DABIGATRAN 75 mg Twarde Kapsułki

Treść ulotki

1. Dabigatran etexilate Teva 75 mg hard capsules
   1. What is Dabigatran etexilato Teva and what it is used for
   2. What you need to know before taking Dabigatran etexilate Teva
   3. How to take Dabigatran etexilate Teva
   4. Possible side effects
   5. How to store Dabigatran etexilate Teva
   6. Contents of the pack and other information
2. Dabigatran etexilate Teva 110 mg hard capsules
   1. What is Dabigatran etexilato Teva and what is it used for
   2. What you need to know before taking Dabigatran etexilate Teva
   3. How to take Dabigatran etexilate Teva
   4. Possible side effects
   5. How to store Dabigatran etexilate Teva
   6. Package contents and other information
3. Dabigatran etexilate Teva 150 mg hard capsules
   1. What is Dabigatran etexilate Teva and what it is used for
   2. What you need to know before taking Dabigatran etexilato Teva
   3. How to take Dabigatran etexilate Teva
   4. Possible side effects
   5. How to store Dabigatran etexilate Teva
   6. Package contents and other information

Dabigatran etexilate Teva 75 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Dabigatran etexilato Teva contains the active substance dabigatran etexilato and belongs to a group of
medicines called anticoagulants. It works by blocking the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilato Teva is used in adults for:

• preventing the formation of blood clots in the veins following surgery for knee or hip replacement

Dabigatran etexilato Teva is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Teva

Do not take Dabigatran etexilate Teva

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ of the body that increase the risk of serious bleeding (for example, gastric ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent the formation of blood clots (for example warfarin, rivaroxaban, apixaban or heparin), except in the case of switching from one anticoagulant treatment to another, when a venous or arterial catheter is applied through which heparin is administered to keep it open or when your heartbeat is restored to
  normal with a procedure called transcatheter ablation for atrial fibrillation.

administered to keep it open or when your heartbeat is restored to
normal with a procedure called transcatheter ablation for atrial fibrillation.

• if your liver function is severely impaired or if you have a liver disease that may cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking ciclosporin orally, a medicine to prevent rejection episodes after an organ transplant.
• if you are taking dronedarone, a medicine used to treat heart rhythm abnormalities.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent blood thinning.

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 suffer from or have suffered from any medical condition or illness, in particular
those included in the following list:

• if you have an increased risk of bleeding such as:
• you have had recent bleeding.
• a surgical tissue sample (biopsy) has been taken in the last month.
• you have suffered a serious injury (e.g. a bone fracture, a head injury or any injury that required surgery).
• you suffer from inflammation of the esophagus or stomach.
• you have problems with stomach acid reflux into the esophagus.
• you are taking medicines that may increase the risk of bleeding. See section 'Other medicines and Dabigatran etexilate Teva' below.
• you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• you suffer from a heart infection (bacterial endocarditis).
• you know you have reduced kidney function or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• you are over 75 years of age.
• you are an adult patient and weigh 50 kg or less.
• only for use 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 conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilate Teva

• if you need to undergo surgery: In this case, Dabigatran etexilate Teva will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Teva before and after surgery exactly at the times indicated by your doctor.
• if a procedure involves the presence of a catheter or an injection into the spine (for example, for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Teva before and after the procedure exactly at the times indicated by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, because urgent assistance is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor urgently. You may need medical attention, as you may be at increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that causes an increased risk of blood clots), inform your doctor who will decide whether it is necessary to change the 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 medicines listed below:

• Medicines that 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), unless they are applied only to the skin
• Medicines for the treatment of altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilate Teva, depending on the condition for which it has been prescribed. See also section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination 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 the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Teva on pregnancy and the fetus are unknown. Do 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 potential, you should avoid pregnancy during treatment with Dabigatran etexilate Teva.
Do not breastfeed during treatment with Dabigatran etexilate Teva.

Driving and using machines
Dabigatran etexilate Teva has no known effects on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate Teva

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

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

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Teva as recommended for the following conditions:
Prevention of blood clot formation after knee or hip replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If your kidney function is reducedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reducedby more than half, you must be treated with a reduced dose of Dabigatran etexilate Teva of 75 mgbecause the risk of bleeding may increase.
For both types of surgery, treatment should not be started in case of bleeding from the surgical site. If treatment cannot be started before the day after surgery, administration should begin with a dose of 2 capsules once a day.
After knee replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1-4 hours after the end of surgery, taking a single capsule. Afterwards, you should take two capsules once a day, for a total of 10 days.
After hip replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1-4 hours after the end of surgery, taking a single capsule. Afterwards, you should take two capsules once a day, for a total of 28-35 days.
Treatment of blood clots and prevention of the formation of new blood clots in children
Dabigatran etexilate Teva must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose.
The doctor may adjust the dose during treatment. Continue to use all other medicines, 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 weight in kilograms (kg) and the age in years of the patient.

Table 1: Dosage table for Dabigatran etexilate Teva capsules.

Single doses requiring combinations of multiple capsules:
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 and 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 must be swallowed whole with a glass of water, to ensure it reaches the stomach. Do not break, chew or empty the pellets from the capsule, as this could increase the risk of bleeding.

Changes to anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions 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 an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Teva at the usual time of day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of recurrence of blood clots in children
The missed dose can be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the missed dose should be skipped.
Do not double the 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 first talking to your doctor, as the risk of developing a blood clot may be greater if you stop treatment too soon. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Teva.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilato Teva acts on blood coagulation, therefore most of the side effects are related to signs such as bruises or bleeding. Bleeding events, which may be major or severe, can occur and constitute the most serious side effects and, regardless of their location, can 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 resolve spontaneously or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. The doctor may decide to keep you under close observation or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped by how often they occur.
Prevention of blood clot formation after a knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells) Abnormal results of liver function tests Uncommon(may affect up to 1 in 100):
• Bleeding that may occur from the nose, in the stomach or intestine, from the penis/vagina or from the urinary tract (including blood in the urine which colors it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after a surgical intervention.
• Formation of hematomas or bruising that occurs after a surgical intervention.
• Presence of blood in the stool detected by a laboratory examination
• Decrease in the number of red blood cells in the blood
• Decrease in the percentage of blood cells
• Allergic reaction
• Vomiting
• Frequent bowel movements with loose or liquid stools
• Feeling unwell
• Wound secretion (leakage of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

Rare(may affect up to 1 in 1,000):

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of insertion of a catheter into a vein.
• Bloody secretion from the site of insertion of a catheter into a vein
• Coughing up blood or sputum stained with blood
• 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 causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Stomach pain or abdominal pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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 to fight infections)
• Hair loss

Treatment of blood clots and prevention of blood clot reformation 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
• Noticeable rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Sudden change in the skin that modifies its color and appearance.
• Formation of a hematoma
• Nose bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Frequent bowel movements with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Uncommon(may affect up to 1 in 100):

• Decrease in the number of white blood cells (which help to fight infections)
• Bleeding that may occur in the stomach or intestine, in the brain, from the rectum, from the penis/vagina or from the urinary tract (including blood in the urine which colors it pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the percentage of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Stomach pain or abdominal pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

Not known(the frequency cannot be estimated on the basis of the available data):

• Absence of white blood cells (which help to 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 that may occur in a joint or due to a wound, a surgical incision, from the injection site or from the site of insertion of the catheter into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal results of liver function tests

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging or blister pack after
the wording "EXP". The expiry date refers to the last day of that month.
For blister packs: Do not store at a temperature above 30  C.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dabigatran etexilate Teva contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, hydroxypropylcellulose, talc and hypromellose.
• The capsule shell contains potassium chloride, carrageenan, titanium dioxide (E171) and hypromellose.

Description of the appearance of Dabigatran etexilate Teva and contents of the pack
Dabigatran etexilate Teva 75 mg are capsules (approximately 18 mm) with head and body white in color, opaque,
filled with pellets ranging in color from whitish to yellowish.
Dabigatran etexilate Teva is available in packs containing 10, 30 or 60 hard capsules in blisters of
aluminium-aluminium.
Dabigatran etexilate Teva is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules
in perforated aluminium blisters, divisible for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A. /AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Teл: +359 2 489 95 85

Luxembourg/Luxemburg
ratiopharm GmbH
Tél: +49 731 402 02

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Magyarország
Teva Gyógyszergyár Zrt.
Tel: (+36) 1 288 6400

Malta
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

Deutschland
ratiopharm GmbH
+49 (0) 731 402 02

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
UAB Teva Baltics Eesti filiaal
Tel.: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66 77 55 90

Ελλάδα
Teva Hellas Α.Ε.
Τηλ: +30 211 880 5000

Österreich
Ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel.: + 34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 78 00

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

România
Teva Pharmaceuticals S.R.L
Tel: +40 21 230 65 24

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf.
Sími: + 354 550 3300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o
Telephone: +421257267911

Italia
Teva Italia S.r.l
Tel:. +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 20 180 5900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 (0)42 12 11 00

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666
[email protected]

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 (0) 207 540 7117

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

Dabigatran etexilate Teva 110 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Dabigatran etexilato Teva contains the active ingredient dabigatran etexilato and belongs to a group of
medicines called anticoagulants. It works by blocking the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilato Teva is used in adults for:

• preventing the formation of blood clots in the veins following surgery for knee or hip replacement.
• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one other risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming in the veins of the legs and lungs.

Dabigatran etexilato Teva is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Dabigatran etexilate Teva

Do not take Dabigatran etexilate Teva

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ in your body that increase the risk of serious bleeding (e.g., gastric ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is applied through which heparin is administered to keep it open or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if your liver function is severely reduced or if you have a liver disease that can cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking ciclosporin orally, a medicine to prevent rejection episodes after an organ transplant.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythms.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent blood thinning.

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 suffer from or have suffered from any medical condition or illness, in particular
those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if a surgical tissue sample (biopsy) has been taken in the last month.
• if you have suffered a serious injury (e.g. a broken bone, a head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that can increase the risk of bleeding. See section 'Other medicines and Dabigatran etexilate Teva' below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know you have reduced kidney function or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• if you are over 75 years old.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: 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 conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Take special care with Dabigatran etexilate Teva

• if you need to undergo surgery: In this case, Dabigatran etexilate Teva will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilate Teva before and after the operation exactly at the times indicated by your doctor.
• if a procedure involves the presence of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilate Teva before and after the procedure exactly at the times indicated by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anesthesia has worn off, as urgent medical attention is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor urgently. You may need medical attention, as you may be at increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that causes an increased risk of blood clots), tell your doctor who will decide if it is necessary to change the 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 medicines listed below:

• Medicines that 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), unless they are applied only to the skin
• Medicines for the treatment of altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilate Teva, depending on the condition for which it has been prescribed. See also section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination 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 the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Teva on pregnancy and the fetus are unknown. Do 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 potential, you should avoid pregnancy during treatment with Dabigatran etexilate Teva.
Do not breastfeed during treatment with Dabigatran etexilate Teva.

Driving and operating machinery
Dabigatran etexilate Teva has no known effects on the ability to drive and operate machinery.

3. How to take Dabigatran etexilate Teva

Dabigatran etexilate Teva capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole:
⦁ Other pharmaceutical forms may be more appropriate for administration to this
population, such as coated granules that can be used in children under 12 years of age
as soon as the child is able to swallow soft foods.
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult
your doctor.

Take Dabigatran etexilate Teva as recommended for the following conditions:
Prevention of blood clot formation after knee or hip replacement surgery
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg).
If your kidney function is reducedby more than half or if you are 75 years of age or older, the recommended dose
is 150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reducedby
more than half, you must be treated with a reduced dose of Dabigatran etexilate Teva of 75 mgbecause
the risk of bleeding may increase.
For both types of surgery, treatment should not be started in case of bleeding from the
surgical site. If treatment cannot be started before the day after surgery,
administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1-4 hours after the end of the
surgery, taking a single capsule. Afterwards, you should take two capsules once a day
for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1-4 hours after the end of the
surgery, taking a single capsule. Afterwards, you should take two capsules once a day
for a total of 28-35 days.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation
of blood clots that develop following an irregular heartbeat and treatment of blood clots in the veins of the legs and lungs, including prevention of re-formation of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice
a day.
If you are taking medicines containing verapamil, you must be treated with a reduced dose of
Dabigatran etexilate Teva, equal to 220 mg taken as one 110 mg capsule twice a day,
because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to
prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be returned to
normal with a procedure called cardioversion. Take Dabigatran etexilate Teva according to the
instructions of your doctor.
If a medical device (stent) has been inserted into 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 the doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Teva according to the instructions of your doctor.
Treatment of blood clots and prevention of the formation of new blood clots 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 each day. The administration interval should be as close as possible to
12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose.
The doctor may adjust the dose during treatment. Continue to use all other medicines, 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 weight in kilograms (kg) and the age in years of the patient.

Table 1: Dosage table for Dabigatran etexilate Teva capsules.

Single doses requiring combinations of multiple capsules:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg or
one 110 mg capsule and two 75 mg
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg
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 arrival in the stomach. Do not break, chew or empty the pellets
from the capsule, as this could increase the risk of bleeding.

Change to anticoagulant treatment
Do not change your anticoagulant treatment without specific indication from your doctor.

If you take more Dabigatran etexilate Teva than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Teva at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Use in adults: Prevention of blockage of blood vessels in the brain or the rest of the body due to
the formation of blood clots that develop following an irregular heartbeat and treatment
of blood clots in the veins of the legs and lungs, including prevention of re-formation
of blood clots in the veins of the legs and lungs.
Use in children: Treatment of blood clots and prevention of re-formation of blood clots.
The forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the forgotten dose should be skipped. 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 first talking to your doctor, as the risk of developing a blood clot
may be greater if you stop treatment too soon. Contact your doctor if
you experience indigestion after taking Dabigatran etexilate Teva.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Teva acts on blood coagulation, therefore most of the side effects are related to signs such as bruises or bleeding. Bleeding events may occur that are major or severe, which constitute the most serious side effects and, regardless of their location, can 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 resolve spontaneously or if you experience signs of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling) consult your doctor immediately. The doctor may decide to keep you under close observation or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction that causes difficulty breathing or dizziness.
Possible side effects are listed below, grouped by frequency with which they occur.
Prevention of blood clot formation after knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Abnormal liver function test results

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

• Bleeding that may occur from the nose, in the stomach or intestine, from the penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or after it, after surgery.
• Formation of hematomas or bruising that occurs after surgery.
• Presence of blood in the stool detected by a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the percentage of blood cells
• Allergic reaction
• Vomiting
• Frequent bowel movements with loose or liquid stools
• Feeling unwell
• Wound secretion (exudation of liquid leaking from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of insertion of a catheter into a vein.
• Bloody secretion from the site of insertion of a catheter into a vein
• Coughing up blood or blood-streaked sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery.
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Significant rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Sudden change in the skin that alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Stomach pain or discomfort
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that develop following an altered heartbeat.

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

• Bleeding that may occur from the nose, in the stomach or intestine, from the penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red) or under the skin.
• Decrease in the number of red blood cells in the blood
• Stomach pain or discomfort
• Indigestion
• Frequent bowel movements with loose or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain.
• Hematoma formation
• Coughing up blood or blood-streaked sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of insertion of the catheter into a vein.
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Significant rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Decrease in the percentage of blood cells.
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

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 percentage of heart attacks with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs, including prevention of the reformation of blood clots in the veins of the legs and/or lungs.

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

• Bleeding that may occur from the nose, in the stomach or intestine, in the rectum, from the penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red) or under the skin.
• Indigestion

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain.
• Hematoma formation
• Coughing up blood or blood-streaked sputum
• Decrease in the number of red blood cells in the blood
• Formation of a hematoma
• Tosse con sangue o espettorato macchiato di sangue
• Allergic reaction
• Sudden change in the skin that alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling unwell
• Vomiting
• Stomach pain or discomfort
• Frequent bowel movements with loose or liquid stools
• Abnormal liver function test results
• Increased liver enzymes

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of insertion of the catheter into a vein.
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Significant rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Difficulty swallowing

Not known(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the percentage 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 problems with the liver or blood.
• Hair loss

In the study program, the percentage of heart attacks with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.
Treatment of blood clots and prevention of the formation of new blood clots 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
• Significant rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Sudden change in the skin, which alters its color and appearance.
• Hematoma formation
• Nose bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Frequent bowel movements with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding that may occur in the stomach or intestine, in the brain, from the rectum, from the penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the percentage of blood cells
• Itching
• Coughing up blood or blood-streaked sputum
• Stomach pain or discomfort
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

Not known(frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Serious allergic reaction causing difficulty breathing or dizziness.
• Serious allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, from a surgical incision, from the injection site or from the site of insertion of the catheter into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging or blister pack after
the wording "EXP". The expiry date refers to the last day of that month.
For blister packs: Do not store at a temperature above 30  C.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Teva contains

• The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, hydroxypropylcellulose, talc and hypromellose.
• The capsule shell contains indigo carmine (E132), potassium chloride, carrageenan, titanium dioxide (E171) and hypromellose.

Description of the appearance of Dabigatran etexilate Teva and package contents
Dabigatran etexilate Teva 110 mg are capsules (approximately 19 mm) with a head and body of blue colour,
opaque, filled with pellets from whitish to yellowish.
Dabigatran etexilate Teva is available in packs containing 10, 30, 60 or 180 hard capsules in blisters
of aluminium-aluminium.
Dabigatran etexilate Teva is available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x
1 hard capsules in perforated aluminium blisters, divisible for single dose.
Not all pack sizes may be marketed.

Marketing authorisation 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 on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A. /AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Teл: +359 2 489 95 85

Luxembourg/Luxemburg
ratiopharm GmbH
Tél: +49 731 402 02

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Magyarország
Teva Gyógyszergyár Zrt.
Tel: (+36) 1 288 6400

Malta
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

Deutschland
ratiopharm GmbH
+49 (0) 731 402 02

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
UAB Teva Baltics Eesti filiaal
Tel.: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66 77 55 90

Ελλάδα
Teva Hellas Α.Ε.
Τηλ: +30 211 880 5000

Österreich
Ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel.: + 34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 78 00

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

România
Teva Pharmaceuticals S.R.L
Tel: +40 21 230 65 24

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf.
Sími: + 354 550 3300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o
Telephone: +421257267911

Italia
Teva Italia S.r.l
Tel:. +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 20 180 5900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 (0)42 12 11 00

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666
[email protected]

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 (0) 207 540 7117

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/

Dabigatran etexilate Teva 150 mg hard capsules

dabigatran etexilate

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Dabigatran etexilate Teva 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 the action of a substance present in the body
involved in the formation of blood clots.
Dabigatran etexilate Teva is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one other risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming in the veins of the legs and lungs.

Dabigatran etexilate Teva is used in children for:

• treating blood clots and preventing the formation of new blood clots.

