Dabigatran etexilate Olpha: detailed information

Patient Information Leaflet

DABIGATRAN ETEXILATE Olpha 75 mg hard capsules

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

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

Contents of this leaflet

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

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

DABIGATRAN ETEXILATO Olpha 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 Olpha 75 mg hard capsules is used in adults for:

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

DABIGATRAN ETEXILATO Olpha 75 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 ETEXILATO Olpha

Do not take DABIGATRAN ETEXILATO 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 reduced.
if you are currently experiencing bleeding.
if you have lesions in an organ that increase the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent 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 heparin is administered through it to keep it open, or when your heartbeat 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 itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking DABIGATRAN ETEXILATO Olpha. You may also need to
contact your doctor during treatment with DABIGATRAN ETEXILATO Olpha if you develop symptoms or if
you need to undergo surgery.
Inform your doctor if you have or have had any medical condition or illness, especially any of the
following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone 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 (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DABIGATRAN ETEXILATO Olpha” below.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know that your kidney function is reduced or if you suffer from dehydration (symptoms include feeling thirsty and reduced urination of dark (concentrated) foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase the risk of having a heart attack.
if you suffer from liver disease associated with abnormal blood test results. In this case, use of this medicine is not recommended.

Take special care with DABIGATRAN ETEXILATO Olpha

if you are scheduled for surgery: In this case, DABIGATRAN ETEXILATO Olpha 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 ETEXILATO Olpha exactly at the time instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or an injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take DABIGATRAN ETEXILATO Olpha exactly at the time instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after the anaesthesia wears off, as urgent medical treatment may be required.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as 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), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and DABIGATRAN ETEXILATO Olpha
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine. In particular, you must inform your doctor before taking DABIGATRAN
ETEXILATO Olpha 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 to treat fungal infections (e.g. ketoconazole, itraconazole), unless applied only to the skin
Medicines to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of DABIGATRAN ETEXILATO Olpha, depending on the condition for which it has been prescribed. See also section 3
Medicines to prevent transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of DABIGATRAN ETEXILATO Olpha 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 ETEXILATO
Olpha.
You must not breastfeed during treatment with DABIGATRAN ETEXILATO Olpha.
Driving and using machines
DABIGATRAN ETEXILATO Olpha has no known effects on the ability to drive vehicles or operate machinery.

3. How to take DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years and older who are able to swallow capsules whole. Appropriate dosage forms and strengths are available for treatment in children under 8 years of age.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take DABIGATRAN ETEXILATO Olpha 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 75 mg of this medicine, as the risk of bleeding may increase.
For both surgeries, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, administration should begin with a dose of 2 capsules once daily.
After knee replacement surgery
You should start treatment with DABIGATRAN ETEXILATO Olpha within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 10 days.
After hip replacement surgery
You should start treatment with DABIGATRAN ETEXILATO Olpha within 1–4 hours after completion of surgery, taking a single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Treatment of blood clots and prevention of new blood clots in children.
DABIGATRAN ETEXILATO Olpha 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 age and body weight. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you otherwise.
Table 1 shows the single and total daily doses of DABIGATRAN ETEXILATO Olpha in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for DABIGATRAN ETEXILATO Olpha

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

Single doses requiring combinations of more than one capsule:
300 mg: two 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 older who are able to swallow capsules whole.
DABIGATRAN ETEXILATE Olpha may be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure gastric release. Do not break, chew, or remove granules from the capsule, as this may increase the risk of bleeding.

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

If you take more DABIGATRAN ETEXILATE Olpha 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 DABIGATRAN ETEXILATE Olpha capsules. Specific treatment options are available.

If you forget to take DABIGATRAN ETEXILATE Olpha
Prevention of blood clots after knee or hip replacement surgery:
Continue with the remaining daily doses of DABIGATRAN ETEXILATE Olpha at your usual time the next day.
Do not take a double dose to make up for a 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 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, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your doctor if you experience stomach problems after taking DABIGATRAN ETEXILATE Olpha.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
DABIGATRAN ETEXILATE Olpha 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, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you 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 the frequency with which they occur.

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

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

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 following a wound or after surgery
Formation of a haematoma or haematoma occurring after surgery
Presence of blood in the stool, detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or watery stools
Feeling unwell
Discharge from the wound (exudation of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by problems with the liver or blood

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

Bleeding
Bleeding that may occur in the brain, from a surgical incision, injection site, or catheter insertion site in a vein
Blood-stained discharge from the catheter insertion site in a vein
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells 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 dark red, swollen, itchy lumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Abdominal or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

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

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

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with dark red, swollen, itchy lumps due to an allergic reaction
Sudden skin changes altering its colour and appearance
Formation of a haematoma
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or watery stools
Indigestion
Hair loss
Increased liver enzymes

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

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

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty 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 laboratory test results for liver function

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 Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Aluminium – Aluminium blisters (OPA/Al/PVC//Al): Do not store above 30 °C.
Aluminium blisters with desiccant coating – Aluminium (OPA/Al/PE//PE/Al/LDPE): This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. 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 Olpha contains

The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate methanesulfonate equivalent to 75 mg of dabigatran etexilate.
The other components are
- capsule contents: 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 package contents
Capsules approximately 18.0 mm long, with an opaque white cap and an opaque white body, size “2”, filled with granules ranging in colour from off-white to yellowish.
The capsules are packaged in blisters made of desiccant-coated aluminium–aluminium (OPA/Al/PE//PE/Al/LDPE) or aluminium–aluminium (OPA/Al/PVC//Al).
Pack sizes:
Blisters containing 10 or 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 European Economic Area countries under the following names:

| Member State | Name | |--------------|------| | Sweden | Dabigatran Etexilate Olpha | | Italy | DABIGATRAN ETEXILATO Olpha |

Patient information leaflet

DABIGATRAN ETEXILATE Olpha 110 mg hard capsules

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

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

Contents of this leaflet

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

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

DABIGATRAN ETEXILATO Olpha 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 Olpha 110 mg hard capsules is used in adults for:

preventing the formation of blood clots in the veins following hip or knee replacement surgery.
preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of 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 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 reduced.
if you have active 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 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 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 before taking DABIGATRAN ETEXILATE Olpha. You may also need to consult your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, especially 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 suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See section “Other medicines and DABIGATRAN ETEXILATE Olpha” 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, foamy urine).
- if you are over 75 years old.
- if you are an adult weighing 50 kg or less.
- only for use in children: if the child has an infection around or within the brain.
if you have had a heart attack or if you have been diagnosed with conditions that increase your risk of having a heart attack.
if you 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 Olpha

if you are scheduled for 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 procedure. It is very important to take
DABIGATRAN ETEXILATE Olpha exactly at the times instructed by your doctor, both before and after the surgery.
if a procedure involves placement of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take DABIGATRAN ETEXILATE Olpha 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 the bladder or intestines after the anaesthesia wears off, as urgent treatment may be needed.
if you fall or injure yourself during treatment, especially if you receive a blow to the head. Call your doctor immediately. Your doctor may consider it necessary to examine you, as you may be at increased risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and 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 inform your doctor before taking DABIGATRAN ETEXILATE Olpha if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for treating fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically 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 reduced dose of DABIGATRAN ETEXILATE Olpha depending on the condition for which it has been prescribed. See also section 3
Medicines to prevent organ transplant rejection (e.g. tacrolimus, cyclosporine)
The combination of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
St. John’s wort, a herbal medicine used to treat depression
Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors
Rifampicin or clarithromycin (two antibiotics)
Antiviral medicines for acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of DABIGATRAN ETEXILATE Olpha 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 Olpha.
You must not breastfeed while taking DABIGATRAN ETEXILATE Olpha.

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

3. How to take DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. Appropriate dosages and pharmaceutical forms are available for treatment in children under 8 years of age.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Take DABIGATRAN ETEXILATO Olpha 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 ETEXILATO Olpha of 75 mg, because the risk of bleeding may increase.

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

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

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

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots formed as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of 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 ETEXILATO Olpha of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at increased risk of bleeding, your doctor may decide to prescribe a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if your heart rhythm needs to be restored to normal through a procedure called cardioversion. Take DABIGATRAN ETEXILATO Olpha 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 ETEXILATO Olpha once your doctor has determined that normal control of blood coagulation has been achieved. Take DABIGATRAN ETEXILATO Olpha as directed by your doctor.

Treatment of blood clots and prevention of new blood clots in children
DABIGATRAN ETEXILATO Olpha 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 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.

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

Table 1: Dosing table for DABIGATRAN ETEXILATO Olpha

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

How to take DABIGATRAN ETEXILATE Olpha
DABIGATRAN ETEXILATE Olpha can be used in adults and children aged 8 years and older who are able to swallow the capsules whole.
DABIGATRAN ETEXILATE Olpha 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 treatment
Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more DABIGATRAN ETEXILATE Olpha than you should
Overdosing on 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 Olpha
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of DABIGATRAN ETEXILATE Olpha at the usual time the next day.
Do not take a double dose to make up for the missed dose.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
DABIGATRAN ETEXILATE Olpha acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of 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 breathing or dizziness.
The possible side effects are listed below, grouped according to frequency.

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

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

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

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

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

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

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

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

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots caused by irregular heartbeat
Common (may affect up to 1 in 10 people):

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

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Formation of a haematoma
Coughing up blood or sputum containing blood
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin alteration changing its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal laboratory test results regarding liver function

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 site of insertion of a venous catheter
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

In one clinical study, the rate of heart attacks was numerically higher with DABIGATRAN ETEXILATE Olpha than with warfarin. The overall incidence was low.

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

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

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

Bleeding that may occur from a surgical incision, injection site, site of insertion of a venous catheter, or in the brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty 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
Difficulty swallowing

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

Difficulty breathing or wheezing
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Decrease in the number or even absence of white blood cells (which help fight infections)
Yellowing of the skin or 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 Olpha than with warfarin. The overall incidence was low. No imbalance in the incidence of heart attacks was observed in patients treated with dabigatran compared to those treated with placebo.

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

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

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding that may occur in the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or sputum containing blood
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 breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or site of insertion of a venous catheter
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal laboratory test results regarding liver function

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 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 carton and on the blister after Exp. The expiry date refers to the last day of that month.
Aluminium-Aluminium blisters (OPA/Al/PVC//Al): Do not store above 30 °C.
Aluminium blisters with desiccant coating - Aluminium (OPA/Al/PE//PE/Al/LDPE): This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DABIGATRAN ETEXILATE Olpha contains

The active substance is dabigatran. Each capsule contains dabigatran etexilate mesilate equivalent to 110 mg of dabigatran etexilate.
The other components are:
capsule contents: 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 ETEXILATE Olpha and package contents
Capsules approximately 19 mm long, with an opaque blue cap and an opaque blue body, size "1", filled with off-white to yellowish granules.
The capsules are packaged in blisters made of aluminum with a desiccant coating–aluminum (OPA/Al/PE//PE/Al/LDPE) or aluminum–aluminum (OPA/Al/PVC//Al).
Pack sizes
Blisters containing: 10, 30, 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:

Member State Name
Sweden Dabigatran Etexilate Olpha
Italy DABIGATRAN ETEXILATE Olpha

Patient information leaflet

DABIGATRAN ETEXILATE Olpha 150 mg hard capsules

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

Contents of this leaflet

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

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

DABIGATRAN ETEXILATO Olpha 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.
DABIGATATRAN ETEXILATO 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 new blood clots from forming in the veins of the legs and lungs. DABIGATRAN ETEXILATO Olpha 150 mg hard capsules is used in children for:
treating blood clots and preventing the formation of new blood clots.

8. What you should 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 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 heartbeat 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 an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking DABIGATRAN ETEXILATE Olpha. You may also need to contact your doctor during treatment with this medicine if you develop symptoms or if you are scheduled for surgery.
Tell your doctor if you have or have had any medical condition or illness, 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 gastroesophageal 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 Olpha” 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 are dehydrated (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 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 Olpha

if you are scheduled for 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 procedure. It is very important to take DABIGATRAN ETEXILATE Olpha exactly at the times instructed by your doctor, both before and after surgery.
if a procedure involves placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anaesthesia or pain relief):
- it is very important to take DABIGATRAN ETEXILATE Olpha exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowels or bladder after the anaesthesia wears off, as urgent medical attention 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 consider it necessary to examine you, as 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), inform your doctor, who will decide whether a change in therapy is needed.

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

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

9. How to take DABIGATRAN ETEXILATO Olpha

DABIGATRAN ETEXILATO Olpha can be used in adults and children aged 8 years and older who are able to swallow capsules whole. Appropriate dosages and pharmaceutical forms are available for treatment in children under 8 years of age.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take DABIGATRAN ETEXILATO Olpha as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs.
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you must take a reduced dose of DABIGATRAN ETEXILATO Olpha of 220 mg taken as one 110 mg capsule twice daily, because the risk of bleeding may increase.
If you are potentially at increased risk of bleeding, your doctor may decide to prescribe you a dose of 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 procedure called trans-catheter ablation for atrial fibrillation. Take DABIGATRAN ETEXILATO Olpha 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 ETEXILATO Olpha after your doctor has determined that normal control of blood coagulation has been achieved. Take DABIGATRAN ETEXILATO Olpha as directed by your doctor.
Treatment of blood clots and prevention of new blood clots in children.
DABIGATRAN ETEXILATO Olpha 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 age and body weight. Your doctor will determine the correct dose for you. Your doctor may adjust the dose during treatment. Continue taking all other medicines unless your doctor tells you to stop any of them.
Table 1 shows the individual and total daily doses of DABIGATRAN ETEXILATO Olpha in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosage table for DABIGATRAN ETEXILATO Olpha

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

How to take DABIGATRAN ETEXILATE Olpha
DABIGATRAN ETEXILATE Olpha can be used in adults and children aged 8 years and older who are able to swallow capsules whole.
DABIGATRAN ETEXILATE Olpha 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 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 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 Olpha
A missed dose may still be taken if there is at least 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not take a double dose to make up for the missed dose.

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

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
DABIGATRAN ETEXILATE Olpha acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or serious bleeding events may occur, which represent the most serious side effects and, regardless of location, may be disabling, life-threatening, or even fatal. In some cases, such bleeding may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop symptoms of excessive bleeding (unusual weakness, feeling of fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to perform a thorough check-up or change your treatment.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.
The possible side effects are listed below, grouped according to frequency.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to 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
Decrease in the number of red blood cells in the blood
Stomach or abdominal pain
Indigestion
Diarrhea with loose or watery stools
Feeling unwell

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

Bleeding
Bleeding that may occur from hemorrhoids, rectum, or brain
Formation of hematoma
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden skin changes affecting color and appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Gastric acid reflux into the esophagus
Vomiting
Difficulty swallowing
Abnormal laboratory test results indicating liver function problems

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

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

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

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

In a clinical study, the rate of heart attacks was numerically higher with DABIGATRAN ETEXILATE Olpha than with warfarin. The overall incidence was low.

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

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

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from hemorrhoids
Decrease in the number of red blood cells in the blood
Formation of hematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden skin changes affecting color and appearance
Itching
Stomach or intestinal ulcer
Inflammation of the esophagus and stomach (including esophageal ulcer)
Gastric acid reflux into the esophagus
Feeling unwell
Vomiting
Stomach or abdominal pain
Diarrhea with loose or watery stools
Abnormal laboratory test results indicating liver function problems
Increased liver enzymes

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

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

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

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

In the clinical study program, the rate of heart attacks was higher with DABIGATRAN ETEXILATE 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 recurrence of blood clots in children
Common (may affect up to 1 in 10 people):

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with itchy, swollen, dark red lumps due to an allergic reaction
Sudden skin changes affecting color and appearance
Formation of hematoma
Nosebleeds
Gastric acid reflux into the esophagus
Vomiting
Feeling unwell
Diarrhea 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, urinary tract (including blood in urine turning it pink or red), or under the skin
Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
Decrease in the proportion of blood cells
Itching
Coughing up blood or blood-stained sputum
Stomach or abdominal pain
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Difficulty breathing or wheezing
Bleeding
Bleeding 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 hemorrhoids
Stomach or intestinal ulcer (including esophageal ulcer)
Abnormal laboratory test results indicating liver function problems

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 carton and on the blister after Exp. The
expiry date refers to the last day of that month.
Aluminium – Aluminium blisters (OPA/Al/PVC//Al): Do not store above 30 °C.
Aluminium blisters with desiccant coating – Aluminium (OPA/Al/PE//PE/Al/LDPE): This medicine does not
require any special storage conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What DABIGATRAN ETEXILATO Olpha contains

The active substance is dabigatran. Each capsule contains dabigatran etexilate mesilate equivalent to 150 mg of dabigatran etexilate.
The other components are:
- Capsule contents: tartaric acid in granules, hypromellose, hydroxypropylcellulose, talc
- Capsule shell: indigo carmine aluminium lake (E132), carrageenan, potassium chloride, titanium dioxide (E171), hypromellose

Description of the appearance of DABIGATRAN ETEXILATO Olpha and package contents
Approximately 22 mm capsules with an opaque blue cap and an opaque white body of size "0", filled with off-white to yellowish granules.
The capsules are packaged in blisters made of desiccant-coated aluminium–aluminium (OPA/Al/PE//PE/Al/LDPE) or aluminium–aluminium (OPA/Al/PVC//Al).
Pack sizes:
Blisters 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 European Economic Area countries under the following names:
Member State Name
Sweden Dabigatran Etexilate Olpha
Italy DABIGATRAN ETEXILATO Olpha