Bigetra

Package Leaflet: Information for the Patient

Bigetra, 75 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 medication 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 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 blood clot formation.
Bigetra is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery.

Bigetra is used in children aged 8 years and older to:

• treat blood clots and prevent recurrent blood clots.

2. Important information before taking Bigetra

When not to take Bigetra

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you are currently bleeding.
• if you have 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 you have an increased tendency to bleed. It can be congenital, of unknown cause, or caused by the use of other medications.
• if you are taking anticoagulant medications (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 maintain catheter patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.
• if you have severe liver problems or liver disease that can lead to death.
• if you are taking oral ketoconazole or itraconazole, medications used to treat fungal infections.
• if you are taking oral cyclosporine, a medication used to prevent transplant rejection.
• if you are taking dronedarone, a medication used to treat heart rhythm disorders.
• if you are taking a combination medication containing glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitis C.
• if you have a mechanical 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 while taking this medication, consult your doctor.
The patient should inform the doctorif they have or have had any medical conditions or diseases, especially those listed below:

• if you have an increased risk of bleeding, such as:
• if you have recently experienced bleeding.
• if you have undergone surgical biopsy within the last month.
• if you have had a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
• if you have esophagitis or gastritis.
• if you have gastroesophageal reflux disease.
• if you are taking medications that may increase the risk of bleeding. See "Bigetra and other medications" below.
• if you are taking anti-inflammatory medications, such as diclofenac, ibuprofen, piroxicam.
• if you have infective endocarditis (bacterial infection of the heart).
• if you have reduced kidney function or are dehydrated (feeling thirsty and producing a small amount of dark, concentrated urine).
• if you are over 75 years old.
• if you are an adult and weigh 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 history of myocardial infarction or if you have been diagnosed with a disease that increases the risk of myocardial infarction.
• if you have liver disease affecting blood test results. In such cases, the use of this medication is not recommended.

When to exercise special caution when taking Bigetra

• if you need to undergo surgery: In this case, 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 your doctor has instructed.
• if the surgical procedure requires the insertion of a catheter or injection into the spine (e.g., for epidural or spinal anesthesia or to reduce pain):
• It is very important to take Bigetra before and after surgery exactly as your doctor has instructed.
• You should immediately inform your doctor if you experience numbness or weakness in your lower limbs or problems with your bowels or bladder after the anesthesia has worn off, as urgent medical attention is required.
• if you have fallen or injured yourself during treatment, especially if you have injured your head. You should seek medical attention immediately. Your doctor will examine you to determine if you are at increased risk of bleeding.
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

Bigetra and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. In particular, before taking Bigetra, tell your doctor if you are taking any of the following medications:

• Anticoagulant medications (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, aspirin).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole), unless they are used only on the skin.
• Medications used to treat heart rhythm disorders (e.g., amiodarone, dronedarone, quinidine, verapamil). In patients taking medications containing amiodarone, quinidine, or verapamil, the doctor may recommend a lower dose of Bigetra, depending on the disease for which it was prescribed. See also section 3.
• Medications used to prevent transplant rejection (e.g., tacrolimus, cyclosporine).
• A combination medication containing glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitis C).
• Anti-inflammatory and pain medications (e.g., aspirin, ibuprofen, diclofenac).
• St. John's Wort, a herbal remedy used to treat depression.
• Antidepressant medications called selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (both antibiotics).
• Antiviral medications used to treat AIDS (e.g., ritonavir).
• Certain medications used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effect of Bigetra on pregnancy and the unborn child is not known. You should not take this medication during pregnancy unless your 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 and older who can swallow capsules whole.
This medication should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor.

Take Bigetra exactly as follows:

Prevention of blood clots after hip or knee replacement surgery
The recommended dose is 220 mg once daily(taken as 2 capsules of 110 mg each).
If kidney function is reducedby more than half or if you are 75 years old or older, the recommended dose is 150 mg once daily(taken as 2 capsules of 75 mg each).
In patients taking medications containing amiodarone, quinidine, or verapamil, the recommended dose of Bigetra is 150 mg once daily(taken as 2 capsules of 75 mg each).
Patient taking verapamil-containing medications, with reduced kidney functionof more than half, should take a reduced dose of 75 mgof Bigetra due to increased bleeding risk.
In both types of surgery, do not start treatment if there is bleeding from the surgical site. If it is not possible to start treatment the day after surgery, start with a dose of 2 capsules once daily.
After knee replacement surgery
Take Bigetra starting with one capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Take Bigetra starting with one capsule within 1 to 4 hours after the end of surgery. Then, take 2 capsules once daily for a total of 28 to 35 days.
Treatment of blood clots and prevention of recurrent blood clots in children
Take Bigetra twice daily, 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 body weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue to take all other medications unless your doctor instructs you to stop taking 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 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. Swallow the capsules whole with a glass of water to help them reach the stomach. Do not crush, chew, or open the capsules, as this may increase the risk of bleeding.

Changing anticoagulant medication

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

Taking more than the recommended dose of Bigetra

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

Missing a dose of Bigetra

Prevention of blood clots after hip or knee replacement surgery
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.
Treatment of blood clots and prevention of recurrent blood clots in children.
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 the missed dose.

Stopping Bigetra treatment

Bigetra should be taken exactly as your doctor has instructed. Do not stop taking this medication without consulting your doctor first, as the risk of blood clots 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, 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 the location. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop on its own or symptoms of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to monitor you closely or change your medication.
If you experience a severe allergic reaction that can cause difficulty breathing or dizziness, contact your doctor immediately.
Side effects are grouped by frequency below:

• Frequent (may affect up to 1 in 10 people):
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Abnormal liver function test results

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

• Bleeding may occur from the nose, stomach, or intestines, brain, anus, penis/vagina, or urinary tract (including urine discoloration due to blood presence), or bleeding under the skin
• Formation of hematomas or bruising after surgery
• Blood in the stool detected by laboratory tests
• Decreased red blood cell count
• Decreased blood cell count
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Nausea
• Wound secretion
• Increased liver enzyme activity
• Jaundice or yellowing of the skin and eyes due to liver or blood disease

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

• Bleeding
• Bleeding into the brain, from the surgical site, injection site, or catheter insertion site
• Blood-tinged secretion from the catheter insertion site
• Coughing up blood or blood-tinged sputum
• Decreased platelet count
• Decreased red blood cell count after surgery
• 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
• Sudden change in skin color and appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulceration)
• Esophagitis and gastritis
• Reflux
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Wound secretion
• Postoperative wound secretion

Unknown frequency (cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decreased or absent white blood cell count (which helps fight infections)
• Hair loss

Treatment of blood clots and prevention of recurrent blood clots in children
Frequent (may affect up to 1 in 10 people):

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

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

• Decreased white blood cell count (which helps fight infections)
• Bleeding into the stomach, brain, anus, penis/vagina, or urinary tract (including urine discoloration due to blood presence), or bleeding under the skin
• Decreased hemoglobin levels in the blood (a substance in red blood cells)
• Decreased blood cell count
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal pain or stomach pain
• Esophagitis and gastritis
• Allergic reaction
• Difficulty swallowing
• Jaundice or yellowing of the skin and eyes due to liver or blood disease

Unknown frequency (cannot be estimated from available data):

• Absent white blood cell count (which helps fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing facial or throat swelling
• Difficulty breathing or wheezing
• Bleeding
• Bleeding into the joint, wound, surgical site, injection site, or catheter insertion site
• Bleeding from hematomas
• Stomach or intestinal ulcer (including esophageal ulceration)
• Abnormal liver function test results

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of 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
By reporting side effects, you can help provide more information on the safety of this medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bigetra

Store the medication out of sight and reach of children.
Do not use this medication 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 stated.
Do not store above 30°C. Store in the original package to protect from light and moisture.
Medications should not be disposed of via wastewater. Ask your pharmacist how to dispose of medications that are no longer needed. 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 75 mg of dabigatran etexilate (as mesylate).
• 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), 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 75 mg is a hard capsule with a white, opaque cap with black printing "D75" and a white, opaque body, filled with yellowish pellets.
This medication is available in packs containing 30 or 60 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: