Andabra: detailed information

Package leaflet: Information for the patient

Andabra 75 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Andabra is 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 in the body involved in blood clot formation.

Andabra is used in adults to:

prevent the formation of blood clots in the veins following surgical replacement of the knee or hip.

Andabra is used in children to:

treat blood clots and prevent 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 are currently experiencing bleeding.
if you have lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent surgery on the brain or eyes).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heart rhythm is being restored to normal through a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or oral itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Andabra. You may also need to speak with your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical tissue removal (biopsy) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Andabra” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you suffer from an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark, concentrated, or foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase your risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In such cases, use of this medicine is not recommended.

Take special care with Andabra

if you are scheduled for surgery: In this case, you will need to temporarily stop taking Andabra due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Andabra exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Andabra exactly at the times instructed by your doctor.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be required.
- if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.
- if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed.

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 following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines for treating irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a reduced dose of Andabra depending on the condition for which it has been prescribed. See also section 3
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used to treat depression
Antidepressants called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Andabra on pregnancy and the unborn baby are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you must avoid becoming pregnant during treatment with Andabra.
You must not breastfeed while taking Andabra.

Driving and using machines
Andabra has no known effect on the ability to drive or 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 that are appropriate for treatment in children under 8 years of age.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.

Take Andabra as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).

If your kidney function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).

If you are taking medicines containing verapamil and your kidney function is reduced by more than half, you must take a reduced dose of Andabra of 75 mg, as the risk of bleeding may increase.

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

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

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

Treatment and prevention of blood clots in children
Andabra should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop.

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

Table 1: Dosing table for Andabra capsules

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

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

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

Instructions for opening the bottle

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

Switching anticoagulant therapy
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 clots after knee or hip replacement surgery
Continue with the remaining daily doses of Andabra at your usual time the next day.
Do not take a double dose to make up for the missed dose.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 serious bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness. The possible side effects are listed below, grouped according to how frequently they occur.

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

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal laboratory test results indicating liver function abnormalities

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

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

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
Blood-stained discharge from the intravenous catheter insertion site
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

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

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Formation of a haematoma
Nosebleeds
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

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

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or intravenous catheter insertion site
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal laboratory test results indicating liver function abnormalities

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

5. How to store Andabra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, 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 any special storage temperature conditions.
Bottle: Store in the original packaging to protect from moisture.
Keep the bottle tightly closed to protect from moisture. This medicine does not require any special storage temperature conditions.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Andabra contains

The active substance is dabigatran etexilate. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
The other components are tartaric acid (pellets 600), 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 the appearance of Andabra and pack contents
Andabra 75 mg are hard capsules (with length 17.7 ± 0.6 mm and width: 6.2 ± 0.3 mm), size 2, with an opaque white cap and an opaque white body printed 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 in 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 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 medicinal product is authorised in the European Economic Area Member States under the following names:

Denmark	Andabra
Germany	Andabra
Greece	Andabra
Spain	Andabra
France	Andabra
Italy	Andabra
Poland	Andabra

Patient information leaflet

Andabra 110 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Andabra is 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 in the body involved in blood clot formation.

Andabra is used in adults for:

preventing the formation of blood clots in the veins following hip or knee replacement surgery.
preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heart rhythm 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 further blood clots from forming 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 reduced.
if you are currently experiencing bleeding.
if you have lesions in an organ of the body that increase the risk of serious bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal through a procedure called catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection episodes.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Andabra. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical removal of tissue (biopsy) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Andabra” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or suffer from dehydration (symptoms include feeling thirsty and reduced volume of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Andabra

if you are scheduled for surgery: In this case, you will need to temporarily stop taking Andabra due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Andabra at exactly the time instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Andabra at exactly the time instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only on the skin
Medicines to treat abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a reduced dose of Andabra depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent organ transplant rejection episodes (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

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

Driving and using machines
Andabra has no known effects on the ability to drive vehicles or 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 capsules whole. Other dosage forms are available that are appropriate for treating children under 8 years of age.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Take Andabra as recommended for the following conditions:

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

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

After knee replacement surgery
Start treatment with Andabra within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 10 days.

After hip replacement surgery
Start treatment with Andabra within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
The recommended dose is 300 mg, taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg, taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Andabra of 220 mg, taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at increased risk of bleeding, your doctor may decide to prescribe a dose of 220 mg, taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal by a procedure called cardioversion. Take Andabra as directed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Andabra after your doctor has determined that normal control of blood clotting has been achieved. Take Andabra as directed by your doctor.

Treatment and prevention of recurrence of blood clots in children
Andabra should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.

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

Table 1: Dosing table for Andabra capsules

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

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

Instructions for opening the bottle

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

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

If you forget to take Andabra
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Andabra at the usual time on the following day. Do not take a double dose to make up for a missed dose.

Use in adults: prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
Use in children: treatment of blood clots and prevention of recurrence of blood clots
The missed dose may still be taken if it is within 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Andabra acts on the blood clotting system; therefore, most of the side effects are related to signs such as bruising or bleeding.

Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.

If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.

The possible side effects are listed below, grouped according to frequency.

Prevention of blood clots after knee or hip replacement surgery

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

Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Abnormal results in liver function laboratory tests

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including presence of blood in the urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
Formation of a haematoma or haematoma occurring after surgery
Presence of blood in the faeces, detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with unformed or liquid stools
Feeling unwell
Discharge from the wound (leakage of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of insertion of a venous catheter
Blood-stained discharge from the site of insertion of a venous catheter
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

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

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including presence of blood in the urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal or stomach pain
Indigestion
Diarrhoea with unformed or liquid stools
Feeling unwell

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Formation of a haematoma
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal results in liver function laboratory 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 insertion of a venous catheter, or in the brain
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

Difficulty breathing or wheezing
Decrease 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 recurrence of blood clots in the legs and/or lungs

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

Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina or urinary tract (including presence of blood in the urine turning it pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Formation of a haematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with unformed or liquid stools
Abnormal results in liver function tests
Increased liver enzymes

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

Bleeding that may occur from a surgical incision, injection site, site of insertion of a venous catheter, or in the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
Hair loss

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

Treatment and prevention of blood clots in children

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden skin alteration changing its colour and appearance
Formation of a haematoma
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with unformed or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina or urinary tract (including presence of blood in the urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Abdominal or stomach pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or the white part of the eyes, caused by liver or blood problems

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or site of insertion of a venous catheter
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal results in liver function tests

Reporting of side effects

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

5. How to store Andabra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, 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 any special storage temperature conditions.
Bottle: store in the original packaging to protect from moisture.
Keep the bottle tightly closed to protect from moisture. This medicine does not require any special storage temperature conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Andabra contains

The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
The other components are tartaric acid (pellet 600), acacia, talc, and hydroxypropylcellulose.
The capsule shell contains carrageenan, FD&C Blue 2/Indigo carmine, potassium chloride, titanium dioxide, water (5%) target moisture, 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 110 mg are hard capsules (with length 19.1 ± 0.6 mm and width 6.7 ± 0.3 mm), size 1, with a
matte light blue cap and a matte light blue body, printed in black with "110".
This medicinal product is available in packs containing 10, 30, 60 or 100 hard capsules in OPA/ALU/PVC-aluminum foil blisters
and OPA/ALU/PE blisters with desiccant-aluminum foil/PE, and a multipack containing 3 packs of 60 hard capsules (180 hard capsules). Each
individual pack in 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 containing desiccant, and white polypropylene (PP) bottles with a low-density polyethylene (LDPE) cap containing desiccant, each containing 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 medicinal product is authorized in the Member States of the European Economic Area under the following
names:

Denmark	Andabra
Germany	Andabra
Greece	Andabra
Spain	Andabra
France	Andabra
Italy	Andabra
Poland	Andabra

Patient Information Leaflet

Andabra 150 mg hard capsules

dabigatran etexilate
Generic medicinal product
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Andabra is 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 in the body involved in blood clot formation.
Andabra is used in adults for:

preventing blood clots in the brain (stroke) and in other blood vessels of the body if there is 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 recurring in the veins of the legs and lungs.

Andabra is used in children for:

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

2. What you should 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 are currently experiencing bleeding.
if you have lesions in an organ of the body that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heart rhythm is being restored to normal by a procedure called transcateter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazolo, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical removal of tissue (biopsy) within the previous month.
- if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the esophagus or stomach.
- if you have gastroesophageal reflux disease (acid reflux into the esophagus).
- if you are taking medicines that may increase the risk of bleeding. See the section “Other medicines and Andabra” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated)/foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you have a liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with Andabra

if you are scheduled for surgery: In this case, you will need to temporarily stop taking Andabra due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Andabra exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anesthesia or for pain relief):
- it is very important to take Andabra exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs, or problems with your bowel or bladder after the anesthesia wears off, as urgent medical care may be needed.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied topically to the skin only
Medicines for treating irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a reduced dose of Andabra depending on the condition for which it has been prescribed. See section 3.
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used to treat depression
Antidepressants called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

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

Driving and using machines
Andabra has no known effects on the ability to drive vehicles or 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 appropriate for age are available for the treatment of children under 8 years of age. Other appropriate dosage forms are available for the treatment of children under 8 years of age.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Take Andabra as recommended for the following conditions:
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots arising from irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older , the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil , you must take a reduced dose of Andabra of 220 mg taken as one 110 mg capsule twice daily , because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding , your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heartbeat needs to be restored to normal by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Take Andabra as directed by your doctor.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Andabra after your doctor has determined that normal blood clotting control has been achieved. Take Andabra as directed by your doctor.
Treatment of blood clots and prevention of blood clot formation in children.
Andabra should be taken twice daily , one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.
The recommended dose depends on the patient's weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily doses of Andabra in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for Andabra capsules

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

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

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

Instructions for opening the bottle

Press and twist the cap.
After removing the capsule, replace the cap on the bottle and close it tightly immediately after taking the dose.

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

If you forget to take Andabra
The missed dose may still be taken if it is within 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped.
Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 represent the most serious side effects and, regardless of their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough examination or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The possible side effects are listed below, grouped according to frequency of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the number of red blood cells in the blood
Abdominal or stomach pain
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, rectum, or brain
Formation of hematoma
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices into the esophagus
Vomiting
Difficulty swallowing
Abnormal results in liver function tests

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

Bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red-dark nodules, swollen and itchy, due to an allergic reaction
Decrease in the proportion of blood cells
Increase in liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

In a clinical study, the incidence 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 recurrence of blood clots in the legs and/or lungs

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

Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, or urinary tract (including blood in urine turning it pink or red), or under the skin
Indigestion

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of hematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin changes altering its color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juices into the esophagus
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhea with loose or liquid stools
Abnormal laboratory test results for liver function
Increase in liver enzymes

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

Bleeding that may occur from a surgical incision, injection site, catheter insertion site in a vein, or brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red-dark nodules, swollen and itchy, due to an allergic reaction
Difficulty swallowing

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

Breathing difficulties or wheezing
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or whites of the eyes, caused by liver or blood problems
Hair loss

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

Treatment and prevention of blood clots in children

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red-dark nodules, swollen and itchy, due to an allergic reaction
Sudden skin changes altering its color and appearance
Formation of hematoma
Nosebleeds
Reflux of gastric juices into the esophagus
Vomiting
Feeling unwell
Diarrhea with loose or liquid stools
Indigestion
Hair loss
Increase in liver enzymes

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

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

Not known (frequency cannot be estimated from 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
Breathing difficulties or wheezing
Bleeding
Bleeding that may occur in a joint, wound, surgical incision, injection site, or catheter insertion site in a vein
Bleeding that may occur from hemorrhoids
Stomach or intestinal ulcer (including esophageal ulcer)
Abnormal results in liver function tests

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

5. How to store Andabra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, 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 any special storage temperature conditions.
Bottle: Store in the original packaging to protect from moisture.
Keep the bottle tightly closed to protect from moisture. This medicine does not require any special storage temperature conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Andabra contains

The active substance is dabigatran etexilate. Each hard capsule contains 150 mg of
dabigatran etexilate (as mesilate).
The other components are tartaric acid (pellet 600), 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 150 mg are hard capsules (with length 21.3±0.7 mm and width 7.5±0.3 mm), size 0, with a pale blue opaque cap and an opaque white body printed in black with "150".
This medicinal product is available in packs containing 10, 30 or 60 hard capsules in OPA/ALU/PVC blisters - aluminium foil and OPA/ALU/PE blisters with desiccant - aluminium/PE foil, and a multiple pack containing 3 packs of 60 hard capsules (180 hard capsules). Each single pack within the multiple pack contains 6 aluminium 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, each 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 European Economic Area member states
under the following names:

Denmark	Andabra
Germany	Andabra
Greece	Andabra
Spain	Andabra
France	Andabra
Italy	Andabra
Poland	Andabra