Prabixan

Package leaflet: Information for the patient

PRABIXAN, 75 mg, hard capsules
dabigatran etexilate
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Prabixan is and what it is used for

Prabixan contains dabigatran etexilate as the active substance and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is responsible for blood clot formation.
Prabixan is used in adults for:

• prevention of blood clots in veins following hip or knee replacement surgery.

Prabixan is used in children for:

• treatment of blood clots and prevention of recurrence of blood clots.

2. Important information before taking Prabixan

When not to take Prabixan

• 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 renal impairment.
• if the patient is currently experiencing bleeding.
• if the patient has a disease of any internal organ that increases the risk of major bleeding (e.g. gastric ulcer, brain injury or intracranial hemorrhage, recent brain or eye surgery).
• if the patient has an increased tendency to bleed, which may be congenital, of unknown cause, or caused by taking other medicines.
• if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching anticoagulant therapy, inserting a venous or arterial catheter with heparin administered through the catheter to maintain its patency, or restoring normal heart rhythm using a procedure called catheter ablation for atrial fibrillation.
• if the patient has severe hepatic impairment or liver disease that may 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 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 fixed-dose combination medicine containing glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C virus infection.
• if the patient has had a mechanical heart valve implanted, which requires lifelong anticoagulant therapy.

Warnings and precautions
Before starting treatment with Prabixan, discuss this with your doctor. If symptoms occur during treatment with this medicine or if the patient has undergone surgery, consult a doctor.
The patient should inform the doctor if they currently have or have previously 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 a surgical tissue biopsy within the last month.
  • if the patient has suffered a serious injury (e.g. bone fracture, head injury, or any injury requiring surgical treatment).
  • if the patient has inflammation of the oesophagus or stomach.
  • if the patient has gastro-oesophageal reflux (backflow of stomach acid into the oesophagus).
  • if the patient is taking medicines that may increase the risk of bleeding. See below “Prabixan with other medicines”.
  • if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, ibuprofen, piroxicam.
  • if the patient has an infection in the heart (bacterial endocarditis).
  • if the patient has reduced kidney function or is dehydrated (feeling thirsty and passing reduced amounts of dark [concentrated] and/or foamy urine).
  • if the patient is over 75 years of age.
  • if the patient is an adult weighing 50 kg or less.
  • only when used in children: if the child has an infection around or within the brain.
• if the patient has had a previous heart attack or has conditions that increase the risk of heart attack.
• if the patient has liver disease affecting blood test results. In such cases, use of this medicine is not recommended.

Special caution is required when taking Prabixan

• if the patient needs to undergo surgery: In such cases, temporary discontinuation of Prabixan is necessary due to the increased risk of bleeding during and immediately after surgery. It is very important to take Prabixan exactly as directed by the doctor before and after surgery.
• if surgery requires insertion of a catheter or administration of a spinal injection (e.g. for epidural or spinal anaesthesia or pain relief):
  • It is very important to take Prabixan exactly as directed by the doctor before and after surgery.
• Immediately inform the doctor if, after the anaesthetic wears off, the patient experiences numbness or weakness in the lower limbs or bowel or bladder dysfunction, as urgent medical care is required.
  • if the patient falls or sustains an injury during treatment, especially if the head is injured. Immediate medical attention is required. The doctor will assess whether there may be an increased risk of bleeding.
  • if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment needs to be changed.

Prabixan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, tell the doctor before taking Prabixan 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 are applied only to the skin.
• Medicines used to treat heart rhythm disorders (e.g. amiodarone, dronedarone, quinidine, verapamil). For patients taking medicines containing amiodarone, quinidine or verapamil, the doctor may recommend a lower dose of Prabixan depending on the condition for which the medicine has been prescribed. See also section 3.
• Medicines used to prevent rejection of transplanted organs (e.g. tacrolimus, cyclosporine).
• A fixed-dose combination medicine containing glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C virus infection).
• 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 known as selective serotonin reuptake inhibitors or serotonin-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
It is not known what effect Prabixan has on pregnancy or the unborn child. Do not take this medicine during pregnancy unless the doctor considers it safe. Women of childbearing potential should avoid becoming pregnant while taking Prabixan.
Breastfeeding must not be undertaken during treatment with Prabixan.

Driving and using machines
Prabixan has no effect or has a negligible effect on the ability to drive and use machines.

3. How to take Prabixan

Prabixan capsules can be used in adults and children aged 8 years or older who are able to swallow capsules whole. Other age-appropriate formulations are available for treating children under 8 years of age.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Take Prabixan exactly as directed below:
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).
If renal function is reduced by more than half, or in patients aged 75 years or older, the recommended dose is 150 mg once daily (taken as 2 capsules of 75 mg).
In patients taking medicines containing amiodarone, quinidine, or verapamil, the recommended dose of Prabixan is 150 mg once daily (taken as 2 capsules of 75 mg).
Patients taking medicines containing verapamil who also have reduced renal function by more than half should take a reduced dose of Prabixan of 75 mg due to an increased risk of bleeding.
In both types of surgery, treatment should not be started if there is bleeding from the surgical site. If treatment cannot be initiated by the next day after surgery, it should be started at a dose of 2 capsules once daily.
After knee replacement surgery
Treatment with Prabixan should be initiated by taking one capsule within 1 to 4 hours after surgery. Then take 2 capsules once daily for a total of 10 days.
After hip replacement surgery
Treatment with Prabixan should be initiated by taking one capsule within 1 to 4 hours after 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
Prabixan should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The interval between doses should ideally be 12 hours.
The recommended dose depends on body weight and age. Your doctor will determine the correct dose and may adjust it during treatment. Continue taking all other medications unless your doctor advises otherwise.
Table 1 shows the single and total daily doses of Prabixan in milligrams (mg).
Doses depend on the patient's body weight in kilograms (kg) and age in years.
Table 1: Dosing table for Prabixan capsules

Single doses requiring a combination 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 Prabixan
Prabixan can be taken with or without food. The capsules should be swallowed whole,
with a glass of water, to help them pass into the stomach. Do not break, chew or empty the pellets from the capsule, as this may increase the risk of bleeding.

Instructions for opening blisters
The pictogram below shows how to remove Prabixan capsules from the blister pack.

Separate the required single dose along the perforated line.
Peel back the protective foil from the blister and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the foil until the capsule is needed.

Switching anticoagulant medication
Do not switch anticoagulant medication without first receiving detailed instructions from your doctor.

Taking more Prabixan than prescribed
Taking too high a dose of this medicine increases the risk of bleeding. If a patient has taken too many capsules, contact a doctor immediately. Specific treatment methods are available.

Missed dose of Prabixan
Prevention of blood clots after hip or knee replacement surgery
Continue taking the missed daily dose of Prabixan at the same time the next day.
Do not take a double dose to make up for a missed dose.

Treatment of blood clots and prevention of recurrent blood clots in children
A missed dose may be taken up to 6 hours before the next scheduled dose.
If less than 6 hours remain before the next scheduled dose, the missed dose should not be taken.
Do not take a double dose to make up for a missed dose.

Stopping Prabixan
Prabixan should be taken as directed by the doctor. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely. Contact your doctor if you experience indigestion after taking Prabixan.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Prabixan affects the blood clotting system, so most side effects are related to symptoms such as bruising or bleeding. Severe or extensive bleeding may occur, which is the most serious side effect and, regardless of location, may lead to disability, be life-threatening, or even result in death. In some cases, these bleedings may not be visible.
If you experience bleeding that does not stop spontaneously, or symptoms of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately. Your doctor may decide to place you under close monitoring or change your treatment.
In case of a serious allergic reaction, which may cause difficulty breathing or dizziness, contact your doctor immediately.

Possible side effects listed below are categorized by their frequency of occurrence:

Prevention of blood clots after hip or knee replacement surgery

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

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

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

• Bleeding may occur from the nose, stomach or intestines, penis/vagina or urinary tract (including pink or red urine due to presence of blood), from haemorrhoids, rectum, under the skin, into joints, due to injury or following injury or surgery
• Formation of haematomas or bruising occurring after surgery
• Blood in stool detected in laboratory tests
• Decrease in the number of red blood cells in the blood
• Decrease in blood cell fraction
• Allergic reaction
• Vomiting
• Frequent passage of loose or watery stools
• Nausea
• Discharge from the wound (fluid leakage from the surgical wound)
• Increased liver enzyme activity
• Yellowing of the skin or whites of the eyes caused by liver or blood disease.

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

• Bleeding
• Bleeding into the brain, from the surgical incision site, injection site, or site of intravenous catheter insertion
• Blood-tinged discharge from the site of intravenous catheter insertion
• Coughing up blood or blood-stained sputum
• 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Itching
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Inflammation of the oesophagus and stomach
• Regurgitation of stomach contents into the oesophagus (reflux)
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid discharge from the wound
• Fluid discharge from the surgical wound.

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.

Treatment 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 consisting of dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in skin colour and appearance
• Formation of haematomas
• Nosebleeds
• Regurgitation of stomach contents into the oesophagus (reflux)
• Vomiting
• Nausea
• Frequent passage of loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzyme activity.

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur into the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including pink or red urine due to presence of blood), or under the skin
• Decrease in haemoglobin levels in the blood (a substance in red blood cells)
• Decrease in blood cell fraction
• Itching
• Coughing up blood or blood-stained sputum
• Abdominal pain or stomach pain
• Inflammation of the oesophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes caused by liver or blood disease.

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 into joints, from wounds, surgical incision sites, injection sites, or sites of intravenous catheter insertion
• Bleeding from haemorrhoids
• Stomach or intestinal ulcer (including oesophageal ulceration)
• Abnormal liver function test results.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Prabixan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Doing so will help protect the environment.

6. Contents of the pack and other information

What Prabixan contains

• The active substance is dabigatran. Each hard capsule contains 75 mg of dabigatran etexilate (as mesylate).
• The other ingredients are: tartaric acid, arabic gum, hypromellose 2910, dimethicone 350, talc and hydroxypropylcellulose.
• The capsule shell contains carrageenan, potassium chloride, titanium dioxide (E 171), purified water and hypromellose 2910.
• The black printing ink contains shellac, iron oxide black (E 172) and potassium hydroxide.

What Prabixan looks like and contents of the pack
Prabixan 75 mg is a hard capsule (approximately 18 × 6 mm) with an opaque white cap and an opaque white body. The imprint “75” is printed on the body of the hard capsule.
The medicine is available in packs containing 10, 30 or 60 hard capsules in blisters made of OPA/Aluminium/PVC//Aluminium foil, packed in a cardboard box.
Unit dose blister:
This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules in perforated, unit-dose blisters made of OPA/Aluminium/PVC//Aluminium foil of the "peel off" type, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer
Laboratori Fundacio Dau
Poligono Industrial Zona - De La Zona Franca De Barcelona
Carrer Lletra C De La Zona Franca 12-14
08040 Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: PRABIXAN 75mg capsules