DABIGATRAN ETEXILATE SANDOZ 110 mg HARD CAPSULES

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

Do not take Dabigatran etexilate Sandoz

• 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 given 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 life-threatening liver disease,
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections,
• if you are taking oral cyclosporin, 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

Talk to your doctor before you start taking dabigatran etexilate. During treatment with this medicine, you may also need to talk to your doctor if you experience any symptoms or if you need to have 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 had bleeding,
• if you have had a tissue removal (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 esophagus or stomach,
• if you have problems with acid reflux in the esophagus,
• if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Dabigatran etexilate Sandoz" below,
• if you are using anti-inflammatory medicines 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/concentrated urine with foam),
• 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 an infection in the brain or around the brain.

• 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 this medicine is not recommended in this case.

Be careful with Dabigatran etexilate Sandoz

• if you need to have surgery:

In this case, dabigatran etexilate should be temporarily stopped 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 insertion 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 anesthesia has ended, 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 your treatment.

Other medicines and Dabigatran etexilate Sandoz

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), except if only applied to the skin,
• medicines used to treat irregular heartbeat (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 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, cyclosporin),
• 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 andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

The effects of dabigatran etexilate on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant unless your doctor considers it necessary. If you are of childbearing potential, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breast-feeding 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.

Dabigatran etexilate Sandozcontainssodium

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

3. How to take Dabigatran etexilate Sandoz

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 suitable for children under 12 years of age as soon as they are able to swallow soft foods.

Follow exactly the administration instructions of this medicine 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 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 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 using medicines 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 medicines 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 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 akneereplacement

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 ahipreplacement

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 heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from reappearing

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 medicines 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 medicine if it is necessary to restore your normal heart rhythm 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 blood clots from reappearing 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 medicines 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 the age in years of the patient.

Table 1: Dosage table for dabigatran etexilate capsules

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 foil.

Instructions for the bottle

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

Changing 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 medicine 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 medicine and the amount ingested.

If you forget to take Dabigatran etexilate Sandoz

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 forgotten doses.

Use in adults: Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal heart rhythm and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from reappearing

Use in children: Treatment of blood clots and prevention of blood clots from reappearing

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 Sandoz

Take dabigatran etexilate exactly as prescribed. Do not interrupt your treatment with this medicine 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 medicine, 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. Major or severe bleeding episodes can occur, which are the most serious adverse effects and can cause disability, be potentially life-threatening, or even cause death, regardless of their location. In some cases, these bleedings 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, 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 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),
• abnormalities in liver function tests.

Uncommon(may affect up to 1 in 100 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,
• 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,
• loose or liquid stools,
• feeling like vomiting,
• wound secretion (discharge of fluid from a surgical wound),
• increase in liver enzymes,
• yellowish discoloration 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 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,
• bloody secretion from 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 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 the 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, 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,
• loose or liquid stools,
• feeling like vomiting.

Uncommon(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 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,
• 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 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,
• increase in 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 the 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 recurrent 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, rectum, penis/vagina, or 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 spots,
• allergic reaction,
• sudden change in skin color and 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 like vomiting,
• vomiting,
• abdominal pain or stomach pain,
• loose or liquid stools,
• abnormalities in liver function tests,
• increase in 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 the 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 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 in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrent 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 appearance,
• formation of hematomas,
• nasal bleeding,
• reflux of gastric juice into the esophagus,
• vomiting,
• feeling like vomiting,
• loose or liquid stools,
• indigestion,
• hair loss,
• increase in 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, brain, rectum, 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,
• yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems.

Frequency not known(frequency cannot be estimated from the 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, at the site of 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),
• abnormalities 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://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 Sandoz

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/EXP. The expiration date is the last day of the month indicated.

Blister and bottle

Store below 30°C.

Bottle

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

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

Composition of Dabigatran Etexilate Sandoz

• The active ingredient is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (in the form of mesilate).
• The other ingredients are:

• capsule contents: 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 and Package Contents

Hard capsule.

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

Dabigatran Etexilate Sandoz is available in:

Opa/Al/desiccant PE-Al/PE blister packs containing 10, 30, 60, 100, 180, and 200 hard capsules.

Opa/Al/desiccant PE-Al/PE blister packs 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 unit-dose blisters.

Multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) in perforated unit-dose blisters Opa/Al/desiccant PE-Alu/PE.

Multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated unit-dose blisters Opa/Al/desiccant PE-Alu/PE.

Polypropylene bottle with child-resistant screw cap containing a 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.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

Sachsen-Anhalt

39179 Barleben,

Germany

or

Pharmadox Healthcare LTD

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

or

Lek Pharmaceuticals, d.d.

Verovskova Ulica 57,

Ljubljana, 1526,

Slovenia

Date of Last Revision of this Leaflet: 09/2024

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