Bigetra

Leaflet accompanying the packaging: patient information

Bigetra, 110 mg, hard capsules

Dabigatran etexilate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bigetra and what is it used for
• 2. Important information before taking Bigetra
• 3. How to take Bigetra
• 4. Possible side effects
• 5. How to store Bigetra
• 6. Contents of the packaging and other information

1. What is Bigetra and what is it used for

Bigetra contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. Its action is based on blocking the substance in the body responsible for the formation of blood clots.
Bigetra is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.
• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve defect and at least one additional risk factor.
• treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Bigetra is used in children aged 8 and older to:

• treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Bigetra

When not to take Bigetra

• if the patient is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney problems.
• if the patient is currently bleeding.
• if the patient has a disease of any internal organ that increases the risk of significant bleeding (e.g. stomach ulcer, brain injury or bleeding into the brain, recent brain or eye surgery).
• if the patient has an increased tendency to bleed. It may be congenital, of unknown cause or caused by the use of other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, introducing a catheter into a vein or artery, when heparin is administered to the catheter to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if the patient has severe liver problems or liver disease that can 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 that prevents the 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 combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if the patient has been implanted with an artificial heart valve that requires continuous anticoagulant therapy.

Warnings and precautions

Before starting Bigetra, discuss it with your doctor. If symptoms occurred during treatment with this medicine or the patient underwent surgery, consult a doctor.
The patient should inform the doctorif they have or have 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 had bleeding.
• if the patient has had a surgical biopsy within the last month.
• if the patient has had a serious injury (e.g. bone fracture, head injury or any injury requiring surgical treatment).
• if the patient has esophagitis or gastritis.
• if the patient has gastroesophageal reflux disease.
• if the patient is taking medicines that may increase the risk of bleeding. See below "Bigetra and other medicines".
• if the patient is taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
• if the patient has an infection of the heart (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing a reduced amount of dark (concentrated) or foamy urine).
• if the patient is over 75 years old.
• if the patient is an adult and weighs 50 kg or less.
• only in the case of use in children: if the child has an infection around or in the brain.
• in the case of a previous heart attack or if the patient has been diagnosed with a disease that increases the risk of heart attack.
• if the patient has liver disease that affects blood test results. In such a case, the use of this medicine is not recommended.

When to be particularly careful when taking Bigetra

• if the patient needs to undergo surgery: In this case, it is necessary to immediately stop taking Bigetra due to the increased risk of bleeding during and after surgery. It is very important to take Bigetra before and after surgery exactly as the doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g. for spinal or epidural anesthesia or to reduce pain):
• It is very important to take Bigetra before and after surgery exactly as the doctor has instructed.
• The patient should immediately inform the doctor if they experience numbness or weakness of the lower limbs or problems with the intestines or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if the patient has fallen or injured themselves during treatment, especially if they have injured their head. The patient should immediately seek medical attention. The doctor will examine the patient to see if there is an increased risk of bleeding.
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide whether to change the treatment.

Bigetra and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
In particular,
the doctor should be informed before taking Bigetra if the patient is 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 used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Bigetra, depending on the disease for which the medicine was prescribed to the patient. See section 3.
• Medicines that prevent the rejection of a transplanted organ (e.g. tacrolimus, cyclosporine).
• A combination medicine containing 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 used to treat depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medicines used to treat AIDS (e.g. ritonavir).
• Certain medicines used to treat epilepsy (e.g. carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Bigetra on pregnancy and the unborn child is not known. This medicine should not be taken during pregnancy unless the doctor considers it safe. Women of childbearing age should avoid becoming pregnant while taking Bigetra.
Bigetra should not be taken during breastfeeding.

Driving and using machines

Bigetra has no or negligible influence on the ability to drive and use machines.

3. How to take Bigetra

Bigetra capsules can be used in adults and children aged 8 and older who can swallow capsules whole.
This medicine should always be taken exactly as the doctor has instructed. In case of doubts, consult a doctor.

Bigetra should be taken as follows:

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
The recommended dose is 220 mg once a day(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or in patients aged 75 or older, the recommended dose is 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking medicines containing amiodarone, quinidine or verapamilshould receive a reduced dose of Bigetra, 150 mg once a day(taken as 2 capsules of 75 mg each).
Patients taking medicines containing verapamilwith reduced kidney function by more than half should take a reduced dose of Bigetra, 75 mg, due to the increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, it should be started with a dose of 2 capsules once a day.
After knee replacement surgery
Bigetra treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 10 days.
After hip replacement surgery
Bigetra treatment should be started with a dose of one capsule within 1 to 4 hours after the end of surgery. Then, 2 capsules should be taken once a day for a total of 28 to 35 days.
Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function, and treatment of blood clots in the veins of the legs and lungs, and prevention of recurrence of blood clots in the veins of the legs and lungs
The recommended dose is 300 mgtaken as one 150 mg capsule twice a day.
In patients aged 80 or older, the recommended dose is 220 mgtaken as one 110 mg capsule twice a day.
Patients taking medicines containing verapamilshould receive a reduced dose of Bigetra, 220 mgtaken as one 110 mg capsule twice a day, due to the increased risk of bleeding.
In patients with a potentially increased risk of bleeding, the doctor may recommend a dose of 220 mgtaken as one 110 mg capsule twice a day.
Treatment with this medicine can be continued if the patient needs to restore normal heart function using a procedure called cardioversion. Bigetra should be taken as instructed by the doctor.
In the case of implantation of a medical device (stent) into a blood vessel to maintain its patency using a procedure called percutaneous coronary intervention with stent implantation, the patient may receive treatment with Bigetra after the doctor has determined that adequate blood clotting control has been achieved. Bigetra should be taken as instructed by the doctor.
Treatment of blood clots and prevention of recurrence of blood clots in children
Bigetra should be taken twice a day, one dose in the morning and one dose in the evening, at approximately the same time every day. The interval between doses should be approximately 12 hours.
The recommended dose depends on the patient's weight and age. The doctor will determine the correct dose. The doctor may adjust the dose during treatment. All other medicines should be continued, unless the doctor instructs to stop taking any of them.
Table 1 shows the single and total daily doses of Bigetra in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.
Table 1: Bigetra dosing table in capsule form

Doses requiring the simultaneous administration of 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 Bigetra

Bigetra can be taken with or without food. The capsules should be swallowed whole, with a glass of water, to facilitate passage into the stomach. They should not be broken, chewed or the pellets spilled from the capsule, as this may increase the risk of bleeding.

Changing anticoagulant medicine

Do not change anticoagulant medicine without receiving detailed instructions from the doctor.

Taking a higher dose of Bigetra than recommended

Taking too much of this medicine increases the risk of bleeding. If the patient has taken too many capsules, they should immediately contact a doctor. Specific treatment methods are available.

Missing a dose of Bigetra

Prevention of blood clots after hip or knee replacement surgery (arthroplasty)
Continue taking the missed daily dose of Bigetra at the same time the next day.
Do not take a double dose to make up for the missed dose.
Use in adults: Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal heart function, and treatment of blood clots in the veins of the legs and lungs, and prevention of recurrence of blood clots in the veins of the legs and lungs
The missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours left until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Bigetra treatment

Bigetra should be taken as instructed by the doctor. Do not stop taking this medicine without consulting a doctor first, as the risk of blood clots may be higher if treatment is stopped prematurely. Consult a doctor if nausea occurs after taking Bigetra.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Bigetra can cause side effects, although not everybody gets them.
Bigetra affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Severe or heavy bleeding may occur, which is the most serious side effect and can lead to disability, be life-threatening, or even fatal, regardless of location. In some cases, these bleedings may not be visible.
In case of bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache or unexplained swelling), consult a doctor immediately. The doctor may decide to monitor the patient closely or change the medicine.
In case of a severe allergic reaction that can cause breathing difficulties or dizziness, consult a doctor immediately.
Side effects are listed below by frequency of occurrence:

• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Blood clots or bruising after surgery
• Blood in the stool, as detected by laboratory tests
• Decrease in red blood cell count
• Decrease in platelet count
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Discharge from the wound (oozing of fluid from the post-operative wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Bleeding
• Bleeding may occur into the brain, from the surgical site, from the injection site or from the catheter insertion site
• Discharge from the catheter insertion site into a vein, discolored by the presence of blood
• Coughing up blood or sputum discolored by the presence of blood
• Decrease in platelet count
• Decrease in red blood cell count after surgery
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash in the form of dark red, raised, itchy bumps, occurring as a result of an allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Abdominal pain or stomach pain
• Nausea
• Difficulty swallowing
• Discharge from the wound or post-operative wound

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

• Difficulty breathing or wheezing
• Decrease in or complete lack of white blood cells (which help fight infections)
• Hair loss

Prevention of blood clots in the brain and body, by preventing the formation of clots that occur during abnormal 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 urine discoloration due to the presence of blood), or bleeding under the skin
• Decrease in red blood cell count
• Abdominal pain or stomach pain
• Nausea
• Frequent loose or liquid stools
• Vomiting

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

• Bleeding
• Bleeding may occur from hemorrhoids, from the rectum or into the brain
• Blood clots
• Coughing up blood or sputum discolored by the presence of blood
• Decrease in platelet count
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

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

• Bleeding may occur into the joint, from the surgical site, from the wound, from the injection site or from the catheter insertion site into a vein
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash in the form of dark red, raised, itchy bumps, occurring as a result of an allergic reaction
• Decrease in platelet count
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Difficulty breathing or wheezing
• Decrease in or complete lack of white blood cells (which help fight infections)
• Hair loss

Treatment of blood clots in the veins of the legs and lungs, and prevention of recurrence of blood clots in the veins of 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 rectum, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Nausea

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

• Bleeding
• Bleeding may occur into the joint or due to injury
• Bleeding may occur from hemorrhoids
• Decrease in red blood cell count
• Blood clots
• Coughing up blood or sputum discolored by the presence of blood
• Allergic reaction
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis or gastritis
• Gastroesophageal reflux disease
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

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

• Bleeding may occur from the surgical site, from the wound, from the injection site or from the catheter insertion site into a vein, or bleeding into the brain
• Decrease in platelet count
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash in the form of dark red, raised, itchy bumps, occurring as a result of an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in or complete lack of red blood cells
• Decrease in or complete lack 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 in patients taking dabigatran was higher than in patients taking warfarin. The overall number of events was small.
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 red blood cell count
• Decrease in platelet count
• Skin rash in the form of dark red, raised, itchy bumps, occurring as a result of an allergic reaction
• Sudden change in skin color and appearance
• Blood clots
• Nosebleeds
• Gastroesophageal reflux disease
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Nausea
• Hair loss
• Increased liver enzyme activity

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

• Decrease in white blood cell count (which help fight infections)
• Bleeding may occur into the stomach or intestines, into the brain, from the rectum, from the penis/vagina or urinary tract (including urine discoloration due to the presence of blood), or bleeding under the skin
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in or complete lack of red blood cells
• Itching
• Coughing up blood or sputum discolored by the presence of blood
• Abdominal pain or stomach pain
• Esophagitis or gastritis
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

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

• Complete lack of white blood cells (which help fight infections)
• Severe allergic reaction causing breathing difficulties or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur into the joint, from the wound, from the surgical site, from the injection site or from the catheter insertion site into a vein
• Bleeding may occur from hemorrhoids.
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If side effects occur, including those not listed in this leaflet, consult a doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bigetra

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Bigetra contains

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, arabic gum, dried dispersion, hypromellose 15cP, dimeticone, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), purified water and hypromellose.
• The black ink used for printing contains shellac, iron oxide black (E 172) and potassium hydroxide.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), indigo carmine (E 132), purified water and hypromellose.

What Bigetra looks like and contents of the pack

Bigetra 110 mg is a hard capsule with a blue, opaque cap with black printing "D110" and a blue, opaque body, filled with yellowish pellets.
This medicine is available in packs of 10, 30, 60, 100 or 180 hard capsules, in aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: