BIGETRA 150 mg HARD CAPSULES

Introduction

Package Leaflet:information for the patient

Bigetra 150 mg hard capsules

dabigatran etexilate

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Bigetra and what is it used for
2. What you need to know before you take Bigetra
3. How to take Bigetra
4. Possible side effects

5 Storage of Bigetra

1. Contents of the pack and other information

1. What is Bigetra and what is it used for

Bigetra 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 the formation of blood clots.

Dabigatran etexilate is used in adults to:

• prevent 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.

and to treat blood clots in the veins of your legs and lungs and to prevent them from forming again in the veins of your legs and lungs.

• treat blood clots in the veins of your legs and lungs and to prevent them from forming again in the veins of your legs and lungs.

Dabigatran etexilate is used in children aged 8 years and older to:

• treat blood clots and prevent them from forming again.

2. What you need to know before you take Bigetra

Do not take Bigetra

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, brain injury or recent brain or eye surgery).

if you are prone to bleeding. This tendency may be inherited, of unknown cause or caused by other medicines.

• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being given heparin through this catheter to keep it open or while your normal heartbeat is being restored through a procedure called catheter ablation for atrial fibrillation.

if your liver function is severely reduced or you have a life-threatening liver disease.

• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral ciclosporin, a medicine used to prevent organ rejection after a transplant.

if you are taking dronedarone, a medicine used to treat irregular heartbeat.

• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warnings and precautions

Tell your doctor before you start taking this medicine. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

Tell your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• if you have recently had bleeding.
• if you have had a surgical removal of tissue (biopsy) in the last month.
• if you have had a serious injury (e.g. a bone fracture, a head injury or any injury that required surgical treatment).

• if you have inflammation of the oesophagus or stomach.
• if you have problems with acid reflux from the stomach into the oesophagus.
• if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Bigetra" below.

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

if you have a heart infection (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 coloured urine).

if you are over 75 years old.

• if you are an adult patient and weigh 50 kg or less.
• only if used in children: if the child has a brain infection or an infection around the brain.

• If you have had a heart attack or if you have been diagnosed with diseases 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 this case.

Be careful with Bigetra

• If you need to have surgery:

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

• If surgery requires the insertion of a catheter or an injection into the spinal column (e.g. for epidural or spinal anaesthesia or for pain relief):

• It is very important that you take dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the anaesthesia has ended, as this situation requires urgent attention.

if you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.

• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor so that they can decide whether it is necessary to modify your treatment.

Other medicines and Bigetra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you must tell 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 the treatment of fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin

• Medicines used to treat irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines that contain verapamil, your doctor may tell you to use a reduced dose of this medicine according to the disease for which it has been prescribed. See section 3.

• Medicines for the prevention of organ rejection after a transplant (e.g. tacrolimus, ciclosporin)

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 medicine for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g. ritonavir)
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of dabigatran etexilate on pregnancy and the fetus are not known. You should not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breast-feeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive and use machines.

3. How to take Bigetra

Dabigatran etexilate capsules can be used in adults and children aged 8 years and older who are able to swallow the capsules whole.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

Take Bigetra as recommended for the following situations:

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and treatment of deep vein thrombosis and pulmonary embolism, including prevention of recurrent deep vein thrombosis and pulmonary embolism

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

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

If you are taking medicines that contain verapamil, you should be given 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 a dose of 220 mg given as one 110 mg capsule twice daily.

You can continue taking this medicine if you need to restore your normal heartbeat through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilate as told by your doctor.

If you have been fitted with a medical device (vascular endoprosthesis) in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis, you may receive treatment with dabigatran etexilate once your doctor has decided that normal blood clotting control has been achieved. Take dabigatran etexilate as told by your doctor.

Treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrent deep vein thrombosis and pulmonary embolism 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 every day. The administration interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue using all other medicines unless your doctor tells you to stop using any.

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.

Doses that require 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 Bigetra

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 to take only its contents, as this may increase the risk of bleeding.

Changing anticoagulant treatment

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

If you take more Bigetra than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bigetra

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

A forgotten dose should be omitted if the time before the next dose is less than 6 hours.

Do not take a double dose to make up for forgotten doses.

If you stop taking Bigetra

Take dabigatran etexilate exactly as prescribed. Do not stop your treatment with this medicine without consulting your doctor first, 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 other 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 all people suffer from them.

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

Episodes of major or severe bleeding may occur, which are the most serious adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional 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 that causes

difficulty breathing or dizziness.

Possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of vascular cerebral or systemic obstruction by blood clot formation

developed after abnormal heart rhythm

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

• Bleeding may occur through the nose, in the stomach or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling like vomiting

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

• Bleeding
• Bleeding may occur from hemorrhoids, the rectum, or the brain
• Formation of hematomas
• Coughing up blood or sputum with blood stains
• 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 skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastroesophageal reflux
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein

• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of leukocytes (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 your legs and lungs, including

prevention of blood clots in the veins of your legs and/or lungs from recurring

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

• Bleeding may occur through the nose, in the stomach or intestine, from the rectum, from the penis/vagina or urinary tract (including blood in the urine that stains 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 in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood stains
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Gastroesophageal reflux
• Feeling like vomiting
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur at the site of a surgical incision, or at the site of an injection, or at the site of a catheter in a vein or from the brain

• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and 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 leukocytes (which help fight infections)
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems
• 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 patients treated with placebo.

Treatment of blood clots and prevention of blood clots from recurring 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, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nosebleeds
• Gastroesophageal reflux
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of leukocytes (which help fight infections)
• Bleeding may occur in the stomach or intestine, from the brain, from the rectum, from the penis/vagina or urinary tract (including blood in the urine that stains 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 sputum with blood stains
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

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

• Absence of leukocytes (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in liver function tests

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bigetra

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

Do not use this medicine after the expiration date stated on the carton or blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bigetra

The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (in the form of mesilate).

The other ingredients are tartaric acid, arabic gum, hypromellose, dimethicone, talc, and hydroxypropylcellulose.

The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E171), indigo carmine (E132), water, and hypromellose.

The black printing ink contains shellac, iron oxide black (E172), and potassium hydroxide.

Appearance of the Product and Package Contents

Bigetra 150 mg is presented in the form of hard capsules with a blue opaque cap with "D150" printed in black and a white opaque body, which contain yellowish granules.

This medicine is presented in cardboard boxes containing 30, 60, 100, or 180 hard capsules in Poliamide/Aluminum/PVC//Aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus: February 2024

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