Dangard

Package leaflet: Information for the patient

DANGARD 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, consult 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DANGARD is and what it is used for

DANGARD 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.
DANGARD is used in adults for:

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

DANGARD is used in children for:

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

2. What you should know before taking DANGARD

Do not take DANGARD

• 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 brain or eye surgery)
• if you have an increased tendency to bleed, which 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 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 permanent anticoagulant use.

Warnings and precautions
Talk to your doctor before taking DANGARD. You may also need to consult your doctor during treatment with DANGARD if you develop symptoms or if you are scheduled for 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 surgical intervention)
  • 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 DANGARD” 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
  • for use in children only: if the child has an infection around or within the brain.
• If you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
• If you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with DANGARD

• if you are scheduled for surgery: In this case, DANGARD 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 DANGARD 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 DANGARD 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 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 DANGARD
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 DANGARD 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 they are 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 DANGARD. See also section 3.
• Medicines to prevent organ 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 for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV/AIDS (e.g. ritonavir)
• Medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
The effects of DANGARD on pregnancy and the unborn baby are unknown. You must not take DANGARD 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 during treatment with DANGARD.
You must not breastfeed while being treated with DANGARD.

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

3. How to take DANGARD

DANGARD capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take DANGARD 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 DANGARD 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
You should start treatment with DANGARD 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
You should start treatment with DANGARD 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.
Treatment of blood clots and prevention of recurrent blood clots in children
DANGARD 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 medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily dose of DANGARD in milligrams (mg). The dose depends on the patient’s weight in kilograms (kg) and age in years.
Table 1: DANGARD 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 DANGARD
DANGARD 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 blister packs
The following images illustrate how to remove DANGARD capsules from the blister

Separate one unit of the blister from the entire blister 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.
• The aluminium foil of the blister must be lifted only when a capsule needs to be removed.

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

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

Treatment of blood clots and prevention of recurrence of 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.

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

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 will get them.
DANGARD 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 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 experience symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to carry out a careful 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 according to the frequency with which 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 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, into a joint, from a wound or following a wound, after surgery
• 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
• Frequent diarrhoea with loose or watery 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 problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein
• Blood-stained discharge from the catheter insertion site into a vein
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
• Sudden skin change 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 in breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Treatment 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 change altering its colour and appearance
• Formation of a haematoma
• Nosebleed
• Reflux of gastric juices into the oesophagus
• Vomiting
• Feeling unwell
• Diarrhoea with loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding 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 problems with the liver or blood

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

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

Reporting of side effects
If you get any side effects, including ones 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.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DANGARD

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 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 DANGARD 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, arabic 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 DANGARD and package contents
DANGARD 75 mg are hard capsules containing granules from almost white to light yellow, 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 unit-dose divisible blisters made of aluminium/OPA-ALU-PVC.

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

Patient Information Leaflet

DANGARD

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

1. What DANGARD is and what it is used for

DANGARD contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking the action of a substance in the body involved in blood clotting.
DANGARD 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 in patients with 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 the recurrence of blood clots in the veins of the legs and lungs.

DANGARD is used in children for:

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

2. What you should know before taking DANGARD

Do not take DANGARD

• 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 bleeding
• if you have organ lesions 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, due to unknown causes, 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 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 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 DANGARD. You may also need to consult your doctor during treatment with DANGARD if you develop symptoms or if you are scheduled for surgery.
Inform 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 esophagus or stomach
  • if you have gastroesophageal reflux disease (acid reflux)
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DANGARD” 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, 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 the risk of having a heart attack.
• If you have liver disease associated with abnormal blood test results. In this case, use of DANGARD is not recommended.

Take special care with DANGARD

• if you are scheduled for surgery: In this case, you will need to temporarily stop taking DANGARD due to the increased risk of bleeding during and shortly after the procedure. It is very important to take DANGARD 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 DANGARD 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 anesthesia wears off, as urgent medical 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 DANGARD
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 DANGARD 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 they are applied only to the skin
• medicines for treating irregular heart rhythm (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 DANGARD. 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 called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• rifampicin or clarithromycin (two antibiotics)
• antiviral medicines for HIV/AIDS (e.g. ritonavir)
• medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
The effects of DANGARD during pregnancy and on the fetus are unknown. You must not take DANGARD 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 DANGARD.
You must not breastfeed while being treated with DANGARD.

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

3. How to take DANGARD

DANGARD capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take DANGARD 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 DANGARD of 75 mg, because the risk of bleeding may increase.
For both procedures, treatment must not be initiated if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with DANGARD 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
You should start treatment with DANGARD 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 forming as a result of 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 DANGARD 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 DANGARD 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 DANGARD of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking DANGARD if your heartbeat needs to be restored to normal through a procedure called cardioversion. Take DANGARD 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 DANGARD after your doctor has determined that normal blood clotting control has been achieved. Take DANGARD as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
DANGARD 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 DANGARD in milligrams (mg). The dose depends on the patient's weight in kilograms (kg) and age in years.
Table 1: DANGARD 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 DANGARD
DANGARD 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
The following images illustrate how to remove DANGARD 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 therapy
Do not change your anticoagulant treatment without specific instructions from your doctor.

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

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

Use in adults: prevention of blockage of blood vessels in the brain or 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 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 a missed dose.

If you stop taking DANGARD
Take DANGARD exactly as prescribed. Do not stop taking DANGARD 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 discomfort after taking DANGARD.
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.
DANGARD 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), 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 breathing or dizziness.
The possible side effects are listed below, grouped according to 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 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
• Haematoma formation or haematoma occurring after surgery
• Presence of blood in 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
• Frequent diarrhoea with unformed or liquid stools
• Feeling of malaise
• Discharge from the wound (oozing 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 catheter insertion site into a vein
• Coughing up blood or blood-stained sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with dark red, swollen, 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 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 forming as a result of irregular heartbeat
Common (may affect up to 1 in 10 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), 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 of malaise

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

• Bleeding
• Bleeding which may occur from haemorrhoids, rectum, or brain
• Haematoma formation
• 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 liver function test results

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

• Bleeding which 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 dark red, swollen, 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 recurrence of blood clots in the legs and/or lungs
Common (may affect up to 1 in 10 people):

• Bleeding which 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 which may occur in a joint or from a wound
• Bleeding which may occur from haemorrhoids
• Decrease in the number of red blood cells in the blood
• Haematoma formation
• 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 of malaise
• Vomiting
• Abdominal or stomach pain
• Diarrhoea with unformed or liquid stools
• Abnormal liver function test results
• Increased liver enzymes

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

• Bleeding which 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 dark red, swollen, 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 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 whites 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 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 dark red, swollen, itchy nodules due to an allergic reaction
• Sudden skin alteration changing its colour and appearance
• Haematoma formation
• Nosebleed
• Reflux of gastric juices into the oesophagus
• Vomiting
• Feeling of malaise
• 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 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 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, 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 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 DANGARD

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.
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 should 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What DANGARD 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/indigo carmine (E132).

Description of the appearance of DANGARD and package contents
DANGARD 110 mg are hard capsules containing almost white to light yellow granules 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 aluminium/OPA-ALU-PVC blisters.
This medicine is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in non-perforated aluminium/OPA-ALU-PVC blisters.
This medicine is also available in high-density polyethylene (plastic) bottles with child-resistant screw cap and integrated desiccant, closed 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
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

Patient Information Leaflet

DANGARD 150 mg hard capsules

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are similar to yours, as 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:

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

1. What DANGARD is and what it is used for

DANGARD 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.
DANGARD is used in adults for:

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

DANGARD is used in children for:

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

2. What you should know before taking DANGARD

Do not take DANGARD

• 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 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 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 heart rhythm is being restored to normal with a procedure called trans-catheter ablation for atrial fibrillation
• if you have severely reduced liver function or a liver disease that could potentially 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 DANGARD. You may also need to consult your doctor during treatment with DANGARD if you develop symptoms or if you are scheduled for surgery.
Inform 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 surgical intervention)
  • if you suffer from inflammation of the oesophagus or stomach
  • if you have gastroesophageal reflux (acid reflux into the oesophagus)
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DANGARD” 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 liver disease associated with abnormal blood test results. In such cases, the use of DANGARD is not recommended.

Exercise special caution with DANGARD

• if you are scheduled for surgery: In this case, DANGARD 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 DANGARD 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 column (e.g. for epidural or spinal anaesthesia or for pain relief):
  • It is very important to take DANGARD 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 bowel or bladder problems after the anaesthesia wears off, as urgent medical treatment may be required.
• 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 DANGARD
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 DANGARD 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, itraconazolo), unless applied only to 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 DANGARD. 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 called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.
• 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 DANGARD during pregnancy and on the fetus are unknown. You must not take DANGARD if you are pregnant 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 DANGARD.
You must not breastfeed during treatment with DANGARD.

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

3. How to take DANGARD

DANGARD capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other age-appropriate dosage forms are available.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take DANGARD as recommended for the following conditions:
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, 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 should take a reduced dose of DANGARD 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 DANGARD 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 DANGARD 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 DANGARD after your doctor has determined that normal blood clotting control has been achieved. Take DANGARD as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
DANGARD must 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 medicines unless your doctor tells you to stop any of them.
Table 1 shows the single and total daily dose of DANGARD in milligrams (mg). The dose depends on the patient's weight in kilograms (kg) and age in years.
Table 1: DANGARD 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 DANGARD
DANGARD can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening the blister pack
The following images illustrate how to remove DANGARD capsules from the blister:

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

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

• Do not push the capsules through the aluminium foil of the blister.
• The aluminium 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 taking 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 DANGARD than you should
Taking too much DANGARD increases the risk of bleeding. Contact your doctor immediately if you have taken an excessive number of DANGARD capsules. Specific treatment options are available.

If you forget to take DANGARD
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 forgotten dose.

If you stop taking DANGARD
Take DANGARD exactly as prescribed. Do not stop taking DANGARD 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 DANGARD.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

DANGARD 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 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 according to their frequency of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to formation of blood clots resulting from 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
• Reduction 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
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden 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

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 itchy, raised, dark red nodules due to an allergic reaction
• Reduction 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
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical study, the rate of heart attacks was higher with dabigatran etexilate 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 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
• Reduction 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
• 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 in a vein, or brain
• Reduction in the number of platelets in the blood
• Severe allergic reaction causing difficulty in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Pronounced skin rash with itchy, raised, dark red nodules due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or 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 new blood clots in children

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

• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Pronounced skin rash with itchy, raised, dark red 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):

• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur in the stomach or intestine, brain, rectum, penis/vagina, urinary tract (including blood in urine turning it pink or red), or under the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or blood-stained 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 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, 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 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 DANGARD

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.
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 should 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 DANGARD contains

• The active substance is dabigatran. Each capsule contains 172.95 mg of dabigatran etexilate (as mesilate), equivalent to 150 mg of dabigatran etexilate.
• The other components are tartaric acid, arabic gum, hypromellose 2910, simethicone 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 DANGARD and pack contents
DANGARD 150 mg are hard capsules containing almost white to light yellowish granules, in hard capsules with a blue cap and a white to almost white body, size 0.
The medicine is available in the following pack sizes:
60 x 1 hard capsules in unit-dose, divided aluminum/OPA-ALU-PVC blisters.
This medicine is available in packs containing 60 x 1 hard capsules in non-perforated aluminum/OPA-ALU-PVC blisters.
This medicine is also available in high-density polyethylene (plastic) bottles with child-resistant screw cap, integrated desiccant, and 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.
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