Dabigatran etexilate Medical Valley: detailed information

Package leaflet: Information for the patient

Dabigatran etexilate Medical Valley 75 mg hard capsules

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

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

Contents of this leaflet

What Dabigatran etexilate Medical Valley is and what it is used for
What you need to know before taking Dabigatran etexilate Medical Valley
How to take Dabigatran etexilate Medical Valley
Possible side effects
How to store Dabigatran etexilate Medical Valley
Contents of the pack and other information

1. What Dabigatran etexilato Medical Valley is and what it is used for

Dabigatran etexilato Medical Valley contains the active substance dabigatran etexilato and belongs to a group of medicines called anticoagulants. This medicine works by blocking a substance in the body that is involved in blood clot formation.
Dabigatran etexilato Medical Valley is used in adults for:

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

Dabigatran etexilato Medical Valley 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 Medical Valley

Do not take Dabigatran etexilate Medical Valley

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 a disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent brain or eye surgery).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is in place and
you are receiving heparin through it to keep it open, or when your heart rhythm is
being restored to normal through a procedure called trans-catheter ablation for atrial
fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
if you are taking oral cyclosporine, a medicine used to prevent organ transplant rejection episodes.
if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
if you are taking a combination product containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
if you have had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions
Talk to your doctor before taking Dabigatran etexilate Medical Valley. You may also need to
contact your doctor during treatment with Dabigatran etexilate Medical Valley 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, particularly any
of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical tissue removal (biopsy) within the previous month.
- if you have had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux disease (acid reflux).
- if you are taking medicines that may increase the risk of bleeding. See the section below “Other medicines and Dabigatran etexilate Medical Valley”.
- if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
- if you have a heart infection (bacterial endocarditis).
- if you know you have reduced kidney function or 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 when used 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 Medical Valley

if you are scheduled for surgery: In this case, you will need to temporarily stop taking Dabigatran etexilate Medical Valley due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilate Medical Valley 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 for pain relief):
- it is very important to take Dabigatran etexilate Medical Valley 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 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 high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilate Medical Valley
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 Medical Valley if you are taking any of the following medicines:

Medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
Medicines for fungal infections (e.g. ketoconazole, itraconazole), unless applied only topically to the skin
Medicines for irregular heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor will instruct you to use a reduced dose of Dabigatran etexilate Medical Valley depending on the condition for which it was prescribed. See 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 for depression
Antidepressants 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)
Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding
The effects of Dabigatran etexilate Medical Valley 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 while taking Dabigatran etexilate
Medical Valley.
You must not breastfeed while taking Dabigatran etexilate Medical Valley.

Driving and using machines
Dabigatran etexilate Medical Valley has no known effect on the ability to drive vehicles or operate
machinery.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other dosage strengths and dosage forms appropriate for age are available.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Medical Valley 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 should be treated with a reduced dose of this medicine of 75 mg, as your risk of bleeding may increase.
For both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, the dose should be started with 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Medical Valley 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 etexilate Medical Valley 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 etexilate Medical Valley 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 to stop any of them.
Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for dabigatran etexilate capsules

Weight/age combinations

Daily dose

Weight in kg	Age in years	Single dose in mg	Total 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 Medical Valley
Dabigatran etexilate Medical Valley can be used by adults and children aged 8 years or older who are able to swallow the capsule whole.
Dabigatran etexilate Medical Valley may be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or empty 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 Medical Valley than you should
Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules of Dabigatran etexilate Medical Valley. Specific treatment options are available.

If you forget to take Dabigatran etexilate Medical Valley
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Medical Valley 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 of blood clots in children
A missed dose may still be taken up to 6 hours before the next scheduled dose.
The missed dose should be skipped if less than 6 hours remain until the next dose.
Do not double the dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Medical Valley
Take Dabigatran etexilate Medical Valley 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 indigestion after taking Dabigatran etexilate Medical Valley.

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 Medical Valley acts on the blood coagulation system; therefore, most side effects are related to signs such as bruising or bleeding. Major or severe bleeding events may occur, which represent the most serious side effects and, regardless of location, can be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not resolve spontaneously, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you more closely or change your medicine.
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 how likely they are to occur.

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

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

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

Bleeding that may occur from the nose, stomach or intestine, penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, rectum, under the skin, in a joint, from a wound or after a wound, following surgery
Formation of haematoma or bruising occurring after a procedure
Presence of blood in faeces, detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with loose or watery stools
Feeling unwell
Wound discharge (leakage of fluid from the surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by 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 venous catheter insertion site
Blood-stained discharge from the venous catheter insertion site
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells in the blood after surgery
Severe allergic reaction causing difficulty in breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Prominent skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Ulcer in the stomach or intestine (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Stomach or abdominal 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 or even complete absence of white blood cells (which help fight infections)
Hair loss

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Prominent skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Haematoma formation
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
Stomach or abdominal pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from 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 venous catheter insertion site
Bleeding from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal liver function laboratory test results

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

5. How to store Dabigatran etexilate Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or on the label of the bottle after "Exp". The expiry date refers to the last day of that month.
Aluminium-Aluminium blister (OPA/Al/PVC-Al): Do not store above 30°C.
Aluminium blister with desiccant coating – Aluminium (OPA/Al/PE-PE/Al/LDPE): This medicine does not require any special storage conditions.
Bottle: Store in the original packaging to protect the medicine from moisture.
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 Medical Valley contains

The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate mesilate equivalent to 75 mg of dabigatran etexilate.

The other components are:

Capsule contents: tartaric acid in granules, hypromellose, hydroxypropylcellulose and talc.
Capsule shell: carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose.

Description of the appearance of Dabigatran etexilate Medical Valley and package contents

Capsules approximately 18.0 mm long, with an opaque white cap and an opaque white body marked with the size '2', filled with granules ranging in colour from whitish to yellowish.
The capsules are packaged in blisters made of aluminium with a desiccant coating - aluminium (OPA/Al/PE-PE/Al/LDPE) and aluminium - aluminium (OPA/Al/PVC-Al), or in a white plastic bottle with a silica gel desiccant container in the cap (PP).

Pack sizes:
Blister packs containing: 10, 10x1 (blister divisible for single dose), 30, 30x1 (blister divisible for single dose), 60, 60x1 (blister divisible for single dose), 100 or 180 hard capsules.
Bottle containing: 60 or 100 hard capsules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28,
23632 Höllviken
Sweden

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara),
Spain

Patient information leaflet

Dabigatran etexilate Medical Valley 110 mg hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could 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 Medical Valley is and what it is used for
What you need to know before taking Dabigatran etexilate Medical Valley
How to take Dabigatran etexilate Medical Valley
Possible side effects
How to store Dabigatran etexilate Medical Valley
Contents of the pack and other information

1. What Dabigatran etexilato Medical Valley is and what it is used for

preventing the formation of blood clots in the veins following knee or hip replacement surgery.
preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs, and preventing the formation of new blood clots in the veins of the legs and lungs.

Dabigatran etexilato Medical Valley 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 Medical Valley

Do not take Dabigatran etexilato Medical Valley

if you are allergic to dabigatran etexilato 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 a disease in an organ of the body that increases the risk of serious 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 to another, when a venous or arterial catheter is in place and you are receiving heparin through it to keep it open, or when your heart rhythm is being restored to normal via a procedure called trans-catheter ablation for atrial fibrillation.
if you have severely reduced liver function or a liver disease that could potentially be life-threatening.
if you are taking oral ketoconazole or 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 etexilato Medical Valley. 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, particularly any of the following:

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical tissue removal (biopsy) within the past month.
- if you have sustained a serious injury (e.g., bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the esophagus or stomach.
- if you have gastroesophageal reflux disease (acid reflux into the esophagus).
- if you are taking medicines that may increase the risk of bleeding. See the section below “Other medicines and Dabigatran etexilato Medical Valley”.
- if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or 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 when used 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 Medical Valley

if you are scheduled for surgery: In this case, you will need to temporarily stop taking Dabigatran etexilato Medical Valley due to the increased risk of bleeding during and shortly after the procedure. It is very important to take Dabigatran etexilato Medical Valley 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 etexilato Medical Valley 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 bowel or bladder problems 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 high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

Other medicines and Dabigatran etexilato Medical Valley
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 etexilato Medical Valley 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 topically to the skin
Medicines to treat irregular heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilato Medical Valley depending on your condition. See 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 for depression
Antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
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 Medical Valley on pregnancy and the unborn baby 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 becoming pregnant while taking Dabigatran etexilato Medical Valley.
You must not breastfeed while taking Dabigatran etexilato Medical Valley.

Driving and using machines
Dabigatran etexilato Medical Valley has no known effects on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole. For the treatment of children under 8 years of age, other dosage strengths and dosage forms appropriate for age are available.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Medical Valley 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 be treated with a reduced dose of Dabigatran etexilate Medical Valley of 75 mg, because your risk of bleeding may increase.
For both surgeries, treatment must not be started if there is active bleeding at the surgical site. If treatment cannot be started until the day after surgery, the dose should be initiated with 2 capsules once daily.
After knee replacement surgery
You should start treatment with Dabigatran etexilate Medical Valley within 1–4 hours after completion of the 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 etexilate Medical Valley within 1–4 hours after completion of the surgery, taking one single capsule. Afterwards, take two capsules once daily for a total of 28–35 days.
Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you should be treated with a reduced dose of Dabigatran etexilate Medical Valley of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased.
If you have a potentially 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. Take Dabigatran etexilate Medical Valley exactly as your doctor has instructed.
If you have had a medical device (stent) inserted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Medical Valley after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Medical Valley exactly as your doctor has instructed.
Treatment of blood clots and prevention of new blood clots in children
Dabigatran etexilate Medical Valley 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 to stop any of them.
Table 1 shows the individual and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for dabigatran etexilate capsules

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 Medical Valley
Dabigatran etexilate Medical Valley can be used by adults and children aged 8 years or older who are able to swallow the capsule whole.
Dabigatran etexilate Medical Valley may be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release into the stomach. Do not break, chew, or empty 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 forget to take Dabigatran etexilate Medical Valley
Prevention of blood clots after knee or hip replacement surgery
Continue with the remaining daily doses of Dabigatran etexilate Medical Valley 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 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 such clots.
Use in children: treatment of blood clots and prevention of recurrence of blood clots.

A missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the dose to make up for a 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 everyone will experience them.
Dabigatran etexilato Medical Valley 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 their location, may be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you develop signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to monitor you more closely or change your medication.
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 their likelihood of occurrence.

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

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

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

Bleeding that may occur from the nose, stomach, or intestine, from penis/vagina or urinary tract (including blood in urine turning it pink or red), from haemorrhoids, from the rectum, under the skin, into a joint, from a wound or after a surgical procedure
Formation of haematoma or bruising occurring after surgery
Presence of blood in the faeces, detected by laboratory testing
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Diarrhoea with unformed or liquid stools
Feeling unwell
Wound discharge (fluid leakage 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 venous catheter insertion site
Blood-stained discharge from the venous catheter insertion site
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the number of red blood cells 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 nodules due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Gastro-oesophageal reflux
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):

Breathing difficulties or wheezing
Decrease in, or even absence of, white blood cells (which help fight infections)
Hair loss

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

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

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Formation of haematoma
Coughing up blood or blood-stained sputum
Decrease in the number of platelets in the blood
Decrease in the amount of haemoglobin in the blood (the substance contained in red blood cells)
Allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Gastro-oesophageal reflux
Vomiting
Difficulty swallowing
Abnormal results in laboratory tests assessing 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 venous catheter insertion site
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Decrease in the proportion of blood cells
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Breathing difficulties or wheezing
Decrease in, or even absence of, white blood cells (which help fight infections)
Hair loss

In a clinical study, the rate of heart attacks with Dabigatran etexilato Medical Valley was higher than with warfarin. The overall incidence was low.

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

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

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Formation of haematoma
Coughing up blood or blood-stained sputum
Allergic reaction
Sudden change in the skin altering its colour and appearance
Itching
Stomach or intestinal ulcer (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Gastro-oesophageal reflux
Feeling unwell
Vomiting
Abdominal or stomach pain
Diarrhoea with unformed or liquid stools
Abnormal results in laboratory tests assessing 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, venous catheter insertion site, or brain
Decrease in the number of platelets in the blood
Severe allergic reaction causing difficulty breathing or dizziness
Severe allergic reaction causing swelling of the face or throat
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Difficulty swallowing

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

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

In the clinical study programme, the rate of heart attacks with Dabigatran etexilato Medical Valley was higher 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 of blood clots and prevention of new blood clots in children
Common (may affect up to 1 in 10 people):

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy nodules due to an allergic reaction
Sudden change in the skin altering its colour and appearance
Formation of haematoma
Nosebleeds
Gastro-oesophageal reflux
Vomiting
Feeling unwell
Diarrhoea with unformed or liquid stools
Indigestion
Hair loss
Increased liver enzymes

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

Decrease in the number of white blood cells (which help fight infections)
Bleeding 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 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
Breathing difficulties or wheezing
Bleeding
Bleeding that may occur in a joint or from a wound, surgical incision, injection site, or venous catheter insertion site
Bleeding that may occur from haemorrhoids
Stomach or intestinal ulcer (including oesophageal ulcer)
Abnormal results in laboratory tests assessing liver function

5. How to store Dabigatran etexilate Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle label 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.
Bottle: Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Package contents and other information

What Dabigatran etexilate Medical Valley contains

The active substance is dabigatran etexilate. 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 and talc.
Capsule shell: indigo carmine aluminium lake (E132), carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose.

Description of the appearance of Dabigatran etexilate Medical Valley and package contents
Capsules approximately 19 mm in size, with an opaque blue cap and an opaque blue body marked '1', filled with whitish to yellowish granules.
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 blister), or in a white plastic bottle with a silica gel desiccant container in the cap (PP).
Pack sizes:
Blister packs containing: 10, 10x1 (blister divisible for single dose), 30, 30x1 (blister divisible for single dose), 60, 60x1 (blister divisible for single dose), 100 or 180 hard capsules.
Bottle containing: 60 or 100 hard capsules.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28,
23632 Höllviken
Sweden

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

Patient information leaflet

Dabigatran etexilate Medical Valley 150 mg hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are 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 Medical Valley is and what it is used for
What you need to know before taking Dabigatran etexilate Medical Valley
How to take Dabigatran etexilate Medical Valley
Possible side effects
How to store Dabigatran etexilate Medical Valley
Contents of the pack and other information

1. What Dabigatran etexilato Medical Valley is and what it is used for

preventing blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
treating blood clots in the veins of the legs and lungs and preventing the formation of new blood clots in the veins of the legs and lungs.

Dabigatran etexilato Medical Valley 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 Medical Valley

Do not take Dabigatran etexilato Medical Valley

if you are allergic to dabigatran etexilato 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 a disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, lesions or bleeding in the brain, recent surgery on the brain or eyes).
if you have an increased tendency to bleed. This may be congenital, of unknown cause, or due to other medicines.
if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, when a venous or arterial catheter is placed and heparin is administered through it to keep it open, or when your heart rhythm 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 lead to death.
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 permanent anticoagulant therapy.

if you have an increased risk of bleeding, such as:
- if you have recently experienced bleeding.
- if you have undergone surgical removal of tissue (biopsy) within the previous month.
- if you have had a serious injury (e.g. bone fracture, head injury, or any injury requiring surgery).
- if you suffer from inflammation of the oesophagus or stomach.
- if you have gastroesophageal reflux disease (acid reflux into the oesophagus).
- if you are taking medicines that may increase the risk of bleeding. See the section below “Other medicines and Dabigatran etexilato Medical Valley”.
- if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, piroxicam.
- if you have an infection of the heart (bacterial endocarditis).
- if you know you have reduced kidney function or 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 when used 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 Medical Valley

if you are scheduled for surgery: In this case, Dabigatran etexilato Medical Valley 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 Medical Valley 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 etexilato Medical Valley exactly at the times instructed by your doctor, both before and after the procedure.
- inform your doctor immediately if you experience numbness or weakness in the legs, or bowel or bladder problems after 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 high risk of bleeding.
if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is needed.

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 heart rhythm (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing verapamil, your doctor may advise you to use a lower dose of Dabigatran etexilato Medical Valley depending on the condition for which it has been prescribed. See 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 for depression
Antidepressants called selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
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 Medical Valley on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor specifically tells you it is safe to do so.
If you are a woman of childbearing age, you must avoid becoming pregnant while taking Dabigatran etexilato Medical Valley.
You must not breastfeed while taking Dabigatran etexilato Medical Valley.

Driving and using machines
Dabigatran etexilato Medical Valley has no known effect on the ability to drive vehicles or operate machinery.

3. How to take Dabigatran etexilate Medical Valley

Dabigatran etexilate Medical Valley capsules can be used in adults and children aged 8 years and older who are able to swallow capsules whole. For the treatment of children under 8 years of age, other dosage strengths and dosage forms appropriate for age are available.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take Dabigatran etexilate Medical Valley as recommended for the following conditions:
Prevention of blood vessel blockage in the brain or elsewhere in the body due to formation of blood clots resulting from irregular heartbeat, and treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of such clots
The recommended dose is 300 mg taken as one 150 mg capsule twice daily.
If you are 80 years of age or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
If you are taking medicines containing verapamil, you should be treated with a reduced dose of Dabigatran etexilate Medical Valley of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may be increased.
If you have a potentially 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 or through a procedure called catheter ablation for atrial fibrillation. Take Dabigatran etexilate Medical Valley exactly as your doctor has instructed.
If you have had a medical device (stent) implanted into a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stenting, you may be treated with Dabigatran etexilate Medical Valley after your doctor has determined that normal blood clotting control has been achieved. Take Dabigatran etexilate Medical Valley exactly as your doctor has instructed.
Treatment of blood clots and prevention of new blood clots in children
Dabigatran etexilate Medical Valley 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 to stop any of them.
Table 1 shows the individual and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Dosing table for dabigatran etexilate capsules

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 Medical Valley
Dabigatran etexilate Medical Valley can be used by adults and children aged 8 years or older who are able to swallow the capsule whole.
Dabigatran etexilate Medical Valley may be taken with or without food. The capsule must be swallowed whole with a glass of water to ensure release into the stomach. Do not break, chew or empty 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 forget to take Dabigatran etexilate Medical Valley
A missed dose may still be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next dose, the missed dose should be skipped. Do not double the next 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 everyone will experience them.
Dabigatran etexilate Medical Valley 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 are the most serious side effects, and which, regardless of location, can be disabling, life-threatening, or even fatal. In some cases, these bleedings may not be obvious.
If you experience any bleeding that does not stop spontaneously, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you more closely or change your medication.
Contact your doctor immediately if you experience a severe allergic reaction causing difficulty in breathing or dizziness.
The possible side effects are listed below, grouped according to the likelihood of occurrence.

Prevention of blockage of blood vessels in the brain or elsewhere in the body due to blood clots forming as a result of irregular heartbeat

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

Bleeding 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
Diarrhoea with loose or liquid stools
Feeling unwell

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

Bleeding
Bleeding that may occur from haemorrhoids, rectum, or brain
Formation of haematoma
Coughing up blood or sputum stained with 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 change in skin colour and appearance
Itching
Ulcer in the stomach or intestine (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Vomiting
Difficulty swallowing
Abnormal results in liver function laboratory tests

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

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

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

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

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

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

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

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

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

Bleeding
Bleeding that may occur in a joint or from a wound
Bleeding that may occur from haemorrhoids
Decrease in the number of red blood cells in the blood
Formation of haematoma
Coughing up blood or sputum stained with blood
Allergic reaction
Sudden change in skin colour and appearance
Itching
Ulcer in the stomach or intestine (including oesophageal ulcer)
Inflammation of the oesophagus and stomach
Reflux of gastric juices into the oesophagus
Feeling unwell
Vomiting
Stomach or abdominal pain
Diarrhoea with loose or liquid stools
Abnormal results in liver function laboratory tests
Increase in liver enzymes

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

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

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

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

In the clinical study programme, the rate of heart attacks with Dabigatran etexilate Medical Valley was higher 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 patients treated with placebo.

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

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

Decrease in the number of red blood cells in the blood
Decrease in the number of platelets in the blood
Pronounced skin rash with red, raised, itchy lumps due to an allergic reaction
Sudden change in skin colour and appearance
Formation of haematoma
Nosebleed
Reflux of gastric juices into the oesophagus
Vomiting
Feeling unwell
Diarrhoea with loose or liquid stools
Indigestion
Hair loss
Increase in 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 sputum stained with blood
Stomach or abdominal pain
Inflammation of the oesophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Absence of white blood cells (which help fight infections)
Severe allergic reaction causing difficulty 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
Ulcer in the stomach or intestine (including oesophageal ulcer)
Abnormal results in liver function laboratory tests

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

5. How to store Dabigatran etexilate Medical Valley

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, the blister pack, or
the label of the bottle after Exp.
The expiry date refers to the last day of that month.
Aluminium – Aluminium blister (OPA/Al/PVC-Al): Do not store above 30°C.
Aluminium blister with desiccant coating – Aluminium (OPA/Al/PE-PE/Al/LDPE): This medicine
does not require any special storage conditions.
Bottle: Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Dabigatran etexilate Medical Valley contains

The active substance is dabigatran etexilate. 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 and talc.
Capsule shell: indigo carmine aluminium lake (E132), carrageenan, potassium chloride, titanium dioxide (E171) and hypromellose.

Description of the appearance of Dabigatran etexilate Medical Valley and pack contents
Capsules approximately 22 mm long, with a blue opaque cap and a white opaque body of size '0', filled with granules ranging in colour from whitish to yellowish.
The capsules are packed in blisters made of aluminium with a desiccant coating - aluminium (OPA/Al/PE-PE/Al/LDPE) and aluminium - aluminium (OPA/Al/PVC-Al), or in a white plastic bottle with a silica gel desiccant container in the cap (PP).

Pack sizes
Blister packs containing: 10, 30, 30x1 (blister packs divisible for single dose), 60, 60x1 (blister packs divisible for single dose), 100 or 180 hard capsules.
Bottle containing: 60 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28,
23632 Höllviken
Sweden

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain