Dabigatran etexilate laboratorios liconsa

Package leaflet: Information for the patient

Dabigatran Etexilate Laboratorios Liconsa, 150 mg, hard capsules
dabigatranum etexilatum
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse effects, 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 called anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.

Dabigatran Etexilate Laboratorios Liconsa is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs, and to prevent 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 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 to any of the other ingredients of this medicine (listed in section 6).

• if the patient has severe impairment of kidney function.

• 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. stomach ulcer, brain injury or intracranial bleeding, 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 impairment of liver function 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 had a mechanical heart valve implanted, which requires continuous use of blood-thinning medicines.

Warnings and precautions
Before starting treatment with Dabigatran Etexilate Laboratorios Liconsa, the patient should discuss this with their doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, they should consult their doctor.
The patient should inform their 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 section 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 in the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark (concentrated) or foamy urine).
  • 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 had a heart attack or 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 special 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.
  • The patient should immediately inform their doctor if they experience numbness or weakness in the legs, or problems with bowel or bladder function after the anaesthetic wears off, as urgent medical care is required.
• if the patient falls or injures themselves during treatment, especially if they injure their head. Immediate medical attention 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 that increases the 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
The patient should inform their doctor or pharmacist about all medicines they are currently taking, have recently taken, or 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 these medicines are applied only to 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 rejection of transplanted organs (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 or serotonin-noradrenaline reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Some medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding
It is not known what effect Dabigatran Etexilate Laboratorios Liconsa has on pregnancy and the unborn child. This medicine should not be taken during pregnancy unless the doctor determines it is safe. Women of childbearing potential should use effective contraception during treatment with Dabigatran Etexilate Laboratorios Liconsa.
Breastfeeding should not be undertaken during treatment with Dabigatran Etexilate Laboratorios Liconsa.

Driving and using machines
Dabigatran Etexilate Laboratorios Liconsa has no effect or has a 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. There are other strengths and pharmaceutical forms of the drug suitable for treating children under 8 years of age.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
Take Dabigatran Etexilate Laboratorios Liconsa exactly as directed below:
Prevention of blood clots in blood vessels of the brain and body by preventing the formation of clots that occur due to irregular heart function, and treatment of blood clots in the veins of the legs and lungs, as well as 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.
For patients aged 80 years or older, the recommended dose is 220 mg taken as one 110 mg capsule twice daily.
Patients taking medicines containing verapamil should receive a reduced dose of Dabigatran Etexilate Laboratorios Liconsa of 220 mg taken as one 110 mg capsule twice daily due to a potentially increased risk of bleeding.
For patients with a potentially increased risk of bleeding, the doctor may recommend treatment with a dose of 220 mg taken as one 110 mg capsule twice daily.
Treatment with this medicine may be continued if the patient requires restoration of normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Dabigatran Etexilate Laboratorios Liconsa should be taken as directed by your doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure known as percutaneous coronary intervention with stent implantation, the patient may receive treatment with Dabigatran Etexilate Laboratorios Liconsa after the doctor has confirmed adequate control of blood coagulation. Dabigatran Etexilate Laboratorios Liconsa should be taken as directed by your doctor.
Treatment of blood clots and prevention of recurrent 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. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg).
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 administered to 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 detailed instructions from your doctor.

Accidental overdose 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 capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Dabigatran Etexilate Laboratorios Liconsa
A missed dose may be taken if there is still at least 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 will experience 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 profuse bleeding may occur, which is the most serious adverse reaction and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, such bleeding may not be visible.
If bleeding occurs that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling) appear, contact your doctor immediately. The doctor may decide to place the patient under close observation or change the 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 in blood vessels of the brain and body by preventing the formation of clots that occur due to irregular heart function

Common (may occur in 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 pink or red urine due to presence of blood), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent passage of loose or watery stools
• Nausea

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

• Bleeding
• Bleeding may occur from hemorrhoids, from the rectum, or into the brain
• Formation of bruises (hematomas)
• Coughing up blood or bloody sputum
• Decrease in the number of platelets in the blood
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• 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)
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results in laboratory tests

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

• Bleeding into a joint, from a surgical incision site, from a wound, from an injection site, or from the site of intravenous catheter insertion may occur
• 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
• Decrease in blood cell count
• Increase in liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

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

In clinical trials, the number of heart attacks was numerically higher with Dabigatran Etexilate Laboratorios Liconsa than with warfarin. The overall number of events was small.

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

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

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

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

• Bleeding
• Bleeding into a joint or following injury may occur
• Bleeding from hemorrhoids may occur
• Decrease in the number of red blood cells in the blood
• Formation of bruises (hematomas)
• Coughing up blood or bloody sputum
• 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)
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent passage of loose or watery stools
• Abnormal liver function test results in laboratory tests
• Increase in liver enzyme activity

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

• Bleeding from a surgical incision site, from an injection site, from the site of intravenous catheter insertion, or bleeding into the brain may occur
• 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
• Skin rash consisting of dark red, raised, itchy bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Decrease in number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes due to liver or blood disease
• Hair loss

In clinical trials, the number of heart attacks was numerically higher with Dabigatran Etexilate Laboratorios Liconsa than with warfarin. The overall number of events was low. No difference in the number of heart attacks was observed between patients treated with dabigatran and those receiving placebo.

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

Common (may occur in 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
• Formation of bruises (hematomas)
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increase in liver enzyme activity

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the anus, from the penis/vagina or urinary tract (including pink or red 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 bloody 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 due to liver or blood disease

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 a joint, from a wound, from a surgical incision site, from an injection site, or from the site of intravenous catheter insertion may occur
• Bleeding from hemorrhoids may occur
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results in laboratory tests

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 of Adverse Drug Reactions
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 to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dabigatran Etexilate Laboratorios Liconsa

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
following: "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 required.
HDPE bottle: Store in the original container 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. Each capsule contains dabigatran etexilate in the form of mesilate equivalent to 150 mg of dabigatran etexilate. The other components are:
• Capsule contents: tartaric acid (in the form of pellets), hypromellose, hydroxypropylcellulose and talc.
• Capsule shell: indigo carmine, aluminium 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 of size "0", filled with white to pale yellow pellets.
The capsules are stored in blisters made of aluminium with a desiccant – aluminium (OPA/Aluminium/PE//PE/Aluminium/LDPE) and aluminium – aluminium (blister OPA/Aluminium/PVC//Aluminium) or in a white plastic bottle with a desiccant in the cap (PP).
Pack sizes:
Blister packs containing: 10, 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: