Dabigatran etexilate Tecnigen 150 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dabigatran Etexilate TecniGen 150 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine,

because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dabigatran Etexilate TecniGen is and what it is used for
2. What you need to know before taking Dabigatran Etexilate TecniGen
3. How to take Dabigatran Etexilate TecniGen
4. Possible side effects
5. How to store Dabigatran Etexilate TecniGen
6. Contents of the pack and other information

1. What Dabigatran Etexilate TecniGen is and what it is used for

This medicine contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Dabigatran etexilate is used in adults for:

• preventing the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treating blood clots in the veins of your legs and lungs and to prevent the recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children for:

• treating blood clots and preventing the recurrence of blood clots.

2. What you need to know before taking Dabigatran Etexilate TecniGen

Do not take Dabigatran Etexilate TecniGen

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you currently have bleeding.
• if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or hemorrhage, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medications.
• if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and heparin is administered through this catheter to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely impaired or if you have a liver disease that could be life-threatening.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heart rhythm.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulant treatment.

Warnings and precautions
Talk to your doctor before starting dabigatran etexilate.
During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are scheduled for surgery.

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

• If you have an increased risk of bleeding, for example:

• if you have recently had bleeding.

• if you have undergone a surgical tissue removal (biopsy) within the last month.

• if you have suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).

• if you have inflammation of the esophagus or stomach.

• if you have gastroesophageal reflux (backflow of stomach juice into the esophagus).

• if you are receiving medicines that may increase the risk of bleeding. See “Other medicines and Dabigatran Etexilate TecniGen” below.

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.

• if you have an infection in the heart (bacterial endocarditis).

• if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark (concentrated)/foamy urine).

• if you are over 75 years old.

• if you are an adult weighing 50 kg or less.

• only if used in children: if the child has a brain infection or infection around the brain.

• If you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in such cases.

Take special care with dabigatran etexilate

• If you need to undergo surgery:

In this case, dabigatran etexilate should be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate before and after surgery exactly as directed by your doctor.

• If surgery requires the placement of a catheter or an injection into the spine (e.g., for epidural or spinal anesthesia or for pain relief):

• It is very important that you take dabigatran etexilate before and after surgery exactly as directed by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in the legs or problems with bowel or bladder function after the anesthesia wears off, as this situation requires urgent medical attention.

• If you fall or get injured during treatment, especially if you hit your head. Seek urgent medical help. You may need to be examined by a doctor, as you may have an increased risk of bleeding.

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Dabigatran Etexilate TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking dabigatran etexilate if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines for treating fungal infections (e.g., ketoconazole, itraconazole), except if applied only to the skin.
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are using medicines containing verapamil, your doctor may instruct you to use a reduced dose of dabigatran etexilate depending on the condition for which it has been prescribed. See section 3.
• Medicines used to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine).
• A combination product of 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 remedy for depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV/AIDS (e.g., ritonavir).
• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of dabigatran etexilate on pregnancy and the unborn fetus are unknown. You must not use this medicine during pregnancy unless your doctor specifically advises it is safe. If you are of childbearing age, you should avoid becoming pregnant while being treated with dabigatran etexilate.

Breastfeeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive or operate machinery.

3. How to take Dabigatran Etexilate TecniGen

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other appropriate pharmaceutical forms available according to age for the treatment of children under 8 years of age.

Always follow exactly the dosing instructions for this medicine as given by your doctor. If you are unsure, consult your doctor again.

Take dabigatran etexilate as recommended for the following conditions:

Prevention of systemic or cerebral vascular obstruction due to blood clot formation caused by irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs.

The recommended dose is 300 mg administered as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg administered as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you should be prescribed a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice daily, as your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of dabigatran etexilate 220 mg administered as one 110 mg capsule twice daily.

You may continue taking this medicine if it becomes necessary to restore your normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) implanted into a blood vessel during a procedure called percutaneous coronary intervention with stent placement, you may receive treatment with dabigatran etexilate once your doctor has determined that normal blood coagulation control has been achieved. Take dabigatran etexilate exactly as directed by your doctor.

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

Dabigatran etexilate should be taken twice daily, one dose in the morning and one dose in the evening, approximately at the same time each day. The dosing interval 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. Your doctor may adjust your dose during treatment. Continue taking all other medications unless your doctor tells you to stop.

Table 1 shows the single doses 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 capsules

Single doses requiring combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran Etexilate TecniGen

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule and take only its contents, as this may increase the risk of bleeding.

Switching anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabigatran Etexilate TecniGen than you should

Taking too much dabigatran etexilate increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount of Dabigatran Etexilate ingested.

If you forget to take Dabigatran Etexilate TecniGen

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

A missed dose should be omitted if less than 6 hours remain before the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Dabigatran Etexilate TecniGen

Take dabigatran etexilate exactly as prescribed. Do not stop your treatment with dabigatran etexilate without first consulting your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking dabigatran etexilate.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding.

Major or severe episodes of bleeding may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, these bleedings may not be evident.

If you experience any episode of bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The possible adverse effects are listed below, grouped according to their frequency of occurrence.

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm

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

• Bleeding may occur from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in the urine which may turn the urine pink or red), or under the skin.
• Decrease in the number of red blood cells in the blood.
• Abdominal pain or stomach ache.
• Indigestion.
• Frequent loose or watery stools.
• Feeling nauseous.

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

• Bleeding.
• Bleeding may occur from hemorrhoids, rectum, or brain.
• Bruising.
• Coughing up blood or blood-streaked sputum.
• Decrease in the number of platelets in the blood.
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells).
• Allergic reaction.
• Sudden change in the skin affecting color and physical appearance.
• Itching.
• Ulcer in the stomach or intestine (including esophageal ulcer).
• Inflammation of the esophagus and stomach.
• Reflux of gastric juice into the esophagus.
• Vomiting.
• Difficulty swallowing.
• Abnormal liver function tests.

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

• Bleeding may occur in a joint, at a surgical incision site, in a wound, at the site of an injection, or at the site of a venous catheter insertion.
• Severe allergic reaction causing difficulty breathing or dizziness.
• Severe allergic reaction causing swelling of the face or throat.
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction.
• Decrease in the proportion of blood cells.
• Increased liver enzymes.
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders.

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

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

In a clinical trial, the rate of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the legs and/or lungs.

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

• Bleeding may occur from the nose, stomach or intestines, rectum, penis/vagina, or urinary tract (including blood in the urine which may turn the urine pink or red), or under the skin.
• Indigestion.

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

• Bleeding.
• Bleeding may occur in a joint or wound.
• Bleeding may occur from hemorrhoids.
• Decrease in the number of red blood cells in the blood.
• Bruising.
• Coughing up blood or blood-streaked sputum.
• Allergic reaction.
• Sudden change in the skin affecting color and physical appearance.
• Itching.
• Ulcer in the stomach or intestine.
• Inflammation of the esophagus and stomach (including esophageal ulcer).
• Reflux of gastric juice into the esophagus.
• Feeling nauseous.
• Vomiting.
• Abdominal pain or stomach ache.
• Frequent loose or watery stools.
• Abnormal liver function tests.
• Increased liver enzymes.

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

• Bleeding may occur at a surgical incision site, at the site of an injection, at the site of a venous catheter insertion, or from the brain.
• 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 with dark red, raised, itchy bumps caused by an allergic reaction.
• Difficulty swallowing.

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

• Difficulty breathing or wheezing.
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells).
• Decrease in the proportion of blood cells.
• Decrease in the number or even absence of white blood cells (which help fight infections).
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders.
• Hair loss.

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarin. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to those treated with placebo.

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

Frequent (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 with dark red, raised, itchy bumps caused by an allergic reaction.
• Sudden change in the skin affecting color and physical appearance.
• Bruising.
• Nosebleeds.
• Reflux of gastric juice into the esophagus.
• Vomiting.
• Feeling nauseous.
• Frequent loose or watery stools.
• Indigestion.
• Hair loss.
• Increased liver enzymes.

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

• Decrease in the number of white blood cells (which help fight infections).
• Bleeding may occur in the stomach or intestines, brain, rectum, penis/vagina, or urinary tract (including blood in the urine which may turn the urine pink or red), or under the skin.
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells).
• Decrease in the proportion of blood cells.
• Itching.
• Coughing up blood or blood-streaked sputum.
• Abdominal pain or stomach ache.
• Inflammation of the esophagus and stomach.
• Allergic reaction.
• Difficulty swallowing.
• Yellowing of the skin or whites of the eyes, caused by liver 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 may occur in a joint or wound, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion.
• Bleeding may occur from hemorrhoids.
• Ulcer in the stomach or intestine (including esophageal ulcer).
• Abnormal liver function tests.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate TecniGen

Keep this medicine out of the sight and reach of children.

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

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran Etexilate TecniGen

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc, and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E-171), hypromellose 2910, and indigo carmine (E-132).

Appearance of the product and contents of the pack

Dabigatran Etexilate TecniGen 150 mg are hard capsules with a blue cap and a white or whitish body, size 0, containing pellets ranging from whitish to pale yellow.

Dabigatran Etexilate TecniGen is available in packs containing 6 x 10 hard capsules in perforated or non-perforated aluminum/OPA-AL-PVC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª Edificio LEKLA,

08950 – Esplugues de Llobregat (Barcelona)

Spain

Or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid

Spain

Or

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira, 11 de 11

2710-089 Sintra

Portugal

Date of the most recent revision of this leaflet: January 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/