Prospecto:information for the patient

Dabigatrán etexilato Sandoz110 mg hard capsules EFG

dabigatrán etexilato

Read this prospect carefullybefore starting to take thismedicine,because it contains important informationfor you

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospect. See section 4.

1.What is Dabigatrán etexilato Sandoz and what is it used for

2.What you need to knowbeforestarting totake Dabigatrán etexilato Sandoz

3.How to take Dabigatrán etexilato Sandoz

4.Possible adverse effects

5Storage of Dabigatrán etexilato Sandoz

6.Contents of the package and additional information

Dabigatrán etexilato Sandoz contains the active ingredient dabigatrán etexilato 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.

Dabigatrán etexilato is used in adults for:

• preventing the formation of blood clots in veins after knee or hip replacement surgery,
• preventing 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 have at least one additional risk factor,
• treating blood clots in the veins of your legs and lungs and to prevent them from coming back.

Dabigatrán etexilato is used in children for:

• treating blood clots and preventing them from coming back.

Do not take Dabigatrán etexilato Sandoz

• if you are allergic to dabigatrán etexilato or any of the other ingredients of this medicine (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, head 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 medicines,
• if you are taking medicines to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing from one anticoagulant treatment to another, while you have a venous or arterial catheter and heparin is being administered 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 if you have any liver disease that may be fatal,
• if you are taking ketoconazole oral or itraconazole, medicines used in the treatment of fungal infections,
• if you are taking ciclosporin oral, a medicine used to prevent organ rejection after a transplant,
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm,
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C,
• if you have had a heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

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

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

• if you are at increased risk of bleeding, for example:

• if you have recently experienced bleeding,
• if you have had a surgical tissue extraction (biopsy) in the last month,
• if you have had a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment),
• if you have inflammation of the oesophagus or stomach,
• if you have problems with reflux of stomach acid into the oesophagus,
• if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Dabigatrán etexilato Sandoz” below,
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam,
• if you have a bacterial infection of the heart (bacterial endocarditis),
• if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-coloured, concentrated urine with foam),
• if you are over 75 years old,
• if you are an adult and weigh 50 kg or less,
• 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 if you have been diagnosed with diseases that increase the risk of having a heart attack,
• if you have liver disease associated with changes in blood test results. The use of this medicine is not recommended in this case.

Be especially careful with Dabigatrán etexilato Sandoz

• if you are to undergo surgery:

In this case, dabigatrán etexilato should be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatrán etexilato exactly as instructed by your doctor before and after surgery,

• if a surgical procedure requires the placement of a catheter or injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):

• it is very important that you take dabigatrán etexilato exactly as instructed by your doctor before and after surgery,
• inform your doctor immediately if you experience numbness or weakness in your legs or intestinal or urinary problems after the end of anaesthesia, as this requires urgent attention.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may be at increased risk of bleeding,
• if you know that you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide whether your treatment needs to be modified.

Other medicines and Dabigatrán etexilato Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.Particularly, inform your doctor before taking dabigatrán etexilato 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 used in the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when applied to the skin,
• medicines used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose of dabigatrán etexilato according to the disease for which you have been prescribed it. See section 3,
• medicines used to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporin),
• 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 medicinal herb 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),
• some medicines used in the treatment of epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine.

The effects of dabigatrán etexilato on pregnancy and the fetus are unknown. Do 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, avoid becoming pregnant during treatment with dabigatrán etexilato.

It is not recommended to breastfeed during treatment with dabigatrán etexilato.

Driving and operating machines

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

Dabigatrán etexilato Sandoz containssodiumsodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is essentially “sodium-free”.

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Other appropriate pharmaceutical forms are available for children under 12 years old, depending on their ability to swallow soft foods.

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

Take Dabigatran etexilate Sandoz as recommended for the following situations:

Prevention of blood clot formation after atotal knee or hip replacement

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

If yourrenal function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (administered as 2 capsules of 75 mg).

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

If you are takingmedications containing verapamil and your renal function is decreased by more than half, you should be instructed to take a reduced dose of dabigatran etexilate of 75 mg, as your risk of bleeding may increase.

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

After atotal knee replacement

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

After atotal hip replacement

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

Prevention of cerebral or systemic vascular obstruction or thrombosis developed after abnormal heart rhythm 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 asone capsule of 150 mg twice a day.

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

If you are takingmedications containing verapamil, you should be instructed to take a reduced dose of dabigatran etexilate of 220 mg taken asone capsule of 110 mg 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 asone capsule of 110 mg twice a day.

You can continue taking this medication if you need to restore your normal heart rhythm using a procedure called cardioversion. Take dabigatran etexilate as instructed by your doctor.

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

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 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 during treatment. Follow all other medications unless your doctor tells you to stop taking one.

The table below shows the single doses and total daily 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 capsules

Single doses that require combinations of more than one capsule:

How to take Dabigatran etexilate Sandoz

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 empty the contents of the capsule, as this may increase the risk of bleeding.

Instructions for the blister pack

• Press the capsules through the blister pack.

Instructions for the bottle

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

Change in anticoagulant treatment

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

If you take more Dabigatran etexilate Sandoz 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 Sandoz

Prevention of blood clot formation after atotal knee or hip replacement

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

Do not take a double dose to compensate for the missed doses.

Use in adults: Prevention of cerebral or systemic vascular obstruction or thrombosis developed after abnormal heart rhythm 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 missed dose can be taken up to 6 hours before the next dose.

A missed dose should be omitted if the remaining time before the next dose is less than 6 hours.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dabigatran etexilate Sandoz

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Dabigatrán etexilate acts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding. Severe or major bleeding episodes may occur, which are the most serious side effects and can cause disability, be potentially fatal, or even lead to death, regardless of their location. In some cases, these bleeding episodes may not be evident.

If you experience any bleeding episode that does not stop on its own 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 side effects are listed below, grouped by frequency of occurrence.

Prevention of blood clot formation after knee or hip arthroplasty.

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

• Decreased blood hemoglobin levels (the substance present in red blood cells),
• Anomalies in liver function tests.

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

• Bleeding may occur through the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), hemorrhoids, rectum, under the skin, a joint, after an injury, or after surgery,
• Formation of hematomas or bruising after surgery,
• Blood detected in stool in a laboratory test,
• Decreased red blood cell count,
• Decreased proportion of blood cells,
• Allergic reaction,
• Vomiting,
• Frequent loose or liquid stools,
• Feeling like vomiting,
• Wound supuration (secretion of liquid from a surgical wound),
• Increased liver enzymes,
• Yellow discoloration of the skin or white 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,
• Bleeding from a catheter in a vein,
• Coughing up blood or sputum with blood spots,
• Decreased platelet count,
• Decreased red blood cell count after surgery,
• Severe allergic reaction that causes difficulty breathing or dizziness,
• Severe allergic reaction that causes facial or throat swelling,
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction,
• Change in skin color and appearance,
• Itching,
• Ulcer in the stomach or intestines (including esophageal ulcer),
• Inflammation of the esophagus and stomach,
• Reflex of stomach juice into the esophagus,
• Abdominal pain or stomach pain,
• Indigestion,
• Difficulty swallowing,
• Liquid leaking from a wound,
• Liquid leaking from a wound after surgery.

Unknown frequency(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing,
• Decreased white blood cell count (which helps fight infections),
• Hair loss.

Prevention of cerebral or systemic vascular occlusion by blood clot formation

developed after abnormal heart rhythm

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

• Bleeding may occur through the nose, stomach, or intestines, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin,
• Decreased red blood cell count,
• Abdominal pain or stomach pain,
• Indigestion,
• Frequent loose or liquid stools,
• Feeling like vomiting

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

• Bleeding,
• 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,
• Bleeding from a catheter in a vein,
• Coughing up blood or sputum with blood spots,
• Decreased platelet count,
• Decreased red blood cell count,
• Allergic reaction,
• Change in skin color and appearance,
• Itching,
• Ulcer in the stomach or intestines (including esophageal ulcer),
• Inflammation of the esophagus and stomach,
• Reflex of stomach 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, in a wound, 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,
• Decreased platelet count,
• Severe allergic reaction that causes difficulty breathing or dizziness,
• Severe allergic reaction that causes facial or throat swelling,
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction,
• Decreased proportion of blood cells,
• Increased liver enzymes,
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems.

Unknown frequency(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing,
• Decreased white blood cell count (which helps fight infections),
• Hair loss.

In a clinical trial, the index of heart attacks with dabigatrán etexilate was numerically higher than with warfarin. The global incidence was low.

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/or lungs

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

• Bleeding may occur through the nose, stomach, or intestines, rectum, penis/vagina, or urinary tract (including blood in the urine that turns 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,
• Decreased red blood cell count,
• Formation of hematomas,
• Coughing up blood or sputum with blood spots,
• Allergic reaction,
• Change in skin color and appearance,
• Itching,
• Ulcer in the stomach or intestines (including esophageal ulcer),
• Inflammation of the esophagus and stomach,
• Reflex of stomach juice into the esophagus,
• Feeling like vomiting,
• 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, or at the site of an injection, or at the site of a catheter in a vein, or from the brain,
• Decreased platelet count,
• Severe allergic reaction that causes difficulty breathing or dizziness,
• Severe allergic reaction that causes facial or throat swelling,
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction,
• Difficulty swallowing.

Unknown frequency(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing,
• Decreased red blood cell count,
• Decreased proportion of blood cells,
• Decreased white blood cell count (which helps fight infections),
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems,
• Hair loss.

In the clinical trial program, the index of heart attacks with dabigatrán etexilate was higher than with warfarin. The global incidence was low. No imbalance in the index of heart attacks was observed in patients treated with dabigatrán 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):

• Decreased red blood cell count,
• Decreased platelet count,
• Urticaria with dark, prominent, and itchy red bumps, caused by an allergic reaction,
• Change in skin color and appearance,
• Formation of hematomas,
• Nasal bleeding,
• Reflex of stomach 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):

• Decreased white blood cell count (which helps fight infections),
• Bleeding may occur through the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that turns the urine pink or red), or under the skin,
• Decreased red blood cell count,
• Decreased 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,
• Yellow discoloration of the skin or white of the eyes, caused by liver or blood problems.

Unknown frequency(frequency cannot be estimated from available data):

• Decreased white blood cell count (which helps fight infections),
• Severe allergic reaction that causes difficulty breathing or dizziness,
• Severe allergic reaction that causes facial or throat swelling,
• 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 intestines (including esophageal ulcer),
• Anomalies in liver function tests.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging, blister pack, or bottleafter CAD/EXP. The expiration date is the last day of the month indicated.

Blister pack and bottle

Store below 30°C.

Bottle

Once opened, the medication must be used within 60 days.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dabigatrán etexilato Sandoz

• The active ingredient is dabigatrán etexilato. Each hard capsule contains 110 mg of dabigatrán etexilato (in the form of mesilato).
• The other components are:

• capsule content: tartaric acid, hypromellose (E464), talc, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate.
• capsule coating: titanium dioxide (E171) and hypromellose (E464).
• black printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), iron oxide black (E172).

Appearance of the product and contents of the package

Hard capsule.

Size "1" capsule with an opaque white cap with the inscription "MD" and an opaque white body with the inscription "110" in black ink, containing a mixture of white to light yellow pellets and a light yellow granulate.

Dabigatrán etexilato Sandoz is available in:

PE-Al/PE blister with desiccant, opaque/Aluminum, containing 10, 30, 60, 100, 180, and 200 hard capsules.

PE-Al/PE blister with desiccant, opaque/Aluminum, containing 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 100 x 1, 180 x 1, and 200 x 1 hard capsules in perforated single-dose blisters.

Multiple pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in perforated single-dose blisters, Opa/Al/desecant PE-Alu/PE.

Multiple pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated single-dose blisters, Opa/Al/desecant PE-Alu/PE.

Polpropylene bottle with a child-resistant polpropylene cap containing desiccant. Packs of 60 hard capsules (1 bottle), 120 hard capsules (2 bottles of 60 hard capsules), and 180 hard capsules (3 bottles of 60 hard capsules).

Do not ingest the desiccant.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

Sachsen-Anhalt

39179 Barleben,

Germany

or

Pharmadox Healthcare LTD

KW20AKordinIndustrial Park,

Paola, PLA3000,

Malta

or

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57,

Ljubljana, 1526,

Slovenia

Last review date of this leaflet: 09/2024

For detailed information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/