Rivaroxaban Bluefish

PATIENT INFORMATION LEAFLET

Information for the user attached to the packaging

Rivaroxaban Bluefish, 15 mg, film-coated tablets

Rivaroxaban Bluefish, 20 mg, film-coated tablets

Treatment initiation pack

Do not use in children
Rivaroxaban

Read the contents of 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.
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for a specific person. 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 any 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

• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 brain or eye surgery),
• 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 given to maintain the patency of a vein or artery 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 inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with 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, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery 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 genital or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the 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 whether the patient should be closely monitored.

If the patient needs to have surgery:

• they must strictly follow the doctor's instructions regarding the intake of this medicine at a precisely specified time before or after surgery,
• if, during the surgical procedure, the patient is scheduled to have a lumbar puncture or spinal catheter insertion (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, as instructed by the doctor,
• the doctor should be informed immediately if, after the anesthesia has ended, the patient experiences symptoms such as: numbness, weakness of the lower limbs, disorders of bowel or bladder function, as in such cases, immediate treatment is necessary.

Children and adolescents

The Rivaroxaban Bluefish treatment initiation pack is not recommended for people under 18 years of age, as it is intended exclusively for the treatment of adults and is not suitable for use in children and adolescents.

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 locally on the skin,
• ketoconazole 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 noradrenaline 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 effect of this medicine may be enhanced. The doctor will decide whether to use this medicine or whether the patient should be closely monitored.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcers.

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 effect of this medicine may be reduced.
The doctor will decide whether to use this medicine or whether the patient should be closely monitored.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use effective contraception while taking Rivaroxaban Bluefish. If you become pregnant while taking this medicine, inform your doctor immediately, 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, ride a bicycle, or operate tools or machines.

Rivaroxaban Bluefish contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should consult 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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, talk to your doctor about other ways to take this medicine. The tablet can be crushed and mixed with water or soft food, such as apple puree, just before taking it. After this mixture, you should eat immediately.
If necessary, your doctor may administer the crushed Rivaroxaban Bluefish tablet through a gastric tube.

How many tablets to take

The recommended dose is one 15 mg Rivaroxaban Bluefish tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Bluefish tablet once a day.
This treatment initiation pack of Rivaroxaban Bluefish 15 mg and 20 mg is intended exclusively for the first 4 weeks of treatment.
After completing this pack, treatment will be continued with Rivaroxaban Bluefish 20 mg once a day, as directed by your doctor.
If you have kidney problems, your doctor may decide to reduce the dose of the medicine after 3 weeks to one 15 mg Rivaroxaban Bluefish tablet once a day, if the risk of bleeding is greater than the risk of another blood clot.

When to take Rivaroxaban Bluefish

Take one tablet every day until your doctor decides to stop 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 treatment.

Taking a higher dose of Rivaroxaban Bluefish than recommended

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

Missing a dose of Rivaroxaban Bluefish

• -If you are taking one 15 mg tablet twice a day and miss a dose, 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, continue taking one 15 mg tablet twice a day.
• -If you are taking one 20 mg tablet once a day and miss a dose, take it as soon as possible. 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

Stopping treatment with Rivaroxaban Bluefish

Do not stop taking Rivaroxaban Bluefish without first discussing it with your doctor, as this medicine treats and prevents serious diseases.
If you have any further questions about the use of this medicine, ask 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 similar blood clot-reducing effects, Rivaroxaban Bluefish can cause bleeding, which can potentially 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.

Tell your doctor immediately 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. A serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The doctor may decide to closely monitor the patient 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 and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe 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)

• reduced red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) when coughing,
• bleeding from the skin or subcutaneous bleeding,
• post-operative bleeding,
• 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 (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased 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 increased 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 muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of heart 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 granulocytic blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 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 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. 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 about 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 about 6 mm.
The treatment initiation pack for the first 4 weeks of treatment contains transparent blisters of PVC/PVDC/Aluminum foil containing 49 film-coated tablets:

• 42 Rivaroxaban Bluefish 15 mg film-coated tablets
• 7 Rivaroxaban Bluefish 20 mg film-coated tablets

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: