Dabigatran etexilate Teva: detailed information

Patient Information Leaflet: Information for the patient

Dabigatran etexilate Teva 75 mg hard capsules

dabigatran etexilate
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Teva is and what it is used for
What you need to know before taking Dabigatran etexilate Teva
How to take Dabigatran etexilate Teva
Possible side effects
How to store Dabigatran etexilate Teva
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 the action of a substance in the body involved in blood clot formation.
Dabigatran Etexilate Teva is used in adults for:

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

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 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 are currently experiencing bleeding.
if you have lesions in an organ of the body that increase the risk of severe bleeding (for example, gastric ulcer, injuries or bleeding in the brain, recent surgery on the brain or eyes).
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 clots (for example, warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place through which heparin is administered to keep it open, or when your heartbeat is restored to normal via a procedure called catheter ablation for atrial fibrillation.
if your liver function is severely reduced or if you have a liver disease that may 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 transplant rejection.
if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical 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 consult your doctor during treatment with this medicine if you experience symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially those listed below:

if you have an increased risk of bleeding, such as:
- you have recently experienced bleeding.
- you have had a surgical tissue sample (biopsy) taken within the last month.
- you have suffered a serious injury (e.g., bone fracture, head trauma, or any injury requiring surgery).
- you have inflammation of the oesophagus or stomach.
- you have gastroesophageal reflux (acid reflux into the oesophagus).
- 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 have an infection of the heart (bacterial endocarditis).
- you know you have reduced kidney function or are dehydrated (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
- you are over 75 years old.
- you are an adult weighing 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 having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Teva

if you are undergoing 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 as directed by your doctor.
if a procedure involves placement of a catheter or injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Dabigatran etexilate Teva before and after the procedure exactly as directed by your doctor.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent medical attention is required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Contact your doctor urgently. You may need medical evaluation, as you may be at increased risk of bleeding.
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 your treatment needs to be adjusted.

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 inform your doctor before taking Dabigatran etexilate Teva if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g., ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heartbeat (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilate Teva, depending on the condition for which it was prescribed. See also section 3.
Medicines to prevent transplant rejection (e.g., tacrolimus, cyclosporine)
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 used to treat depression
Antidepressants 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)
Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Teva on pregnancy and the unborn child are unknown. You must not take this medicine if you are pregnant, unless your doctor tells you it is safe. If you are a woman of childbearing age, you must avoid pregnancy during treatment with Dabigatran etexilate Teva.
You must not breastfeed during treatment with Dabigatran etexilate Teva.

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

3. How to take Dabigatran etexilate Teva

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

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

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Take Dabigatran etexilate Teva as recommended for the following conditions:
Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you should be treated with a reduced dose of Dabigatran etexilate Teva of 75 mg, because the risk of bleeding may increase.
For both types of surgery, treatment must not be started if there is bleeding from the surgical site. If treatment cannot be initiated before the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1–4 hours after the end of surgery, taking one single capsule. Afterwards, take two capsules once daily 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 one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment of blood clots and prevention of new blood clots 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 the patient's weight and age. Your doctor will determine the correct dose.
Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop 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.

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
From 11 to less than 13 kg	From 8 to less than 9 years	75	150
From 13 to less than 16 kg	From 8 to less than 11 years	110	220
From 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
From 26 to less than 31 kg	From 8 to less than 18 years	150	300
From 31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
From 61 to less than 71 kg	From 8 to less than 18 years	300	600
From 71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

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 delivery to the stomach. Do not break, chew, or empty the pellets from the capsule, as this could increase the risk of bleeding.

Changing your 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. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva

Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Teva at your usual time the next day.
Do not take a double dose to make up for the missed dose.

Treatment of blood clots and prevention of recurrent blood clots in children
The missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not double the dose to make up for the missed dose.

If you stop taking Dabigatran etexilate Teva
Take Dabigatran etexilate Teva exactly as prescribed. Do not stop taking this medicine without first discussing it with your doctor, 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Dabigatran etexilate Teva acts on blood coagulation; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious 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 spontaneously, or if you develop 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 close observation or to change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to the frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin 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, stomach or intestine, from the penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, from the rectum, under the skin, in a joint, from a wound or after surgery.
Formation of haematomas or bruising occurring after surgery.
Presence of blood in the stool detected by laboratory testing.
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 discharge (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 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 venous catheter.
Blood-stained discharge from the site of insertion of a venous catheter.
Coughing up blood or blood-stained sputum.
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.
Pronounced skin rash, characterized by dark red, swollen, itchy bumps due to an allergic reaction.
Sudden skin change altering its colour and appearance.
Itching.
Stomach or intestinal ulcer (including oesophageal ulcer).
Inflammation of the oesophagus and stomach.
Reflux of gastric juice into the oesophagus.
Abdominal pain or stomach ache.
Indigestion.
Difficulty swallowing.
Fluid leaking from a wound.
Fluid leaking from a wound after surgery.

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

Difficulty breathing or wheezing.
Decrease in the number or even absence of white blood cells (which help fight infections).
Hair loss.

Treatment and prevention of recurrence of 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.
Pronounced skin rash, characterized by dark red, swollen, itchy bumps due to an allergic reaction.
Sudden skin change altering its colour and appearance.
Formation of a haematoma.
Nosebleed.
Reflux of gastric juice into the oesophagus.
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, from the brain, from the rectum, from the penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin.
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells).
Decrease in the percentage of blood cells.
Itching.
Coughing up blood or blood-stained sputum.
Abdominal pain or stomach ache.
Inflammation of the oesophagus 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 the 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 that may occur in a joint or due to a wound, surgical incision, injection site, or site of insertion of a venous catheter.
Bleeding from haemorrhoids.
Stomach or intestinal ulcer (including oesophageal ulcer).
Abnormal liver function test results.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 after
the words "EXP". The expiry date refers to the last day of that month.
For blister pack: Do not store above 30 °C.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines 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 75 mg of dabigatran etexilate (as mesilate).
The other components 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 hard capsules (approximately 18 mm) with white, opaque body and cap,
filled with off-white to yellowish pellets.
Dabigatran etexilate Teva is available in packs containing 10, 30 or 60 hard capsules in aluminium-aluminium blisters.
Dabigatran etexilate Teva is also available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated aluminium blisters, divided into single-dose units.
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:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A. /AG UAB Teva Baltics
Tel/Tél: +32 3 820 73 73 Tel: +370 5 266 02 03

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл: +359 2 489 95 85 Tél: +49 731 402 02

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251 007 111 Tel: (+36) 1 288 6400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44 98 55 11 Tel: +44 (0) 207 540 7117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
+49 (0) 731 402 02 Tel: +31 800 0228 400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel.: +372 6610801 Tlf: +47 66 77 55 90

Ελλάδα Österreich
Teva Hellas Α.Ε. Ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 211 880 5000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: + 34 91 387 32 80 Tel: +48 22 345 93 00

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda
Tél: +33 1 55 91 78 00 Tel: +351 21 476 75 50

Hrvatska România
Pliva Hrvatska d.o.o Teva Pharmaceuticals S.R.L
Tel: + 385 1 37 20 000 Tel: +40 21 230 65 24

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

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o
Sími: + 354 550 3300 Telephone: +421257267911

Italia Suomi/Finland
Teva Italia S.r.l Teva Finland Oy
Tel:. +39 028917981 Puh/Tel: +358 20 180 5900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 (0)42 12 11 00
Τηλ: +30 211 880 5000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67 323 666 Ireland
[email protected] 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/

Patient Information Leaflet

Dabigatran etexilate Teva 110 mg hard capsules

dabigatran etexilate
Read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Teva is and what it is used for
What you need to know before taking Dabigatran etexilate Teva
How to take Dabigatran etexilate Teva
Possible side effects
How to store Dabigatran etexilate Teva
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 the action of a substance in the body involved in blood clot formation.
Dabigatran etexilate Teva is used in adults for:

preventing the formation of blood clots in the veins following hip or knee replacement surgery.
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 new blood clots from forming 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 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 are currently experiencing bleeding.
if you have lesions in any organ of the body that increase the risk of severe bleeding (e.g., gastric ulcer, lesions or bleeding in the brain, recent surgery on the brain or eyes).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place through which heparin is administered to keep it open, or when your heartbeat is being restored to normal via a procedure called catheter ablation for atrial fibrillation.
if your liver function is severely reduced or if you have a liver disease that could lead to death.
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 transplant rejection.
if you are taking dronedarone, a medicine used to treat heart rhythm disorders.
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 consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly those listed below:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have had a surgical tissue sample (biopsy) taken within the last month.
- if you have suffered a serious injury (e.g., bone fracture, head trauma, or any injury requiring surgery).
- if you have inflammation of the oesophagus or stomach.
- if you have gastro-oesophageal reflux (acid reflux).
- if you are taking medicines that may 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 have an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult 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 your risk of having a heart attack.
if you have a liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Teva

if you are scheduled for 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 exactly as directed by your doctor before and after the procedure.
if a procedure involves placement of a catheter or injection into the spinal column (e.g., for epidural or spinal anaesthesia or pain relief):
- it is very important to take Dabigatran etexilate Teva exactly as directed by your doctor before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in the legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent medical attention is required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor urgently. Medical evaluation may be necessary, as you may be at increased risk of bleeding.
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 your treatment needs to be adjusted.

Medicines that reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g., ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heartbeat (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a lower dose of Dabigatran etexilate Teva, depending on the condition for which it has been prescribed. See also section 3.
Medicines to prevent organ transplant rejection (e.g., tacrolimus, cyclosporine)
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 used to treat 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 used to treat epilepsy (e.g., carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Teva on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe. If you are a woman of childbearing age, you must avoid becoming pregnant while being treated with Dabigatran etexilate Teva.
You must not breastfeed while being treated with Dabigatran etexilate Teva.

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

3. How to take Dabigatran etexilate Teva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Teva as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you should be treated with a reduced dose of Dabigatran etexilate Teva of 75 mg, because the risk of bleeding may increase.

For both types of surgery, treatment must not be started if there is bleeding from the surgical site. If treatment cannot be initiated before the day after surgery, administration should begin with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran etexilate Teva should begin within 1–4 hours after the end of surgery, taking one single capsule. Afterwards, take two capsules once daily 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 one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from irregular heartbeat, 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 taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines 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 the risk of bleeding may increase.
If you are potentially at increased 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 your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabigatran etexilate Teva as directed by your doctor.

If you have had a medical device (stent) placed 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 control of blood clotting has been achieved. Take Dabigatran etexilate Teva as directed by your doctor.

Treatment and prevention of blood clots 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 the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop 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.

Weight/age combinations		Single dose in mg	Total daily dose in mg
Weight in kg	Age in years	Single dose in mg	Total daily dose in mg
From 11 to less than 13 kg	From 8 to less than 9 years	75	150
From 13 to less than 16 kg	From 8 to less than 11 years	110	220
From 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
From 26 to less than 31 kg	From 8 to less than 18 years	150	300
From 31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
From 61 to less than 71 kg	From 8 to less than 18 years	300	600
From 71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

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

If you forget to take Dabigatran etexilate Teva
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Teva at your usual time 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 elsewhere in the body due to blood clots developing as a result of an irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots.

Use in children: Treatment of blood clots and prevention of recurrence of blood clots.

A missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before 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 treatment is stopped too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Teva.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Dabigatran etexilato Teva affects blood clotting; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious 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 spontaneously, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Prevention of blood clots after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

Decrease in the amount of haemoglobin 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, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or following a wound, after surgery
Formation of bruises or bruising occurring after surgery
Presence of blood in the stool detected by laboratory testing
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 discharge (leakage of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
Blood-stained discharge from a venous catheter insertion site
Coughing up blood or blood-stained sputum
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
Pronounced skin rash, characterised by dark red, raised, itchy bumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice into the oesophagus
Abdominal pain or stomach ache
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat
Common (may affect up to 1 in 10 people):

Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal pain or stomach ache
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 haemorrhoids, rectum, or brain
Formation of a haematoma
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice into the oesophagus
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, wound, injection site, or catheter insertion site in a vein
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash, characterised by dark red, raised, itchy bumps due to an allergic reaction
Decrease in the percentage of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Difficulty breathing or wheezing
Decrease in the number or even absence of white blood cells (which help fight infections)
Hair loss

In a clinical study, the rate of heart attacks with Dabigatran etexilato 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 recurrence of blood clots in the legs and/or lungs
Common (may affect up to 1 in 10 people):

Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including blood in urine turning 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 from haemorrhoids
Decrease in the number of red blood cells in the blood
Formation of a haematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juice into the oesophagus
Feeling unwell
Vomiting
Abdominal pain or stomach ache
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 from a surgical incision, injection site, catheter insertion site in a vein, or 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
Pronounced skin rash, characterised by dark red, raised, itchy bumps due to an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin 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 liver or blood problems
Hair loss

In the study programme, the rate of heart attacks with Dabigatran etexilato 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 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
Pronounced skin rash, characterised by dark red, raised, itchy bumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Formation of a haematoma
Nosebleeds
Reflux of gastric juice into the oesophagus
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, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the percentage of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal pain or stomach ache
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the 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 that may occur in a joint or due to a wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to 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 pack or blister after the wording "EXP". The expiry date refers to the last day of that month.
For blister pack: Do not store above 30 °C.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. 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 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.

Description of the appearance of Dabigatran etexilate Teva and package contents
Dabigatran etexilate Teva 110 mg are capsules (approximately 19 mm) with a blue, opaque cap and body, filled with off-white to yellowish pellets.
Dabigatran etexilate Teva is available in packs containing 10, 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 aluminium blisters, divided into single-dose units.
Not all pack sizes may be marketed.