Auralgan

Patient Information Leaflet

AURALGAN 75 mg hard capsules

dabigatran etexilate
Equivalent 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AURALGAN is and what it is used for

AURALGAN 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.

AURALGAN is used in adults for:

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

AURALGAN is used in children for:

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

2. What you should know before taking AURALGAN

Do not take AURALGAN

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).

• if you have severely reduced kidney function.

• if you are currently experiencing bleeding.

• if you have organ lesions 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, due to unknown causes, or caused by other medicines.

• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heartbeat is being restored to normal by 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.

• 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 AURALGAN. You may also need to consult your doctor during treatment with AURALGAN if you develop symptoms or need to undergo surgery.
Inform your doctor if you currently have or have previously had any medical condition or illness, especially 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 esophagus or stomach.
  • if you have gastroesophageal reflux problems.
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and AURALGAN” 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 suffer from liver disease associated with abnormal blood test results. In such cases, the use of [Product Name] is not recommended.

Take special care with AURALGAN

• if you are scheduled for surgery: In this case, AURALGAN will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take AURALGAN exactly at the time instructed by your doctor, both before and after surgery.
• if a procedure involves placement of a catheter or injection into the spinal canal (e.g. for epidural or spinal anesthesia or pain relief):
  • It is very important to take AURALGAN exactly at 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 bowels 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 hit your head. Seek immediate medical attention. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and AURALGAN
Inform 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 AURALGAN if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are applied only to the skin
• Medicines to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor will instruct you to use a reduced dose of AURALGAN. See also section 3.
• Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
• A combination product containing 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 known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for AIDS (e.g. ritonavir)
• Medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

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

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

3. How to take AURALGAN

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

Take AURALGAN 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 [Product Name] of 75 mg, because the risk of bleeding may increase.

For both types of surgery, treatment should 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 AURALGAN within 1–4 hours after the end of surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 10 days.

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

Treatment of blood clots and prevention of recurrence in children
AURALGAN 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 child’s age and body weight. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you otherwise.

Table 1 shows the single and total daily dose of AURALGAN in milligrams (mg). The dose depends on the patient’s weight in kilograms (kg) and age in years.

Table 1: AURALGAN dosing table

Single doses requiring combinations of more than one capsule:
300 mg: two 150 mg capsules or
four 75 mg capsules
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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 AURALGAN
AURALGAN 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 blister packs
The following images illustrate how to remove AURALGAN capsules from the blister pack

Separate one unit from the entire blister pack along the perforated line.

Lift the aluminium foil on the back and remove the capsule.

• Do not push the capsules through the aluminium foil of the blister pack.
• The aluminium foil of the blister pack should only be lifted when a capsule needs to be removed.

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

If you take more AURALGAN than you should
Taking too much AURALGAN 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 AURALGAN

Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of AURALGAN at the 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 take a double dose to make up for the missed dose.

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If you stop taking AURALGAN
Take AURALGAN exactly as prescribed. Do not stop taking AURALGAN 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 AURALGAN.

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 everybody gets them.
AURALGAN affects the blood coagulation system; therefore, most of the adverse reactions are related to signs such as bruising or bleeding.
Major or severe bleeding events may occur, which represent the most serious adverse reactions and, regardless of 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 resolve spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling tired, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to carry out a thorough check-up 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 how often 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 liver function test results

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

• Bleeding which may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
• Bruising or haematoma occurring after surgery
• Presence of blood in the stool detected by laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reactions
• Vomiting
• Frequent diarrhoea with unformed or liquid stools
• Feeling unwell
• Wound discharge (leakage 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 which may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
• Blood-stained discharge from the venous 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 after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Reflux of gastric 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 new blood clots in children
Common (may affect up to 1 in 10 people):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Bruising
• Nosebleeds
• 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 which 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 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 reactions
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

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

5. How to store AURALGAN

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

• The active substance is dabigatran. Each capsule contains 86.48 mg of dabigatran etexilate (as mesilate), equivalent to 75 mg of dabigatran etexilate.
• The other components are tartaric acid, acacia gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose. The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), and hypromellose 2910.

Description of the appearance of AURALGAN and contents of the pack
AURALGAN 75 mg are hard capsules containing almost white to light yellow granules in white to almost white hard capsules of size 2.
The medicine is available in the following pack sizes:
10x1 and 30x1 hard capsules in divided aluminum/OPA-ALU-PVC blisters for single doses.
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Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.R.L.
Via Marghera, 29
20149-Milano- Italy

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat (Barcelona)
Spain
or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain
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Patient Information Leaflet

AURALGAN

110 mg hard capsules
dabigatran etexilate
equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What AURALGAN is and what it is used for

AURALGAN 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.
AURALGAN is used in adults for:

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

AURALGAN is used in children for:

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

2. What you should know before taking AURALGAN

Do not take AURALGAN

• 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 organ lesions 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. 10/9
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and heparin is administered through it to keep it open, or when your heartbeat is being restored to normal through a procedure called trans-catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection 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 permanent anticoagulant use.

Warnings and precautions
Talk to your doctor before taking AURALGAN. You may also need to consult your doctor during treatment with AURALGAN if you develop symptoms or if you are scheduled for surgery.
Inform your doctor if you currently have or have previously 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 surgical intervention).
  • if you suffer from inflammation of the esophagus or stomach.
  • if you have gastroesophageal reflux (acid reflux into the esophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and AURALGAN” 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 passing small amounts of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an active infection around or within the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with AURALGAN

• if you are scheduled for surgery: In this case, AURALGAN will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take AURALGAN exactly at the times 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 anesthesia or pain relief): 11/9
• it is very important to take AURALGAN 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 the legs or bowel or bladder problems after anesthesia 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, seek immediate medical attention. Your doctor may consider it necessary to examine you, as you may be at high risk of bleeding.
  • If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and AURALGAN
Inform 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 AURALGAN if you are taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, 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 will instruct you to use a reduced dose of AURALGAN. See also section 3.
• medicines to prevent transplant rejection episodes (e.g. tacrolimus, cyclosporine)
• a combination product containing 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 known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
• rifampicin or clarithromycin (two antibiotics)
• antiviral medicines for AIDS (e.g. ritonavir)
• medicines for treating epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
The effects of AURALGAN on pregnancy and the unborn child are unknown. You must not take AURALGAN 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 during treatment with AURALGAN.
You must not breastfeed during treatment with AURALGAN.

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

3. How to take AURALGAN

AURALGAN capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other dosage forms appropriate for age are available.
12/9
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Take AURALGAN as recommended for the following conditions:
Prevention of blood clot formation 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 [Product Name] of 75 mg, because the risk of bleeding may increase.
For both surgeries, 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 AURALGAN within 1–4 hours after completion of the surgical procedure, taking one single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with AURALGAN within 1–4 hours after completion of the surgical procedure, 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 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 of AURALGAN 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 AURALGAN 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 you a dose of AURALGAN of 220 mg taken as one 110 mg capsule twice daily.
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You may continue taking AURALGAN if a procedure called cardioversion is needed to restore your heart rhythm to normal. Take AURALGAN 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 AURALGAN after your doctor has determined that normal control of blood coagulation has been achieved. Take AURALGAN as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
AURALGAN 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 age and weight. 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 dose of AURALGAN in milligrams (mg). The dose depends on the patient's weight in kilograms (kg) and age in years.
Table 1: AURALGAN dosing table

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 AURALGAN
AURALGAN can be taken with or without food. The capsule should 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 blister packs
14/9
The following images illustrate how to remove AURALGAN capsules from the blister pack.

Separate one unit of the blister from the entire blister along the perforated line.

Lift the aluminum foil on the back and remove the capsule.

• Do not push the capsules through the aluminum foil of the blister.
• The aluminum foil of the blister should be lifted only when a capsule needs to be removed.

Instructions for 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 receiving specific instructions from your doctor.

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

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

Use in adults: prevention of blockage of blood vessels in the brain or 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 blood clots in the veins of the legs and lungs.

Use in children: treatment of blood clots and prevention of recurrence of blood clots.

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 take a double dose to make up for the missed dose.

If you stop taking AURALGAN
Take AURALGAN exactly as prescribed. Do not stop taking AURALGAN without talking to your doctor first, 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 AURALGAN.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.
15/9

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
AURALGAN affects the blood coagulation system; therefore, most of the side effects are related to signs such as bruising or bleeding.
Serious or major bleeding events may occur, which represent the most severe 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 check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.

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

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 liver function test results

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 surgery
• Formation of haematoma or haematoma occurring after surgery
• Presence of blood in faeces, detected by laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent diarrhoea with loose 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, injection site, or catheter insertion site in a vein
• Blood-stained discharge from the catheter insertion site in a vein
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Gastric acid reflux 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 available data):

• Difficulty in breathing or wheezing
• Decrease in, 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, 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
• Diarrhoea with loose or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from haemorrhoids, rectum, or brain
• Formation of haematoma
• Coughing up blood or blood-stained sputum
• 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 changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Gastric acid reflux into the oesophagus
• 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, wound, injection site, or catheter insertion site in a vein
• 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 available data):

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

In a clinical study, the rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of reformation of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, stomach or intestine, rectum, penis/vagina, 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 from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of haematoma
• Coughing up blood or blood-stained sputum
• Allergic reaction
• Sudden skin changes altering its colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Inflammation of the oesophagus and stomach
• Gastric acid reflux into the oesophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhoea with loose or liquid stools
• Abnormal liver function test results
• Increased 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 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 available data):

• Difficulty in 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, or even absence of, white blood cells (which help fight infections)
• Yellowing of the skin or the white part of the eyes, caused by liver or blood problems
• Hair loss

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin changes altering its colour and appearance
• Formation of haematoma
• Nosebleeds
• Gastric acid reflux 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 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 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 pain or stomach ache
• Inflammation of the oesophagus and stomach
• Allergic reactions
• 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 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 in breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AURALGAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, blister pack, or bottle
after Exp. The expiry date refers to the last day of that month.
Blister pack: Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Bottle: Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Once opened, the medicine should be used within 4 months. Keep the bottle tightly closed.
Do not dispose of medicines via wastewater or household waste. 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 AURALGAN contains

• The active substance is dabigatran. Each capsule contains 126.83 mg of dabigatran etexilate (as mesilate), equivalent to 110 mg of dabigatran etexilate.
• The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), hypromellose 2910 and FD&C Blue No. 2/indigotine (E132).

Description of the appearance of AURALGAN and contents of the pack
AURALGAN 110 mg are hard capsules containing granules ranging from almost white to light yellow, in size 1 blue hard capsules.
The medicine is available in the following pack sizes: 10 x 1, 30 x 1 and 60 x 1 hard capsules in unit dose divided blisters made of aluminium/OPA-ALU-PVC.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in non-perforated blisters made of aluminium/OPA-ALU-PVC.
This medicine is also available in high-density polyethylene (plastic) bottles with child-resistant screw cap and integrated desiccant, sealed with a fibre seal, containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
20/9
Via Marghera, 29
Milan, Italy

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat (Barcelona)
Spain
or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain
21/9

Patient Information Leaflet

AURALGAN 150 mg hard capsules

dabigatran etexilate
Equivalent 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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:

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

1. What AURALGAN is and what it is used for

AURALGAN 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 that is involved in blood clot formation.
AURALGAN is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body if the patient has 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 re-forming in the veins of the legs and lungs.

AURALGAN is used in children for:

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

2. What you should know before taking AURALGAN

Do not take AURALGAN

• 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 organ lesions 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 from one anticoagulant treatment to another, when a venous or arterial catheter is in place and you are receiving heparin 22/9

through it to keep it open, or when your heartbeat is being restored to normal
by 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.
• 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 AURALGAN. You may also need to consult your doctor during
treatment with AURALGAN if you develop symptoms or need to undergo surgery.
Inform your doctor if you have or have had any medical condition or illness, especially 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 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 section “Other medicines and AURALGAN” below.
  • if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam.
  • if you have an infection of the heart (bacterial endocarditis).
  • if you know that your kidney function is reduced or if you are dehydrated (symptoms include feeling thirsty and producing small amounts of dark (concentrated)/foamy urine).
  • if you are over 75 years old.
  • if you are an adult weighing 50 kg or less.
  • only for use in children: if the child has an infection around or within the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• if you have liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with AURALGAN

• if you are scheduled for surgery: In this case, AURALGAN will need to be temporarily discontinued due to the increased risk of bleeding during and shortly after the procedure. It is very important to take AURALGAN exactly at the times 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 anesthesia or pain relief):
  • It is very important to take AURALGAN 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 anesthesia wears off, as urgent treatment may be required. 23/9
• if you fall or injure yourself during treatment, especially if you hit your head. Seek immediate medical attention. 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 autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and AURALGAN
Inform 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 AURALGAN if you are
taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are applied only topically on the skin.
• medicines used to treat abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor will instruct you to use a reduced dose of AURALGAN. See also section 3.
• medicines used to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine).
• a combination product containing 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 known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• rifampicin or clarithromycin (two antibiotics).
• antiviral medicines for HIV/AIDS (e.g. ritonavir).
• medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

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

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

3. How to take AURALGAN

AURALGAN capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take AURALGAN as recommended for the following conditions:
24/9
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from 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 should take a reduced dose of AURALGAN 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 AURALGAN 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 or by a procedure called trans-catheter ablation for atrial fibrillation. Take AURALGAN 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 AURALGAN after your doctor has determined that normal blood clotting control has been achieved. Take AURALGAN as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
AURALGAN 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 age and body weight. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor tells you otherwise.
Table 1 shows the single and total daily dose of AURALGAN in milligrams (mg). The dose depends on the patient's weight in kilograms (kg) and age in years.
Table 1: AURALGAN dosing table

Single doses requiring combinations of more than one capsule:
25/9
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 AURALGAN
AURALGAN may 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 blisters
The following images illustrate how to remove AURALGAN capsules from the blister pack

Separate one unit of the blister from the entire blister along the perforated line

Lift the aluminum foil on the back and remove the capsule.

• Do not push the capsules through the aluminum foil of the blister.
• The aluminum foil of the blister should be lifted only when a capsule needs to be removed.

Instructions for the bottle

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

Switching anticoagulant treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.
If you take more AURALGAN than you should
Taking too much AURALGAN increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of AURALGAN capsules. Specific treatment options are available.
If you forget to take AURALGAN
The missed dose can still be taken up to 6 hours before taking the next 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 forgotten dose.
If you stop taking AURALGAN
26/9
Take AURALGAN exactly as prescribed. Do not stop taking AURALGAN 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 AURALGAN.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
AURALGAN affects 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 check-up 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.

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.

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 bloody sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden skin changes altering its color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastric acid reflux into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

27/9
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 into 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, raised, itchy nodules due to an allergic reaction
• Decrease in the proportion of blood cells
• Increased 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):

• 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 rate of heart attacks was higher with dabigatran etexilate than with warfarin. The overall incidence was low.

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

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

• Bleeding that may occur from the nose, 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 bloody 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
• Gastric acid reflux into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhea with loose or liquid stools
• Abnormal liver function test results
• Increased 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 into 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, raised, itchy nodules due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the 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 etexilate than with warfarin. The overall incidence was low. In patients treated with dabigatran, no imbalance in the incidence of heart attacks was observed compared to patients treated with placebo.

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

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin changes altering its color and appearance
• Formation of hematoma
• Nosebleeds
• Gastric acid reflux 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):

• 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 bloody sputum
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reactions
• 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
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint, wound, surgical incision, injection site, or catheter insertion site into a vein
• Bleeding that may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulcer)
• Abnormal liver function test results

Reporting of side effects
If you get any side effects, 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AURALGAN

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: Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Bottle: Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture. Once opened, the medicine must be used within 4 months.
Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. 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 AURALGAN contains

• The active substance is dabigatran. Each capsule contains 172.95 mg of dabigatran etexilate (as mesylate), equivalent to 150 mg of dabigatran etexilate.
• The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), hypromellose 2910, and FD&C Blue No. 2/indigotine (E132).

Description of the appearance of AURALGAN and contents of the package
AURALGAN 150 mg are hard capsules containing granules from almost white to light yellow, in hard capsules with a blue cap and a body from white to almost white, size 0.
This medicinal product is available in the following pack sizes:
60 x 1 hard capsules in single-dose, divisible blisters made of aluminium/OPA-ALU-PVC.
This medicinal product is also available in packs containing 60 x 1 hard capsules in non-perforated blisters made of aluminium/OPA-ALU-PVC.
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This medicinal product is additionally available in high-density polyethylene (plastic) bottles with child-resistant screw caps and integrated desiccant, sealed with a fibre seal, containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 - Milano, Italy

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
08950 – Esplugues de Llobregat (Barcelona)
Spain
OR
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain

This Patient Information Leaflet was last approved on
31/9