ANDABRA 75 mg Kapsułki Twarde

Treść ulotki

1. Andabra 75 mg hard capsules
   1. What is Andabra and what is it used for
   2. What you need to know before taking Andabra
   3. How to take Andabra
   4. Possible side effects
   5. How to store Andabra
   6. Package contents and other information
2. Andabra 110 mg hard capsules
   1. What is Andabra and what it is used for
   2. What you need to know before taking Andabra
3. Take Andabra before and after surgery exactly at the time indicated by your doctor.
   1. How to take Andabra
   2. Possible side effects
   3. How to store Andabra
   4. Contents of the pack and other information
4. Andabra 150 mg hard capsules
   1. What is Andabra and what is it used for
   2. What you need to know before taking Andabra
   3. How to take Andabra
   4. Possible side effects
   5. How to store Andabra
   6. Package contents and other information

Andabra 75 mg hard capsules

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

1. What is Andabra and what is it used for

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

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

Andabra is used in children for:

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

2. What you need to know before taking Andabra

Do not take Andabra

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you have ongoing bleeding.
• if you have injuries to an organ in your body that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This may be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is

returned to normal with a procedure called catheter 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 Andabra. 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 surgical removal of tissue (biopsy) 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 Andabra” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know you have reduced kidney function or suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• only for use in children: if the child has an infection around 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.

Be particularly careful with Andabra

• if you need to undergo surgery: In this case, Andabra 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 Andabra 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 the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Andabra before and after the operation exactly at the time told to you 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 Andabra
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 Andabra 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 Andabra based on the condition for which it has been prescribed. See also section 3
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, ciclosporin)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Andabra on pregnancy and the fetus are unknown. Do not take this medicine if you are
pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you should avoid
pregnancy during treatment with Andabra.
Do not breastfeed during treatment with Andabra.

Driving and operating machinery
Andabra has no known effects on the ability to drive vehicles and operate machinery.

3. How to take Andabra

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

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

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reducedby more than half, you must take a reduced dose of Andabra of 75 mgbecause the risk of bleeding may increase.
For both procedures, 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 Andabra 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 Andabra 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 blood clot formation in children.

Andabra 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 taking any of them.
Table 1 shows the single and total daily doses of Andabra 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 Andabra 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 Andabra
Andabra can be taken with or without food. The capsule should 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.

Instructions for opening the bottle

• Press and turn to open.
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

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

If you take more Andabra 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 Andabra
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Andabra at the usual time of day. Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of blood clot reformation in children.
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 a missed dose.

If you stop taking Andabra
Take Andabra 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 upset after taking Andabra.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Andabra 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, can 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 serious allergic reaction that causes difficulty breathing or dizziness. The possible side effects are listed below, grouped by the frequency with which they occur.
Prevention of blood clot formation after 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 laboratory test results for liver function Uncommon(may affect up to 1 in 100 people):
• Bleeding that may occur from the nose, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine which 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 bruising 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 soft 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
• Bloody secretion from the site of catheter insertion into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe 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 from available data):
• Difficulty breathing or wheezing
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Treatment of blood clots and prevention of re-formation of blood clots in children.

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

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• 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
• Nose bleeding
• 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 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 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 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 esophageal ulcer)
• Abnormal laboratory test results for liver function Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Andabra

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, blister or bottle after
"Exp.". The expiry date refers to the last day of that month.
Blister: store in the original packaging to protect from moisture.
This medicine does not require special storage temperature conditions.
Bottle: store in the original packaging to protect from moisture.
This medicine does not require special storage temperature conditions.
Keep the bottle tightly closed to protect from moisture. This medicine does not require particular
storage temperature conditions.
Do not dispose of any medicine in 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 Andabra contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are tartaric acid (600 pellet), acacia, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide, water (5%) target humidity and hypromellose.
• The black printing ink contains shellac (E904), black iron oxide (E172) and potassium hydroxide (E525).

Description of Andabra and package contents
Andabra 75 mg are hard capsules (with a length of 17.7± 0.6 mm and a width of 6.2± 0.3 mm), No. 2, with an
opaque white cap and an opaque white body imprinted in black with "75".
This medicine is available in packs containing 10, 30 or 60 hard capsules in OPA/ALU/PVC blisters

• aluminium foil and OPA/ALU/PE blister with desiccant - aluminium foil/PE.

This medicine is also available in white high-density polyethylene (HDPE) bottles with a polypropylene (PP) cap with desiccant and white polypropylene (PP) bottles with a low-density polyethylene (LDPE) cap with desiccant containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece

Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece
Pharmathen International S.A.
Industrial Park
Sapes,Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

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

Andabra 110 mg hard capsules

dabigatran etexilate
Generic medicine

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

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

1. What is Andabra and what it is used for

Andabra contains the active substance dabigatran etexilate and belongs to a group of medicines
called anticoagulants. It blocks the action of a substance present in the body involved in the
formation of blood clots.
Andabra 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 disturbance 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.

Andabra is used in children for:

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

2. What you need to know before taking Andabra

Do not take Andabra

• 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 in your body 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 changing anticoagulant treatment, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heartbeat is restored to normal with a procedure called catheter 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 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 Andabra. You may also need to talk to your doctor during the
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 surgical removal of tissue (biopsy) 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 Andabra” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know you have reduced kidney function or suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/frothy urine).
• if you are over 75 years old.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Take special care with Andabra

• if you are going to have surgery: In this case, Andabra 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

Take Andabra before and after surgery exactly at the time indicated by your doctor.

• if surgery 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 Andabra before and after surgery exactly at the time indicated by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, because urgent 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 autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy.

Other medicines and Andabra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine. In particular, you must tell your doctor before taking Andabra 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 to treat fungal infections (e.g. ketoconazole, itraconazole) unless they are only applied to the skin
• Medicines to treat 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 Andabra 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, 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 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 Andabra on pregnancy and the fetus are unknown. You should not take this medicine if you are
pregnant unless your doctor tells you that it is safe to do so. If you are a woman of childbearing potential, you should avoid
pregnancy during treatment with Andabra.
You should not breastfeed during treatment with Andabra.

Driving and operating machinery
Andabra has no known effects on the ability to drive vehicles and operate machinery.

3. How to take Andabra

Andabra capsules can be used in adults and children aged 8 years and over who are
able to swallow the capsules whole. Other dosage forms are available for the treatment of
children under 8 years of age.
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.

Take Andabra 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 has decreasedby more
than half, you should take a reduced dose of Andabra of 75 mgbecause the risk of bleeding
may increase.
For both procedures, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after the
surgical procedure, administration should begin with a dose of 2 capsules once a day.

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

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

Instructions for opening the bottle

• Press and turn to open
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

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

If you take more Andabra than you should
Taking too much of this medicine increases the risk of bleeding. Seek immediate attention

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

If you forget to take Andabra
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of Andabra at the usual time of 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 as a result of irregular 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 should be skipped. Do not
take a double dose to make up for a missed dose.

If you stop taking Andabra
Take Andabra 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 problems after taking Andabra.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Andabra acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding.
Major or serious 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 that causes difficulty breathing or dizziness.
Possible side effects are listed below, grouped by the frequency with which they occur.
Prevention of blood clot formation after knee or hip replacement surgery

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

• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Abnormal results of laboratory tests on liver function Uncommon(may affect up to 1 in 100 people):
• Bleeding that may occur from the nose, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine that turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it, after a surgical intervention
• Formation of 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 part of the eyes, caused by problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bloody secretion from the site of catheter insertion into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after surgery
• 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
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric 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 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, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine that turns it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Pain in the abdomen or stomach
• Indigestion
• Diarrhea with loose or liquid stools
• Feeling unwell Uncommon(may affect up to 1 in 100 people):
• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain.
• Formation of 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 ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of laboratory tests on liver function 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 part 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 numerically higher with dabigatran than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs including prevention of the reformation of blood clots in the veins of the legs and/or lungs

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

• Bleeding that may occur from the nose, 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 that turns it pink or red) or under the skin
• Indigestion Uncommon(may affect up to 1 in 100 people):
• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• 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 ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Pain in the abdomen or stomach
• Diarrhea with loose 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 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 part 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 dabigatran than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance was observed in the percentage of heart attacks compared to patients treated with placebo.

Treatment of blood clots and prevention of blood clot formation 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 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 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 penis/vagina or from the urinary tract (including the presence of blood in the urine that 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 part 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 ulcer of the esophagus)
• Abnormal results of liver function tests Reporting of side effectsIf 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 Andabra

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, blister or bottle after
"Exp.". The expiry date refers to the last day of that month.
Blister: store in the original package to protect from moisture.
This medicine does not require special storage temperature conditions.
Bottle: store in the original package to protect from moisture.
This medicine does not require special storage temperature conditions.
Keep the bottle tightly closed to protect from moisture. This medicine does not require particular
storage temperature conditions.
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 Andabra contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other ingredients are tartaric acid (600 pellet), acacia, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, FD&C Blue 2/Indigo carmine, potassium chloride, titanium dioxide, water (5%) target humidity and hypromellose.
• The black printing ink contains shellac (E904), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Andabra and contents of the pack
Andabra 110 mg are hard capsules (with length 19.1± 0.6 mm and width 6.7± 0.3 mm), No. 1, with a
light blue opaque cap and a light blue opaque body imprinted in black with "110".
This medicinal product is available in packs containing 10, 30, 60 or 100 hard capsules in blisters
OPA/ALU/PVC-aluminum foil and OPA/ALU/PE blisters with desiccant-aluminum foil/PE and a
multipack containing 3 packs of 60 hard capsules (180 hard capsules). Each single pack of the
multipack contains 6 aluminum blisters of 10 hard capsules.
This medicinal product is also available in white high-density polyethylene (HDPE) bottles with a
polypropylene (PP) cap with desiccant and white polypropylene (PP) bottles with a low-density
polyethylene (LDPE) cap with desiccant containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece

Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

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

Andabra 150 mg hard capsules

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

1. What is Andabra and what is it used for

Andabra contains the active ingredient dabigatran etexilate and belongs to a group of medicines
called anticoagulants. It blocks the action of a substance present in the body involved in the
formation of blood clots.
Andabra 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 additional risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming in the veins of the legs and lungs.

Andabra is used in children for:

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

2. What you need to know before taking Andabra

Do not take Andabra

• 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 in your body 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 switching anticoagulant treatment, when a venous or arterial catheter is placed and heparin is administered 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 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 to prevent rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeats.
• 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 the permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking Andabra. You may also need to talk to your doctor during the
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 surgical removal of tissue (biopsy) in the previous month.
• if you have sustained 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 Andabra” 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 test results. In this case, the use of this medicine is not recommended.

Be particularly careful with Andabra

• if you need to undergo surgery: In this case, Andabra 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

Andabra 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 the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take Andabra 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, 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 whether it is necessary to change therapy.

Other medicines and Andabra
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 Andabra 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 heartbeats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may tell you to use a reduced dose of Andabra depending on the condition for which it has been prescribed. 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 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 Andabra on pregnancy and the fetus are unknown. Do not take this medicine if you are
pregnant unless your doctor tells you it is safe to do so. If you are a woman of childbearing potential, you should avoid
pregnancy during treatment with Andabra. Do not breastfeed during treatment with Andabra.

