DABIGATRAN 75 mg Twarde Kapsułki

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

Dabigatran etexilate Biocon 75 mg hard capsules

dabigatran etexilate

Generic medicine

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

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

Dabigatran etexilato Biocon contains the active ingredient 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 etexilato Biocon is used in adults for:

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

Dabigatran etexilato Biocon 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 Biocon

Do not take Dabigatran etexilato Biocon

• if you are allergic to dabigatran etexilato or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely impaired kidney function.
• if you are bleeding.
• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• 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 clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, while you have a venous or arterial catheter and are receiving heparin through this catheter to keep it open or while your heartbeat is

returned to normal with a procedure called transcatheter ablation for atrial
fibrillation.

• if you have severely impaired liver function or a liver disease that could in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine to prevent organ rejection after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeats.
• 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 etexilato Biocon. You may also need to
talk to your doctor during treatment with Dabigatran etexilato Biocon if you experience symptoms or if
you need to undergo surgery.

Tell your doctor if you suffer from or have suffered from any medical condition or illness, in particular
one of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have bled recently.
• if you have undergone surgical removal of tissue (biopsy) in the last month.
• if you have experienced a serious injury (e.g. bone fracture, 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 etexilato Biocon” below.
• if you are taking anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced emissions of dark (concentrated) / foamy urine).
• if you are over 75 years of age.
• 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 etexilato Biocon

• if you are going to have surgery: In this case, Dabigatran etexilato Biocon will need to be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important to take Dabigatran etexilato Biocon before and after surgery exactly at the times indicated by your doctor.
• if an operation 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 Biocon before and after the operation 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 end of anesthesia, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor urgently. A medical check-up may be necessary, as you may be at high risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that causes an increased risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy.

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

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumone, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole) unless they are applied only to the skin
• Medicines for treating abnormal heartbeats (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 etexilato Biocon based on the condition for which it has been prescribed. See also section 3.
• Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving drugs (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's wort, a herbal medicine for treating 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 Biocon on pregnancy and the developing baby are unknown. You should
not take Dabigatran etexilato Biocon if you are pregnant unless your doctor tells you that it is
safe to do so. If you are a woman of childbearing potential, you should avoid becoming pregnant while taking
Dabigatran etexilato Biocon. You should not breastfeed while taking Dabigatran
etexilato Biocon.

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

3. How to take Dabigatran etexilate Biocon

Dabigatran etexilate Biocon capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, there are other dosage forms appropriate for the age.
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Bioconas 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 has decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Biocon of 75 mgbecause the risk of bleeding may increase.
For both types of surgery, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should be started with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, 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 Biocon must be taken twice a day, one dose in the morning and one dose 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 Biocon 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 Biocon

Single doses requiring combinations of more than one capsule:
300 mg: two capsules of 150 mg or
four capsules of 75 mg
260 mg: one capsule of 110 mg plus one capsule of 150 mg or
one capsule of 110 mg plus two capsules of 75 mg
220 mg: two capsules of 110 mg
185 mg: one capsule of 75 mg plus one capsule of 110 mg
150 mg: one capsule of 150 mg or
two capsules of 75 mg

How to take Dabigatran etexilate Biocon
Dabigatran etexilate Biocon can be taken with or without food. The capsule must be swallowed whole with a glass of water, to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as this may increase the risk of bleeding.

Instructions for opening the blisters
The following images illustrate how to remove the Dabigatran etexilate Biocon capsules from the blister
Separate a unit of the blister from the whole blister along the perforated line
Lift the film on the back and remove the capsule.

• Do not push the capsules through the back film of the blister
• Do not peel off the blister film until you need to remove a capsule.

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

If you take more Dabigatran etexilate Biocon than you should
Taking too much Dabigatran etexilate Biocon 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 Biocon
Prevention of blood clot formation after a knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Biocon at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of the reformation of blood clots in children.
A forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, a forgotten dose must be skipped.
Do not take a double dose to make up for a missed dose.
In a

If you stop taking Dabigatran etexilate Biocon
Take Dabigatran etexilate Biocon exactly as prescribed. Do not stop taking this medicine without first talking to your doctor because 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 Biocon.
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 etexilato Biocon acts on the blood coagulation system; therefore, most
of the side effects are related to signs such as bruising or bleeding.
Major or severe bleeding events may occur, which constitute the most
serious side effects, and which, regardless of 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 resolve spontaneously or if you experience the symptoms of
excessive bleeding (exceptional weakness, feeling of 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 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 blood clot formation after a knee or
hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Unusual results in liver function tests

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

• Bleeding that may occur from the nose, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from or after a lesion or after surgery
• Formation of a hematoma or bruise that occurs after surgery
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the percentage of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with soft or liquid stools
• Feeling unwell
• Secretion from the wound (liquid that oozes from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white part 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 catheter insertion into a vein
• Blood-stained secretion from the site of catheter insertion into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after surgery
• Serious allergic reaction that causes difficulty breathing or dizziness
• Serious allergic reaction that causes swelling of the face or throat
• Skin 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 in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Pain in the abdomen or stomach
• 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
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Treatment of blood clots and prevention of re-formation of blood clots in children.
Common (may affect up to 1 in 10 people):

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Skin 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
• Nosebleed
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with soft or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur at the level of the stomach or intestine, in the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red) or under the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the percentage of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Pain in the abdomen or stomach
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part 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 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 from a lesion, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Unusual results in 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dabigatran etexilato Biocon

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 package or blister after
Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30 ºC.
Store in the original package to protect the medicine from moisture.
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 Biocon contains

• The active ingredient is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (as mesylate) equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are tartaric acid, gum arabic, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171) and hypromellose.

Description of the appearance of Dabigatran etexilate Biocon and package contents
Dabigatran etexilate Biocon 75 mg are hard capsules, filled with granules of colour from whitish to
pale yellow in hard capsules from white to off-white of size 2.
This medicinal product is available in packs containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose blisters made of Aluminium/OPA-ALU-PVC perforated.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biocon Pharma Malta I Limited
The Victoria Centre, Unit 2, Lower
Ground Floor, Valletta Road, Mosta
MST 9012, Malta

Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50

• 08950 – Esplugues de Llobregat (Barcelona) Spain

Or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain

This medicinal product is authorised in the Member States of the European Economic Area with
the following names

Dabigatran etexilate Biocon 110 mg hard capsules

dabigatran etexilate

Generic medicine

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

1. What is Dabigatran etexilate Biocon and what it is used for

Dabigatran etexilate Biocon contains the active ingredient 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 Biocon is used in adults for:

• preventing the formation of blood clots in the veins following knee or hip replacement surgery.
• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a form of irregular heartbeat called non-valvular atrial fibrillation and at least one additional 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 Biocon 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 Biocon

Do not take Dabigatran etexilate Biocon

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely impaired kidney function.
• if you are bleeding.
• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury 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 clotting (for example warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, while you have a venous or arterial catheter and are receiving heparin through this catheter to keep it open, or while your heartbeat is being restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that could in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• 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 Biocon. You may also need to
talk to your doctor during treatment with Dabigatran etexilate Biocon 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 one
of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone surgical removal of tissue (biopsy) in the previous month.
• if you have experienced a serious injury (e.g. bone fracture, 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 Biocon” 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 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.
• for use in children only: if the child has an infection around the brain or inside it.
• 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 Biocon

• if you need to undergo surgery: In this case, Dabigatran etexilate Biocon will need to be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important to take Dabigatran etexilate Biocon before and after surgery exactly at the time you have been told by your doctor.
• if an operation 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 Biocon before and after the operation exactly at the times you have been told 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 worn off, as urgent care is needed.
• if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary to examine you because you may be at high risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change your therapy.

Other medicines and Dabigatran etexilate Biocon
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 Biocon 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 treating fungal infections (e.g. ketoconazole, itraconazole) unless they are only applied to the skin
• Medicines for treating abnormal heartbeats (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 Biocon depending on the condition for which it has been prescribed. See also section 3
• Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain relief medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for treating 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 treating epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Biocon on pregnancy and the developing baby are unknown. You should not
take Dabigatran etexilate Biocon 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 becoming pregnant while taking
Dabigatran etexilate Biocon.
You should not breastfeed while taking Dabigatran etexilate Biocon.

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

3. How to take Dabigatran etexilate Biocon

Dabigatran etexilate Biocon capsules can be used in adults and in children aged 8 years or older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other dosage forms appropriate for the age are available. Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Biocon 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 decreasedby more than half, you must take a reduced dose of Dabigatran etexilate Biocon of 75 mgbecause the risk of bleeding may increase.
For both types of surgery, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should be started with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules once a day for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, 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 body vessels due to the formation of blood clots that have developed following abnormal heartbeats and treatment of blood clots in the veins of the legs and lungs including the 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 of Dabigatran etexilate Biocon is 220 mg taken as one 110 mg capsule twice a day.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilate Biocon of 220 mg to be taken as one 110 mg capsule twice a day, because the risk of bleeding may increase.
If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be restored to normal with a procedure called cardioversion. Take Dabigatran etexilate Biocon according to your doctor's instructions.
If you have had a medical device (stent) inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stent, you may be treated with Dabigatran etexilate Biocon after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Biocon as your doctor has told you.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Biocon should be taken twice a day, one dose in the morning and one dose in the evening, at approximately 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 Biocon 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 Biocon
Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or
two 75 mg capsules

How to take Dabigatran etexilate Biocon
Dabigatran etexilate Biocon can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as this may increase the risk of bleeding.

Instructions for opening the blisters
The following images illustrate how to remove the Dabigatran etexilate Biocon capsules from the blister
Separate a unit of the blister from the whole blister along the perforated line
Lift the film on the back and remove the capsule.

• Do not push the capsules through the back film of the blister
• Do not detach the blister film until you need to remove a capsule.

Change of anticoagulant treatment
Do not change your anticoagulant treatment without receiving specific instructions from your doctor.

If you take more Dabigatran etexilate Biocon than you should
Taking too much 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 Biocon
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Biocon at the usual time of day 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 body vessels due to the formation of blood clots that have developed following abnormal heartbeats and treatment of blood clots in the veins of the legs and lungs including the 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
A forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, a forgotten dose should be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Biocon
Take Dabigatran etexilate Biocon exactly as prescribed. Do not stop taking this medicine without talking to your doctor first because 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 Biocon.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

blood clot can be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Biocon.
If you have any doubts 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 etexilate Biocon acts on the blood coagulation system, so most of the side effects are related to
signs such as bruising or bleeding.
Major or severe bleeding events may occur, which constitute the most serious side effects, and which,
regardless of location, can become disabling, life-threatening or even lead to death. In some cases these
bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or unexplained
swelling) consult your doctor immediately. The doctor may decide to keep you under close observation or
to change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing difficulty
breathing or dizziness.
The possible side effects are listed below, grouped by the 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):

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

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

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the
  urinary tract (including blood in the urine that colors it pink or red), from hemorrhoids, from the rectum,
  under the skin, in a joint, from or after an injury or after surgery
• Formation of hematoma or bruising that occurs after surgery
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the percentage of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (fluid leaking from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white 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
  catheter insertion into a vein
• Bloody secretion from the catheter insertion site into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction 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
• Skin rash characterized by bumps, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated based on available data):

• Difficulty breathing or wheezing
• Reduction 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 body vessels due to
formation of blood clots developed following abnormal heartbeats
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the
  urinary tract (including blood in the urine that colors it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Pain in the abdomen or stomach
• Indigestion
• Diarrhea 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
• Formation of hematoma
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction 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 in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results in 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 causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Skin rash characterized by bumps, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the percentage of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

• Difficulty breathing or wheezing
• Reduction 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 was higher with Dabigatran etexilate Biocon
than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs including prevention of
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, at the level of the stomach or intestines, from the rectum, from
  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 from a lesion
• Bleeding that may occur from hemorrhoids
• Reduction in the number of red blood cells in the blood
• Formation of hematoma
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling unwell
• Vomiting
• Pain in the abdomen or stomach
• Diarrhea with loose or liquid stools
• Abnormal results in liver function tests
• Increased liver enzymes

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

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

Not known (frequency cannot be estimated based on available data):

• Difficulty breathing or wheezing
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the percentage of blood cells
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood
• Hair loss

In the clinical study program the rate of heart attacks was higher with Dabigatran etexilate
Biocon than with warfarin. The overall incidence was low. In patients treated with dabigatran no
imbalance was observed in the rate of heart attacks 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):

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Skin rash characterized by bumps, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of hematoma
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

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

Not known (frequency cannot be estimated based on 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 lesion, from a surgical incision, from the injection site or from the
  site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Abnormal results in liver function tests

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can contribute to providing more information on the safety of
this medicine.

5. How to store Dabigatran etexilato Biocon

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 package or blister after
EXP. The expiry date refers to the last day of the month.
Do not store at a temperature above 30 ºC.
Store in the original package to protect the medicine from moisture.
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 Biocon contains

• The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesylate) equivalent to 110 mg of dabigatran etexilate.
• The other components are tartaric acid, gum arabic, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), FD&C blue 2/ indigo carmine (E-132) and hypromellose.

Description of the appearance of Dabigatran etexilate Biocon and package contents
Dabigatran etexilate Biocon 110 mg are hard capsules, containing granules of colour from whitish to
pale yellow in blue hard capsules of size 1.
This medicine is available in packs containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated single-dose blisters in Aluminium/OPA-ALU-PVC
perforated.
A multi-pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a
multi-pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in blister
single-dose in perforated aluminium/OPA-ALU-PVC.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Biocon Pharma Malta I Limited
The Victoria Centre, Unit 2, Lower
Ground Floor, Valletta Road, Mosta
MST 9012, Malta

Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50

• 08950 – Esplugues de Llobregat (Barcelona) Spain

Or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations

Dabigatran etexilate Biocon 150 mg hard capsules

dabigatran etexilate

Generic medicine

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

1. What is Dabigatran etexilate Biocon and what it is used for

Dabigatran etexilate Biocon 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 Biocon is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a form of irregular heartbeat called non-valvular atrial fibrillation and at least one additional 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 Biocon 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 Biocon

Do not take Dabigatran etexilate Biocon

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely impaired kidney function.
• if you are bleeding.
• if you have a disease in an organ that increases the risk of serious bleeding (e.g. stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. This can be congenital, due to unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that could in any way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for preventing organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• 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 Biocon. 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 one
of those included in the following list:

• if you have an increased risk of bleeding such as:
• if you have bled recently.
• if you have undergone surgical removal of tissue (biopsy) in the previous month.
• if you have suffered a serious injury (e.g. a bone fracture, 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 may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilate Biocon” 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 reduced emissions of dark (concentrated)/foamy 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.

Take special care with Dabigatran etexilate Biocon

• if you are going to have surgery: In this case, Dabigatran etexilate Biocon will need to be temporarily stopped due to the increased risk of bleeding during and shortly after surgery. It is very important to take Dabigatran etexilate Biocon before and after surgery exactly at the times told to you by your doctor.
• if an operation 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 Biocon before and after the operation exactly at the times told to you by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or bowel or bladder problems after the anesthesia has worn off, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary to examine you because you may be at high risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide whether it is necessary to change therapy.

Other medicines and Dabigatran etexilate Biocon
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 Biocon if you are taking any of the medicines listed below:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumone, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole) unless they are only applied to the skin
• Medicines for treating abnormal heartbeats (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 etexilate Biocon based on the condition for which it has been prescribed to you. See also section 3
• Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving drugs (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for treating 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 treating epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Biocon on pregnancy and the unborn child are unknown. You should
not take this medicine if you are pregnant unless your doctor advises you that it is safe to do so. If you
are a woman of childbearing potential, you should avoid becoming pregnant while taking Dabigatran etexilate
Biocon.
You should not breastfeed while taking Dabigatran etexilate Biocon.

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

3. How to take Dabigatran etexilate Biocon

Dabigatran etexilate Biocon capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other dosage forms appropriate for the age are available.
Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.

Take Dabigatran etexilate Biocon as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or blood vessels in the body due to the formation of blood clots developed as a result of irregular heartbeats 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 one 150 mg capsule twice a day.
If you are 80 years 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 take a reduced dose of Dabigatran etexilate Biocon of 220 mg taken as one 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 one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be restored to normal with a procedure called cardioversion or through a procedure called transcatheter ablation for atrial fibrillation. Take Dabigatran etexilate Biocon as your doctor has told you.
If a medical device (stent) has been inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stent, you may be treated with Dabigatran etexilate Biocon after the doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Biocon as your doctor has told you.
Treatment of blood clots and prevention of the formation of new blood clots in children.

Dabigatran etexilate Bioconmust be taken twice a day, one dose in the morning and one dose 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 individual and total daily doses of Dabigatran etexilate Biocon 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 Biocon
Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or
two 75 mg capsules

How to take Dabigatran etexilate Biocon
Dabigatran etexilate Biocon can be taken with or without food. The capsule must be swallowed whole with a glass of water, to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as this may increase the risk of bleeding.

Instructions for opening the blisters
The following images illustrate how to remove the Dabigatran etexilate Biocon capsules from the blister
Separate a unit of the blister from the whole blister along the perforated line
Lift the film on the back and remove the capsule.

• Do not push the capsules through the aluminum foil of the blister
• Do not peel off the blister film until you need to remove a capsule.

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

If you take more Dabigatran etexilate Bioconthan you should

Taking too much 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 Biocon
A forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, a forgotten dose must be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Biocon
Take Dabigatran etexilate Biocon exactly as prescribed. Do not stop taking this medicine without first talking to your doctor because 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 Biocon.
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 Biocon acts on the blood coagulation system; therefore, most of the side
effects are related to signs such as bruising or bleeding.
Major or serious bleeding events may occur, which constitute the most serious side effects, and
which, regardless of 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 symptoms of
excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or
inexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under
close observation or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing 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 blood vessels throughout the body due to
blood clots developed as a result of altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Diarrhea with soft 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
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin present 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 in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Unusual results in 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 lesion, from the injection site or from the site of catheter insertion into a vein
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Skin rash characterized by bumps, dark red in color, swollen, itchy caused by an allergic reaction
• Reduction in the percentage of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Difficulty breathing or wheezing
• Reduction 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 was higher with Dabigatran etexilate Biocon than
with warfarin.
The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs including the prevention of
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, at the level of the stomach or intestines, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which 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 from a lesion
• Bleeding that may occur from hemorrhoids
• Reduction 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 in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhea with soft or liquid stools
• Unusual results in liver function tests
• Increased liver enzymes

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

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

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

• Difficulty breathing or wheezing
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Reduction in the percentage of blood cells
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood
• Hair loss

In the clinical study program, the rate of heart attacks was higher with Dabigatran etexilate
Biocon than with warfarin. The overall incidence was low. In patients treated with dabigatran, no
imbalance in the incidence of heart attacks was observed compared with 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):

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Skin rash characterized by bumps, dark red in color, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Bruising
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with soft or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur at the level of the stomach or intestines, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red) or under the skin
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Reduction in the percentage of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part 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 lesion, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Unusual results in 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 at
. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dabigatran etexilato Biocon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the blister pack after SCAD.
The expiry date refers to the last day of the month.
Do not store at a temperature above 30 ºC.
Store in the original package to protect the medicine from moisture.
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 Biocon contains

• The active ingredient is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesylate) equivalent to 150 mg of dabigatran etexilate.
• The other ingredients are tartaric acid, gum arabic, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), FD&C blue 2/ Indigo carmine (E-132) and hypromellose.

Description of the appearance of Dabigatran etexilate Biocon and package contents
Dabigatran etexilate Biocon 150 mg are hard capsules, containing granules of colour from whitish to
pale yellow, in hard capsules with a body from white to off-white and a blue cap, size 0.
This medicine is available in packs containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in single-dose blisters made of Aluminium/OPA-ALU-PVC perforated.
A multi-pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a
multi-pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in blister
single-dose of aluminium/OPA-ALU-PVC perforated.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biocon Pharma Malta I Limited
The Victoria Centre, Unit 2, Lower
Ground Floor, Valletta Road, Mosta
MST 9012, Malta

Manufacturers:
Galenicum Health, S.L.U.
Sant Gabriel, 50

• 08950 – Esplugues de Llobregat (Barcelona) Spain

Or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations