Bigetra 110 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bigetra 110 mg hard capsules EFG

dabigatran etexilate

Read the entire 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

What Bigetra is and what it is used for
What you need to know before taking Bigetra
How to take Bigetra
Possible side effects
How to store Bigetra
Contents of the pack and other information

1. What Bigetra is and what it is 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 blood clotting.

Dabigatran etexilate is used in adults for:

preventing the formation of blood clots in the veins after knee or hip replacement surgery.
preventing the formation of blood clots in the brain (stroke) and in other blood vessels in 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 recurrence of blood clots in the veins of your legs and lungs.

Dabigatran etexilate is used in children 8 years of age and older for:

treating blood clots and preventing blood clots from recurring.

2. What you need to know before taking Bigetra

Do not take Bigetra

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 your body that increases the risk of serious bleeding

(e.g., stomach ulcer, brain injury or bleeding, recent surgery of the brain or eyes).

if you are prone to bleeding. This tendency may be congenital, 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 anticoagulant treatment,

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 reduced or 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 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 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 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 acid into the esophagus).
if you are receiving 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 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 and weigh 50 kg or less.
only when used in children: if the child has an infection in or 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. Use of

this medicine is not recommended in this case.

Take special care with Bigetra

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 at the times instructed by your doctor.

If surgery requires placement of a catheter or injection into the spinal column (e.g., for epidural or spinal anesthesia or pain relief):
It is very important that you take dabigatran etexilate before and after surgery exactly at the times instructed by your doctor.
Inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after anesthesia ends, as this situation requires urgent medical attention.
If you fall or are 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 treatment adjustment may be necessary.

Other medicines and Bigetra

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 to treat fungal infections (e.g., ketoconazole, itraconazole), except when applied only to the skin
Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of this medicine 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 fetus are unknown. You should not use this medicine during pregnancy unless your doctor tells you 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 use of 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 or older who are able to swallow the capsules whole.

Always follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor again.

Take Bigetra as recommended for the following situations:

Prevention of blood clots after knee or hip replacement surgery

The recommended dose is 220 mg once daily (administered as 2 capsules of 110 mg).

If your renal function is reduced by more than half, or if you are 75 years of age or older, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

If you are taking medications containing verapamil and your renal function is reduced by more than half, you should be prescribed a reduced dose of dabigatran etexilate of 75 mg, because your risk of bleeding may increase.

In both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should begin with 2 capsules once daily.

After knee replacement surgery

Begin treatment with dabigatran etexilate 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 10 days.

After hip replacement surgery

Begin treatment with dabigatran etexilate 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 28–35 days.

Prevention of stroke or systemic embolism due to blood clots caused by irregular heartbeat, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of such clots

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, because your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 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. Take dabigatran etexilate exactly as directed by your doctor.

If you have had a medical device (vascular stent) placed in a blood vessel to keep it open 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 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 taking any of them.

Table 1 shows the single doses 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: Dosing table for dabigatran etexilate capsules

Weight/Age combinations	Single dose in mg	Total daily dose in mg
Weight in kg	Age in years
11 to less than 13 kg	8 to less than 9 years	75	150
13 to less than 16 kg	8 to less than 11 years	110	220
16 to less than 21 kg	8 to less than 14 years	110	220
21 to less than 26 kg	8 to less than 16 years	150	300
26 to less than 31 kg	8 to less than 18 years	150	300
31 to less than 41 kg	8 to less than 18 years	185	370
41 to less than 51 kg	8 to less than 18 years	220	440
51 to less than 61 kg	8 to less than 18 years	260	520
61 to less than 71 kg	8 to less than 18 years	300	600
71 to less than 81 kg	8 to less than 18 years	300	600
81 kg or more	10 to less than 18 years	300	600

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 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 and 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. 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: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bigetra

Prevention of blood clots after knee or hip replacement surgery

Take the remaining daily doses of dabigatran etexilate at the same time on the following day.

Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of stroke or systemic embolism due to blood clots 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

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

A missed dose may 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 a missed dose.

If you stop taking Bigetra

Take dabigatran etexilate exactly as prescribed. Do not stop treatment with this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped 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 bleeding episodes 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 bleeding episode 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 blood clots after knee or hip replacement surgery

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

Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
Abnormal liver function tests

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

Bleeding from the nose, stomach or intestines, penis/vagina, or urinary tract (including blood in urine turning urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or from or after an injury or surgery
Formation of bruises or bruising after surgery
Detection of blood in stool in a laboratory test
Decrease in the number of red blood cells in the blood
Decrease in the proportion of blood cells
Allergic reaction
Vomiting
Frequent loose or watery stools
Feeling nauseous
Wound discharge (leakage of fluid from a surgical wound)
Increased liver enzymes
Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

Bleeding
Bleeding may occur in the brain, at the site of a surgical incision, at the injection site, or at the site where a venous catheter was inserted
Blood-tinged discharge from the site where a venous catheter was inserted
Coughing up blood or sputum with blood streaks
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 with dark red, raised, itchy bumps caused by an allergic reaction
Sudden change in the skin affecting color and physical appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juice into the esophagus
Abdominal pain or stomach pain
Indigestion
Difficulty swallowing
Fluid leaking from a wound
Fluid leaking from a wound after surgery

Frequency 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

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

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

Bleeding from the nose, stomach or intestines, penis/vagina, urinary tract (including blood in urine turning 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 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 sputum with blood streaks
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
Stomach or intestinal ulcer (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, at a wound, at an injection site, or at the site where a venous catheter was inserted
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 problems

Frequency 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 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 recurrence of blood clots in the veins of your legs and/or lungs

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

Bleeding from the nose, stomach or intestines, rectum, penis/vagina, urinary tract (including blood in urine turning 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 sputum with blood streaks
Allergic reaction
Sudden change in the skin affecting color and physical appearance
Itching
Stomach or intestinal ulcer (including esophageal ulcer)
Inflammation of the esophagus and stomach
Reflux of gastric juice into the esophagus
Feeling nauseous
Vomiting
Abdominal pain or stomach pain
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 an injection site, at the site where a venous catheter was inserted, 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 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 problems
Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarina. 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 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 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 from the stomach or intestines, brain, rectum, penis/vagina, urinary tract (including blood in urine turning 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 streaks
Abdominal pain or stomach pain
Inflammation of the esophagus and stomach
Allergic reaction
Difficulty swallowing
Yellowing 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 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, surgical incision, injection site, or site where a venous catheter was inserted
Bleeding may occur from hemorrhoids
Stomach or intestinal ulcer (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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 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 light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bigetra

The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).

The other components 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, black iron oxide (E172) and potassium hydroxide.

Nature of the product and contents of the container

Bigetra 110 mg is presented as hard capsules with an opaque blue cap printed with "D110" in black and an opaque blue body, containing yellowish granules.

This medicine is available in cardboard boxes containing 10, 30, 60, 100 or 180 hard capsules in blisters made of Polyamide/Aluminum/PVC//Aluminum.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jósefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

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

Poland	Bigetra
Germany	Bigetra
Italy	Bigetra
Spain	Bigetra 110 mg hard capsules EFG
Latvia	Bigetra 110 mg hard capsules
Hungary	Bigetra 110 mg hard capsule

Date of the most recent review of this leaflet: February 2024

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