Dabigatran Etexilate Laboratorios Liconsa

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Laboratorios Liconsa, 150 mg, hard capsules

dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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 brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heart rhythm 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).
• if the patient has an increased tendency to bleed. This can be congenital, of unknown cause or caused by the use of other medicines.

...

Special 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, 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 suffered a serious injury (e.g. 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 non-steroidal anti-inflammatory drugs, 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 history of myocardial infarction or if the patient has been diagnosed with diseases that increase the risk of myocardial infarction.
• if the patient has liver disease, affecting liver function test results. In such cases, the use of this medicine is not recommended.

When to be particularly careful when taking Dabigatran Etexilate Laboratorios Liconsa

• if the patient needs to undergo surgery: In such cases, it is necessary to discontinue the use of 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 spinal or epidural anesthesia or to reduce 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 may be necessary.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should seek medical attention immediately. The doctor will examine the patient to determine 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:

• blood thinning medicines (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole), unless these medicines are used only on the skin.
• medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing 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 after transplantation (e.g. tacrolimus, cyclosporine).
• a combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• 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 avoid becoming pregnant while taking Dabigatran Etexilate Laboratorios Liconsa.
During treatment with Dabigatran Etexilate Laboratorios Liconsa, breastfeeding should be avoided.

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 used in adults and children aged 8 years and older who can swallow the capsules whole. There are other strengths and pharmaceutical forms of the medicine suitable for the treatment of 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 in the brain and body, by preventing the formation of clots that occur during irregular heart rhythm 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 mg taken as one 150 mg capsule twice a day.
In patients aged 80 years or older, the recommended dose of the medicine is 220 mg taken as one 110 mg capsule twice a day.
Patient taking medicines containing verapamilshould receive a reduced dose of Dabigatran Etexilate Laboratorios Liconsa, up to 220 mg taken as one 110 mg capsule twice a day, due to the possible increased risk of bleeding.
In patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken as one 110 mg capsule twice a day.
Treatment can be continued if the patient needs to restore normal heart function using a procedure called cardioversion or using a procedure called catheter ablation in atrial fibrillation. 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 adequate blood clotting control has been achieved. 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 body 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).
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 used in 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 its 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. There are specific treatments available.

Missing a dose of Dabigatran Etexilate Laboratorios Liconsa

A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, the missed dose should not be taken.
A double dose should not be taken to make up for a 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 prematurely. The patient should contact their doctor if they experience nausea after taking Dabigatran Etexilate Laboratorios Liconsa.
If the patient has any further questions about the use of this medicine, they should ask 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. Major or severe bleeding can 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 bleedings 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 monitor the patient closely or change the medicine.
If a severe allergic reaction occurs, which can cause difficulty breathing or dizziness, the patient should immediately contact their doctor.
Side effects are listed below by frequency:

• 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 discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased red blood cell count
• Abdominal pain or stomach pain
• Nausea
• Diarrhea
• Uncommon (may affect up to 1 in 100 people):
• Bleeding
• Bleeding may occur from hematomas, from the rectum, from the brain, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Hematomas
• Coughing up blood or sputum discolored with 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 ulcers (including esophageal ulcers)
• 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 a joint, from a surgical wound, from an injection site, or from a catheter insertion site
• 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 white blood cell count
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Hair loss
• Unknown frequency (cannot be estimated from the available data):
• Difficulty breathing or wheezing
• Decreased red blood cell count
• Decreased white blood cell count (which help fight infections)

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 rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Nausea
• Uncommon (may affect up to 1 in 100 people):
• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decreased red blood cell count
• Hematomas
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Abnormal liver function test results
• Increased liver enzyme activity
• 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 red blood cell count
• Decreased white blood cell count (which help fight infections)
• Jaundice of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks in patients taking Dabigatran Etexilate Laboratorios Liconsa was higher than in patients taking warfarin. The overall number of events was low.

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
• Hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Diarrhea
• Nausea
• Hair loss
• Increased liver enzyme activity
• Uncommon (may affect up to 1 in 100 people):
• Decreased white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, from the brain, from the rectum, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased red blood cell count
• Itching
• Coughing up blood or sputum discolored with 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 a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dabigatran Etexilate Laboratorios Liconsa

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
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 they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dabigatran Etexilate Laboratorios Liconsa contains

• The active substance of the medicine is dabigatran etexilate. Each capsule contains dabigatran etexilate in the form of mesylate, equivalent to 150 mg of dabigatran etexilate. The other ingredients are:
• capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose, and talc.
• capsule shell: indigo carmine, 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 22 mm in length, with a light blue, opaque cap and a light blue, opaque body, size "0", filled with white to light yellow pellets.
The capsules are stored 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).
Pack sizes:
Blister packs containing: 10, 30, 30x1 (single-dose blister), 60, 60x1 (single-dose blister), 100, or 180 hard capsules.
Bottles containing: 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Liconsa, S.A.
C/Dulcinea S/n
28805 Alcalá de Henares
Madrid
Spain
Phone: +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:

Sweden	Dabigatran etexilat Laboratorios Liconsa 150 mg hard capsules
Hungary	Dabigatran Etexilat Laboratorios Liconsa 150 mg hard capsules
Croatia	Dabigatran Abela 150 mg capsules
Italy	Dabigatran etexilato Medical Valley 150 mg
Poland	Dabigatran Etexilat Laboratorios Liconsa 150 mg
Romania	Dabigatran etexilat Laboratorios Liconsa 150 mg capsules
Bulgaria	Dabigatran Etexilat Laboratorios Liconsa 150 mg hard capsules Дабигатран Етексилат Лабораториос Ликонса 150 mg твърди капсули
Czech Republic	Dabigatran Etexilat Laboratorios Liconsa 150 mg
Germany	Dabigatranetexilat Laboratorios Liconsa 150 mg
Spain	Dabigatran Etexilato Laboratorios Liconsa 150 mg hard capsules EFG
Portugal	Dabigatran Etexilat Laboratorios Liconsa 150 mg

Date of last revision of the leaflet: