Rivaroxaban bluefish

Package leaflet: Information for the user

Rivaroxaban Bluefish, 15 mg, film-coated tablets
Rivaroxaban Bluefish, 20 mg, film-coated tablets
Starter pack
Do not use in children
Rivaroxabanum
Please read 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 further questions, please consult 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.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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:

• 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 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, trauma 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-mentioned conditions.
Warnings and precautions
Before starting to take Rivaroxaban Bluefish, consult your doctor or
pharmacist.
When to exercise particular caution with Rivaroxaban Bluefish

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) 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 treatment with 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 in which the bronchi are dilated and 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 an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned.

If the patient suspects any of the above-mentioned conditions, inform the 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 taking this medicine at a specific time before or after surgery,
• if during surgery a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or intrathecal anaesthesia or for pain relief),
• it is very important to take Rivaroxaban Bluefish before and after the puncture or removal of the catheter, as directed by the doctor,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness of the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment will be required in such cases.

Children and adolescents
The starter pack of Rivaroxaban Bluefish is not recommended for individuals under 18 years of age,
as it is intended exclusively for adult patients and is not suitable for use in children and adolescents.
Rivaroxaban Bluefish with other medicines
Inform your doctor or pharmacist about all medicines currently taken or 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above-mentioned conditions, inform the 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 stomach or duodenal ulcers, 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 ), an herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above-mentioned conditions, inform the 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 contact 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 as instructed by the doctor. If in doubt, consult
the doctor or pharmacist.
Rivaroxaban Bluefish should be taken with food. The tablet should be swallowed whole,
preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking this
medicine with the doctor. The tablet may be crushed and mixed with water or soft food, such as
apple puree, immediately before administration. After taking this mixture, a meal should be
consumed without delay.
If necessary, the doctor may administer crushed Rivaroxaban Bluefish tablets via a gastric tube.
How many tablets to take
The recommended dose is one 15 mg Rivaroxaban Bluefish tablet twice daily for the first
3 weeks. After this initial period, the recommended dose is one 20 mg Rivaroxaban
Bluefish tablet once daily.
This starter pack containing Rivaroxaban Bluefish 15 mg and 20 mg is intended exclusively for the first 4 weeks of treatment.
After completing this pack, treatment will continue with Rivaroxaban
Bluefish 20 mg once daily, as directed by the doctor.
If a patient has kidney problems, the doctor may decide to reduce the dose after
3 weeks to one 15 mg Rivaroxaban Bluefish tablet once daily, if the risk of bleeding
is greater than the risk of another blood clot.
When to take Rivaroxaban Bluefish
One tablet should be taken every day until the 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.
The doctor will decide how long treatment should continue.
Taking more Rivaroxaban Bluefish than prescribed
If a patient has taken more Rivaroxaban Bluefish than prescribed, contact the doctor immediately.
Taking too high a dose of Rivaroxaban Bluefish increases the risk of bleeding.
Missed dose of Rivaroxaban Bluefish

• 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, resume taking one 15 mg tablet twice daily.
• If taking one 20 mg tablet once daily and a dose is missed, take it as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.

Stopping Rivaroxaban Bluefish
Do not stop taking Rivaroxaban Bluefish without first consulting the doctor,
as this medicine treats and prevents serious medical conditions.
If there are any further questions about the use of this medicine, consult the
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other medicines with a similar action of reducing 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.
Immediately contact a doctor if any of the following side effects occur:

• Signs of bleeding
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, reduced level of consciousness, and neck stiffness. A serious medical emergency. Immediate medical assistance must be sought!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The 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, haematological disorders and systemic symptoms (DRESS syndrome). The frequency of occurrence 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; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of occurrence of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and not uncommon (angioedema and allergic oedema may occur in 1 in 100 people).

General list of possible side effects:
Common (may occur in up to 1 in 10 people)

• reduction in red blood cell count 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, gum bleeding,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (haematoma, bruising),
• presence of blood in sputum (haemoptysis) during 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, diarrhoea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general reduction in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident 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, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood test results may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry 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),
• localised swelling,
• accumulation of blood (haematoma) in the groin as a complication of cardiac catheterisation procedure when the catheter is inserted into the artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of white granular 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 impaired kidney function (anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of side effects
If any adverse effects occur, including any possible side effects not listed
in this leaflet, consult a doctor or pharmacist. Side 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 . Side effects can also be reported to the marketing authorisation holder. Reporting of side effects helps to 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 must 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 packaging and other information

What Rivaroxaban Bluefish contains

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

What Rivaroxaban Bluefish looks like and contents of the pack
Rivaroxaban Bluefish 15 mg coated tablets are red, round, biconvex, with an embossed mark “1” on one side and a diameter of approximately 5 mm.
Rivaroxaban Bluefish 20 mg coated tablets are reddish-brown, round, biconvex, with an embossed mark “2” on one side and a diameter of approximately 6 mm.
The starter pack for the first 4 weeks of treatment contains transparent blisters made of PVC/PVDC/aluminium foil containing 49 coated tablets:

• 42 coated tablets of Rivaroxaban Bluefish 15 mg
• 7 coated tablets of Rivaroxaban Bluefish 20 mg

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 the United Kingdom (Northern Ireland) under the following names: