Dabigatran etexilate Teva 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dabigatrán etexilato Teva 150 mg hard capsules EFG

dabigatran etexilate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dabigatrán etexilato Teva is and what it is used for
2. What you need to know before taking Dabigatrán etexilato Teva
3. How to take Dabigatrán etexilato Teva
4. Possible side effects
5. How to store Dabigatrán etexilato Teva
6. Contents of the pack and other information

1. What Dabigatran Etexilate Teva is and what it is used for

Dabigatran Etexilate Teva contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is involved in blood clot formation.

Dabigatran Etexilate Teva is used in adults to:

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

• treat blood clots in the veins of the legs and lungs and to prevent the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Teva is used in children to:

• treat blood clots and prevent their recurrence.

2. What you need to know before taking Dabigatrán etexilato Teva

Do not take Dabigatrán etexilato Teva

• if you are allergic to dabigatran etexilate or to 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 serious bleeding (for example, stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have a higher tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
• if you are taking medicines to prevent blood clotting (for example, warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while you have an intravenous or arterial line and are receiving heparin through this line to keep it open, or while undergoing a procedure called catheter ablation for atrial fibrillation to restore normal heart rhythm.
• if you have severely reduced liver function or a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythms.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulation.

Warnings and precautions

Talk to your doctor before taking Dabigatrán etexilato Teva. You may also need to speak with your doctor during treatment with this medicine if you experience symptoms or need to undergo a surgical procedure.

Tell your doctor if you have or have had any condition or illness, particularly any of the following:

• if you have an increased risk of bleeding, for example:

• if you have recently bled.

• if you have undergone surgical tissue removal (biopsy) within the last month.

• if you have suffered a serious injury (for example, a bone fracture, head trauma, or any injury requiring surgical treatment).

• if you have inflammation of the oesophagus or stomach.

• if you have problems with gastric juice refluxing into the oesophagus.

• if you are receiving medicines that may increase the risk of bleeding. See 'Other medicines and Dabigatrán etexilato Teva' below.

• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.

• if you have an infection of the heart (bacterial endocarditis).

• if you know you have reduced kidney function or are dehydrated (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).

• if you are over 75 years old.

• if you are an adult weighing 50 kg or less.

• only if used in children: if the child has an infection around or within the brain.

• if you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.

• if you have a liver disease associated with changes in blood tests. In this case, use of this medicine is not recommended.

Take special care with Dabigatrán etexilato Teva

• if you need surgery:

In this case, Dabigatrán etexilato Teva should be temporarily discontinued due to an increased risk of bleeding during and shortly after the procedure. It is very important that you take Dabigatrán etexilato Teva before and after the procedure exactly at the times instructed by your doctor.

• if a procedure involves a catheter or injection into the spine (for example, for epidural or spinal anaesthesia or for pain relief):

• it is very important that you take Dabigatrán etexilato Teva before and after the procedure exactly at the times instructed by your doctor.

• inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical attention is required.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical advice. You may need to be examined by a doctor, as your risk of bleeding may be increased.

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment adjustment is necessary.

Other medicines and Dabigatrán etexilato Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatrán etexilato Teva if you are taking any of the following medicines:

• Medicines to reduce blood clotting (for example, warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines to treat fungal infections (for example, ketoconazole, itraconazole), unless applied only to the skin.
• Medicines to treat abnormal heart rhythms (for example, amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatrán etexilato Teva depending on the condition for which it has been prescribed. See section 3.
• Medicines to prevent organ rejection after transplantation (for example, tacrolimus, cyclosporine).
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Anti-inflammatory and pain-relieving medicines (for example, 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 (for example, ritonavir).
• Certain medicines used to treat epilepsy (for example, carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of Dabigatrán etexilato Teva on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy 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 Dabigatrán etexilato Teva.

You must not breastfeed while taking Dabigatrán etexilato Teva.

Driving and using machines

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

3. How to take Dabigatran etexilate Teva

Dabigatran etexilate Teva capsules may be used in adults and children over 8 years of age who are able to swallow the capsules whole:

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

Always take this medicine exactly as your doctor has told you. Consult your doctor if you are unsure.

Take Dabigatran etexilate Teva as recommended for the following conditions:

Prevention of blockage of cerebral or systemic blood vessels due to blood clot formation following abnormal heartbeats, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.

The recommended dose is 300 mg as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you should be treated with a reduced dose of Dabigatran etexilate Teva of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may increase.

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

You may continue taking this medicine if it becomes necessary to restore normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilate Teva as directed by your doctor.

If a medical device (stent) has been implanted in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Teva after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Teva as directed by your doctor.

Treatment of blood clots and prevention of their recurrence in children

Dabigatran etexilate Teva should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Continue taking all other medications unless your doctor tells you to stop taking any of them.

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.

Single doses requiring 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 delivery to the stomach. Do not break, chew, or empty the granules from the capsule, as this may increase the risk of bleeding.

Switching anticoagulant treatment

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

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. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva

A missed dose may be taken if there is still at least 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next scheduled dose. Do not double the next 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 consulting your doctor first, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Teva.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Dabigatran etexilate Teva affects blood clotting, so most side effects are related to signs such as bruising or bleeding. Serious or major bleeding may occur, which represent the most severe side effects and, regardless of their location, may become disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.

If you experience any bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under observation or switch your medication.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The following are possible side effects, grouped according to their likelihood.

Prevention of obstruction of brain or body blood vessels due to blood clot formation following abnormal heartbeats.

Common (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 turning it pink or red), or under the skin.
• Decrease in the number of red blood cells in the blood
• Stomach or abdominal pain
• Indigestion
• Frequent loose or soft stools
• Feeling sick

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

• Bleeding
• Bleeding may occur in hemorrhoids, rectum, or brain.
• Bruising
• Coughing up blood or bloody sputum
• 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 the skin affecting its color and appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Unusual results in laboratory tests assessing liver function

Uncommon (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 an injection, or from the site where a catheter enters a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red bumps caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increase in 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 or even absence 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 with warfarin. The overall incidence was low.

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

Common (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 turning it 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 from an injury
• Hemorrhoids may bleed
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or bloody sputum
• Allergic reaction
• Sudden change in the skin affecting its color and appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric juice reflux into the esophagus
• Feeling sick
• Vomiting
• Stomach or abdominal pain
• Frequent loose or soft stools
• Unusual results in laboratory tests assessing liver function
• Increase in liver enzymes

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

• Bleeding may occur from a surgical incision, from the site of an injection, from the site where a catheter enters a vein, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red 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 or even absence 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 myocardial infarction with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low. No imbalance in the rate of myocardial infarction was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of their recurrence in children

Common (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 raised, itchy, dark red bumps caused by an allergic reaction
• Sudden change in the skin affecting its color and appearance
• Bruising
• Nosebleeds
• Gastric juice reflux into the esophagus
• Vomiting
• Feeling sick
• Frequent loose or soft 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 turning it 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 bloody sputum
• Stomach or abdominal 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):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing 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 an injection or from the site where a catheter enters a vein
• Bleeding from hemorrhoids may occur
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Unusual results in laboratory tests assessing 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 not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V.

By reporting adverse effects, you can help provide 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 expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month indicated.

In blister packs: Do not store above 30°C.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging when no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Teva

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

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

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

Appearance of the product and contents of the pack

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

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

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

Not all pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this package leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu , and on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}.

This package leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.