Rivaroxaban bluefish

Package leaflet: Information for the user

Rivaroxaban Bluefish, 10 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery.
• 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. 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 in 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 you
suspect any of the above-mentioned conditions apply to you.
Warnings and precautions
Before starting Rivaroxaban Bluefish, consult your doctor or
pharmacist.
When to exercise particular caution with Rivaroxaban Bluefish

• if the patient has an increased risk of bleeding due to conditions such as:
• moderate or severe kidney disease, as kidney function may affect the amount of drug 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,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (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 genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary,
• if the patient has abnormal blood pressure or if surgery or other treatment to remove a blood clot from the lungs is planned.

If you suspect any of the above conditions apply to you, inform your 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 to undergo surgery:

• strictly follow the doctor's instructions regarding the exact timing of taking this medicine before or after surgery,
• if during a 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),
• strictly follow the doctor's instructions regarding the exact timing of taking Rivaroxaban Bluefish,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban Bluefish 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
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 you are taking:

• certain antifungal medicines (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 (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect any of the above conditions apply to you, inform your 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 the patient to be at increased risk of developing stomach or duodenal ulcers,
treatment to prevent peptic ulcer disease may be prescribed.
If you are taking:

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

If you suspect any of the above conditions apply to you, inform your 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 you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Rivaroxaban Bluefish. If you become pregnant while taking this medicine, inform your 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 you have previously been diagnosed with intolerance to certain sugars, you should consult your 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 as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one tablet of Rivaroxaban Bluefish 10 mg once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Bluefish 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban Bluefish may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about alternative ways of taking this medicine. The tablet may be crushed and mixed with water or soft food such as apple puree, immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban Bluefish tablets via a gastric tube.

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.

To prevent blood clots in the veins after hip or knee replacement surgery:
Take the first tablet between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

If you take more Rivaroxaban Bluefish than you should
If you take more Rivaroxaban Bluefish than prescribed, contact your doctor immediately. Taking too high a dose of Rivaroxaban Bluefish increases the risk of bleeding.

If you forget to take Rivaroxaban Bluefish
If you forget to take a dose, take the tablet as soon as you remember. Then take the next tablet the following day, and continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed dose.

Stopping Rivaroxaban Bluefish
Do not stop taking Rivaroxaban Bluefish without first talking to your doctor, as this medicine helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, 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 could potentially 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 should immediately contact your doctor if any of the following adverse effects occur:

• Signs of bleeding
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and neck stiffness. This is 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 effects is very rare (occurring in 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 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 adverse effects:
Common (may occur in up to 1 in 10 people)

• reduction in red blood cells which may cause pale 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) when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of 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 occur in up to 1 in 100 people)

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

Rare (may occur in 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,
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of granulocytic white 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 blood in the urine, leading to kidneys being unable to function properly (anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects
not listed in this leaflet, consult your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to gather 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.
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 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 10 mg of rivaroxaban.
• Other ingredients are:
  Core of the tablet: 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 10 mg coated tablets are light red, round, biconvex and have a diameter of approximately 6 mm.
Rivaroxaban Bluefish 10 mg tablets are packed in PVC/PVDC/Aluminum blisters.
Pack sizes: 10, 14, 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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names: