Rivaroxaban Orion

Leaflet accompanying the packaging: information for the user

Rivaroxaban Orion, 15 mg, film-coated tablets

Rivaroxaban Orion, 20 mg, film-coated tablets

Rivaroxabanum

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Rivaroxaban Orion 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 patient's body, if the patient has a form of irregular heart rhythm called atrial fibrillation not caused by a heart valve problem.
• 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.

Rivaroxaban Orion is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs after at least 5 days of initial treatment with injectable anti-coagulant medicines. Rivaroxaban Orion 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 Orion

When not to take Rivaroxaban Orion

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding
• if you have 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 brain or eye surgery)
• if you are 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 you have liver disease that leads to an increased risk of bleeding
• if you are pregnant or breastfeeding. Do not take Rivaroxaban Orion, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaroxaban Orion, you should consult your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Orion

• if you have an increased risk of bleeding, such 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
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin) during the change of anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Orion and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite the use of medicines
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus) e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus) or tumors located in the stomach, intestines, genital or urinary system
• vascular disease in 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 heart valves
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide on possible changes in treatment
• if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, you should inform

your doctorbefore taking Rivaroxaban Orion. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close observation.

If you need to have surgery:

• you must follow your doctor's instructions regarding the intake of Rivaroxaban Orion at a precisely specified time before or after surgery.
• if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Orion before and after the puncture or catheter removal, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivaroxaban Orion 15 mg or 20 mg tablets are not recommended for children with a body weight below30 kg.
There is a lack of sufficient data on the use of Rivaroxaban Orion in children and adolescents for indications in adults.

Rivaroxaban Orion and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, even those that are available without a prescription.

• If you are taking
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally 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 you suspect that you have any of the above conditions, you should inform

your doctorbefore taking Rivaroxaban Orion, as the action of Rivaroxaban Orion may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close observation.
If the doctor believes that you are at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent ulcers.

• If you are 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 the group of antibiotics

If you suspect that you have any of the above conditions, you should inform

your doctorbefore taking Rivaroxaban Orion, as the action of Rivaroxaban Orion may be reduced. The doctor will decide whether to use Rivaroxaban Orion and whether the patient should be subject to particularly close observation.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Orion 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 Orion contains lactose

This medicine contains 20.5 mg and 27.3 mg of lactose (in the form of lactose monohydrate), respectively, in 15 mg and 20 mg tablets. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Other excipients

This 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 Orion

This medicine should always be taken according to your doctor's instructions. If you are unsure, you should ask your doctor or pharmacist.
Rivaroxaban Orion should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Rivaroxaban Orion. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give you a crushed Rivaroxaban Orion 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 Rivaroxaban Orion 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Rivaroxaban Orion 15 mg tablet once a day.

If you need a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one Rivaroxaban Orion 15 mg tablet once a day (or one Rivaroxaban Orion 10 mg tablet once a day in case of kidney problems) in combination with an antiplatelet medicine 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 Rivaroxaban Orion 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Orion 20 mg tablet

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 Rivaroxaban Orion 20 mg tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Orion 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clot formation.

• -Children and adolescentsThe dose of Rivaroxaban Orion depends on body weight and will be calculated by your doctor.
• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one Rivaroxaban Orion 15 mg tablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban Orion 20 mg tablet once a day. Each dose of Rivaroxaban Orion should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.

The dose of Rivaroxaban Orion depends on body weight, so it's essential to come to scheduled doctor's appointments, as it may be necessary to adjust the dose depending on weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose. Do not divide the tablet to get a partial dose. If a smaller dose is needed, other pharmaceutical forms, such as an oral suspension, may be more suitable. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension.
If an oral suspension is not available, you can crush a Rivaroxaban Orion tablet and mix it with water or apple sauce immediately before taking. After such a mixture, you should eat a meal. If necessary, your doctor may also give you a crushed Rivaroxaban Orion tablet through a gastric tube.

In case of spitting up or vomiting

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

You should contact your doctor if you spit up or vomit the dose or vomit after taking Rivaroxaban Orion.

When to take Rivaroxaban Orion

The tablet(s) should be taken every day until your doctor decides to stop the treatment.
It's best to take the tablet(s) at the same time every day, as it's easier to remember.
Your doctor will decide how long you should continue the treatment.
Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take Rivaroxaban Orion as directed by your doctor.

Missing a dose of Rivaroxaban Orion

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet oncea day and you miss a dose, you should 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 at the usual time the next day, and then take one tablet once a day.

• Adults: If you take 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) taken in one day. The next day, continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivaroxaban Orion

If you take too many Rivaroxaban Orion tablets, you should contact your doctor immediately. Taking too much Rivaroxaban Orion increases the risk of bleeding.

Stopping the treatment with Rivaroxaban Orion

You should not stop taking Rivaroxaban Orion without first talking to your doctor, as Rivaroxaban Orion treats and prevents serious diseases.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Orion can cause side effects, although not everybody gets them.
Like other medicines with a similar action to reduce blood clot formation, Rivaroxaban Orion may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will 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 in 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 that you need to be closely monitored or change your treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes in 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 patients).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; 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 patients) and uncommon (angioedema and allergic edema may occur in 1 in 100 patients).

General list of possible side effects in adults, children, and adolescents:

Common ( may affect up to 1 in 10 people)

• reduction 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 tract (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)
• appearance of blood in sputum when coughing
• 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 your 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
• 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 your doctor)
• blood test results may show increased bilirubin levels, increased activity of some pancreatic or liver enzymes, or increased 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)
• localized 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 granular blood cells that 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 Orion were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common ( may affect more than 1 in 10 patients)

• headache
• fever
• nosebleeds, vomiting

Common ( may affect up to 1 in 10 patients)

• rapid heartbeat
• blood test results may show increased bilirubin levels (bile pigment)
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding

Uncommon ( may affect up to 1 in 100 patients)

• blood test results may show increased direct bilirubin levels (bile pigment)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 Orion

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Orion contains

• -The active substance of Rivaroxaban Orion is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• -The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, croscarmellose sodium, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172)

What Rivaroxaban Orion looks like and contents of the pack

15 mg film-coated tablets:
The tablets are red, round, biconvex, 6 mm in diameter, with the marking "15" on one side and smooth on the other side.
The tablets are available in transparent PVC/PVDC/Aluminum blisters in cartons containing 10, 14, 28, 42, 98, or 100 tablets.
20 mg film-coated tablets:
The tablets are dark red, round, biconvex, 7 mm in diameter, with the marking "20" on one side and smooth on the other side.
The tablets are available in transparent PVC/PVDC/Aluminum blisters in cartons containing 10, 14, 28, 42, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia
Adalvo Ltd.
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
3000 San Ġwann SĠN
Malta
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: