Dabigatran etexilate Biocon: detailed information

Patient Information Leaflet

Dabigatran Etexilate Biocon 75 mg Hard Capsules

dabigatran etexilate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran Etexilate Biocon is and what it is used for
What you need to know before taking Dabigatran Etexilate Biocon
How to take Dabigatran Etexilate Biocon
Possible side effects
How to store Dabigatran Etexilate Biocon
Contents of the pack and other information

1. What Dabigatran etexilate Biocon is 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 in the body that is 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 a surgical replacement of the knee or hip.

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 etexilato Biocon

Do not take Dabigatran etexilato 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 reduced kidney function.
if you are bleeding.
if you have a disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, lesion or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, due to unknown causes, or caused by other medicines.
if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when 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 heart rhythm is being

restored to normal with a procedure called trans-catheter ablation for atrial
fibrillation.

if you have severely reduced liver function or a liver disease that could potentially 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 rejection after organ transplantation.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
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 etexilato Biocon. You may also need to
consult your doctor during treatment with Dabigatran etexilato Biocon if you develop symptoms or
need to undergo surgery.
Inform your doctor if you have or have had any medical condition or illness, particularly
one of those listed below:

if you have an increased risk of bleeding, such as:
if you have recently bled.
if you have undergone surgical removal of tissue (biopsy) within the last month.
if you have sustained a serious injury (e.g. bone fracture, head injury, or any injury requiring surgery).
if you suffer from inflammation of the esophagus or stomach.
if you have problems with gastric acid reflux into the esophagus.
if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran etexilato Biocon” 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 that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and reduced urination of dark-colored (concentrated) / foamy urine).
if you are over 75 years of age.
if you are an adult and weigh 50 kg or less.
for use in children only: if the child has an infection around or within 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 a liver disease associated with abnormalities in blood tests. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilato Biocon

if you need to undergo surgery: In this case, Dabigatran etexilato Biocon will need to be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important to take Dabigatran etexilato Biocon exactly at the times prescribed by your doctor, both before and after surgery.
if surgery involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Dabigatran etexilato Biocon exactly at the times prescribed by your doctor, both before and after surgery.
inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after the anaesthesia wears off, as urgent medical care may be needed.
if you fall or injure yourself 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 increases the risk of blood clots), inform your doctor, who will decide whether therapy needs to be changed.

Other medicines and Dabigatran etexilato Biocon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine. In particular, you must inform your doctor before taking Dabigatran
etexilato Biocon 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 to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines to treat abnormal heart rhythms (e.g. amiodarone, dronedarone, quinidine, verapamil).
If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilato 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-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 etexilato Biocon on pregnancy and the unborn child are unknown. You must not
take Dabigatran etexilato Biocon if you are pregnant unless your doctor advises that it is
safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant while taking
Dabigatran etexilato Biocon. You must not breastfeed while taking Dabigatran
etexilato Biocon.

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

3. How to take Dabigatran etexilate Biocon

Dabigatran etexilate Biocon capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Biocon 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 must take a reduced dose of Dabigatran etexilate Biocon of 75 mg, as the risk of bleeding may increase.
For both types of surgical procedures, treatment must not be initiated if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with Dabigatran etexilate Biocon within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment and prevention of new blood clots in children.
Dabigatran etexilate Biocon 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 medications unless your doctor tells you to stop any of them.
Table 1 shows the individual and total daily doses of Dabigatran etexilate Biocon 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 Biocon

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 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 gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.
Instructions for opening the blister packs
The following images illustrate how to remove the capsules of Dabigatran etexilate Biocon from the blister

Two-step diagram showing how to peel off a dressing strip and how to lift the upper protective layer

Separate one unit from the entire blister along the perforated line.
Lift the film on the back and remove the capsule.

Do not push the capsules through the back foil of the blister
Do not peel off the blister film until a capsule needs to be removed.

Switching 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. Contact your doctor
immediately if you have taken an excessive number of capsules. Specific treatment options are available.
If you forget to take Dabigatran etexilate Biocon
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Biocon at the usual time on the
following day.
Do not take a double dose to make up for a forgotten dose.
Treatment of blood clots and prevention of recurrence of blood clots in children
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, a missed dose should be skipped.
Do not take a double dose to make up for a forgotten 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, 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 Biocon.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Dabigatran etexilate Biocon acts on the blood clotting system; therefore, most of the 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 location, may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you experience symptoms of excessive bleeding (unusual weakness, unusual tiredness, 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 in breathing or dizziness.

The possible side effects are listed below, grouped according to how frequently they occur.

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)
Unusual results in liver function tests

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

Bleeding which may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in the urine turning it pink or red), from haemorrhoids, rectum, under the skin, into a joint, or from or after an injury or surgery
Formation of haematoma or bruising occurring after surgery
Presence of blood in the stool, detected by laboratory test
Decrease in the number of red blood cells in the blood
Decrease in the percentage of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or watery stools
Feeling unwell
Discharge from the wound (fluid leaking from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
Bleeding which may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
Blood-stained discharge from the catheter insertion site into a vein
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 in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash with dark red, swollen, itchy bumps caused by 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 or stomach pain
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 of blood clots 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
Skin rash with dark red, swollen, itchy bumps caused by an allergic reaction
Sudden skin changes altering its colour and appearance
Formation of haematoma
Nosebleed
Reflux of gastric juice into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or watery 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 which may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including blood in the urine turning it pink or red), or under the skin
Decrease in the amount of 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 or stomach pain
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 in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding which may occur in a joint or from an injury, surgical incision, injection site, or catheter insertion site into a vein
Bleeding which may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Unusual results in liver function tests

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 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 etexilate Biocon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after
Exp. The expiry date refers to the last day of the month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 Biocon contains

The active substance is dabigatran. Each hard capsule contains 86.48 mg of dabigatran etexilate (as mesilate), equivalent to 75 mg of dabigatran etexilate.
The other components are tartaric acid, acacia gum, hypromellose 2910, dimethicone 350, talc and hydroxypropyl cellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171) and hypromellose.

Description of the appearance of Dabigatran etexilate Biocon and contents of the pack
Dabigatran etexilate Biocon 75 mg are hard capsules filled with granules ranging in colour from whitish to pale yellow, in size 2 hard capsules of white to whitish colour.
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 perforated Al/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 names

Malta	Dabigatran etexilate Biocon 75 mg hard capsules
Germany	Dabigatran etexilate Biocon 75 mg hard capsules
Italy	Dabigatran etexilate Biocon
Netherlands	Dabigatran etexilate Biocon 75 mg hard capsules
Austria	Dabigatran etexilate Biocon 75 mg hard capsules

Patient information leaflet

Dabigatran etexilate Biocon 110 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine as 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 others, even if they have the same symptoms as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Biocon is and what it is used for
What you need to know before taking Dabigatran etexilate Biocon
How to take Dabigatran etexilate Biocon
Possible side effects
How to store Dabigatran etexilate Biocon
Contents of the pack and other information

1. What Dabigatran etexilate Biocon is and what it is used 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 type 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 forming again 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 reduced kidney function.
if you are bleeding.
if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, lesion or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may 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 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 heart rhythm is being restored to normal via a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially 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 rejection after transplantation.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
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
consult your doctor during treatment with Dabigatran etexilate Biocon if you develop symptoms or
need to undergo surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly one
included in the following list:

if you have an increased risk of bleeding, such as:
if you have recently experienced bleeding.
if you have undergone surgical removal of tissue (biopsy) within the previous month.
if you have sustained a severe injury (e.g. bone fracture, head injury, or any injury requiring surgical intervention).
if you suffer from inflammation of the oesophagus or stomach.
if you have gastroesophageal reflux (acid reflux into the oesophagus).
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 have an infection of the heart (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)/foamy urine).
if you are over 75 years old.
if you are an adult weighing 50 kg or less.
only for use in children: if the child has an infection around or within 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 Biocon

if you are undergoing surgery: In this case, you will need to temporarily stop taking Dabigatran etexilate Biocon due to an increased risk of bleeding during and shortly after surgery. It is very important to take Dabigatran etexilate Biocon exactly at the times instructed by your doctor, both before and after surgery.
if surgery involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to take Dabigatran etexilate Biocon exactly at the times instructed by your doctor, both before and after the procedure.
inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anaesthesia wears off, as urgent treatment may be needed.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Contact your doctor immediately. Your doctor may consider it necessary to examine you, as 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), inform your doctor, who will decide whether a change in therapy is needed.

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 inform your doctor before taking Dabigatran etexilate Biocon 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 abnormal heart rhythms (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of 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)
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)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Biocon on pregnancy and the unborn child are unknown. You must
not take Dabigatran etexilate Biocon during pregnancy unless your doctor advises you that it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant while taking
Dabigatran etexilate Biocon.
You must 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 operate machinery.

3. How to take Dabigatran etexilato Biocon

Dabigatran etexilato Biocon capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor.

Take Dabigatran etexilato Biocon 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 must take a reduced dose of Dabigatran etexilato Biocon of 75 mg, because the risk of bleeding may increase.

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

After knee replacement surgery
You should start treatment with Dabigatran etexilato Biocon within 1–4 hours after the end of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.

After hip replacement surgery
You should start treatment with Dabigatran etexilato Biocon within 1–4 hours after the end of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Prevention of blood vessel blockage in the brain or body due to blood clots caused by irregular heartbeats, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
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 of Dabigatran etexilato Biocon is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran etexilato Biocon of 220 mg taken as one 110 mg capsule twice daily, 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 daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabigatran etexilato Biocon as directed by your doctor.

If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilato Biocon once your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilato Biocon exactly as instructed by your doctor.

Treatment and prevention of new blood clots in children
Dabigatran etexilato Biocon 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 and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you otherwise.

Table 1 shows the individual and total daily doses of Dabigatran etexilato Biocon in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilato Biocon

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

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 gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the blister packs
The following images illustrate how to remove the Dabigatran etexilate Biocon capsules from the blister

Two-step diagram showing how to separate a tablet strip from a blister pack and how to lift the upper protective sheet

Separate one unit from the entire blister along the perforated line.
Lift the foil from the back and remove the capsule.

Do not push the capsules through the foil backing of the blister
Do not peel back the foil until you are ready to remove a capsule.

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

Use in adults: Prevention of blockage of blood vessels in the brain or body due to blood clots caused by irregular heartbeats, 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 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, 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 Biocon.

If you have any doubts about using this medicine, consult 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 clotting system, so most of the side effects are related to signs such as bruising or bleeding.
Major or serious bleeding events may occur, which are 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 stop spontaneously, or if you experience symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you closely or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing breathing difficulties or dizziness.
The possible side effects are listed below, grouped by frequency of occurrence.

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 haemoglobin 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, stomach or intestine, from penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from or after an injury or after surgery
Formation of haematoma or bruising occurring after surgery
Presence of blood in faeces, detected by laboratory test
Reduction in the number of red blood cells in the blood
Reduction in the percentage of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or liquid stools
Feeling unwell
Discharge from the wound (fluid leaking from the surgical wound)
Increase in liver enzymes
Yellowing of the skin or the white part 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, 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
Reduction in the number of platelets in the blood
Reduction in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterised by raised, dark red, swollen, itchy bumps caused by an allergic reaction
Sudden skin alteration changing 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 or stomach pain
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
Reduction in the number or even absence of white blood cells (which help fight infections)
Hair loss

Prevention of blood vessel blockage in the brain or body due to blood clots formed as a result of abnormal heartbeats
Common (may affect up to 1 in 10 people):

Bleeding that may occur from the nose, stomach or intestine, from penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Reduction in the number of red blood cells in the blood
Abdominal or stomach pain
Indigestion
Diarrhoea 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 haematoma
Coughing up blood or blood-stained sputum
Reduction in the number of platelets in the blood
Reduction in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin alteration changing 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
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 an injury, from the injection site or from the site of insertion of a venous catheter
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Skin rash characterised by raised, dark red, swollen, itchy bumps caused by an allergic reaction
Reduction in the percentage of blood cells
Increase in liver enzymes
Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the 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 etexilato Biocon than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of re-formation of blood clots in the veins of the legs and/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 from an injury
Bleeding that may occur from haemorrhoids
Reduction in the number of red blood cells in the blood
Formation of haematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin alteration changing 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 or stomach pain
Diarrhoea with loose or liquid stools
Unusual results in liver function tests
Increase in liver enzymes

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

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

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

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

In the clinical study programme, the rate of heart attacks was higher with Dabigatran etexilato Biocon than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the rate of heart attacks was observed compared to patients treated with placebo.

Treatment of blood clots and prevention of 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 characterised by raised, dark red, swollen, itchy bumps caused by an allergic reaction
Sudden skin alteration changing its colour and appearance
Formation of haematoma
Nosebleed
Reflux of gastric juice into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or liquid stools
Indigestion
Hair loss
Increase in 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 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
Reduction in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Reduction in the percentage of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or the white part 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 in 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 from an injury, from a surgical incision, from the injection site or from the site of insertion of a venous catheter
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Unusual results in liver function tests

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 etexilate Biocon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box or blister after EXP. The expiry date refers to the last day of the month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 Biocon contains

The active substance is dabigatran. Each hard capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 mg of dabigatran etexilate.
The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), FD&C Blue No. 2 / indigo carmine (E-132) and hypromellose.

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

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 names

Malta	Dabigatran etexilate Biocon 110 mg hard capsules
Germany	Dabigatran etexilate Biocon 110 mg hard capsules
Italy	Dabigatran etexilate Biocon
Netherlands	Dabigatran etexilate Biocon 110 mg hard capsules
Austria	Dabigatran etexilate Biocon 110 mg hard capsules

Patient information leaflet

Dabigatran etexilate Biocon 150 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Dabigatran etexilate Biocon is and what it is used for
What you need to know before taking Dabigatran etexilate Biocon
How to take Dabigatran etexilate Biocon
Possible side effects
How to store Dabigatran etexilate Biocon
Contents of the pack and other information

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

preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heart rhythm 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 the recurrence of blood clots 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 reduced 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, lesion or bleeding in the brain, recent brain or eye surgery).
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 clotting (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 and heparin is administered through it to keep it open, or when your heartbeat is restored to normal by a procedure called trans-catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially 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 abnormal heart rhythm.
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 Biocon. You may also need to contact 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 any of the following:

if you have an increased risk of bleeding such as:
if you have recently bled.
if you have undergone surgical removal of tissue (biopsy) within the previous month.
if you have suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgery).
if you suffer from inflammation of the oesophagus or stomach.
if you have problems with gastric acid reflux into the oesophagus.
if you are taking medicines that may increase the risk of bleeding. See the 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 urination of dark (concentrated)/foamy urine).
if you are over 75 years of age.
if you are an adult patient weighing 50 kg or less.
only for use in children: if the child has an infection around or within 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 suffer from liver disease associated with abnormal blood test results. In this case, the use of this medicine is not recommended.

Take special care with Dabigatran etexilate Biocon

if you are due to undergo surgery: In this case, you will need to temporarily stop taking Dabigatran etexilate Biocon 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 instructed by your doctor.
if surgery involves the placement of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia or pain relief):
it is very important to take Dabigatran etexilate Biocon before and after surgery exactly at the times instructed by your doctor.
inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical care is required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as 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), inform your doctor, who will decide whether a change in therapy is necessary.

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 inform your doctor before taking Dabigatran etexilate Biocon 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 to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines to treat abnormal heart rhythms (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may instruct 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 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
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)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

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

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

3. How to take Dabigatran etexilato Biocon

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

Take Dabigatran etexilato Biocon as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots caused by irregular heartbeats, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots.

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 must take a reduced dose of Dabigatran etexilato Biocon of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilato Biocon exactly 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 etexilato Biocon after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilato Biocon exactly as directed by your doctor.

Treatment of blood clots and prevention of new blood clots in children.

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

Table 1 shows the individual and total daily doses of Dabigatran etexilato Biocon in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilato Biocon

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

Instructions for opening the blister packs
The following images illustrate how to remove Dabigatran etexilate Biocon capsules from the blister

Two-step diagram showing how to separate a tablet strip from a blister pack and how to lift a paper sheet flap

Separate one unit of the blister from the entire blister along the perforated line.
Peel back the film on the back and remove the capsule.

Do not push the capsules through the aluminium foil of the blister
Do not peel back the blister film until you are ready to remove a capsule.

Switching 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. Contact your doctor immediately if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Biocon
A missed dose can 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 double the dose to make up for a forgotten dose.

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 gets them.
Dabigatran etexilate Biocon acts on the blood coagulation system; 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 adverse reactions, 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 stop spontaneously, or if you experience symptoms of excessive bleeding (unusual weakness, feeling of 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 the frequency of occurrence.

Prevention of blockage of blood vessels in the brain or 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
Stomach or abdominal pain
Indigestion
Diarrhea with loose or watery stools
Feeling unwell

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

Bleeding
Bleeding that may occur from hemorrhoids, rectum, or brain
Formation of hematoma
Coughing up blood or bloody sputum
Decrease in the number of platelets in the blood
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin reaction changing its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Vomiting
Difficulty swallowing
Abnormal liver function test results

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

Bleeding that may occur in a joint, from a surgical incision, injury, 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
Skin rash characterized by raised, dark red, swollen, itchy bumps due to an allergic reaction
Decrease in the percentage of blood cells
Increase in liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

In one 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 legs and lungs, including prevention of re-formation 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 from an injury
Bleeding that may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of hematoma
Coughing up blood or bloody sputum
Allergic reaction
Sudden skin reaction changing its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Feeling unwell
Vomiting
Stomach or abdominal pain
Diarrhea with loose or watery stools
Abnormal liver function test results
Increase in 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
Skin rash characterized by raised, dark red, swollen, 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 hemoglobin in the blood (the substance contained in red blood cells)
Decrease in the percentage of blood cells
Decrease in 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 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 to patients treated with placebo.

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Skin rash characterized by raised, dark red, swollen, itchy bumps due to an allergic reaction
Sudden skin reaction changing its color and appearance
Formation of hematoma
Nosebleed
Gastric acid reflux into the esophagus
Vomiting
Feeling unwell
Diarrhea with loose or watery stools
Indigestion
Hair loss
Increase in liver enzymes

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

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

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 from an injury, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from hemorrhoids
Stomach or intestinal ulcer (including esophageal 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 at the following address
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran etexilate Biocon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after EXP.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 Biocon contains

The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate), equivalent to 150 mg of dabigatran etexilate.
The other components are tartaric acid, acacia gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), FD&C Blue No. 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 whitish to pale yellow granules, with a hard capsule body ranging from white to whitish and a blue cap, size 0.
This medicine is available in packages containing:
10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated unit-of-use blisters made of aluminium/OPA-ALU-PVC.
A multipack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated unit-of-use blisters of aluminium/OPA-ALU-PVC.
Not all pack sizes may be marketed.

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 names

Malta	Dabigatran etexilate Biocon 150 mg hard capsules
Germany	Dabigatran etexilate Biocon 150 mg hard capsules
Italy	Dabigatran etexilate Biocon
Netherlands	Dabigatran etexilate Biocon 150 mg hard capsules
Austria	Dabigatran etexilate Biocon 150 mg hard capsules