Rivaroxaban bluefish

Package leaflet: Information for the user

Rivaroxaban Bluefish, 15 mg, film-coated tablets
Rivaroxaban Bluefish, 20 mg, film-coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Rivaroxaban Bluefish is and what it is used for
2. What you need to know 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 Rivaroxaban Bluefish is and what it is 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 in other blood vessels throughout the body in cases of an irregular heart rhythm called non-valvular atrial fibrillation.
• 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 veins and/or lungs. This medicine is used in children and adolescents under 18 years of age weighing 30 kg and above to:
• treat blood clots and prevent recurrence of blood clots in the veins or blood vessels of the lungs, following initial treatment for at least 5 days with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency for blood clots to form.

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 is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Bluefish, and inform your doctor if the patient suspects any of the above conditions.

Warnings and precautions
Before starting to take Rivaroxaban Bluefish, consult your doctor or
pharmacist.
When to exercise special caution with Rivaroxaban Bluefish

• if the patient has an increased risk of bleeding, such as in the following conditions:
• 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 blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Bluefish with other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the reproductive or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment needs to be changed,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects any of the above conditions, they should inform their doctor
before taking Rivaroxaban Bluefish. The doctor will decide whether to use this medicine or whether the patient requires particularly close monitoring.
If the patient needs surgery:

• strictly follow the doctor's instructions regarding taking this medicine at the exact time before or after surgery,
• if during the surgical procedure a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief),
• it is very important to take Rivaroxaban Bluefish before and after the puncture or catheter removal exactly as directed by the doctor,
• immediately inform the doctor if, after the anaesthesia wears off, the patient experiences symptoms such as: numbness, weakness in the lower limbs, difficulty with bowel movements or urination, as immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban Bluefish tablets are not recommended for children weighing less than 30 kg. There is
insufficient data on the use of the medicine in children and adolescents for indications approved in
adults.
Rivaroxaban Bluefish with 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,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV infection 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-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions, they should inform their doctor
before 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 requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing a stomach or duodenal ulcer, they may prescribe treatment to prevent peptic 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 for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions, they should inform their doctor
before 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 requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use this medicine if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Bluefish. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Bluefish may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Bluefish contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban Bluefish should be taken with food. Swallow the tablet whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of administration with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After administering this mixture, a meal should be given immediately.
If necessary, your doctor may administer crushed Rivaroxaban Bluefish tablets via a gastric tube.

How many tablets to take

• Adults
• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one 20 mg Rivaroxaban Bluefish tablet once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Bluefish tablet once daily.

If a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement) is required, there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Bluefish tablet once daily (or one 10 mg Rivaroxaban Bluefish tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one 15 mg Rivaroxaban Bluefish tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one 20 mg Rivaroxaban Bluefish tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one 20 mg Rivaroxaban Bluefish tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Bluefish tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescents The 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 body weight from 30 kg to 50 kg is one 15 mg Rivaroxaban Bluefish tablet once daily.
• The recommended dose for children and adolescents with body weight above 50 kg is one 20 mg Rivaroxaban Bluefish tablet once daily. 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 as a reminder. Parents or caregivers: monitor the child to ensure the full dose has been taken.

Since the dose of Rivaroxaban Bluefish depends on body weight, it is important to attend scheduled medical appointments, as the dose may need to be adjusted according to changes in body weight.
Never adjust the dose of Rivaroxaban Bluefish on your own. If necessary, the doctor will adjust the dose.
Do not split the tablet to achieve a lower dose. If a lower dose is required, other pharmaceutical forms are available.
For children and adolescents who cannot swallow tablets whole, an alternative pharmaceutical form should be used.
If an alternative pharmaceutical form is not available, the Rivaroxaban Bluefish tablet may be crushed and mixed with water or apple puree immediately before administration. After administering this mixture, a meal should be given. If necessary, the doctor may also administer crushed Rivaroxaban Bluefish tablets via a gastric tube.

If a dose is vomited or spat out

• less than 30 minutes after taking Rivaroxaban Bluefish, take a new dose.
• more than 30 minutes after taking Rivaroxaban Bluefish, do not take a new dose. In this case, take the next dose of Rivaroxaban Bluefish at the usual time.

If repeated vomiting or spitting out of the dose occurs after taking Rivaroxaban Bluefish, contact your doctor.

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 each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure called cardioversion is performed to restore normal heart rhythm, take the tablet(s) as directed by your doctor.

Missed dose of Rivaroxaban Bluefish

• Adults, children and adolescents: If taking one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take it as soon as remembered. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• Adults: If taking one 15 mg tablet twice daily and a dose is missed, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If a dose is missed, two 15 mg tablets may be taken at the same time to achieve a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Rivaroxaban Bluefish
If a patient has taken more than the recommended dose of Rivaroxaban Bluefish, contact the doctor immediately. Taking too high a dose of Rivaroxaban Bluefish increases the risk of bleeding.

Stopping Rivaroxaban Bluefish
Do not stop taking Rivaroxaban Bluefish without first discussing it with your doctor, as this medicine treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban Bluefish may cause bleeding, which potentially can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You must contact your doctor immediately if any of the following adverse reactions occur:

• 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 neck stiffness. A serious medical emergency. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). The frequency of these adverse reactions 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; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 adverse reactions:
Common (may affect up to 1 in 10 people)

• reduction in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or under the skin,
• postoperative bleeding,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by the doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see bleeding signs above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, blood cells involved in clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests ordered by the doctor),
• blood tests may show increased levels of bilirubin, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria,

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• blood collection (hematoma) in the groin as a complication of cardiac catheterization when the 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, causing lung inflammation (eosinophilic pneumonia).

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

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (anticoagulant-associated nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban Bluefish were similar to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions 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 increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, blood cells that help in clotting)
• heavy menstrual bleeding
  Uncommon (may affect up to 1 in 100 people)
• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 . Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the 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 pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Bluefish contains

• The active substance is rivaroxaban. One 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 coated tablets 15 mg are red, round, biconvex, with the engraved mark "1" on one side and a diameter of approximately 5 mm.
Rivaroxaban Bluefish coated tablets 20 mg are reddish-brown, round, biconvex, with the engraved mark "2" on one side and a diameter of approximately 6 mm.
The tablets are packaged in PVC/PVDC/Aluminium blisters.
Pack sizes for 15 mg: 10, 14, 28, 30, 42, 98, 100 tablets
Pack sizes for 20 mg: 10, 28, 30, 98, 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: