DABIDOSE 75 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Dabidose 75 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 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 is Dabidose and what is it used for
2. What you need to know before you take Dabidose
3. How to take Dabidose
4. Possible side effects
5. Storage of Dabidose
6. Contents of the pack and other information

1. What is Dabidose and what is it used for

Dabidose is a medicine that 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.

Dabidose is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults.

2. What you need to know before you take Dabidose

Do not take Dabidose

• 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 cerebral hemorrhage, 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 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 through a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely impaired 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 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, which can occur in the following situations:
• • if you have recently had 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 has 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 medicines 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 eliminating 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 if you 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 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 Dabidose 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 to be examined by a doctor, as you may have a higher risk of bleeding.
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so that they can decide if it is necessary to modify the treatment.

Children and adolescents

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

Other medicines and Dabidose

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, you must tell your doctor before taking Dabidose 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), except if only applied to the skin
• Medicines used in the treatment of abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil) If you are using medications that contain amiodarone, quinidine, or verapamil, your doctor will indicate that you should use a reduced dose of Dabidose. See also 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 medication used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal remedy 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 Dabidose on pregnancy and the fetus are unknown. You should not use Dabidose 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 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 medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free".

3. How to take Dabidose

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

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

If your kidney function is reduced by 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 that contain 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 that contain verapamil and your kidney function is reduced by more than half, you should be indicated a reduced dose of Dabidose of 75 mg because 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 Dabidose 1-4 hours after surgery, taking a single capsule. After that, you should take 2 capsules once a day for a total of 10 days.

After hip replacement surgery

You should start treatment with Dabidose 1-4 hours after surgery, taking a single capsule. After that, you should take 2 capsules once a day for a total of 28-35 days.

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 pack:

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

Separate a single 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 tightly immediately after taking your dose.

Switching from one anticoagulant to another

Do not switch from one anticoagulant to another without specific instructions from your doctor.

If you take more Dabidose than you should

If you take more Dabidose than recommended, you may have a higher risk of bleeding.

Tell your doctor immediately if you take more than the prescribed dose of Dabidose. There are specific treatment options available.

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

If you forget to take Dabidose

Take the remaining daily doses of Dabidose at the same time the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Dabidose

Take Dabidose exactly as prescribed.

Do not stop your treatment with Dabidose without consulting your doctor first, as the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience indigestion after taking Dabidose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dabidose acts on blood clotting; therefore, most side effects are related to signs such as bruising or bleeding.

Major or severe bleeding episodes may occur, which are the most serious side effects and can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleeding episodes may not be apparent.

If you experience any bleeding episode that does not stop by itself or if you experience signs of excessive bleeding, exceptional weakness, tiredness, paleness, dizziness, headache, or unexplained swelling, consult your doctor immediately.

Your doctor may decide to keep you under close observation or change your medication.

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

Side effects are listed below, grouped by frequency:

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

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

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

• Bleeding may be from the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), from hemorrhoids, in 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 red blood cells in the blood
• Allergic reaction
• Vomiting
• Frequent or liquid stools
• Feeling like vomiting
• Pus discharge from a wound (discharge of fluid from a surgical wound)
• Increased liver enzymes
• Yellowing 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 be in the brain, at the site of a surgical incision, at the site of injection, or at the site of a catheter insertion in a vein
• Bloody discharge from the site of a catheter insertion 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 appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Gastric juice reflux 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 the available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es

By reporting side effects, you can help provide 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 expiry date which is stated on the packaging, blister, or bottle after "EXP". The expiry date is the last day of the month indicated.

Blister pack: Store in the original packaging to protect from moisture

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabidose

• The active ingredient is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate in the form of mesylate.

• The other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid pellets, hydroxypropylcellulose, mannitol (E 421), talc, and magnesium stearate.

• The capsule shell contains red iron oxide (E-172), titanium dioxide (E-171), and hypromellose.

• The black printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide (E-172), and potassium hydroxide.

Appearance of the Product and Packaging Contents

Dabidose is a hard capsule.

Dabidose 75 mg hard capsules with opaque pink cap and body, size 2, containing a mixture of tartaric acid pellets and a granulate that contains dabigatran etexilate and excipients. The capsules are printed with the inscription “DA75”.

Dabidose 75 mg hard capsules are available in packages containing 30 and 60 capsules in perforated aluminum unit-dose blisters.

Dabidose 75 mg hard capsules are also available in polyethylene (plastic) bottles with desiccant and filler, with a polypropylene cap containing 60 hard capsules.

Only some 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 Leaflet: January 2021

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