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

Do not take Dabigatran etexilato Teva

• if you are allergic to dabigatran etexilato or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ of the body that increase the risk of serious bleeding (e.g. gastric ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent the formation of blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except in the case of switching from one anticoagulant treatment to another, when a venous or arterial catheter is applied through which heparin is administered to keep it open or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if your liver function is severely impaired or if you have a liver disease that can cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking ciclosporin orally, a medicine to prevent rejection after an organ transplant.
• if you are taking dronedarone, a medicine used to treat heart rhythm abnormalities.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had or will have an artificial heart valve implanted that requires permanent blood thinning.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilato 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 suffer from or have suffered from any medical condition or illness, especially those included in the following list:

• if you have an increased risk of bleeding, such as:
• if you have had recent bleeding.
• if a surgical tissue sample (biopsy) has been taken in the last month.
• if you have suffered a serious injury (e.g. a bone fracture, a head trauma or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that can increase the risk of bleeding. See the paragraph 'Other medicines and Dabigatran etexilato Teva' below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know you have reduced kidney function or if you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• only for use 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 conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Be particularly careful with Dabigatran etexilato Teva

• if you need to undergo surgery: In this case, Dabigatran etexilato Teva will need to be temporarily stopped due to an increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran etexilato Teva before and after the operation exactly at the times indicated by your doctor.
• if a procedure involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Dabigatran etexilato Teva before and after the procedure exactly at the times indicated by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anesthesia has ended, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor urgently. You may need medical attention, as you may be at increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that causes an increased risk of blood clots), inform your doctor who will decide whether it is necessary to change treatment.

Other medicines and Dabigatran etexilato 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 etexilato Teva if you are taking any of the medicines listed below:

• Medicines that 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), unless they are applied only to the skin
• Medicines for the treatment of altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may tell you to use a reduced dose of Dabigatran etexilato Teva depending on the condition for which it has been prescribed. See also section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination 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 the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilato Teva on pregnancy and the fetus are unknown. Do 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 potential, you should avoid pregnancy during treatment with Dabigatran etexilato Teva.
Do not breastfeed during treatment with Dabigatran etexilato Teva.

Driving and using machines
Dabigatran etexilato Teva has no known effects on the ability to drive and use machines.

3. How to take Dabigatran etexilate Teva

Dabigatran etexilate Teva capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole:
⦁ Other pharmaceutical forms may be more appropriate for administration to this
population, such as coated granules that can be used in children under 12 years of age
as soon as the child is able to swallow soft foods.
Take this medicine following exactly the instructions of your doctor. If you have doubts consult your
doctor.

Take Dabigatran etexilate Teva as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or the rest of the body due to the formation
of blood clots that develop following an altered heartbeat and treatment of blood clots in the
legs and lungs, including prevention of the reformation of blood clots in the legs and lungs
The recommended dose is 300 mg taken as a 150 mg capsule twice a day.
If you are 80 years or older, the recommended dose is 220 mg taken as a 110 mg capsule twice
a day.
If you are taking medicines containing verapamil, you must be treated with a reduced dose of
Dabigatran etexilate Teva, equal to 220 mg taken as a 110 mg capsule twice a day,
because the risk of bleeding may increase.
If you are potentially exposed to a higher risk of bleeding, your doctor may decide to
prescribe you a dose of 220 mg taken as a 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be returned to
normal with a procedure called cardioversion or with a procedure called transcatheter ablation
for atrial fibrillation. Take Dabigatran etexilate Teva according to your doctor's instructions.
If a medical device (stent) has been inserted into 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 the doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Teva according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots 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 each day. The administration interval should be as close as
possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose.
The doctor may adjust the dose during treatment. Continue to use all other
medicines, 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). Doses depend on weight in kilograms (kg) and patient age in years.

Table 1: Dosage table for Dabigatran etexilate Teva capsules.

Single doses requiring combinations of multiple capsules:
300 mg: two 150 mg capsules or
four 75 mg capsules
mg
260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule and 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 must be swallowed whole
with a glass of water, to ensure arrival in the stomach. Do not break, chew or empty the pellets
from the capsule to avoid increasing the risk of bleeding.

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

If you take more Dabigatran etexilate Teva than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva
The missed dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the missed dose should be skipped. 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 first talking to your doctor, 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 doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran etexilate Teva acts on blood coagulation, therefore most of the side effects are related to signs such as bruises or bleeding. Bleeding events may occur that are major or serious, which constitute the most serious side effects and, regardless of their location, can 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 resolve spontaneously or if you experience signs of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling) consult your doctor immediately. The doctor may decide to keep you under close observation or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction that causes difficulty breathing or dizziness.
The possible side effects are listed below, grouped by the frequency with which they occur.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that develop following an altered heartbeat.

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

• Bleeding that may occur from the nose, in the stomach or intestine, from the penis/vagina or from the urinary tract (including blood in the urine that colors it pink or red) or under the skin.
• Decrease in the number of red blood cells in the blood
• Stomach pain or abdominal pain
• Indigestion
• Frequent bowel movements with loose or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain.
• Bruising
• 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 (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of liver function tests

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of catheter insertion into a vein.
• Serious allergic reaction that causes difficulty breathing or dizziness
• Serious allergic reaction that causes swelling of the face or throat
• Noticeable rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Decrease in the percentage of blood cells
• Increase in liver enzymes
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

Not known(frequency cannot be estimated on the basis of 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 percentage of heart attacks with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs, including prevention of the reformation of blood clots in the veins of the legs and/or lungs.

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

• Bleeding that may occur from the nose, in the stomach or intestine, in the rectum, from the penis/vagina or from the urinary tract (including blood in the urine that colors it pink or red) or under the skin.
• Indigestion

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

• Bleeding
• Bleeding that may occur in a joint or due to a wound.
• Bleeding that may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling unwell
• Vomiting
• Stomach pain or abdominal pain
• Frequent bowel movements with loose or liquid stools
• Abnormal results of liver function tests
• Increase in liver enzymes

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

• Bleeding that may occur from a surgical incision, from the injection site or from the site of catheter insertion into a vein or from the brain.
• Decrease in the number of platelets in the blood
• Serious allergic reaction that causes difficulty breathing or dizziness
• Serious allergic reaction that causes swelling of the face or throat
• Noticeable rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Difficulty swallowing

Not known(frequency cannot be estimated on the basis of available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the percentage 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 problems with the liver or blood.
• Hair loss

In the study program, the percentage of heart attacks with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.
Treatment of blood clots and prevention of the formation of new blood clots 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
• Noticeable rash, characterized by dark red, swollen and itchy bumps, caused by an allergic reaction.
• Sudden change in the skin that modifies its color and appearance.
• Bruising
• Bleeding from the nose
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Frequent bowel movements with 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 that may occur in the stomach or intestine, from the brain, from the rectum, from the penis/vagina or from the urinary tract (including blood in the urine that colors it pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the percentage of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Stomach pain or abdominal pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood.

Not known(frequency cannot be estimated on the basis of available data):

• Absence of white blood cells (which help fight infections)
• Serious allergic reaction that causes difficulty breathing or dizziness.
• Serious allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or due to a wound, a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Abnormal results of liver function tests

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging or blister pack after
the wording "EXP". The expiry date refers to the last day of that month.
For blister pack: Do not store at a temperature above 30  C.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Teva contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, hydroxypropylcellulose, talc and hypromellose.
• The capsule shell contains indigo carmine (E132), potassium chloride, carrageenan, titanium dioxide (E171) and hypromellosa. Description of the appearance of Dabigatran etexilate Teva and contents of the pack

Dabigatran etexilate Teva 150 mg are capsules (approximately 22 mm) with a blue, opaque cap
and a white, opaque body, filled with pellets ranging in color from whitish to yellowish.
Dabigatran etexilate Teva is available in packs containing 30, 60 or 180 hard capsules in blisters
made of aluminum-aluminum.
Dabigatran etexilate Teva is available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x
1 hard capsules in perforated aluminum blisters, divisible for single dose administration.
Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicine, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A. /AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Teл: +359 2 489 95 85

Luxembourg/Luxemburg
ratiopharm GmbH
Tél: +49 731 402 02

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Magyarország
Teva Gyógyszergyár Zrt.
Tel: (+36) 1 288 6400

Malta
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

Deutschland
ratiopharm GmbH
+49 (0) 731 402 02

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
UAB Teva Baltics Eesti filiaal
Tel.: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66 77 55 90

Ελλάδα
Teva Hellas Α.Ε.
Τηλ: +30 211 880 5000

Österreich
Ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel.: + 34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 78 00

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

Ireland
România
Teva Pharmaceuticals S.R.L
Tel: +40 21 230 65 24

Slovenija
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf.
Sími: + 354 550 3300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o
Telephone: +421257267911

Italia
Teva Italia S.r.l
Tel:. +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 20 180 5900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 (0)42 12 11 00

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666
[email protected]

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 (0) 207 540 7117

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

PATIENT ALERT CARD
Dabigatran etexilate Teva 75 mg hard capsules
Dabigatran etexilate Teva 110 mg hard capsules
Dabigatran etexilate Teva 150 mg hard capsules

• This card must always be carried with you or by the person assisting the patient.
• Make sure you are using the most recent version

Dear patient / Person assisting a pediatric patient,
Your doctor has prescribed/has prescribed for the child a treatment with Dabigatran etexilate Teva. To
use Dabigatran etexilate Teva safely, take into account the important information contained
in the package leaflet.
Since this patient alert card contains important information regarding your
treatment/the child's treatment, this card must always be carried with you/the child to
inform healthcare professionals about the treatment with Dabigatran etexilate Teva.

Dabigatran etexilate Teva Information for the patient/for the person assisting a pediatric patient
Information about your treatment or the child's treatment

• Dabigatran etexilate Teva thins the blood. It is used to treat existing blood clots or to prevent the formation of dangerous blood clots.
• When taking Dabigatran etexilate Teva, follow your doctor's/the child's doctor's instructions. Do not skip a dose or stop taking Dabigatran etexilate Teva without talking to your doctor/the child's doctor.
• Tell your doctor/the child's doctor about all the medicines you/the child are taking.
• Before any surgery or invasive procedures, inform your doctor/the child's doctor about taking Dabigatran etexilate Teva.
• Dabigatran etexilate Teva capsules can be taken with or without food. The capsule must be swallowed whole with a glass of water. The capsule must not be broken or chewed and the pellets must not be emptied from the capsule.

When to contact your doctor

• Taking Dabigatran etexilate Teva may increase the risk of bleeding. Contact your doctor/the child's doctor immediately if you/the child experience any of the possible signs and symptoms of bleeding: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding gums, cuts that bleed unusually long, abnormal menstrual flow or vaginal bleeding, blood in the urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or material that looks like coffee grounds.
• If you fall or get injured, especially if you hit your head, seek urgent medical attention.
• Do not stop taking Dabigatran etexilate Teva without talking to your doctor/the child's doctor if you/the child experience heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Dabigatran etexilate Teva Information for healthcare professionals

• Dabigatran etexilate Teva is an oral anticoagulant (direct thrombin inhibitor).
• It may be necessary to interrupt Dabigatran etexilate Teva before surgery or other invasive procedures.
• In case of major bleeding, the administration of Dabigatran etexilate Teva must be stopped immediately.
• A specific neutralizing agent (idarucizumab) is available for adult patients. The efficacy and safety of the specific neutralizing agent idarucizumab have not been established in pediatric patients.
• For details and recommendations on how to neutralize the anticoagulant effect of Dabigatran etexilate Teva, please refer to the Summary of Product Characteristics of Dabigatran etexilate Teva and idarucizumab.
• Dabigatran etexilate Teva is primarily eliminated by the kidneys; adequate diuresis must be maintained. Dabigatran etexilate Teva is dialyzable.

Complete this section or ask your doctor/the child's doctor to do so.
Patient information
________________________________
Patient name
_________________________________
Date of birth
_________________________________
Indication for which anticoagulation is used
_________________________________
Dose of Dabigatran etexilate Teva