BIGETRA 75 mg Капсулы Твердые

Содержание инструкции

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

Bigetra 75 mg hard capsules

dabigatran etexilate
Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may 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 Bigetra is and what it is used for
• 2. What you need to know before you take Bigetra
• 3. How to take Bigetra
• 4. Possible side effects
• 5. How to store Bigetra
• 6. Contents of the pack and other information

1. What is Bigetra and what is it used for

Bigetra contains the active ingredient dabigatran etexilate and belongs to a group of medicines
called anticoagulants. This medicine blocks the action of a substance present
in the body and involved in the formation of blood clots.
Bigetra is used in adults for:

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

Bigetra is used in children aged 8 years and older for:

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

2. What you need to know before taking Bigetra

Do not take Bigetra

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when 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 ciclosporin, a medicine for the prevention of rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• 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 use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Bigetra. You may also need to talk to your doctor
during treatment with this medicine if you experience symptoms or if you are 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 a biopsy (surgical removal of tissue) in the past month.
• if you have suffered serious injuries (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 acid reflux into the esophagus.
• if you are taking medicines that can increase the risk of bleeding. See the section “Other medicines and Bigetra” below.
• if you are taking anti-inflammatory medicines 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 suffer from dehydration (symptoms include feeling thirsty and passing a reduced amount of dark (concentrated)/frothy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• only for use in children: if the child has an infection around 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.

Pay particular attention with Bigetra

• if you are to undergo surgery: in this case Bigetra will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take Bigetra before and after the operation 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 Bigetra before and after the operation exactly at the time 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 ended, because 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 need 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 therapy.

Other medicines and Bigetra
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 Bigetra 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 altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Bigetra depending on the condition for which it has been prescribed to you. See also section 3
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's wort, a herbal medicine for 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 the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
The effects of dabigatran etexilate on pregnancy and the fetus are unknown. You should not take this
medicine if you are pregnant unless your doctor tells you that you can. If you are a woman of
childbearing potential, you should avoid pregnancy during treatment with Bigetra.
You should not breastfeed during treatment with Bigetra.

Driving and using machines
Bigetra has no known effects on the ability to drive vehicles and use machines.

3. How to take Bigetra

Bigetra capsules can be used in adults and children aged 8 years and over who are
able to swallow the capsules whole.
Take this medicine following exactly the instructions of your doctor. If you have doubts consult
your doctor.

Take Bigetra 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 dose
recommended 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 Bigetra of 75 mgbecause the risk of
bleeding may increase.
For both surgeries, 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 begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Bigetra 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 Bigetra 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.

Bigetra must be taken twice a day, one dose in the morning and one in the evening, approximately at
the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will establish the correct dose. The
doctor may adjust the dose during treatment. Continue to use all other
medicines, unless your doctor tells you to stop using any of them.
Table 1 shows the single and total daily doses of Bigetra 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 Bigetra capsules

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

How to take Bigetra
Bigetra can be taken with or without food. The capsule must be swallowed whole with a glass
of water, to ensure release in the stomach. Do not break, chew or remove the granules
from the capsule as it may increase the risk of bleeding.

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

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

If you forget to take Bigetra
Prevention of blood clot formation after knee or hip replacement surgery.
If you forget to take a dose, continue with the remaining daily doses of Bigetra 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.
The missed dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the missed dose should be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Bigetra
Take Bigetra exactly as prescribed. Do not stop taking this medicine without talking to
your doctor first, as the risk of developing a blood clot may be higher if you
stop treatment too soon. Contact your doctor if you experience stomach problems after
taking Bigetra.
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 also cause side effects, although not everyone will experience them.
Bigetra acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding. Major or severe bleeding events may occur, which constitute the most serious side effects, and which, regardless of location, may be 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 subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty breathing or dizziness.
Possible side effects are listed below, grouped according to how often 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 liver function test results

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 the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after surgery
• Formation of a hematoma or hematoma that occurs after an operation
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of fluid 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
• Secretion stained with blood 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 an operation
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after an operation

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

Treatment of blood clots and prevention of blood clot reformation 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
• Noticeable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Nose bleeding
• Reflux of gastric juices 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 intestine, from the brain, from the rectum, from the penis/vagina or from the urinary tract (including the presence of blood in the urine which turns 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 proportion 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)
• 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 a wound, 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 of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Bigetra

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
“Expiry”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and 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. Contents of the pack and other information

What Bigetra contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, talc, dimethicone and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), water and hypromellose.
• The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Bigetra and contents of the pack
Bigetra 75 mg is in the form of a hard capsule with an opaque white cap with radial black printing “D75”
and an opaque white body, containing a yellowish pellet.
This medicine is available in cardboard packs of 30 or 60 hard capsules in blisters of
Polyamide/Aluminum/PVC//Aluminum.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed s.r.l., Via G. Mazzini 20, 20123 Milano, Italy

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Poland: Bigetra
Germany: Bigetra
Italy: Bigetra
Spain: Bigetra 75 mg hard capsules EFG
Latvia: Bigetra 75 mg cietās kapsulas
Hungary: Bigetra 75 mg kemény kapszula

Bigetra 110 mg hard capsules

dabigatran etexilate
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 Bigetra is and what it is used for
• 2. What you need to know before you take Bigetra
• 3. How to take Bigetra
• 4. Possible side effects
• 5. How to store Bigetra
• 6. Contents of the pack and other information

1. What is Bigetra and what is it used for

Bigetra contains the active substance dabigatran etexilate and belongs to a group of medicines
called anticoagulants. This medicine blocks the action of a substance present
in the body involved in the formation of blood clots.
Bigetra is used in adults for:

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

Bigetra is used in children aged 8 years and older for:

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

2. What you need to know before taking Bigetra

Do not take Bigetra

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or caused by other medicines.
• if you are taking medicines to prevent blood clots from forming (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 reduced liver function or a liver disease that may in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking ciclosporin orally, a medicine for the prevention of rejection episodes after organ 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 use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Bigetra. 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 had recent bleeding.
• if you have had a biopsy (surgical removal of tissue) in the past month.
• if you have experienced serious injuries (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 Bigetra” 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 that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts 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.

Be particularly careful with Bigetra

• if you need to undergo surgery: in this case, Bigetra will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take Bigetra before and after the operation exactly at the time told to you by your doctor.
• if an operation involves the presence of a catheter or an injection into your spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Bigetra before and after the operation exactly at the time told to you by your doctor.
• immediately tell 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 need 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 Bigetra
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 Bigetra 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 altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of Bigetra based on the condition for which it has been prescribed to you. See section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John’s Wort, a herbal medicine for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Bigetra on pregnancy and the fetus are unknown. You should not take this medicine if
you are pregnant unless your doctor tells you that you can. If you are a woman of childbearing potential, you should avoid
pregnancy during treatment with Bigetra.
You should not breastfeed during treatment with Bigetra.

Driving and using machines
Bigetra has no known effects on the ability to drive vehicles and operate machines.

3. How to take Bigetra

Bigetra capsules can be used in adults and children aged 8 years and older who are
able to swallow the capsules whole.
Take this medicine following the instructions of your doctor exactly. If you have doubts, consult
your doctor.

Take Bigetra 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 Bigetra of 75 mgbecause the risk of
bleeding may increase.
For both surgeries, 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 begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with Bigetra within 1-4 hours after the end of 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 Bigetra within 1-4 hours after the end of 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 the rest of the body due to the formation
of blood clots that have developed following an altered heartbeat 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 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 Bigetra of 220
mg taken as one 110 mg capsule twice a day, because the risk of bleeding may
increase.
If you are potentially at higher risk of bleeding, your doctor may decide to
prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be restored
to normal with a procedure called cardioversion. Take Bigetra 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 Bigetra after your doctor has determined that normal blood coagulation control has been achieved. Take Bigetra according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in
children.

Bigetra must be taken twice a day, one dose in the morning and one 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 establish the correct dose. The
doctor may adjust the dose during treatment. Continue to use all other
medicines, unless your doctor tells you to stop using any of them.
Table 1 shows the single and total daily doses of Bigetra 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 Bigetra capsules
Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg capsule plus one 150 mg capsule or
one 110 mg capsule plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg capsule plus one 110 mg capsule
150 mg: one 150 mg capsule or
two 75 mg capsules

How to take Bigetra
Bigetra 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 it may increase the risk of bleeding.

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

If you take more Bigetra 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 Bigetra
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Bigetra at the usual time of the next day.
Do not take a double dose to make up for a missed dose.

Use in adults: prevention of blockage of blood vessels in the brain or the rest of the body
due to the formation of blood clots that have developed following an altered heartbeat 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
The forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the forgotten dose must be skipped.
Do not double the dose to make up for a missed dose.

If you stop taking Bigetra
Take Bigetra exactly as prescribed. Do not stop taking this medicine without
talking to your doctor first, as the risk of developing a blood clot may be higher
if you stop treatment too soon. Contact your doctor if you experience stomach problems
after taking Bigetra.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Bigetra 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 be 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. Your doctor may decide to subject you to a thorough check-up or
change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction causing difficulty
breathing or dizziness.
Possible side effects are listed below, grouped according to how frequently 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 liver function test results

Not common (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 a wound or
following surgery

• Formation of a hematoma or hematoma 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 proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of fluid 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 1000 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
• Secretion stained with blood 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 causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Notable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices 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 the rest of the body due to
formation of blood clots developed following 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 intestine, from penis/vagina or from the
  urinary tract (including the presence of blood in the urine which colors it pink or of

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

Not common (may affect up to 1 in 100 people):

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• Formation of a 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 of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

Rare (may affect up to 1 in 1000 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 or from the brain
• Serious allergic reaction causing difficulty breathing or dizziness
• Serious allergic reaction causing swelling of the face or throat
• Notable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the proportion 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 percentage of heart attacks was higher with Bigetra 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 intestine, from the rectum, from
  penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or of

red) or under the skin

• Indigestion Not common (may affect up to 1 in 100 people):
• Bleeding
• Bleeding that may occur in a joint or from a wound
• Bleeding that may occur from hemorrhoids
• Reduction in the number of red blood cells in the blood
• Formation of a hematoma
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Pain in the abdomen or stomach
• Diarrhea with loose or liquid stools
• Abnormal liver function test results
• Increased liver enzymes

Rare (may affect up to 1 in 1000 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
• Notable skin rash with nodules, 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 proportion 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 percentage of heart attacks was higher with Bigetra than
  with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the
  incidence of heart attacks was observed compared to patients treated with placebo.
  Treatment of blood clots and prevention of the formation of new blood clots in
  children.
  Common (may affect up to 1 in 10 people):
• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Notable skin rash with nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Bleeding from the nose
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Not common (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, 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 in the blood (the substance contained in red blood cells)
• Reduction in the proportion 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 wound, 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 of the stomach or intestine (including esophageal ulcer)
• Abnormal liver function test results

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 Bigetra

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 that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and 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. Contents of the pack and other information

What Bigetra contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E132), water and hypromellose.
• The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Bigetra and contents of the pack
Bigetra 110 mg is in the form of a hard capsule with an opaque blue cap with radial black printing
“D110” and an opaque blue body, containing a yellowish pellet.
This medicine is available in cardboard packs of 10, 30, 60, 100 or 180 hard capsules in
blisters of Polyamide/Aluminum/PVC//Aluminum inserted in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed s.r.l., Via G. Mazzini 20, 20123 Milan, Italy

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Poland: Bigetra
Germany: Bigetra
Italy: Bigetra
Spain: Bigetra 110 mg hard capsules EFG
Latvia: Bigetra 110 mg cietās kapsulas
Hungary: Bigetra 110 mg kemény kapszula

Bigetra 150 mg hard capsules

Equivalent medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 Bigetra is and what it is used for
• 2. What you need to know before you take Bigetra
• 3. How to take Bigetra
• 4. Possible side effects
• 5. How to store Bigetra
• 6. Contents of the pack and other information

1. What is Bigetra and what is it used for

Bigetra contains the active ingredient dabigatran etexilate and belongs to a group of medicines
called anticoagulants. This medicine blocks the action of a substance present
in the body involved in the formation of blood clots.
Bigetra is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one further 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.

Bigetra is used in children aged 8 years and older for:

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

2. What you need to know before taking Bigetra

Do not take Bigetra

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or the

stomach, injuries or bleeding to the brain or the eyes).

• if you have an increased tendency to bleed. This may be congenital, due to unknown cause or caused by other medicines.
• if you are taking medicines to prevent blood clots from forming (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 reduced liver function or a liver disease that may somehow cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral ciclosporin, a medicine for the prevention of rejection episodes after organ 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 use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Bigetra. 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 had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the previous month.
• if you have experienced serious injuries (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 may increase the risk of bleeding. See section “Other medicines and Bigetra” below.
• if you are taking anti-inflammatory medicines 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 you suffer from dehydration (symptoms include feeling thirsty and passing small amounts 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.

Be particularly careful with Bigetra

• if you need to undergo surgery: in this case, Bigetra will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take Bigetra before and after the operation exactly at the time you have been told by your doctor.
• if an operation involves the placement of a catheter or an injection into your spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Bigetra before and after the operation exactly at the time you have been told by your doctor.
• immediately tell your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, because 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 need 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 Bigetra
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 Bigetra 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 altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may tell you to use a reduced dose of Bigetra depending on the condition for which it has been prescribed to you. See section 3.
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Bigetra on pregnancy and the fetus are unknown. You should not take this medicine if
you are pregnant unless your doctor tells you that you can. If you are a woman of childbearing potential, you should avoid
pregnancy during treatment with Bigetra.
You should not breastfeed during treatment with Bigetra.

Driving and using machines
Bigetra has no known effects on the ability to drive vehicles and operate machines.

3. How to take Bigetra

Bigetra capsules can be used in adults and children aged 8 years and over who are
able to swallow the capsules whole. For the treatment of children under 12 years of age, Bigetra coated granules are available as soon as they are able to ingest soft food.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult
your doctor.

Take Bigetra as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation
of blood clots that have developed following an altered heartbeat 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 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 Bigetra to
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 Bigetra 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 can be treated
with Bigetra after your doctor has determined that normal blood coagulation control has been achieved. Take Bigetra according to your doctor's instructions.
Treatment of blood clots and prevention of the formation of new blood clots in
children.

Bigetra must be taken twice a day, one dose in the morning and one in the evening, approximately at the
same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will establish 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 Bigetra 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 Bigetra capsules

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

How to take Bigetra
Bigetra 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 it may increase the risk of bleeding.

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

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

If you forget to take Bigetra
The forgotten dose can still be taken up to 6 hours before the next dose. If less than
6 hours remain until the next dose, the forgotten dose should be skipped. Do not double the dose to
make up for the forgotten dose.

If you stop taking Bigetra
Take Bigetra 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 stomach discomfort after
taking Bigetra.
If you have any questions 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.
Bigetra 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 be disabling, life-threatening or even lead to death. In some
cases, these bleedings may not be apparent.
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. Your doctor may decide to subject you to a thorough check-up or
change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction causing difficulty
breathing or dizziness.
The possible side effects are listed below, grouped according to how frequently they
occur.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of
blood clots developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, in the stomach or intestines, from the penis/vagina or from the urinary
  tract (including blood in the urine which turns 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 alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of liver function tests

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the
  site of catheter insertion into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Notable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the proportion 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 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 percentage of heart attacks was higher with Bigetra 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, in the stomach or intestines, from the rectum, from the penis/vagina or
  from the urinary tract (including blood in the urine which turns 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 wound
• 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 alters its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhea with soft or liquid stools
• Abnormal results of 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
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Notable skin rash due to the presence of nodules, dark red, 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 proportion 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 percentage of heart attacks was higher with Bigetra than with
  warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of
  heart attacks was observed compared to patients treated with placebo.

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

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Notable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that alters its color and appearance
• Bruising
• Nosebleeds
• Reflux of gastric juices 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 in the stomach or intestines, in the brain, from the rectum, from the penis/vagina or
  from the urinary tract (including blood in the urine which turns 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 proportion 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 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)
• 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 a wound, 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 of the stomach or intestine (including ulcer of the esophagus)
• Abnormal results of liver function tests

Reporting of side effects
If you get any side effects, 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 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 Bigetra

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 that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from light and 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. Contents of the pack and other information

What Bigetra contains
The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as
mesylate).
The other ingredients are tartaric acid, gum arabic, hypromellose, dimethicone, talc and
hydroxypropylcellulose.
The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo
carmine (E132), water and hypromellose.
The black printing ink contains shellac, black iron oxide (E172) and potassium hydroxide.

Description of the appearance of Bigetra and contents of the pack
Bigetra 150 mg is in the form of a hard capsule with an opaque blue cap with radial black
printing “D150” and an opaque white body, containing a yellowish pellet.
This medicine is available in cardboard packs of 30, 60, 100 or 180 hard capsules in blisters
of Polyamide/Aluminum/PVC//Aluminum inserted in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed s.r.l., Via G. Mazzini 20, 20123 Milano, Italy

Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Poland: Bigetra
Germany: Bigetra
Italy: Bigetra
Spain: Bigetra 150 mg hard capsules
Latvia: Bigetra 150 mg cietās kapsulas
Hungary: Bigetra150 mg kemény kapszula