Dabigatran etexilate laboratorios liconsa

Package leaflet: Information for the patient

Dabigatran Etexilate Laboratorios Liconsa, 75 mg, hard capsules
dabigatranum etexilatum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dabigatran Etexilate Laboratorios Liconsa is and what it is used for
2. What you need to know 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 pack and other information

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

Dabigatran Etexilate Laboratorios Liconsa contains dabigatran etexilate as the active substance and
belongs to a group of medicines known as anticoagulants. It works by blocking a substance in the body responsible for blood clot formation.
Dabigatran Etexilate Laboratorios Liconsa is used in adults to:

• prevent the formation of blood clots in veins after hip or knee replacement surgery.

Dabigatran Etexilate Laboratorios Liconsa is used in children to:

• treat blood clots and to prevent 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 function impairment.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric or duodenal ulcer, brain injury or intracranial haemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. This may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter, when heparin is administered through the catheter to maintain its patency, or during a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe liver function 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 rejection of a transplanted organ.
• if the patient is taking dronedarone, a medicine used to treat heart rhythm disorders.
• if the patient is taking a fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has a mechanical heart valve, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Laboratorios Liconsa, discuss this with your
doctor. If symptoms occur while taking this medicine or if the patient undergoes a surgical
procedure, consult a doctor immediately.
The patient should inform the doctor if they currently have or have previously 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 a surgical tissue biopsy within the last month.
  • if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
  • if the patient has inflammation of the oesophagus or stomach.
  • if the patient has gastro-oesophageal reflux (acid reflux into the oesophagus).
  • if the patient is taking medicines that may increase the risk of bleeding. See below “Dabigatran Etexilate Laboratorios Liconsa and other medicines”.
  • if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
  • if the patient has an infection of the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing less urine, which may be dark (concentrated) or foamy).
  • if the patient is over 75 years of age.
  • if the patient is an adult with a body weight of 50 kg or less.
  • only when used in children: if the child has an infection around or within the brain.
• if the patient has previously had a heart attack or if the patient has been diagnosed with conditions that increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

When to exercise particular caution when taking Dabigatran Etexilate Laboratorios Liconsa

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Dabigatran Etexilate Laboratorios Liconsa is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Dabigatran Etexilate Laboratorios Liconsa exactly as directed by the doctor both before and after surgery.
• if surgery requires insertion of a catheter or injection into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
  • It is very important to take Dabigatran Etexilate Laboratorios Liconsa exactly as directed by the doctor both before and after surgery.
• Immediately inform the doctor if the patient experiences numbness or weakness in the legs or problems with bowel or bladder function after the anaesthesia wears off, as urgent medical care is required.
  • if the patient falls or injures themselves during treatment, especially if the head is injured. Immediate medical evaluation is required. The doctor will assess whether there is an increased risk of bleeding.
  • if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing an increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is necessary.

Dabigatran Etexilate Laboratorios Liconsa and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently
taken, or plans to take. In particular, before taking Dabigatran Etexilate Laboratorios Liconsa,
the patient should inform the doctor 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 these are applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For 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 also section 3.
• Medicines used to prevent rejection of a transplanted organ (e.g. tacrolimus, cyclosporine).
• A fixed-dose 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 known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs).
• 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
It is unknown what effect Dabigatran Etexilate Laboratorios Liconsa has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing potential should use effective contraception to prevent pregnancy while taking Dabigatran Etexilate Laboratorios Liconsa.
Breastfeeding is not recommended during treatment with Dabigatran Etexilate Laboratorios Liconsa.

Driving and using machines
Dabigatran Etexilate Laboratorios Liconsa has no effect or has negligible effect 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 are able to swallow capsules whole. Other strengths and pharmaceutical forms of the medicine are appropriate for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Take Dabigatran Etexilate Laboratorios Liconsa exactly as directed below:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily (taken as 2 capsules of 110 mg).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced renal function by more than half should take a reduced dose of 75 mg of this medicine due to an increased risk of bleeding.

In both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started with a dose of 2 capsules once daily.

After knee replacement surgery
Treatment with Dabigatran Etexilate Laboratorios Liconsa should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 10 days.

After hip replacement surgery
Treatment with Dabigatran Etexilate Laboratorios Liconsa should begin with one capsule taken 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.

Treatment and prevention of recurrence of blood clots in children
Dabigatran Etexilate Laboratorios Liconsa should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should be as close as possible to 12 hours.

The recommended dose depends on body weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other prescribed medicines unless your doctor advises otherwise.

Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for dabigatran etexilate in capsule form

Single 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 are able to swallow capsules whole.

Dabigatran Etexilate Laboratorios Liconsa may be taken with or without food.
The capsule should be swallowed whole with a glass of water to facilitate passage into the stomach. Do not crush, chew, or empty the pellets from the capsule, as this may increase the risk of bleeding.

Switching anticoagulant therapy
Do not switch anticoagulant medication without receiving specific instructions from your doctor.

Taking more than the recommended dose of Dabigatran Etexilate Laboratorios Liconsa
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many Dabigatran Etexilate Laboratorios Liconsa capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran Etexilate Laboratorios Liconsa
Prevention of blood clots after surgery (hip or knee replacement)
Continue taking the missed daily dose of Dabigatran Etexilate Laboratorios Liconsa at the usual time on the following day.
Do not take a double dose to make up for a missed dose.

Treatment and prevention of recurrence of blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken.
Do not take a double dose to make up for a missed dose.

Stopping Dabigatran Etexilate Laboratorios Liconsa
Dabigatran Etexilate Laboratorios Liconsa should be taken exactly as prescribed by the doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if gastrointestinal discomfort occurs after taking Dabigatran Etexilate Laboratorios Liconsa.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Dabigatran Etexilate Laboratorios Liconsa affects the blood clotting system; therefore, most adverse reactions are related to symptoms such as bruising or bleeding. Severe or major bleeding may occur, which is the most serious adverse reaction, and regardless of location, it may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close observation or change your treatment.
In case of a severe allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

The possible adverse reactions listed below are grouped according to their frequency of occurrence:

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

• Decrease in haemoglobin 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, stomach or intestines, penis/vagina or urinary tract (including pink or red-coloured urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, following injury or after a surgical procedure
• Development of bruises or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell count
• Allergic reaction
• Vomiting
• Frequent passage of loose or liquid stools
• Nausea
• Discharge of fluid from the wound (oozing from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver disease or blood disorders

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-tinged 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
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Discharge of fluid from the wound
• Discharge of fluid from the surgical wound

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

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

Treatment and prevention of recurrence of blood clots in children

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Development of bruises
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur from the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red-coloured urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain 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 disease or blood disorders

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:

Department of Monitoring Adverse Reactions of Medicinal Products
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

Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dabigatran Etexilate Laboratorios Liconsa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle
after: "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Aluminium blister: Do not store above 30°C.
Aluminium blister with desiccant: No special storage instructions apply.
HDPE bottle: Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Dabigatran Etexilate Laboratorios Liconsa contains

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

Other components are:

• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• Capsule contents: 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 of size "2", filled with pellets ranging in colour from white to pale yellow.
The capsules are stored in blisters made of aluminium with a moisture-absorbing agent –
aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) and aluminium – aluminium (blister
OPA/Aluminium/PVC//Aluminium) or in a white plastic bottle with a moisture-absorbing cap
(PP).
Pack sizes:
Blister packs containing: 10, 10x1 (unit dose blister), 30, 30x1 (unit dose blister),
60, 60x1 (unit dose blister), 100 or 180 hard capsules.
Bottles containing: 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area
under the following names: