Dabigatran etexilate EG Stada

Package leaflet: Information for the patient

Dabigatran Etexilate EG STADA 75 mg hard capsules

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

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

Contents of this leaflet:

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

1. What Dabigatran Etexilate EG STADA is and what it is used for

Dabigatran Etexilate EG STADA 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.
Dabigatran Etexilate EG STADA is used in adults for:

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

Dabigatran Etexilate EG STADA is used in children for:

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

2. What you should know before taking Dabigatran Etexilate EG STADA

Do not take Dabigatran Etexilate EG STADA

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently experiencing bleeding.
• if you have lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, injuries 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 heparin is administered through it to keep it open, or when your heartbeat is restored to normal via 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 or pharmacist before taking Dabigatran Etexilate EG STADA. You may also
need to contact your doctor during treatment with this medicine 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 underwent a biopsy (surgical removal of tissue) within the previous month.
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery).
  • if you have inflammation of the oesophagus or stomach.
  • if you suffer from gastroesophageal reflux (backflow of stomach acid into the oesophagus).
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran Etexilate EG STADA” below.
  • if you are taking non-steroidal anti-inflammatory drugs 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, 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 this medicine is not recommended.

Take special care with Dabigatran Etexilate EG STADA

• if you are scheduled for surgery: In this case, Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA before and after surgery exactly at the time instructed by your doctor.
• if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
  • it is very important to take Dabigatran Etexilate EG STADA before and after the procedure exactly at the time instructed by your doctor.
  • inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent treatment may be required.
• if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may 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 Dabigatran Etexilate EG STADA
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 Dabigatran
Etexilate EG STADA if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
• Medicines for irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Dabigatran Etexilate EG STADA depending on the condition for which it has been prescribed. 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-noradrenaline reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV/AIDS (e.g. ritonavir)
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

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

Driving and using machines
Dabigatran Etexilate EG STADA has no known effects on the ability to drive or use
machinery.

3. How to take Dabigatran Etexilate EG STADA

Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA as recommended for the following conditions:

Prevention of blood clots after hip or knee 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 Dabigatran Etexilate EG STADA of 75 mg, as the risk of bleeding may increase.

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

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

After hip replacement surgery
Start treatment with Dabigatran Etexilate EG STADA 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 new blood clots in children
Dabigatran Etexilate EG STADA 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 to stop any of them.

Single dose of Dabigatran Etexilate EG STADA in milligrams (mg) according to patient weight in kilograms (kg) and age in years, to be administered twice daily:
Indicates that dosing recommendations cannot be provided.

How to take Dabigatran Etexilate EG STADA
Dabigatran Etexilate EG STADA 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 the granules from the capsule, as this may increase the risk of bleeding.

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

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

If you forget to take Dabigatran Etexilate EG STADA

Prevention of blood clots after hip or knee replacement surgery
Continue with the remaining daily doses of Dabigatran Etexilate EG STADA at your usual time the next day. Do not take a double dose to make up for the missed dose.

Treatment of blood clots and prevention of recurrence 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 a missed dose.

If you stop taking Dabigatran Etexilate EG STADA
Take Dabigatran Etexilate EG STADA exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach discomfort after taking Dabigatran Etexilate EG STADA.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Dabigatran Etexilate EG STADA acts on the blood coagulation system; therefore, most 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, can 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 listed below are grouped according to their 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 injury, or following surgery
• Formation of haematoma or haematoma occurring after surgery
• Presence of blood in stools, detected by laboratory testing
• Decrease in blood cell count
• Decrease in proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhoea with loose or watery stools
• Feeling unwell
• Discharge from wound (leakage of fluid from surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
• Blood-stained discharge from the site of intravenous catheter insertion
• 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 in 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 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 available data):

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

Treatment of blood clots and prevention of recurrence 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
• Skin rash appearing as red, raised, itchy lumps due to an allergic reaction
• Sudden skin change altering its colour and appearance
• Formation of 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 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 in breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran Etexilate EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Dabigatran Etexilato EG STADA contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), and hypromellose.

Description of the appearance of Dabigatran Etexilato EG STADA and package contents
Dabigatran Etexilato EG STADA 75 mg capsules are white or off-white hard capsules of size 2, filled with off-white to pale yellow granules.
Dabigatran Etexilato EG STADA is available in packaging containing 1 x 10, 1 x 30 or 1 x 60 hard capsules in perforated aluminum/OPA-ALU-PVC blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
EG S.p.A.
Via Pavia, 6
20136 – Milan
Italy

Manufacturer
Galenicum Health S.L.
Edificio Lekla
Avinguda Cornella 144
Esplugues De Llobregat
08950 Barcelona
Spain
Or
SAG Manufacturing S.L.U
Crta. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid – Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient information leaflet: information for the patient

Dabigatran Etexilate EG STADA 110 mg hard capsules

dabigatran etexilate
Generic medicine
Please read this entire 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 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dabigatran Etexilato EG STADA is and what it is used for

Dabigatran Etexilato EG STADA contains the active substance dabigatran etexilato and belongs to a
group of medicines called anticoagulants. It blocks the action of a substance in the body involved
in blood clot formation.
Dabigatran Etexilato EG STADA 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.

Dabigatran Etexilato EG STADA is used in children for:

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

2. What you should know before taking Dabigatran Etexilate EG STADA

Do not take Dabigatran Etexilate EG STADA

• 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 via 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 itraconazolo, medicines used to treat fungal infections;
• if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection;
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm;
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C;
• if you have had a mechanical heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dabigatran Etexilate EG STADA. You may also
need to contact your doctor during treatment with this medicine 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 a biopsy (surgical removal of tissue) within the previous month;
  • if you have sustained serious injuries (e.g. bone fracture, head injury, or any injury requiring surgery);
  • if you suffer from inflammation of the oesophagus or stomach;
  • if you have gastroesophageal reflux disease (acid reflux into the oesophagus);
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran Etexilate EG STADA” 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 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 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 Dabigatran Etexilate EG STADA

• if you are scheduled for surgery: In this case, Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA 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 spine (e.g. for epidural or spinal anaesthesia or pain relief):
  • it is very important to take Dabigatran Etexilate EG STADA 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 problems with bowel or bladder function after the anaesthesia wears off, as urgent medical treatment may be required.
  • If you fall or injure yourself during treatment, especially if you sustain a head injury, call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.
  • If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

Other medicines and Dabigatran Etexilate EG STADA
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 Dabigatran
Etexilate EG STADA if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically to the skin.
• Medicines used to treat abnormal heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a reduced dose of Dabigatran Etexilate EG STADA depending on the condition for which it has been prescribed. 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 remedy used for 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).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

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

Driving and using machines
Dabigatran Etexilate EG STADA has no known effects on the ability to drive vehicles or operate
machinery.

3. How to take Dabigatran Etexilate EG STADA

Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA of 75 mg, because the risk of bleeding may increase.

For both types of surgery, 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 Dabigatran Etexilate EG STADA within 1–4 hours after completion of the surgical procedure, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.

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

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

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take Dabigatran Etexilate EG STADA 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 Dabigatran Etexilate EG STADA after your doctor has determined that normal control of blood coagulation has been achieved.
Take Dabigatran Etexilate EG STADA as directed by your doctor.

Treatment of blood clots and prevention of new blood clots in children
Dabigatran Etexilate EG STADA 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 and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Single dose of Dabigatran Etexilate EG STADA in milligrams (mg) according to patient weight in kilograms (kg) and age in years, to be administered twice daily:
This means that dosing recommendations cannot be established.

How to take Dabigatran Etexilate EG STADA
Dabigatran Etexilate EG STADA 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 blister packs
The following images illustrate how to remove the capsules of Dabigatran Etexilate EG STADA 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 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 specific instructions from your doctor.

If you take more Dabigatran Etexilate EG STADA than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran Etexilate EG STADA

Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran Etexilate EG STADA at your 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 formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of 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 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 double the dose to make up for a missed dose.

If you stop taking Dabigatran Etexilate EG STADA
Take Dabigatran Etexilate EG STADA exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach discomfort after taking Dabigatran Etexilate EG STADA.

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 will experience them.
Dabigatran Etexilate EG STADA 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 evident.
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), consult your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to their frequency of occurrence.

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

• decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells);
• abnormal results in liver function tests.

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

• bleeding that may occur from the nose, stomach or intestine, from penis/vagina or urinary tract (including presence of blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or following a wound, after surgery;
• formation of haematoma or haematoma occurring after surgery;
• presence of blood in the faeces, detected by laboratory test;
• reduction in the number of blood cells;
• reduction in the proportion of blood cells;
• allergic reaction;
• vomiting;
• diarrhoea with loose or liquid stools;
• feeling of malaise;
• 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 that may occur in the brain, from a surgical incision, injection site, or catheter insertion site into a vein;
• blood-stained discharge from the site of venous catheter insertion;
• coughing up blood or blood-stained sputum;
• reduction in the number of platelets in the blood;
• reduction in the number of red blood cells in the blood after surgery;
• severe allergic reaction causing difficulty in breathing or dizziness;
• severe allergic reaction causing swelling of the face or throat;
• skin rash appearing as red, raised, itchy lumps due to an allergic reaction;
• sudden skin alteration changing its colour and appearance;
• itching;
• stomach or intestinal 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;
• reduction in the number or even absence of white blood cells (which help fight infections);
• hair loss.

Prevention of blockage of blood vessels in the brain or 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, from penis/vagina or urinary tract (including presence of 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;
• diarrhoea with loose or liquid stools;
• feeling of malaise.

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;
• reduction in the number of platelets in the blood;
• reduction in the amount of haemoglobin in the blood (the substance contained in red blood cells);
• allergic reaction;
• sudden skin alteration changing its colour and appearance;
• itching;
• stomach or intestinal ulcer (including oesophageal ulcer);
• inflammation of the oesophagus and stomach;
• reflux of gastric juices into the oesophagus;
• vomiting;
• difficulty swallowing;
• abnormal results in liver function tests.

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

• bleeding that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site into a vein;
• severe allergic reaction causing difficulty in breathing or dizziness;
• severe allergic reaction causing swelling of the face or throat;
• prominent skin rash with red, raised, itchy lumps 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 the available data):

• difficulty in 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 EG STADA 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 presence of 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 haemorrhoids;
• reduction in the number of red blood cells in the blood;
• formation of haematoma;
• coughing up blood or blood-stained sputum;
• allergic reaction;
• sudden skin alteration changing its colour and appearance;
• itching;
• stomach or intestinal ulcer (including oesophageal ulcer);
• inflammation of the oesophagus and stomach;
• reflux of gastric juices into the oesophagus;
• feeling of malaise;
• vomiting;
• abdominal or stomach pain;
• diarrhoea with loose or liquid stools;
• abnormal results in liver function tests;
• increased liver enzymes.

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

• bleeding that may occur from a surgical incision, injection site, catheter insertion site into 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;
• prominent skin rash with red, raised, itchy lumps due to an allergic reaction;
• difficulty swallowing.

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

• difficulty in breathing or wheezing;
• reduction in the amount of haemoglobin 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 programme, the rate of heart attacks was higher with Dabigatran Etexilate EG STADA 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 recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

• reduction in the number of red blood cells in the blood;
• reduction in the number of platelets in the blood;
• prominent skin rash with red, raised, itchy lumps due to an allergic reaction;
• sudden skin alteration changing its colour and appearance;
• formation of haematoma;
• nosebleed;
• reflux of gastric juices into the oesophagus;
• vomiting;
• feeling of malaise;
• diarrhoea 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 or urinary tract (including presence of blood in urine turning it pink or red), or under the skin;
• reduction in the amount of haemoglobin 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 oesophagus and stomach;
• allergic reaction;
• difficulty swallowing;
• yellowing of the skin or whites of the eyes, caused by liver or blood problems.

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

• absence of white blood cells (which help fight infections);
• severe allergic reaction causing difficulty in breathing or dizziness;
• severe allergic reaction causing swelling of the face or throat;
• difficulty in breathing or wheezing;
• bleeding;
• bleeding that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site into a vein;
• bleeding that may occur from haemorrhoids;
• stomach or intestinal ulcer (including oesophageal ulcer);
• abnormal results in liver function tests.

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

5. How to store Dabigatran Etexilate EG STADA

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 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.
After opening, the medicine must be used within 4 months. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dabigatran Etexilato EG STADA contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose, and indigo carmine (E-132).

Description of the appearance of Dabigatran Etexilato EG STADA and package contents
Dabigatran Etexilato EG STADA 110 mg capsules are blue, size 1 hard capsules filled with whitish to pale yellow granules.
This medicinal product is available in packaging containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated blisters of Aluminum/OPA-ALU-PVC, divisible into single doses.
This medicinal product is also available in packaging containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in non-perforated blisters of Aluminum/OPA-ALU-PVC.
Multiple pack containing 3 boxes of 60 x 1 hard capsules (180 hard capsules) or multiple pack containing 2 boxes of 50 x 1 hard capsules (100 hard capsules) in perforated blisters of Aluminum/OPA-ALU-PVC, divisible into single doses.
Multiple pack containing 3 boxes of 60 x 1 hard capsules (180 hard capsules) or multiple pack containing 2 boxes of 50 x 1 hard capsules (100 hard capsules) in non-perforated blisters of Aluminum/OPA-ALU-PVC.
This medicinal product is also available in high-density polyethylene (plastic) bottles with child-resistant screw cap and integrated desiccant, sealed with a foil, containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano

Manufacturers
Galenicum Health, S.L.U., Sant Gabriel, 50, Esplugues de Llobregat 08950 Barcelona (Spain)
Or
SAG Manufacturing S.L.U, Crta. N-I, Km 36, 28750 San Agustin de Guadalix, Madrid (Spain)
Or
STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel (Germany)
Or
Pharmadox Healthcare Limited, Kkw46 Kordin Industrial Park, Paola, PLA 3000 (Malta)

Package leaflet: Information for the patient

Dabigatran Etexilate EG STADA 150 mg hard capsules

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

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

Contents of this leaflet:

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

1. What Dabigatran Etexilate EG STADA is and what it is used for

Dabigatran Etexilate EG STADA 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.
Dabigatran Etexilate EG STADA is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body if there is a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor;
• treating blood clots in the veins of the legs and lungs and preventing blood clots from recurring in the veins of the legs and lungs.

Dabigatran Etexilate EG STADA is used in children for:

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

2. What you need to know before taking Dabigatran Etexilate EG STADA

Do not take Dabigatran Etexilate EG STADA

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6);
• if your kidney function is severely reduced;
• if you have active bleeding;
• if you have lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery);
• 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 heart rhythm is being restored to normal via 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 or pharmacist before taking Dabigatran Etexilate EG STADA. You may also need to consult your doctor during treatment with this medicine if you experience 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 a biopsy (surgical removal of tissue) 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 gastro-oesophageal reflux (acid reflux into the oesophagus);
  • if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and Dabigatran Etexilate EG STADA” 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 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 Dabigatran Etexilate EG STADA

• If you are scheduled for surgery: You will need to temporarily stop taking Dabigatran Etexilate EG STADA due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran Etexilate EG STADA before and after surgery exactly at the time instructed by your doctor.
• 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 Dabigatran Etexilate EG STADA before and after the procedure exactly at the time instructed by your doctor;
• contact your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical care is required.
  • If you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may decide that you need to be examined, as you may be at high risk of bleeding.
  • If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be changed.

Other medicines and Dabigatran Etexilate EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran Etexilate EG STADA if you are taking any of the following medicines:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless 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 may advise you to use a lower dose of Dabigatran Etexilate EG STADA depending on the condition for which it has been prescribed. See also section 3.
• Medicines to prevent 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).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

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

Driving and using machines
Dabigatran Etexilate EG STADA has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran Etexilate EG STADA

Dabigatran Etexilate EG STADA 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 instructed by your doctor. If you have any doubts, consult your doctor.

Take Dabigatran Etexilate EG STADA as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of Dabigatran Etexilate EG STADA of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.
You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion or via a catheter ablation procedure for atrial fibrillation. Take Dabigatran Etexilate EG STADA exactly 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 Dabigatran Etexilate EG STADA after your doctor determines that normal blood clotting control has been achieved.
Take Dabigatran Etexilate EG STADA as instructed by your doctor.

Treatment of blood clots and prevention of new blood clots in children
Dabigatran Etexilate EG STADA should be taken twice daily, once in the morning and once 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 and may adjust it during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.

Single dose of Dabigatran Etexilate EG STADA in milligrams (mg) according to patient weight in kilograms (kg) and age in years, to be administered twice daily:
Means that dosing recommendations cannot be provided.

How to take Dabigatran Etexilate EG STADA
Dabigatran Etexilate EG STADA 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 the granules from the capsule, as this may increase the risk of bleeding.

Instructions for opening blister packs
The following images illustrate how to remove Dabigatran Etexilate EG STADA capsules from the blister

Separate one unit 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 only be lifted 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 specific instructions from your doctor.

If you take more Dabigatran Etexilate EG STADA than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran Etexilate EG STADA
A 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, skip the missed dose. Do not double the dose to make up for a missed one.

If you stop taking Dabigatran Etexilate EG STADA
Take Dabigatran Etexilate EG STADA exactly as prescribed. Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach discomfort after taking Dabigatran Etexilate EG STADA.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dabigatran Etexilate EG STADA acts on the blood clotting system; therefore, most side effects are related to signs such as bruising or bleeding.
Major or severe bleeding events may occur, which are 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 develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to carry out a thorough check-up or change your treatment.
Inform your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to 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;
• stomach or abdominal pain;
• indigestion;
• diarrhoea with loose or watery 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 sputum stained with blood;
• reduction in the number of platelets in the blood;
• reduction 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;
• 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 that may occur in a joint, from a surgical incision, wound, injection site, or catheter insertion site in a vein;
• severe allergic reaction causing difficulty breathing or dizziness;
• severe allergic reaction causing swelling of the face or throat;
• skin rash appearing as red, raised, itchy lumps 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 EG STADA 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 haemorrhoids;
• reduction in the number of red blood cells in the blood;
• formation of haematoma;
• coughing up blood or sputum stained with blood;
• 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;
• feeling unwell;
• vomiting;
• stomach or abdominal pain;
• diarrhoea with loose or watery 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 breathing or dizziness;
• severe allergic reaction causing swelling of the face or throat;
• prominent skin rash with red, raised, itchy lumps 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 haemoglobin 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 programme, the rate of heart attacks was higher with Dabigatran Etexilate EG STADA 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 recurrence of blood clots in children

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

• reduction in the number of red blood cells in the blood;
• reduction in the number of platelets in the blood;
• prominent skin rash with red, raised, itchy lumps due to an allergic reaction;
• sudden skin changes altering its colour and appearance;
• formation of haematoma;
• nosebleeds;
• 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):

• 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 haemoglobin in the blood (the substance contained in red blood cells);
• reduction in the proportion of blood cells;
• itching;
• coughing up blood or sputum stained with blood;
• stomach or abdominal 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 that may occur in a joint or from a wound, surgical incision, injection site, or catheter insertion site in a vein;
• bleeding that 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dabigatran Etexilate EG STADA

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.
After opening, the medicine must be used within 4 months. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dabigatran Etexilate EG STADA contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, hypromellose, simethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose and indigo carmine (E-132).

Description of the appearance of Dabigatran Etexilate EG STADA and package contents
Dabigatran Etexilate EG STADA 150 mg capsules are blue hard capsules of size 0, filled with whitish to pale yellow granules.
This medicinal product is available in packs containing 10 x 1, 30 x 1 or 60 x 1 hard capsules in perforated unit-dose divisible blisters made of Aluminium/OPA-ALU-PVC.
This medicinal product 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.
Multiple packs containing 3 boxes of 60 x 1 hard capsules (180 hard capsules) or multiple packs containing 2 boxes of 50 x 1 hard capsules (100 hard capsules) in perforated unit-dose divisible blisters made of Aluminium/OPA-ALU-PVC.
Multiple packs containing 3 boxes of 60 x 1 hard capsules (180 hard capsules) or multiple packs containing 2 boxes of 50 x 1 hard capsules (100 hard capsules) in non-perforated blisters made of Aluminium/OPA-ALU-PVC.
This medicinal product is also available in high-density polyethylene (plastic) bottles with child-resistant screw cap and integrated desiccant, sealed with a foil, containing 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy

Manufacturers
Galenicum Health, S.L.U., Sant Gabriel, 50, Esplugues de Llobregat 08950 Barcelona (Spain)
Or
SAG Manufacturing S.L.U, Crta. N-I, Km 36, 28750 San Agustin de Guadalix, Madrid (Spain)
Or
STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel (Germany)
Or
Pharmadox Healthcare Limited, Kkw46 Kordin Industrial Park, Paola, PLA 3000 (Malta)