Bigetra

Package Leaflet: Information for the Patient

Bigetra, 150 mg, Hard Capsules

Dabigatran Etexilate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Pack 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 involves blocking a 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 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 problem 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 years 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 major bleeding (e.g., stomach ulcer, brain injury or bleeding, 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, or when heparin is administered to maintain catheter patency or restore normal heart function through 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 used to prevent organ rejection.
• 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 fitted with an artificial heart valve that requires continuous anticoagulation.

Warnings and Precautions

Before starting treatment with Bigetra, discuss it with your doctor. If you have experienced symptoms or undergone surgery during treatment with this medicine, consult your 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 experienced bleeding.
• if the patient has undergone 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 esophageal or stomach inflammation.
• if the patient has stomach contents flowing back into the esophagus.
• if the patient is taking medicines that may increase the risk of bleeding. See "Bigetra and Other Medicines" below.
• if the patient is taking anti-inflammatory or pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• if the patient has a heart infection (bacterial endocarditis).
• if the patient has reduced kidney function or is dehydrated (feeling thirsty and producing less 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 heart attack or if the patient has been diagnosed with a disease that increases the risk of a heart attack.
• if the patient has liver disease that affects blood test results. In such cases, the use of this medicine is not recommended.

When to be Particularly Careful When Taking Bigetra

• if the patient needs to undergo surgery: In such cases, it is necessary to discontinue the use of 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 prescribed by the doctor.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or to relieve pain):
• It is very important to take Bigetra before and after surgery exactly as prescribed by the doctor.
• The patient should immediately inform the doctor if they experience numbness or weakness in 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 determine 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 your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor before taking Bigetra if you are taking any of the following
medicines:

• Medicines that prevent 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 they are used only on the skin.
• Medicines used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medicines containing verapamil, the doctor may recommend a lower dose of Bigetra, depending on the disease for which the medicine was prescribed. See section 3.
• Medicines used to prevent organ rejection (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 or noradrenaline 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.
Do not breastfeed while taking Bigetra.

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 years or older who can swallow the capsules whole.
This medicine should always be taken exactly as prescribed by the doctor. If you are unsure, consult your doctor.

Take Bigetra as Follows:

To prevent blood clots in the brain and body by preventing the formation of clots that occur during abnormal heart function and to 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.
The recommended dose is 300 mg taken in the form of one 150 mg capsule twice a day.
In patients aged 80 years or older, the recommended dose of Bigetra is 220 mg taken in the form of one 110 mg capsule twice a day.
Patients taking medicines containing verapamilshould receive a reduced dose of Bigetra to 220 mg taken in the form of one 110 mg capsule twice a daydue to the possible increased risk of bleeding.
In patients with potentially increased risk of bleeding, the doctor may recommend a dose of 220 mg taken in the form of one 110 mg capsule twice a day.
Treatment with this medicine can be continued if the patient needs to restore normal heart function through a procedure called cardioversion or through a procedure called catheter ablation in atrial fibrillation. Bigetra should be taken as prescribed 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 confirmed that blood clotting is under control. Bigetra should be taken as prescribed 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 recommends stopping any of them.
Table 1 shows the single and total daily doses of Bigetra in milligrams (mg).
Doses are based on the patient's weight in kilograms (kg) and age in years.
Table 1:
Bigetra Capsule Dosing Table

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 Medication

Do not change anticoagulant medication without receiving detailed instructions from your doctor.

Taking a Higher Dose of Bigetra than Recommended

Taking too much of this medicine increases the risk of bleeding. If you have taken too many capsules, contact your doctor immediately. Specific treatments are available.

Missing a Dose of Bigetra

A missed dose can be taken up to 6 hours before the next scheduled dose.
If there are less than 6 hours until the next scheduled dose, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Treatment with Bigetra

Bigetra should be taken as prescribed by the doctor. Do not stop taking this medicine without consulting your doctor first, as the risk of blood clot formation may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Bigetra.
If you have any further questions about the use of this medicine, ask your 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. Major or severe bleeding can 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 by itself or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your 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 difficulty breathing or dizziness, contact your doctor immediately.
The following side effects are possible:

• Bleeding may occur from the nose, into the stomach or intestines, from the penis/vagina or urinary tract (including urine discolored pink or red due to the presence of blood), or bleeding under the skin
• Decrease in red blood cell count
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Nausea

The following side effects are also possible:

• Bleeding
• Bleeding may occur from hematomas, from the rectum, or into the brain
• Formation of hematomas
• Coughing up blood or sputum discolored with 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 or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal and stomach inflammation
• Reflux of stomach contents into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormal liver function test results

The following side effects are also possible:

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

The following side effects are also possible:

• Breathing difficulties or wheezing
• Decrease in white blood cell count (which help fight infections)
• Hair loss

In clinical trials, the number of heart attacks in patients taking Bigetra was higher than in patients taking warfarin. The overall number of events was small.
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 following side effects are possible:

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

The following side effects are also possible:

• Bleeding
• Bleeding may occur into a joint or due to injury
• Bleeding may occur from hematomas
• Decrease in red blood cell count
• Formation of hematomas
• Coughing up blood or sputum discolored with blood
• Allergic reaction
• Sudden change in skin color or appearance
• Itching
• Stomach or intestinal ulcers (including esophageal ulcers)
• Esophageal and stomach inflammation
• Reflux of stomach contents into the esophagus
• Nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormal liver function test results
• Increased liver enzyme activity

The following side effects are also possible:

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

The following side effects are also possible:

• Breathing difficulties or wheezing
• Decrease in hemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell count
• Decrease in white blood cell count (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 low.
Treatment of blood clots and prevention of recurrence of blood clots in children
The following side effects are possible:

• Decrease in red blood cell count
• Decrease in platelet count
• Skin rash in the form of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin color or appearance
• Formation of hematomas
• Nosebleeds
• Reflux of stomach contents into the esophagus
• Vomiting
• Nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzyme activity

The following side effects are also possible:

• 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 discolored pink or red 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 blood cell count
• Itching
• Coughing up blood or sputum discolored with blood
• Abdominal pain or stomach pain
• Esophageal and stomach inflammation
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes due to liver or blood disease

The following side effects are also possible:

• Lack of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Breathing difficulties or wheezing
• Bleeding
• Bleeding may occur into a joint, from a wound, from a surgical wound, from an injection site, or from a catheter insertion site into a vein
• Bleeding may occur from hematomas
• Stomach or intestinal ulcers (including esophageal ulcers)
• Abnormal liver function test results

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 will help to gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to Store 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 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 package 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 Pack and Other Information

What Bigetra Contains

• The active substance is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, arabic gum, dried dispersion, hypromellose 15cP, dimethicone, 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.

What Bigetra Looks Like and Contents of the Pack

Bigetra 150 mg is a hard capsule with a blue, opaque cap with a black print "D150" and a white, opaque body, filled with yellowish pellets.
This medicine is available in packs containing 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
phone: 22 732 77 00

Manufacturer

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

Date of Last Revision of the Leaflet: