Rivaroxaban Bluefish

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the user

Rivaroxaban Bluefish, 15 mg, film-coated tablets

Rivaroxaban Bluefish, 20 mg, film-coated tablets

Rivaroxabanum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Rivaroxaban Bluefish and what is it used for

This medicine contains the active substance rivaroxaban and is used in adults to

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body in case of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. This medicine is used in children and adolescents under 18 years of age with a body weight of 30 kg or more to:
• treat and prevent the recurrence of blood clots in the veins or blood vessels of the lungs, after initial treatment lasting at least 5 days with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Bluefish

When not to take Rivaroxaban Bluefish

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take Rivaroxaban Bluefish, and also inform your doctor if you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaroxaban Bluefish, consult your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Bluefish

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body,
• if the patient is taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a venous or arterial catheter (see "Rivaroxaban Bluefish and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines, or the genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Bluefish. The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.

If the patient needs to undergo surgery:

• they must strictly follow the doctor's recommendations regarding the intake of this medicine at a precisely specified time before or after surgery,
• if a spinal puncture or catheter insertion into the spine is planned during the surgical procedure (e.g. for spinal or epidural anesthesia or pain relief)
• it is very important to take Rivaroxaban Bluefish before and after the puncture or catheter removal, in accordance with the doctor's recommendations
• the patient should immediately inform their doctor if, after the anesthesia, they experience symptoms such as: numbness, weakness of the lower limbs, disturbances in bowel or bladder function, as in such cases immediate treatment is necessary.

Children and adolescents

Rivaroxaban Bluefish tablets are not recommended for children with a body weight below 30 kg. There is insufficient data on the use of this medicine in children and adolescents for adult indications.

Rivaroxaban Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

If the patient is taking:

• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Bluefish, as the action of this medicine may be enhanced. The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcer disease.

If the patient is taking:

• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking this medicine, as the action of this medicine may be reduced.
The doctor will decide whether to use this medicine or to subject the patient to particularly close monitoring.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Rivaroxaban Bluefish. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban Bluefish may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive vehicles, ride bicycles, or operate tools or machines.

Rivaroxaban Bluefish contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Rivaroxaban Bluefish

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Rivaroxaban Bluefish should be taken with food. The tablet should be swallowed whole, preferably with water.
If you have difficulty swallowing the whole tablet, you should discuss other ways of taking this medicine with your doctor. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking. After taking this mixture, you should eat a meal. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg tablet of Rivaroxaban Bluefish once a day. If you have kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban Bluefish once a day.

If the patient needs a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement) then there is limited evidence to support a dose reduction to one 15 mg tablet of Rivaroxaban Bluefish once a day (or one 10 mg tablet of Rivaroxaban Bluefish once a day in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots. The recommended dose is one 15 mg tablet of Rivaroxaban Bluefish twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Bluefish once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one 20 mg tablet of Rivaroxaban Bluefish once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg tablet of Rivaroxaban Bluefish once a day, if the risk of bleeding is greater than the risk of further blood clot formation.
• Children and adolescentsThe recommended dose of Rivaroxaban Bluefish depends on the patient's body weight and will be individually adjusted by the doctor.
• The recommended dose for children and adolescents with a body weight from 30 kg to 50 kgis one 15 mg tablet of Rivaroxaban Bluefishonce a day.
• The recommended dose for children and adolescents with a body weight above 50 kgis one 20 mg tablet of Rivaroxaban Bluefishonce a day. Each dose of Rivaroxaban Bluefish should be taken with a drink (e.g. water or juice) during a meal. Tablets should be taken daily at approximately the same time. Consider setting an alarm reminder. Parents or caregivers: you should observe the child to ensure that they have taken the full dose.

Since the dose of Rivaroxaban Bluefish depends on body weight, it is essential to follow the scheduled doctor's appointments, as the dose may need to be adjusted depending on changes in body weight.
Never adjust the dose of Rivaroxaban Bluefish yourself. If necessary, your doctor will adjust the dose.
Do not divide the tablet to get a smaller dose. If a smaller dose is required, other pharmaceutical forms are available.
In the case of children and adolescents who are unable to swallow tablets whole, another pharmaceutical form should be used.
If another pharmaceutical form is not available, the Rivaroxaban Bluefish tablet can be crushed and mixed with water or apple puree immediately before taking. After taking this mixture, you should eat a meal. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

In case of spitting up a dose or vomiting

• less than 30 minutes after taking Rivaroxaban Bluefish, you should take a new dose.
• more than 30 minutes after taking Rivaroxaban Bluefish, do nottake a new dose. In this case, you should take the next dose of Rivaroxaban Bluefish at the usual time.

In case of repeated spitting up of a dose or vomiting after taking Rivaroxaban Bluefish, you should contact your doctor.

When to take Rivaroxaban Bluefish

You should take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue the treatment.
Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body:
If your heart rhythm requires restoration of a normal rhythm using a procedure called cardioversion, you should take the tablet(s) at the time recommended by your doctor.

Missing a dose of Rivaroxaban Bluefish

• Adults, children, and adolescents: If you are taking one 20 mg or one 15 mg tablet oncea day and you miss a dose, you should take it as soon as you remember. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then continue taking one tablet once a day.
• Adults: If you are taking one 15 mg tablet twicea day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, you should continue taking one 15 mg tablet twice a day.

Taking a higher dose of Rivaroxaban Bluefish than recommended

If you have taken a higher dose of Rivaroxaban Bluefish than recommended, you should contact your doctor immediately. Taking too much Rivaroxaban Bluefish increases the risk of bleeding.

Stopping the treatment with Rivaroxaban Bluefish

You should not stop taking Rivaroxaban Bluefish without first talking to your doctor, as this medicine treats and prevents a serious disease.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines with a similar action to reduce blood clot formation, Rivaroxaban Bluefish may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

You should immediately inform your doctor if you experience any of the following side effects:

• Signs of bleeding
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You should immediately call for medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of serious allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing (hemoptysis),
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by the doctor)
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increase in the activity of some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show an increase in bilirubin levels, activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,

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

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) in the groin as a complication of cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs)
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Rivaroxaban Bluefish were similar to those observed in adults and were mainly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting Common(may affect up to 1 in 10 people)
• rapid heartbeat
• blood tests may show an increase in bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• heavy menstrual bleeding Uncommon(may affect up to 1 in 100 people)
• blood tests may show an increase in direct bilirubin levels

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Bluefish

Keep the 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 month.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Bluefish contains

• The active substance of the medicine is rivaroxaban. One film-coated tablet contains 15 or 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172)

What Rivaroxaban Bluefish looks like and contents of the pack

Rivaroxaban Bluefish 15 mg film-coated tablets are red, round, biconvex with the inscription "1" on one side and a diameter of approximately 5 mm.
Rivaroxaban Bluefish 20 mg film-coated tablets are reddish-brown, round, biconvex with the inscription "2" on one side and a diameter of approximately 6 mm.
The tablets are packaged in a blister pack of PVC/PVDC/Aluminum.
Pack sizes of 15 mg: 10, 14, 28, 30, 42, 98, 100 tablets
Pack sizes of 20 mg: 10, 28, 30, 98, 100 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
tel. +46 8 51 91 16 00

Manufacturer

Sofarimex-Indústria Química e Farmacêutica, S.A.
Avenida das Indústrias, Alto de Colaride
2735-213 Cacém
Portugal

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: