.

Dabidose 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.

Adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of cerebral or systemic vascular obstruction due to 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, penis/vagina, or 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 of nausea

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• 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
• Gastroesophageal reflux
• Vomiting
• Difficulty swallowing
• Abnormalities 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 insertion 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 red blood cells in the blood
• Increased liver enzymes
• Yellowish discoloration of the skin or 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 was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of your legs and lungs, including prevention of these blood clots from reappearing in the veins of your legs and/or lungs

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

• Bleeding may occur from the nose, stomach, or intestine, rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Indigestion

Infrequent (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 spots
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine
• Inflammation of the esophagus and stomach
• Gastroesophageal reflux
• Feeling of nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities 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, or at the site of an injection, or at the site of a catheter insertion 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
• Decrease in the proportion of red blood cells in the blood

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 number of red blood cells in the blood
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with Dabigatran was higher than with warfarin. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

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 does not appear in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System for Human Use:

www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabidose

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

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

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

Bottle: Once the bottle is opened, the medicine must be used within the next 4 months. Keep the bottle tightly closed. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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.

6. Package Contents and Additional Information

Dabidose Composition

• The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (in the form of mesilate)
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid pellets, hydroxypropylcellulose, mannitol, talc, and magnesium stearate.
• The capsule shell contains red iron oxide (E-172), titanium dioxide (E-171), and hypromellose.
• The black ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide (E-172), and potassium hydroxide.

Product Appearance and Package Contents

Dabidose is a hard capsule.

Dabidose 150 mg hard capsules have a pink, opaque cap and body, size 0, containing a mixture of tartaric acid pellets and a granulate that contains dabigatran etexilate and excipients. The capsules are printed with the inscription "DA150"

Dabidose 150 mg hard capsules are available in packages containing 60 hard capsules in perforated aluminum blisters.

Dabidose 150 mg hard capsules are also available in polyethylene (plastic) bottles with a desiccant and filler, with a polypropylene cap, containing 60 hard capsules.

Only certain package sizes may be marketed.

Marketing Authorization Holder

PTR Pharma Consulting, Lda.

Rua Brito Pais, 8C, 1495-028 Algés, Portugal

Manufacturer

TOWA PHARMACEUTICAL EUROPE S.L.

C/Sant Martí, 75-97, Martorelles, 08107, Barcelona, Spain.

Pharmadox Healthcare Ltd.

Address:

KW20A Kordin Industrial Park Paola

PLA3000, Malta

Date of the last revision of this prospectus: January 2021

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