DABIGATRAN ETEXILATE TEVA 150 mg HARD CAPSULES

2. What you need to know before you take Dabigatran Etexilate Teva

Do not take Dabigatran Etexilate Teva

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you are bleeding.
• if you have a 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 have a greater tendency to bleed. This can be innate, of unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching treatment, while having a venous or arterial line and receiving heparin through this line to keep it open or while being restored to a normal heartbeat through a procedure called catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that can cause death.
• if you are taking ketoconazole or itraconazole by mouth, medicines for treating fungal infections.
• if you are taking cyclosporin by mouth, a medicine for preventing organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat irregular heartbeats.
• 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 anticoagulation.

Warnings and precautions

Talk to your doctor before taking Dabigatran Etexilate Teva. You may also need to talk to your doctor during treatment with this medicine if you experience symptoms or if you need to undergo surgery.

Tell your doctorif you have or have had any condition or disease, in particular any of the following:

• if you have a higher risk of bleeding, for example

• if you have bled recently.
• if you have had surgical removal of tissue (biopsy) in the last month.
• if you have had a severe injury (e.g. bone fracture, head trauma or any injury that requires surgical treatment).
• if you have inflammation of the esophagus or stomach.
• if you have problems with acid reflux from the stomach into the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See 'Other medicines and Dabigatran Etexilate Teva' below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you have a heart infection (bacterial endocarditis).
• if you know you have reduced kidney function or are dehydrated (symptoms include feeling thirsty and passing reduced amounts of dark-colored/foamy 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 an infection around or inside 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 that is associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be careful with Dabigatran Etexilate Teva

• if you need to have surgery:

In this case, Dabigatran Etexilate Teva should be temporarily stopped due to a higher risk of bleeding during and shortly after surgery. It is very important that you take Dabigatran Etexilate Teva before and after surgery exactly at the times your doctor has told you.

• if a procedure involves a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia or to relieve pain):

• it is very important that you take Dabigatran Etexilate Teva before and after the procedure exactly at the times your doctor has told you.
• tell your doctor immediately if you have numbness or weakness in your legs or problems with your bowel or bladder after the end of anesthesia, because urgent attention is needed.

• if you fall or injure yourself during treatment, especially if you hit your head. Go to your doctor urgently. You may need to be examined by a doctor, as you may be at a higher risk of bleeding.
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes a higher risk of blood clots), tell your doctor, who will decide whether it is necessary to change your treatment.

Other medicines and Dabigatran Etexilate Teva

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 Teva, 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 treating fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin.
• Medicines for treating irregular heartbeats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines that contain amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Dabigatran Etexilate Teva depending on the disease for which you have been prescribed. See section 3.
• Medicines for preventing 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 serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g. ritonavir)
• Certain medicines for treating epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of Dabigatran Etexilate Teva on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you should avoid becoming pregnant while taking Dabigatran Etexilate Teva.

You should not breast-feed while taking Dabigatran Etexilate Teva.

Driving and using machines

Dabigatran Etexilate Teva has no known effects on the ability to drive or use machines.

3. How to take Dabigatran Etexilate Teva

The capsules of Dabigatran Etexilate Teva can be used in adults and children over 8 years old who are able to swallow the capsules whole:

• Other pharmaceutical forms may be more suitable for administration to this population, such as coated granules, which can be used in children under 12 years old as soon as the child is able to swallow soft foods.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Dabigatran Etexilate Teva as recommended for the following conditions:

Prevention of blockage of brain or body vessels by blood clot formation after irregular heartbeats and treatment of blood clots in the veins of the legs and lungs, including prevention of blood clots coming back in the veins of the legs and lungs.

The recommended dose is 300 mg in a 150 mg capsule twice a day.

If you are 80 years old or older, the recommended dose is 220 mg in a 110 mg capsule twice a day.

If you are taking medicines that contain verapamil, you should be treated with a reduced dose of Dabigatran Etexilate Teva of 220 mg taken as a 110 mg capsule twice a day, because your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg taken as a 110 mg capsule twice a day.

You can continue taking this medicine if you need to have your heartbeat restored to normal through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take Dabigatran Etexilate Teva as your doctor has told you.

If a medical device (stent) has been placed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stent, you may be treated with Dabigatran Etexilate Teva after your doctor has decided that normal blood clotting control has been achieved. Take Dabigatran Etexilate Teva as your doctor has told you.

Treatment of blood clots and prevention of their coming back in children

Dabigatran Etexilate Teva should be taken twice a day, one dose in the morning and one 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 as treatment progresses. Continue taking all your other medicines unless your doctor tells you to stop taking any.

Table 1 shows the single and total daily doses of Dabigatran Etexilate Teva 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 Teva capsules.

Doses that require combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran Etexilate Teva

Dabigatran Etexilate Teva can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure it reaches the stomach. Do not break, chew or empty the granules from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant treatment

Do not change your anticoagulant treatment without your doctor's specific guidance.

If you take more Dabigatran Etexilate Teva 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.

If you forget to take Dabigatran Etexilate Teva

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

A missed dose should be omitted if the time remaining is less than 6 hours before the next dose is due. Do not take a double dose to make up for a missed dose.

If you stop taking Dabigatran Etexilate Teva

Take Dabigatran Etexilate Teva exactly as prescribed. Do not stop taking this medicine without talking to 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 Dabigatran Etexilate Teva.

If you have any other questions on 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 Teva affects blood coagulation, so most side effects are related to signs such as bruising or bleeding. Significant or severe bleeding may occur, which are the most serious side effects and, regardless of their location, can be disabling, life-threatening, or even fatal. In some cases, these bleeds may not be apparent.

If you experience any bleeding 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 observation or change your medication.

Immediately report to your doctor if you experience a severe allergic reaction that causes difficulty breathing or dizziness.

The following are possible side effects, grouped by their probability.

Prevention of cerebral or bodily vessel obstruction by the formation of blood clots after abnormal heartbeats.

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

• You may bleed from the nose, stomach, or intestines, 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 or stomach pain
• Indigestion
• Frequent soft or liquid stools
• Feeling sick

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

• Bleeding
• Bleeding may occur in the hemorrhoids, rectum, or brain.
• Formation of hematomas
• Coughing up blood or sputum stained with blood
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (substance contained in red blood cells).
• 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
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Unusual laboratory test results for liver function

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

• Bleeding may occur in a joint, from a surgical incision, from a wound, from the site of injection, or from 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 characterized by dark red, elevated, and itchy bumps, caused by an allergic reaction.
• Decrease in the proportion of blood cells
• Increased liver enzymes
• 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):

• Difficulty breathing or wheezing
• Decrease in the number of white blood cells (which help fight infections).

• Hair loss

In a clinical study, the rate of myocardial infarction with Dabigatran etexilate Teva was numerically higher than that of warfarin. The overall incidence was low.

Treatment of blood clots in the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs.

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

• You may bleed 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 from an injury
• Hemorrhoids may bleed
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum stained with blood
• 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
• Reflux of gastric juice into the esophagus
• Feeling sick
• Vomiting
• Abdominal or stomach pain
• Frequent soft or liquid stools
• Unusual laboratory test results for liver function
• Increased liver enzymes

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

• Bleeding may occur from a surgical incision, from the site of injection, or from 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 characterized by dark red, elevated, and itchy bumps, caused by an allergic reaction.
• Difficulty swallowing

Frequency not known(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (substance contained in red blood cells).
• Decrease in the proportion of blood cells
• Decrease in the number of white blood cells (which help fight infections).
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems.
• Hair loss

In the study program, the rate of infarcts with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low. No imbalance was observed in the rate of myocardial infarction in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of their recurrence 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 characterized by dark red, elevated, and itchy bumps, caused by an allergic reaction.
• Sudden change in skin color and appearance.
• Formation of hematomas
• Nosebleed
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling sick
• Frequent soft 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 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 (substance contained in red blood cells).
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood.
• Abdominal 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):

• Lack 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 from an injury, from a surgical incision, or from the site of injection or from the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Unusual laboratory test results for liver function

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 national notification system included in Appendix V.

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

5. Storage of Dabigatran etexilate Teva

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

Do not use this medicine after the expiration date that appears on the carton or blister after "EXP". The expiration date is the last day of the month indicated.

In blister: Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dabigatran etexilate Teva

• The active ingredient is dabigatran etexilate. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).

• The other ingredients are tartaric acid, hydroxypropylcellulose, talc, and hypromellose.

• The capsule shell contains carmine indigo (E132), potassium chloride, carrageenan, titanium dioxide (E171), and hypromellose.

Appearance of the Product and Package Contents

Dabigatran etexilate Teva 150 mg are capsules (approximately 22 mm) with a light blue opaque cap and a white opaque body, filled with white to yellowish granules.

Dabigatran etexilate Teva is available in packages of 30, 60, or 180 hard capsules in aluminum-aluminum blisters.

Dabigatran etexilate Teva is available in packages containing 10 x 1, 30 x 1, 60 x 1, 100 x 1, or 180 x 1 hard capsules in perforated unit-dose aluminum blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Manufacturer

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares, Guadalajara

SPAIN

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu, and on the website of the {Spanish Agency for Medicines and Health Products (AEMPS)} (http://www.aemps.gob.es/)}.

On the website of the European Medicines Agency, you can find this prospectus in all the languages of the European Union/European Economic Area.