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

3. How to take Andabra

Andabra capsules can be used in adults and children aged 8 years and over who are
able to swallow the capsules whole. Other dosage forms suitable for age are available for the treatment of
children under 8 years of age. Other appropriate dosage forms are available for treatment in children
under 8 years of age.
Take this medicine following the instructions of your doctor exactly as stated. If you have any doubts consult your
doctor.

Take Andabra as recommended for the following conditions:
Prevention of blood vessel obstruction in the brain or the rest of the body due to the formation
of blood clots 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 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 Andabra 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 returned to
normal with a procedure called cardioversion or through a procedure called catheter ablation for
atrial fibrillation. Take Andabra according to your doctor's instructions.
If a medical device (stent) has been inserted into a blood vessel to keep it open
as part of a procedure called percutaneous coronary intervention with stent, you may be treated with
Andabra after your doctor has determined that normal blood coagulation control has been achieved. Take Andabra according to your doctor's instructions.
Treatment of blood clots and prevention of blood clot formation in children.

Andabra 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 any of them.
Table 1 shows the single and total daily doses of Andabra 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 Andabra 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 Andabra
Andabra 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.

Instructions for opening the bottle

• press and rotate the cap.
• After removing the capsule, reposition the cap on the bottle and close it tightly immediately after taking the dose.

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Andabra 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. The doctor may decide to subject you to a thorough check
or to change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction that causes
difficulty breathing or dizziness.
Possible side effects are listed below, grouped by how frequently
they occur.
Prevention of obstruction of blood vessels in the brain or the rest of the body due to
blood clots that have developed as a result of 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 that 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 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 liver function test results Rare(may affect up to 1 in 1,000 people):
• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of catheter insertion into a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Significant 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 part of the eyes, caused by problems with the liver or blood

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

• Difficulty breathing or wheezing
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss In a clinical study, the percentage of heart attacks was numerically higher with dabigatran 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, in the stomach or intestines, from the rectum, from the penis/vagina or from the urinary tract (including blood in the urine that turns it pink or red) or under the skin
• 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 laboratory test results for liver function
• 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 that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Significant 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 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 part 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 dabigatran than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance was observed in the percentage of heart attacks compared to patients treated with placebo.

Treatment of blood clots and prevention of blood clot formation
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
• Significant 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 that 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
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a 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 liver function test results Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 Andabra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package, blister or
bottle after "Exp.". The expiry date refers to the last day of that month.
Blister: store in the original package to protect from moisture.
This medicine does not require special storage temperature conditions.
Bottle: store in the original package to protect from moisture.
This medicine does not require special storage temperature conditions.
Keep the bottle tightly closed to protect from moisture. This medicine does not require
special storage temperature conditions.
Do not dispose of any medicine in 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 Andabra contains

• The active ingredient is dabigatran etexilate. Each hard capsule contains 150 mg of

dabigatran etexilate (as mesylate).

• The other ingredients are tartaric acid (600 pellet), acacia, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, FD&C Blue 2/Indigo carmine, potassium chloride, titanium dioxide, water (5%) target humidity and hypromellose.
• The black printing ink contains shellac (E904), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Andabra and package contents
Andabra 150 mg are hard capsules (with length 21.3± 0.7 mm and width 7.5± 0.3
mm), size 0, with a light blue opaque cap and an opaque white body with "150" imprinted in black.
This medicine is available in packs containing 10, 30 or 60 hard capsules in
OPA/ALU/PVC blisters - aluminum foil and OPA/ALU/PE blisters with desiccant -
aluminum/PE foil and a multipack containing 3 packs of 60 hard capsules
(180 hard capsules). Each single pack of the multipack contains 6
aluminum blisters of 10 hard capsules.
This medicine is also available in white high-density polyethylene (HDPE)
bottles with a polypropylene (PP) cap with desiccant and white polypropylene
(PP) bottles with a low-density polyethylene (LDPE) cap with desiccant with 60
hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece

Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

This medicine is authorised in the Member States of the European Economic Area
under the following denominations: