Rivaroxaban orion

Package leaflet: Information for the user

Rivaroxaban Orion, 15 mg, coated tablets
Rivaroxaban Orion, 20 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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. This medicine may harm others, 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 Orion is and what it is used for
2. What you need to know 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 Rivaroxaban Orion is and what it is 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 body in patients with a type of irregular heartbeat 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 of the legs and (or) lungs.

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

• treat blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable anticoagulant medicines. Rivaroxaban Orion 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 using Rivaroxaban Orion

When not to use Rivaroxaban Orion

• 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 the patency of an intravenous or arterial catheter
• 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 Orion, and also inform the doctor if the patient suspects that any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Orion, consult a doctor or
pharmacist.
When to exercise special caution with Rivaroxaban Orion

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because 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) during transition of anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Rivaroxaban Orion and other medicines")
  • coagulation disorders
  • very high blood pressure that does not decrease despite treatment
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the oesophagus and throat), e.g. due to gastroesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system
  • vascular disease of the posterior segment of the eye (retinopathy)
  • lung disease in which bronchi 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 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 abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs. If the patient suspects that any of the above conditions apply, inform the doctor before using Rivaroxaban Orion. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Orion before or after surgery.
• if during surgery a catheter is planned or a spinal puncture is to be performed (e.g. for epidural or spinal anaesthesia or pain relief):
• it is very important to take Rivaroxaban Orion before and after the puncture or catheter removal exactly as directed by the doctor
• due to the need for special caution, immediately inform the doctor if numbness or weakness of the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Rivaroxaban Orion 15 mg or 20 mg tablets are not recommended for children weighing less than
30 kg.
There is insufficient data on the use of Rivaroxaban Orion in children and adolescents for indications approved in adults.
Rivaroxaban Orion 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 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 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 that any of the above conditions apply, inform the doctor before using Rivaroxaban Orion, as the effect of Rivaroxaban Orion may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcer, preventive treatment for peptic ulcer disease may be prescribed.
• 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 that any of the above conditions apply, inform the
doctor before using Rivaroxaban Orion, as the effect of Rivaroxaban Orion may be reduced. The doctor will decide whether to use Rivaroxaban Orion and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Orion 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 Orion. If the patient becomes pregnant while taking Rivaroxaban Orion, inform the doctor immediately. The doctor will decide on further management.
Driving and operating machinery
Rivaroxaban Orion may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Orion contains lactose
This medicine contains 20.5 mg and 27.3 mg of lactose (as monohydrate lactose), respectively, in the 15 mg and 20 mg tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Other excipients
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Orion

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban Orion tablets should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Orion with your doctor. The tablet may be crushed and mixed with water or soft food such as apple puree, immediately before administration. After taking this mixture, the patient should eat a meal without delay.
If necessary, your doctor may administer crushed Rivaroxaban Orion 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 Orion tablet once daily. If the patient has impaired kidney function, the dose may be reduced to one 15 mg Rivaroxaban Orion tablet once daily.

  If a procedure to open 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 Orion tablet once daily (or one 10 mg Rivaroxaban Orion tablet once daily in case of impaired kidney function), in combination with an antiplatelet medicine such as clopidogrel.

• For the 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 Orion tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg Rivaroxaban Orion tablet once daily.
  After at least 6 months of treatment for blood clots, your 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 impaired kidney function and is taking one 20 mg Rivaroxaban Orion tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Orion tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

• Children and adolescents The dose of Rivaroxaban Orion depends on body weight and will be calculated by the doctor.

  • Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one 15 mg Rivaroxaban Orion tablet once daily.
  • Recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban Orion tablet once daily. Each dose of Rivaroxaban Orion should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: monitor the child to ensure the full dose has been taken.

The dose of Rivaroxaban Orion depends on body weight, so it is important to attend scheduled appointments with your doctor, as dose adjustments may be needed due to changes in weight.
Never adjust the dose on your own. If necessary, your doctor will adjust the dose.
Do not split tablets to achieve partial doses. If a lower dose is required, other pharmaceutical forms such as granules for oral suspension may be more appropriate. For children and adolescents who cannot swallow whole tablets, rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban Orion tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, the patient should eat a meal. If necessary, your doctor may also administer crushed Rivaroxaban Orion tablets via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking Rivaroxaban Orion: 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 at the usual time.

Contact your doctor if repeated vomiting or spitting out the dose occurs after taking Rivaroxaban Orion.

When to take Rivaroxaban Orion
Take the tablet(s) every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, Rivaroxaban Orion should be taken as directed by your doctor.

Missed dose of Rivaroxaban Orion

• Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet 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.

• Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

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

Stopping Rivaroxaban Orion treatment
Do not stop taking Rivaroxaban Orion without first discussing it with your doctor, as Rivaroxaban Orion 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 all medicines, Rivaroxaban Orion may cause adverse reactions, although not everyone will experience them.
As with other medicines that have a similar effect in reducing blood clot formation, Rivaroxaban Orion may cause bleeding, which potentially could 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 inform the doctor if the patient experiences any of the following
adverse reactions:

• 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, sudden 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. 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. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 patients).
• Signs of severe allergic reactions
  • swelling of the face, lips, oral cavity, tongue or throat; 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 patients) and uncommon (angioedema and allergic edema may occur in 1 in 100 patients).

General list of possible adverse reactions in adults, children and adolescents:
Common ( may occur in 1 out of 10 patients )

• decrease 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding in 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
• 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 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 occur in 1 out of 100 patients )

• bleeding into the brain or inside the skull (see signs of bleeding 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 performed by the doctor)

• 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 1 out of 1,000 patients )

• bleeding into muscles

• cholestasis (bile stasis), hepatitis, including liver cell damage

• yellowing of the skin and eyes (jaundice)

• localized swelling

• blood accumulation (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 1 out of 10,000 patients )

• 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 blood in the urine, leading to impaired kidney function (anticoagulant-associated 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).

Adverse reactions in children and adolescents
Generally, adverse reactions observed in children and adolescents treated with Rivaroxaban Orion were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common ( may occur in more than 1 out of 10 patients )

• headache
• fever
• nosebleeds, vomiting

Common ( may occur in 1 out of 10 patients )

• rapid heartbeat
• blood tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low number of platelets, blood cells that help in clotting)
• excessive menstrual bleeding

Uncommon ( may occur in 1 out of 100 patients )

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Orion

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on each blister. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 Orion contains

• The active substance 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, sodium croscarmellose, 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
Coated tablets 15 mg:
The tablets are red, round, biconvex, with a diameter of 6 mm, marked with "15" on one side and smooth on the other side.
The tablets are available in transparent PVC/PVDC/Aluminium blister packs in cardboard cartons containing 10, 14, 28, 42, 98 or 100 tablets.
Coated tablets 20 mg:
The tablets are dark red, round, biconvex, with a diameter of 7 mm, marked with "20" on one side and smooth on the other side.
The tablets are available in transparent PVC/PVDC/Aluminium blister packs in cardboard cartons containing 10, 14, 28, 42, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]