Dabigatran Etexilate Laboratorios Liconsa

Leaflet accompanying the packaging: patient information

Dabigatran Etexilate Laboratorios Liconsa, 75 mg, hard capsules

dabigatran etexilate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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.
• 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. Package contents 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 is to block the 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.

Dabigatran Etexilate Laboratorios Liconsa is used in children to:

• treat blood clots and prevent recurrent blood clots.

2. Important information before taking Dabigatran Etexilate Laboratorios Liconsa

When not to take Dabigatran Etexilate Laboratorios Liconsa

Warnings and precautions

Before starting treatment with Dabigatran Etexilate Laboratorios Liconsa, the patient should discuss it with their doctor. If symptoms occurred during treatment with this medicine or the patient underwent surgery, 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:

• only in the case of use in children: if the child has an infection around or in the brain.

When to be particularly careful when taking Dabigatran Etexilate Laboratorios Liconsa

• 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 the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.

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 it was prescribed. See also 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 avoid becoming pregnant while taking Dabigatran Etexilate Laboratorios Liconsa.

While taking 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 or older who can swallow the capsules whole.

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

The patient should take Dabigatran Etexilate Laboratorios Liconsa as follows:

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 in patients aged 75 years or older,

the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).

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

Patient taking verapamil-containing medicines, with reduced kidney functionby more than half, should take a reduced dose of 75 mgof this medicine 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, two 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, two capsules should be taken once a day for a total of 28 to 35 days.

Treatment of blood clots and prevention of recurrent 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 in capsule form

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 or 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 Dabigatran Etexilate Laboratorios Liconsa capsules, they should immediately contact their doctor. There are specific treatments 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 of blood clots and prevention of recurrent blood clots in children.

The 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 patient should not take the missed dose.

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 first consulting their doctor, as the risk of blood clots may be higher if treatment is stopped too early.

The patient should contact their doctor if they experience nausea after taking Dabigatran Etexilate Laboratorios Liconsa.

If the patient has any further doubts about the use of 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 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 on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) occur, 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, which can cause difficulty breathing or dizziness, the patient should immediately contact their doctor.

Side effects are listed below by frequency:

Prevention of blood clots after hip or knee replacement surgery

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

• Decreased hemoglobin in the blood (a substance in red blood cells)
• Abnormal liver function test results
• Bleeding may occur from the nose, stomach, or intestines, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Formation of hematomas or bruising 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
• Wound secretion
• Increased liver enzyme activity
• Jaundice of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur in the brain, from the surgical wound, from the injection site, or from the catheter insertion site
• Blood-tinged secretion from the catheter insertion site
• Coughing up blood or blood-tinged sputum
• 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 ulcers (including esophageal ulcers)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal or stomach pain
• Nausea
• Difficulty swallowing
• Wound secretion
• Wound secretion after surgery

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

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

Treatment of blood clots and prevention of recurrent 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
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Nausea
• 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 in the stomach, intestines, brain, anus, penis/vagina, or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decreased hemoglobin in the blood (a substance in red blood cells)
• Decreased hematocrit
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal 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

Frequency not known (cannot be estimated from the available data):

• Decreased white blood cell count (which helps 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 in the joints, from the surgical wound, from the injection site, or from the catheter insertion site
• Bleeding from hematomas
• 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 Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

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 a desiccant: No special storage precautions are required.

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. Package contents and other information

What Dabigatran Etexilate Laboratorios Liconsa contains

• The active substance is dabigatran etexilate in the form of mesylate. Each capsule contains dabigatran etexilate in the form of mesylate equivalent to 75 mg of dabigatran etexilate.

Other ingredients are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropyl cellulose, and talc.
• Capsule shell: carrageenan, potassium chloride, titanium dioxide (E 171), and hypromellose.

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

Hard capsules, approximately 18.0 mm in length, with a white, opaque cap and a white, opaque body, size "2", filled with pellets of a color ranging from white to light yellow.

The capsules are stored in aluminum blisters with a desiccant (OPA/Aluminum/PE//PE/Aluminum/LDPE) or aluminum-aluminum (OPA/Aluminum/PVC//Aluminum) blisters 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 pack sizes may be marketed.

Marketing authorization holder

Laboratorios Liconsa, S.A.

Dulcinea Street, s/n

28805 Alcalá de Henares

Madrid

Spain

Phone: +34 93 330 62 12

Manufacturer

Laboratorios Liconsa S.A.

Miralcampo Avenue 7

Miralcampo Industrial Estate

19200 Azuqueca De Henares

Guadalajara

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Date of last revision of the leaflet: