DABIGATRAN 75 mg Hard Capsules

Зміст інструкції

1. DABIGATRAN ETEXILATE Olpha 75 mg hard capsules
   1. What is DABIGATRAN ETEXILATE Olpha and what it is used for
   2. What you need to know before taking DABIGATRAN ETEXILATE Olpha
   3. How to take DABIGATRAN ETEXILATE Olpha
   4. Possible side effects
   5. How to store DABIGATRAN ETEXILATE Olpha
   6. Contents of the pack and other information
2. DABIGATRAN ETEXILATE Olpha 110 mg hard capsules
   1. What is DABIGATRAN ETEXILATE Olpha and what it is used for
   2. What you need to know before taking DABIGATRAN ETEXILATE Olpha
   3. How to take DABIGATRAN ETEXILATO Olpha
   4. Possible side effects
   5. How to store DABIGATRAN ETEXILATE Olpha
   6. Contents of the pack and other information
3. DABIGATRAN ETEXILATE Olpha 150 mg hard capsules
   1. What is DABIGATRAN ETEXILATE Olpha and what is it used for
   2. What you need to know before taking DABIGATRAN ETEXILATE Olpha
   3. How to take DABIGATRAN ETEXILATO Olpha
   4. Possible side effects
   5. How to store DABIGATRAN ETEXILATE Olpha
   6. Package Contents and Other Information

DABIGATRAN ETEXILATE Olpha 75 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Contents of this leaflet

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

1. What is DABIGATRAN ETEXILATE Olpha and what it is used for

DABIGATRAN ETEXILATE Olpha contains the active ingredient dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
DABIGATRAN ETEXILATO Olpha 75 mg hard capsulesis used in adults for:

• preventing the formation of blood clots in the veins following surgery for knee or hip replacement. DABIGATRAN ETEXILATO Olpha 75 mg hard capsulesis 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 Olpha

Do not take DABIGATRAN ETEXILATE Olpha

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent the formation of blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that could in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking DABIGATRAN ETEXILATE Olpha. You may also need to
talk to your doctor during treatment with DABIGATRAN ETEXILATE Olpha if you experience symptoms or if
you need to undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one of those
included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the past month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that can increase the risk of bleeding. See the section “Other medicines and DABIGATRAN ETEXILATE Olpha” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you know that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated) urine with foam).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Take special care with DABIGATRAN ETEXILATE Olpha

• if you need to undergo surgery: In this case, DABIGATRAN ETEXILATE Olpha will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time told to you by your doctor.
• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time told to you by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has worn off, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because you may be at increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if you need to change therapy.

Other medicines and DABIGATRAN ETEXILATE Olpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. In particular, you must tell your doctor before taking DABIGATRAN
ETEXILATE Olpha if you are taking any of the medicines listed below:

• Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for treating fungal infections (e.g. ketoconazole, itraconazole) unless they are only applied to the skin
• Medicines for treating altered heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine or verapamil, your doctor may tell you to use a reduced dose of DABIGATRAN ETEXILATE Olpha based on the condition for which it was prescribed to you. See also section 3
• Medicines to prevent rejection episodes after organ transplantation (e.g. tacrolimus, cyclosporine)
• The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for the treatment of depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
• Some medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

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

Driving and using machines
DABIGATRAN ETEXILATE Olpha has no known effects on the ability to drive and operate machines.

3. How to take DABIGATRAN ETEXILATE Olpha

DABIGATRAN ETEXILATE Olpha can be used in adults and children aged 8 years and over who are able to swallow the capsules whole. There are appropriate dosages and pharmaceutical forms for the treatment of children under 8 years of age.
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor.

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

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing amiodarone, quinidine or verapamil, the recommended dose is 150 mg
once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is reducedby more than half, you must take a reduced dose of 75 mgof this medicine because the risk of bleeding
may increase.
For both surgeries, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with DABIGATRAN ETEXILATE Olpha within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 10 days.

After hip replacement surgery
You should start treatment with DABIGATRAN ETEXILATE Olpha within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 28-35 days.
Treatment of blood clots and prevention of the formation of new blood clots in children.

DABIGATRAN ETEXILATE Olpha must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on age and weight. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of DABIGATRAN ETEXILATE Olpha in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for DABIGATRAN ETEXILATE Olpha
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 DABIGATRAN ETEXILATE Olpha
DABIGATRAN ETEXILATE Olpha can be used in adults and children aged 8 years and over who are able to swallow the capsules whole.
DABIGATRAN ETEXILATE Olpha can be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as it may increase the risk of bleeding.

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

If you take more DABIGATRAN ETEXILATE Olpha than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of DABIGATRAN ETEXILATE Olpha capsules. Specific treatment options are available.

If you forget to take DABIGATRAN ETEXILATE Olpha
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of DABIGATRAN ETEXILATE Olpha at the usual time of the next day.
Do not take a double dose to make up for a missed dose.
Treatment of blood clots and prevention of the reformation of blood clots in children.
The missed dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until 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 Olpha
Take DABIGATRAN ETEXILATE Olpha exactly as prescribed. Do not stop taking this medicine without first talking to your doctor because the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience stomach problems after taking DABIGATRAN ETEXILATE Olpha.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
DABIGATRAN ETEXILATO Olpha acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding. Major or serious bleeding events may occur, which constitute the most serious side effects, and which, regardless of location, can be disabling, life-threatening or even lead to death. In some cases, this bleeding may not be obvious.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a severe allergic reaction that causes difficulty breathing or dizziness.
The possible side effects are listed below, grouped by how often they occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Abnormal laboratory test results for liver function Uncommon (may affect up to 1 in 100 people):
• Bleeding that may occur from the nose, at the level of the stomach or intestine, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), from hemorrhoids, from the rectum, under the skin, in a joint, from a wound or following it or after surgery
• Formation of a hematoma or hematoma that occurs after an operation
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Secretion stained with blood from the site of catheter insertion into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after an operation
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

• Difficulty breathing or wheezing
• Reduction in the number or even absence of white blood cells (which help fight infections)
• Hair loss Treatment of blood clots and prevention of re-formation of blood clots in children Common (may affect up to 1 in 10 people):
• Reduction in the number of red blood cells in the blood
• Reduction in the number of platelets in the blood
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Nosebleed
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes Uncommon (may affect up to 1 in 100 people):
• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur at the level of the stomach or intestine, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Pain in the abdomen or stomach
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including esophageal ulcer)
• Abnormal laboratory test results for liver function

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

5. How to store DABIGATRAN ETEXILATE Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp. The
expiry date refers to the last day of that month.
Aluminum – Aluminum Blister (OPA/Al/PVC//Al): Do not store at a temperature above 30 °C.
Aluminum Blister with desiccant coating – Aluminum (OPA/Al/PE//PE/Al/LDPE): This medicine does not
require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DABIGATRAN ETEXILATO Olpha contains

• The active ingredient is dabigatran etexilate. Each capsule contains dabigatran etexilate mesylate equivalent to 75 mg of dabigatran etexilate.
• The other ingredients are
• capsule content: tartaric acid in granules, hypromellose, hydroxypropylcellulose, talc
• Capsule shell: carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose

Description of the appearance of DABIGATRAN ETEXILATO Olpha and contents of the pack
Capsules of approximately 18.0 mm with an opaque white cap and opaque white body of size “2” filled with granules
ranging in colour from off-white to yellowish.
The capsules are packaged in blisters made of Aluminium with desiccant coating–Aluminium
(OPA/Al/PE//PE/Al/LDPE) or Aluminium-Aluminium (OPA/Al/PVC//Al)
Packs:
Blister containing: 10, 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Member StateName
Sweden Dabigatran Etexilate Olpha
Italy DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATE Olpha 110 mg hard capsules

Generic medicine

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

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

Contents of this leaflet

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

1. What is DABIGATRAN ETEXILATE Olpha and what it is used for

DABIGATRAN ETEXILATE Olpha contains the active ingredient dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
DABIGATRAN ETEXILATE Olpha 110 mg hard capsules is used in adults for:

• preventing the formation of blood clots in the veins following surgery for knee or hip replacement.
• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disturbance called non-valvular atrial fibrillation and at least one further risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming in the veins of the legs and lungs. DABIGATRAN ETEXILATE Olpha 110 mg hard capsules 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 Olpha

Do not take DABIGATRAN ETEXILATE Olpha

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This can be congenital, due to an unknown cause or due to other medicines.
• if you are taking medicines to prevent blood clots from forming (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and you are receiving heparin through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that could in any way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for preventing rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product based on glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires the permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking DABIGATRAN ETEXILATE Olpha. You may also need to
talk to your doctor during treatment with this medicine if you experience symptoms or if you need to
undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one of those
included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have undergone a biopsy (surgical removal of tissue) in the previous month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DABIGATRAN ETEXILATE Olpha” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated) urine with foam).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around the brain or inside it.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood test results. In this case, the use of this medicine is not recommended.

Be particularly careful with DABIGATRAN ETEXILATE Olpha

• if you need to undergo surgery: In this case, DABIGATRAN ETEXILATE Olpha will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take

DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time you have been told by
your doctor.

• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time you have been told by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, as urgent care is needed.
• if you fall or get injured during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may consider it necessary to examine you because you may be exposed to an increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide whether it is necessary to change therapy.

Other medicines and DABIGATRAN ETEXILATE Olpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In particular, tell your doctor before taking DABIGATRAN
ETEXILATE Olpha if you are taking any of the medicines listed below:

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

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

Driving and using machines
DABIGATRAN ETEXILATE Olpha has no known effects on the ability to drive vehicles and operate machinery.

3. How to take DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are appropriate dosages and pharmaceutical forms for the treatment in children under 8 years of age.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor.

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

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

150 mg once a day(taken as 2 capsules of 75 mg).
If you are taking medicines containing verapamil and your kidney function is decreasedby more than half, you must take a reduced dose of DABIGATRAN ETEXILATO Olpha of 75 mgbecause the risk of bleeding may increase.
For both procedures, treatment should not be started in case of bleeding at the surgical site. If treatment cannot be started until the day after surgery, administration should begin with a dose of 2 capsules once a day.

After knee replacement surgery
You should start treatment with DABIGATRAN ETEXILATO Olpha within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 10 days.

After hip replacement surgery
You should start treatment with DABIGATRAN ETEXILATO Olpha within 1-4 hours after the end of the surgery, taking a single capsule. Subsequently, you should take two capsules, once a day, for a total of 28-35 days.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that have developed following an irregular heartbeat and treatment of blood clots in the veins of the legs and lungs including the prevention of re-formation of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.
If you are taking medicines containing verapamil, you must take a reduced dose of DABIGATRAN ETEXILATO Olpha of 220 mg taken as one 110 mg capsule twice a day, because the risk of bleeding may increase.
If you are potentially exposed to a higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be returned to normal with a procedure called cardioversion. Take DABIGATRAN ETEXILATO Olpha according to your doctor’s instructions.
If a medical device (stent) has been inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stent, you may be treated with DABIGATRAN ETEXILATO Olpha after your doctor has determined that normal blood coagulation control has been achieved. Take DABIGATRAN ETEXILATO Olpha according to your doctor’s instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

DABIGATRAN ETEXILATO Olpha must be taken twice a day, one dose in the morning and one in the evening, approximately at the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on age and weight. Your doctor will establish the correct dose. Your doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of DABIGATRAN ETEXILATO Olpha in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for DABIGATRAN ETEXILATO Olpha

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 DABIGATRAN ETEXILATO Olpha
DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years or older who are able to swallow the capsules whole.
DABIGATRAN ETEXILATO Olpha can be taken with or without food. The capsule must be swallowed whole with a glass of water, to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as it may increase the risk of bleeding.

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

If you take more DABIGATRAN ETEXILATO Olpha than you should
Taking too much of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take DABIGATRAN ETEXILATO Olpha
Prevention of blood clot formation after knee or hip replacement surgery
Continue with the remaining daily doses of DABIGATRAN ETEXILATO Olpha at the usual time of day next day.
Do not take a double dose to make up for a missed dose.
Use in adults: prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that have developed following an irregular heartbeat and treatment of blood clots in the veins of the legs and lungs including the prevention of re-formation of blood clots in the veins of the legs and lungs
Use in children: treatment of blood clots and prevention of re-formation of blood clots
The forgotten dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until the next dose, the forgotten dose should be skipped. Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
DABIGATRAN ETEXILATO Olpha acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding. Major or serious bleeding events may occur, which constitute the most serious side effects, and which, regardless of the location, can be disabling, life-threatening or even lead to death. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. The doctor may decide to subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction that causes difficulty breathing or dizziness.
Possible side effects are listed below, grouped by how frequently they occur.
Prevention of blood clot formation after knee or hip replacement surgery
Common (may affect up to 1 in 10 people):

• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Abnormal results of laboratory tests on liver function Uncommon (may affect up to 1 in 100 people):
• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), from hemorrhoids, from the

rectum, under the skin, in a joint, from a wound or following it or after surgery

• Formation of a hematoma or hematoma that occurs after an operation
• Presence of blood in the stool, detected by laboratory examination
• Reduction in the number of red blood cells in the blood
• Reduction in the proportion of blood cells
• Allergic reaction
• Vomiting
• Diarrhea with loose or liquid stools
• Feeling unwell
• Secretion from the wound (exudation of fluid from the surgical wound)
• Increased liver enzymes
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

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

• Bleeding
• Bleeding that may occur in the brain, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bloody secretion from the site of catheter insertion into a vein
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the number of red blood cells in the blood after an operation
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Pain in the abdomen or stomach
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

Not known (frequency cannot be estimated based on available data):

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

Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of
blood clots developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Pain in the abdomen or stomach
• Indigestion
• Diarrhea with loose or liquid stools
• Feeling unwell

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

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• Formation of a hematoma
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of laboratory tests on liver function

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of catheter insertion into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

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

In a clinical study, the percentage of heart attacks was numerically higher with DABIGATRAN
ETEXILATO Olpha than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs including prevention of
reformation of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
• 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 a hematoma
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine
• Inflammation of the esophagus and stomach (including ulcer of the esophagus)
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Pain in the abdomen or stomach
• Diarrhea with loose or liquid stools
• Abnormal results of laboratory tests on liver function
• Increased liver enzymes

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

• Bleeding that may occur from a surgical incision or from the injection site or from the site of catheter insertion into a vein or from the brain
• Reduction in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Difficulty swallowing

Not known (frequency cannot be estimated based on available data):

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

In the clinical study program, the percentage of heart attacks was higher with DABIGATRAN
ETEXILATO Olpha 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 reformation 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
• Noticeable skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Formation of a hematoma
• Bleeding from the nose
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes Uncommon (may affect up to 1 in 100 people):
• Reduction in the number of white blood cells (which help fight infections)
• Bleeding that may occur at the level of the stomach or intestines, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which turns it pink or red) or under the skin
• Reduction in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Pain in the abdomen or stomach
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Abnormal results of laboratory tests on liver function

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

5. How to store DABIGATRAN ETEXILATE Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the blister after Exp. The expiry
date refers to the last day of that month.
Aluminum – Aluminum Blister (OPA/Al/PVC//Al): Do not store at a temperature above 30 °C.
Aluminum blister with desiccant coating – Aluminum (OPA/Al/PE//PE/Al/LDPE): This medicine does not
require any particular storage conditions.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that you
no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DABIGATRAN ETEXILATO Olpha contains

• The active ingredient is dabigatran. Each capsule contains dabigatran etexilate mesylate equivalent to 110 mg of dabigatran etexilate.
• The other ingredients are
• capsule content: tartaric acid in granules, hypromellose, hydroxypropylcellulose, talc
• Capsule shell: indigo carmine aluminum lake (E132), carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose

Description of the appearance of DABIGATRAN ETEXILATO Olpha and contents of the pack
Capsules of approximately 19 mm with opaque blue cap and opaque blue body of size “1” filled with granules
of colour ranging from off-white to yellowish.
The capsules are packaged in blisters made of Aluminum with desiccant coating–Aluminum
(OPA/Al/PE//PE/Al/LDPE) or Aluminum-Aluminum (OPA/Al/PVC//Al)
Pack sizes
Blister containing: 10, 30, 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Member StateName
Sweden Dabigatran Etexilate Olpha
Italy DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATE Olpha 150 mg hard capsules

Generic medicine

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

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

Contents of this leaflet

• 7. What DABIGATRAN ETEXILATE Olpha is and what it is used for
• 8. What you need to know before you take DABIGATRAN ETEXILATE Olpha
• 9. How to take DABIGATRAN ETEXILATE Olpha
• 10. Possible side effects
• 11. How to store DABIGATRAN ETEXILATE Olpha
• 12. Contents of the pack and other information

7. What is DABIGATRAN ETEXILATE Olpha and what is it used for

DABIGATRAN ETEXILATE Olpha contains the active substance dabigatran etexilate and belongs to a group
of medicines called anticoagulants. It blocks the action of a substance present in the body
involved in the formation of blood clots.
DABIGATRAN ETEXILATE Olpha 150 mg hard capsules is used in adults for:

• preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of heart rhythm disorder called non-valvular atrial fibrillation and at least one additional risk factor.
• treating blood clots in the veins of the legs and lungs and preventing blood clots from reforming in the veins of the legs and lungs. DABIGATRAN ETEXILATE Olpha 150 mg hard capsules is used in children for:
• treating blood clots and preventing the formation of new blood clots.

8. What you need to know before taking DABIGATRAN ETEXILATE Olpha

Do not take DABIGATRAN ETEXILATE Olpha

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely impaired.
• if you have ongoing bleeding.
• if you have injuries to an organ that increase the risk of serious bleeding (e.g. stomach ulcer, injuries or bleeding in the brain, recent surgery to the brain or eyes).
• if you have an increased tendency to bleed. This may be congenital, due to unknown cause or due to other medicines.
• if you are taking medicines to prevent the formation of blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when you are switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heartbeat is restored to normal with a procedure called transcatheter ablation for atrial fibrillation.
• if you have severely impaired liver function or a liver disease that may in some way cause death.
• if you are taking ketoconazole or itraconazole orally, medicines for the treatment of fungal infections.
• if you are taking oral cyclosporine, a medicine for the prevention of rejection episodes after organ transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeat.
• if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
• if you have had an artificial heart valve implanted that requires permanent use of anticoagulants.

Warnings and precautions
Talk to your doctor before taking DABIGATRAN ETEXILATE Olpha. You may also need to
talk to your doctor during treatment with this medicine if you experience symptoms or if you need to
undergo surgery.

Tell your doctorif you suffer from or have suffered from any medical condition or illness, in particular one of those
included in the following list:

• if you have an increased risk of bleeding such as:
• if you have had recent bleeding.
• if you have had a biopsy (surgical removal of tissue) in the previous month.
• if you have experienced serious injuries (e.g. bone fracture, head injury or any injury that required surgery).
• if you suffer from inflammation of the esophagus or stomach.
• if you have problems with stomach acid reflux into the esophagus.
• if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DABIGATRAN ETEXILATE Olpha” below.
• if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if you suffer from a heart infection (bacterial endocarditis).
• if you are aware that your kidney function is reduced or you suffer from dehydration (symptoms include feeling thirsty and passing small amounts of dark (concentrated) urine with foam).
• if you are over 75 years of age.
• if you are an adult patient and weigh 50 kg or less.
• for use in children only: if the child has an infection around or inside the brain.
• if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of developing a heart attack.
• if you suffer from a liver disease, associated with changes in blood tests. In this case, the use of this medicine is not recommended.

Take special care with DABIGATRAN ETEXILATE Olpha

• if you need to undergo surgery: In this case, DABIGATRAN ETEXILATE Olpha will need to be temporarily stopped due to the increased risk of bleeding during and shortly after the operation. It is very important to take DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time told to you by your doctor.
• if an operation involves the presence of a catheter or an injection into the spine (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to take DABIGATRAN ETEXILATE Olpha before and after the operation exactly at the time told to you by your doctor.
• immediately inform your doctor if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anesthesia has ended, because urgent care is needed.
• if you fall or injure yourself during treatment, especially if you hit your head. Call your doctor immediately. Your doctor may need to examine you because you may be at increased risk of bleeding.
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change your therapy.

Other medicines and DABIGATRAN ETEXILATE Olpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In particular, you must tell your doctor before taking DABIGATRAN
ETEXILATE Olpha if you are taking any of the medicines listed below:

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

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

Driving and using machines
DABIGATRAN ETEXILATE Olpha has no known effects on the ability to drive vehicles and operate machinery.

9. How to take DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years and over who are able to swallow the capsules whole. There are appropriate dosages and pharmaceutical forms for the treatment of children under 8 years of age.
Take this medicine following the doctor’s instructions exactly. If you have any doubts, consult your doctor.

Take DABIGATRAN ETEXILATO Olpha as recommended for the following conditions:
Prevention of blood vessel obstruction in the brain or the rest of the body due to the formation of blood clots that have developed as a result of an altered heartbeat and treatment of blood clots in the legs and lungs including the prevention of re-formation of blood clots in the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice a day.
If you are 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice a day.
If you are taking medicines containing verapamil, you must take a reduced dose of DABIGATRAN ETEXILATO Olpha of 220 mg taken as one 110 mg capsule twice a day, because the risk of bleeding may increase.
If you are potentially exposed to a higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice a day.
You can continue to take this medicine if your heartbeat needs to be restored to normal with a procedure called cardioversion or via a procedure called transcatheter ablation for atrial fibrillation. Take DABIGATRAN ETEXILATO Olpha according to the doctor’s instructions.
If you have had a medical device (stent) inserted into a blood vessel to keep it open as part of a procedure called percutaneous coronary intervention with stent, you can be treated with DABIGATRAN ETEXILATO Olpha after the doctor has determined that normal blood coagulation control has been achieved. Take DABIGATRAN ETEXILATO Olpha according to the doctor’s instructions.
Treatment of blood clots and prevention of the formation of new blood clots in children.

DABIGATRAN ETEXILATO Olpha must be taken twice a day, one dose in the morning and one in the evening, at approximately the same time each day. The administration interval should be as close as possible to 12 hours.
The recommended dose depends on age and weight. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. Continue to use all other medicines, unless your doctor tells you to stop taking any of them.
Table 1 shows the single and total daily doses of DABIGATRAN ETEXILATO Olpha in milligrams (mg). The doses depend on the weight in kilograms (kg) and the age in years of the patient.
Table 1: Dosage table for DABIGATRAN ETEXILATO Olpha

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 DABIGATRAN ETEXILATO Olpha
DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years and over who are able to swallow the capsules whole.
DABIGATRAN ETEXILATO Olpha can be taken with or without food. The capsule must be swallowed whole with a glass of water, to ensure release at the gastric level. Do not break, chew or remove the granules from the capsule as it may increase the risk of bleeding.

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

If you take more DABIGATRAN ETEXILATO Olpha than you should
Taking an excessive amount of this medicine increases the risk of bleeding. Seek immediate medical attention if you have taken an excessive number of capsules. Specific treatment options are available.

If you forget to take DABIGATRAN ETEXILATO Olpha
The missed dose can still be taken up to 6 hours before the next dose.
If less than 6 hours remain until 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 ETEXILATO Olpha
Take DABIGATRAN ETEXILATO Olpha exactly as prescribed. Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience stomach problems after taking DABIGATRAN ETEXILATO Olpha.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
DABIGATRAN ETEXILATO Olpha acts on the blood coagulation system, therefore most of the side effects are related to signs such as bruises or bleeding. Major or serious bleeding events may occur, which constitute the most serious side effects, and which, regardless of location, can be disabling, life-threatening or even lead to death. In some cases, these bleedings may not be evident.
If you experience any bleeding that does not resolve spontaneously or if you experience symptoms of excessive bleeding (exceptional weakness, feeling of fatigue, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to subject you to a thorough check-up or change the treatment.
Immediately inform your doctor if you experience a serious allergic reaction that causes difficulty breathing or dizziness.
Possible side effects are listed below, grouped by how often they occur.
Prevention of blockage of blood vessels in the brain or the rest of the body due to the formation of blood clots that have developed following an altered heartbeat
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red), or under the skin
• Reduction in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Diarrhea with soft or liquid stools
• Feeling unwell

Not common (may affect up to 1 in 100 people):

• Bleeding
• Bleeding that may occur from hemorrhoids, from the rectum or in the brain
• Bruising
• Coughing up blood or sputum stained with blood
• Reduction in the number of platelets in the blood
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juices into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal results of laboratory tests on liver function

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

• Bleeding that may occur in a joint, from a surgical incision, from a wound, from the injection site or from the site of catheter insertion into a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Reduction in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

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

In a clinical study, the percentage of heart attacks was numerically higher with DABIGATRAN
ETEXILATO Olpha than with warfarin. The overall incidence was low.
Treatment of blood clots in the veins of the legs and lungs, including prevention of the reformation of blood clots in the veins of the legs and/or lungs
Common (may affect up to 1 in 10 people):

• Bleeding that may occur from the nose, at the level of the stomach or intestines, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red) or under the skin
• Indigestion

Not common (may affect up to 1 in 100 people):

• Bleeding
• Bleeding that may occur in a joint or from a wound
• Bleeding that may occur from hemorrhoids
• Reduction in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum stained with blood
• Allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Itching
• Ulcer of the stomach or intestine
• Inflammation of the esophagus and stomach (including ulcer of the esophagus)
• Reflux of gastric juices into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Diarrhea with soft or liquid stools
• Abnormal results of laboratory tests on liver function
• Increased liver enzymes

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

• Bleeding that may occur from a surgical incision or from the injection site or from the site of catheter insertion into a vein or from the brain
• Reduction in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Difficulty swallowing

Not known (frequency cannot be estimated based on available data):

• Difficulty breathing or wheezing
• Reduction in the amount of hemoglobin present 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 to fight infections)
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood
• Hair loss

In the clinical study program, the percentage of heart attacks was higher with DABIGATRAN
ETEXILATO Olpha 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 the reformation 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
• Significant skin rash due to the presence of nodules, dark red, swollen, itchy caused by an allergic reaction
• Sudden change in the skin that modifies its color and appearance
• Bruising
• Nosebleeds
• Reflux of gastric juices into the esophagus
• Vomiting
• Feeling unwell
• Diarrhea with soft or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes Not common (may affect up to 1 in 100 people):
• Reduction in the number of white blood cells (which help to fight infections)
• Bleeding that may occur at the level of the stomach or intestines, from the brain, from the rectum, from penis/vagina or from the urinary tract (including the presence of blood in the urine which colors it pink or red) or under the skin
• Reduction in the amount of hemoglobin present in the blood (the substance contained in red blood cells)
• Reduction in the proportion of blood cells
• Itching
• Coughing up blood or sputum stained with blood
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or the white part of the eyes, caused by problems with the liver or blood

Not known (frequency cannot be estimated based on available data):

• Absence of white blood cells (which help to fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding that may occur in a joint or from a wound, from a surgical incision, from the injection site or from the site of catheter insertion into a vein
• Bleeding that may occur from hemorrhoids
• Ulcer of the stomach or intestine (including ulcer of the esophagus)
• Abnormal results of laboratory tests on liver function

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

11. How to store DABIGATRAN ETEXILATE Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp. The expiry
date refers to the last day of that month.
Aluminum – Aluminum Blister (OPA/Al/PVC//Al): Do not store at a temperature above 30 °C.
Aluminum blister with desiccant coating – Aluminum (OPA/Al/PE//PE/Al/LDPE): This medicine does not
require any particular storage conditions.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you no longer
use. This will help protect the environment.

12. Package Contents and Other Information

What DABIGATRAN ETEXILATE Olpha contains

• The active ingredient is dabigatran. Each capsule contains dabigatran etexilate mesylate equivalent to 150 mg of dabigatran etexilate.
• The other ingredients are
• capsule content: tartaric acid in granules, hypromellose, hydroxypropyl cellulose, talc
• Capsule shell: indigo carmine aluminum lake (E132), carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose

Description of the appearance of DABIGATRAN ETEXILATE Olpha and package contents
Capsules of approximately 22 mm with an opaque blue cap and opaque white body of size “0” filled with granules
ranging in color from off-white to yellowish.
The capsules are packaged in blisters made of Aluminum with desiccant coating–Aluminum
(OPA/Al/PE//PE/Al/LDPE) or Aluminum-Aluminum (OPA/Al/PVC//Al)
Pack sizes:
Blister containing: 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares, Guadalajara
19200, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Member StateName
Sweden Dabigatran Etexilate Olpha
Italy DABIGATRAN ETEXILATO Olpha