Dabigatran Etexilate Laboratorios Liconsa

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Laboratorios Liconsa, 110 mg, hard capsules

dabigatran etexilate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dabigatran Etexilate Laboratorios Liconsa and what is it used for
• 2. Important information before taking Dabigatran Etexilate Laboratorios Liconsa
• 3. How to take Dabigatran Etexilate Laboratorios Liconsa
• 4. Possible side effects
• 5. How to store Dabigatran Etexilate Laboratorios Liconsa
• 6. Contents of the packaging and other information

1. What is Dabigatran Etexilate Laboratorios Liconsa and what is it used for

Dabigatran Etexilate Laboratorios Liconsa contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action involves blocking a substance in the body responsible for the formation of blood clots.

Dabigatran Etexilate Laboratorios Liconsa is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Laboratorios Liconsa is used in children to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Dabigatran Etexilate Laboratorios Liconsa

When not to take Dabigatran Etexilate Laboratorios Liconsa

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney impairment.
• if the patient is currently bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).

Blood may flow more easily than normal, which may increase the risk of bleeding.

• if the patient has an increased tendency to bleed. This may be inherited, of unknown cause or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant treatment, introducing a venous catheter or when heparin is administered to maintain catheter patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver impairment or liver disease that may lead to death.
• if the patient is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if the patient is taking oral cyclosporine, a medicine used to prevent organ rejection.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if the patient has a mechanical heart valve that requires lifelong anticoagulation.

Warnings and precautions

Before starting treatment with Dabigatran Etexilate Laboratorios Liconsa, the patient should discuss it with their doctor. If the patient has experienced symptoms or undergone surgery during treatment with this medicine, they should consult their doctor.

The patient should inform their doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if the patient has an increased risk of bleeding, such as:
• if the patient has recently experienced bleeding.
• if the patient has undergone surgical biopsy within the last month.
• if the patient has had a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See "Dabigatran Etexilate Laboratorios Liconsa and other medicines" below.
• if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if the patient has infective endocarditis (bacterial infection of the heart).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing less urine).
• if the patient is over 75 years old.
• if the patient is an adult and their body weight is 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a previous heart attack or if the patient has been diagnosed with diseases that increase the risk of heart attack.
• if the patient has liver disease that affects blood test results. In such cases, the use of this medicine is not recommended.

When to exercise special caution when taking Dabigatran Etexilate Laboratorios Liconsa

• if the patient needs to undergo surgery: In this case, it is necessary to discontinue Dabigatran Etexilate Laboratorios Liconsa due to the increased risk of bleeding during and after surgery. It is very important to take Dabigatran Etexilate Laboratorios Liconsa before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia or to relieve pain):
• It is very important to take Dabigatran Etexilate Laboratorios Liconsa before and after surgery exactly as the doctor has instructed.
• The patient should immediately inform their doctor if they experience numbness or weakness in their lower limbs or problems with their intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should immediately seek medical attention. The doctor will examine the patient to check if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

Dabigatran Etexilate Laboratorios Liconsa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should tell their doctor before taking Dabigatran Etexilate Laboratorios Liconsa if they are taking any of the following medicines:

• medicines that reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are used only on the skin.
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Dabigatran Etexilate Laboratorios Liconsa, depending on the condition for which the medicine was prescribed. See section 3.
• medicines used to prevent organ rejection (e.g. tacrolimus, cyclosporine).
• a combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac).
• St. John's Wort, a herbal medicine used to treat depression.
• antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• rifampicin or clarithromycin (both antibiotics).
• antiviral medicines used to treat AIDS (e.g. ritonavir).
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Dabigatran Etexilate Laboratorios Liconsa on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should prevent pregnancy while taking Dabigatran Etexilate Laboratorios Liconsa.

While taking Dabigatran Etexilate Laboratorios Liconsa, the patient should not breastfeed.

Driving and using machines

Dabigatran Etexilate Laboratorios Liconsa has no or negligible influence on the ability to drive and use machines.

3. How to take Dabigatran Etexilate Laboratorios Liconsa

Dabigatran Etexilate Laboratorios Liconsa capsules can be taken by adults and children aged 8 years and older who can swallow the capsules whole. There are other strengths and forms of this medicine suitable for children under 8 years of age.

This medicine should always be taken exactly as the doctor has instructed. If the patient is unsure, they should consult their doctor.

How to take Dabigatran Etexilate Laboratorios Liconsa

Prevention of blood clots after hip or knee replacement surgery

The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).

If kidney function is reducedby more than half or if the patient is 75 years old or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).

Patients taking medicines containing amiodarone, quinidine or verapamilshould take a dose of 150 mg once a day(taken as 2 capsules of 75 mg each).

Patient taking verapamil-containing medicineswith reduced kidney functionby more than half should take a reduced dose of 75 mgof Dabigatran Etexilate Laboratorios Liconsa due to the increased risk of bleeding.

In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once a day.

After knee replacement surgery

Treatment with Dabigatran Etexilate Laboratorios Liconsa should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 10 days.

After hip replacement surgery

Treatment with Dabigatran Etexilate Laboratorios Liconsa should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 28 to 35 days.

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heart function, and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

The recommended dose is 300 mgtaken as one 150 mg capsule twice a day.

For patients 80 years old or older, the recommended dose is 220 mgtaken as one 110 mg capsule twice a day.

Patient taking verapamil-containing medicinesshould receive a reduced dose of Dabigatran Etexilate Laboratorios Liconsa to 220 mgtaken as one 110 mg capsule twice a daydue to the increased risk of bleeding.

For patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as one 110 mg capsule twice a day.

Treatment with this medicine can be continued if the patient needs to restore normal heart function using a procedure called cardioversion. Dabigatran Etexilate Laboratorios Liconsa should be taken as instructed by the doctor.

In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran Etexilate Laboratorios Liconsa after the doctor has confirmed that blood clotting is under control. Dabigatran Etexilate Laboratorios Liconsa should be taken as instructed by the doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children

Dabigatran Etexilate Laboratorios Liconsa should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.

The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. The patient should continue to take all other medicines, unless the doctor instructs them to stop taking 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:

Dabigatran etexilate dosing table

Doses requiring more than one capsule:

300 mg:

two 150 mg capsules or

four 75 mg capsules

260 mg:

one 110 mg capsule and one 150 mg capsule or

one 110 mg capsule and two 75 mg capsules

220 mg:

two 110 mg capsules

185 mg:

one 75 mg capsule and one 110 mg capsule

150 mg:

one 150 mg capsule or

two 75 mg capsules

How to take Dabigatran Etexilate Laboratorios Liconsa

Dabigatran Etexilate Laboratorios Liconsa can be taken by adults and children aged 8 years and older who can swallow the capsules whole.

Dabigatran Etexilate Laboratorios Liconsa can be taken with or without food.

The capsule should be swallowed whole with a glass of water to facilitate passage into the stomach. It should not be broken, chewed or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

The patient should not change their anticoagulant medicine without receiving detailed instructions from their doctor.

Taking a higher dose of Dabigatran Etexilate Laboratorios Liconsa than recommended

Taking too much of this medicine increases the risk of bleeding. If the patient has taken too many capsules, they should immediately contact their doctor. Specific treatments are available.

Missing a dose of Dabigatran Etexilate Laboratorios Liconsa

Prevention of blood clots after hip or knee replacement surgery

The patient should continue taking the missed daily dose of Dabigatran Etexilate Laboratorios Liconsa at the same time the next day.

The patient should not take a double dose to make up for the missed dose.

Treatment in adults: Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heart function, and treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

Treatment in children: Treatment of blood clots and prevention of recurrence of blood clots

The missed dose can be taken up to 6 hours before the next scheduled dose.

If there are less than 6 hours before the next scheduled dose, the missed dose should not be taken.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Dabigatran Etexilate Laboratorios Liconsa

Dabigatran Etexilate Laboratorios Liconsa should be taken exactly as the doctor has instructed. The patient should not stop taking this medicine without consulting their doctor first, as the risk of blood clots may be higher if treatment is stopped too early. The patient should contact their doctor if they experience indigestion after taking Dabigatran Etexilate Laboratorios Liconsa.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dabigatran Etexilate Laboratorios Liconsa can cause side effects, although not everybody gets them.

Dabigatran Etexilate Laboratorios Liconsa affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Severe or heavy bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening or even fatal, regardless of the location. In some cases, these bleeds may not be visible.

If bleeding occurs that does not stop by itself, or if there are symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache or unexplained swelling), the patient should immediately contact their doctor. The doctor may decide to closely monitor the patient or change the medicine.

If a severe allergic reaction occurs that can cause difficulty breathing or dizziness, the patient should immediately contact their doctor.

Side effects are grouped by frequency below:

Prevention of blood clots after hip or knee replacement surgery

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

• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, into the stomach or intestines, from the anus, penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Blood clots or bruising that occur after surgery
• Blood in the stool, as detected by laboratory tests
• Decreased red blood cell count
• Decreased hematocrit
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Discharge from the wound
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical wound, from the injection site or from the catheter insertion site
• Discharge from the catheter insertion site into a vein, discolored by blood
• Coughing up blood or sputum discolored by blood
• Decreased platelet count
• Decreased red blood cell count after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge from the wound

Unknown frequency (cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during irregular heart function

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

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

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

• Bleeding
• Bleeding may occur from hemorrhoids or from the anus
• Bleeding into the brain
• Blood clots
• Coughing up blood or sputum discolored by blood
• Decreased platelet count
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into the joint, from the surgical wound, from the injection site or from the catheter insertion site into a vein
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Decreased hematocrit
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

Unknown frequency (cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots in the veins of the legs and lungs and prevention of recurrence of blood clots in the veins of the legs and lungs

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

• Bleeding may occur from the nose, into the stomach or intestines, from the anus, penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur into the joint or due to injury
• Bleeding may occur from hemorrhoids
• Decreased red blood cell count
• Blood clots
• Coughing up blood or sputum discolored by blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical wound, from the injection site or from the catheter insertion site into a vein or bleeding into the brain
• Decreased platelet count
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

Unknown frequency (cannot be estimated from the available data):

• Difficulty breathing or wheezing
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Decreased white blood cell count (which helps fight infections)
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Hair loss

Treatment of blood clots and prevention of recurrence of blood clots in children

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

• Decreased red blood cell count
• Decreased platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Blood clots
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the anus, penis/vagina or urinary tract (including urine discoloration due to blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or sputum discolored by blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice of the skin or whites of the eyes due to liver or blood disease

Unknown 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 facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the joint, from the wound, from the surgical wound, from the injection site or from the catheter insertion site into a vein
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Al. Jerozolimskie 181C

PL-02 222 Warsaw

Tel.: + 48 22 49 21 301

Fax: + 48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Dabigatran Etexilate Laboratorios Liconsa

The medicine should be stored out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after "EXP" or "EXP". The expiry date refers to the last day of the month.

Aluminum blister: Do not store above 30°C.

Aluminum blister with desiccant: No special storage precautions.

HDPE bottle: Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran Etexilate Laboratorios Liconsa contains

• The active substance is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesylate, equivalent to 110 mg of dabigatran etexilate. The other ingredients are:
• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• Capsule shell: indigotine, aluminum lake (E 132), carrageenan, potassium chloride, titanium dioxide (E 171) and hypromellose.

What Dabigatran Etexilate Laboratorios Liconsa looks like and contents of the pack

Hard capsules, approximately 19.0 mm in length, with a light blue, opaque cap and a light blue, opaque body, size "1", filled with white to light yellow pellets.

The capsules are packaged in aluminum blisters with a desiccant - aluminum (OPA/Aluminum/PE//PE/Aluminum/LDPE) and aluminum - aluminum (blister OPA/Aluminum/PVC//Aluminum) or in a white plastic bottle with a desiccant in the cap (PP).

Package sizes:

Blister packs containing: 10, 10x1 (single-dose blister), 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100 or 180 hard capsules.

Bottles containing: 100 hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder

Laboratorios Liconsa, S.A.

C/Dulcinea S/n

28805 Alcalá de Henares

Madrid

Spain

Tel: + 34 93 330 62 12

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7

Poligono Industrial Miralcampo

19200 Azuqueca De Henares

Guadalajara

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: