Rivaroxaban Orion

Package Leaflet: Information for the User

Rivaroxaban Orion, 10 mg, Film-Coated Tablets

Rivaroxaban
You should read the contents of this leaflet carefully before taking the medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

• You should keep this leaflet to be able to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack:

• 1. What Rivaroxaban Orion is and what it is used for
• 2. Important information before you take 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after surgery, there is an increased risk of blood clots forming.
• 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 new blood clots from forming in the veins of the legs and/or lungs. Rivaroxaban Orion belongs to a group of medicines called anticoagulants. Its action is to block the factor Xa involved in blood clotting and thus reduce the tendency to form blood clots.

2. Important information before you take 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 that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery)
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to another anticoagulant or when heparin is given to maintain the patency of a venous or arterial catheter
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding. Do not take Rivaroxaban Orion and inform your doctorif you think any of the above conditions apply to you.

If you think any of the above conditions apply to you, tell your doctor before taking Rivaroxaban Orion. Your doctor will decide whether to use this medicine and whether you need to be kept under close observation.

Warnings and precautions

Before taking Rivaroxaban Orion, tell your doctor or pharmacist.

When to be extra careful while taking Rivaroxaban Orion

• if you have an increased risk of bleeding, such as:
• mild or moderate kidney disease, as kidney function may affect the amount of medicine in your body
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) during the switch to another anticoagulant or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban Orion and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite treatment
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal reflux disease (where stomach acid flows back into the esophagus)
• eye diseases (retinopathy)
• lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous lung bleeding
• if you have a heart valve replacement
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, tell your doctor

before taking Rivaroxaban Orion. Your doctor will decide whether to use this medicine and whether you need to be kept under close observation.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Rivaroxaban Orion at a specific time before or after surgery.
• if you are scheduled for a procedure that involves catheterization or spinal puncture (e.g., for epidural or spinal anesthesia):
• you must carefully follow your doctor's instructions regarding the intake of Rivaroxaban Orion at a specific time
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness in your legs, difficulty urinating or defecating, as you may need immediate treatment.

Children and adolescents

Rivaroxaban Orion 10 mg tablets are not recommended for people under 18 years of age. There is limited data on the use of this medicine in children and adolescents.

Rivaroxaban Orion and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.

• -If you are taking:
• certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol)
• certain antibiotics (e.g., clarithromycin, erythromycin)
• certain antiviral medicines for HIV or AIDS (e.g., ritonavir)
• other medicines that prevent 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 for irregular heart rhythm
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If you think any of the above conditions apply to you, tell your doctor

before taking Rivaroxaban Orion, as the effect of Rivaroxaban Orion may be increased. Your doctor will decide whether to use this medicine and whether you need to be kept under close observation.

• -If you are taking:
• certain medicines for epilepsy (e.g., phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine for depression
• rifampicin, an antibiotic

If you think any of the above conditions apply to you, tell your doctor

before taking Rivaroxaban Orion, as the effect of Rivaroxaban Orion may be reduced. Your doctor will decide whether to use Rivaroxaban Orion and whether you need to be kept under 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 during treatment with Rivaroxaban Orion. If you become pregnant during treatment with this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Orion may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Orion contains lactose

This medicine contains 25.1 mg of lactose (in the form of lactose monohydrate). If you have 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 it is essentially "sodium-free".

3. How to take Rivaroxaban Orion

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg tablet of Rivaroxaban Orion once daily.
• To treat blood clots in the legs and lungs and to prevent new 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 Orion 10 mg once daily for you.

Swallow the tablet whole with water. You can take this medicine with or without food. If you have difficulty swallowing the whole tablet, 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.

When to take Rivaroxaban Orion

Take one tablet each day until your doctor decides to stop the treatment. It is best to take the tablet at the same time every day, as this will help you to remember to take it. Your doctor will decide how long you should continue the treatment. To prevent blood clots in the legs after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery. Treatment usually lasts 5 weeks for patients after major hip surgery and 2 weeks for patients after major knee surgery.

If you take more Rivaroxaban Orion than you should

If you take more tablets than you should, contact your doctor immediately. Taking more Rivaroxaban Orion than recommended may increase the risk of bleeding.

If you forget to take Rivaroxaban Orion

If you forget to take a dose, take it as soon as you remember. Take the next tablet at the usual time and then continue taking one tablet once daily as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rivaroxaban Orion

Do not stop taking Rivaroxaban Orion without talking to your doctor first, as this medicine prevents a serious disease. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Orion can cause side effects, although not everybody gets them. As with other medicines that prevent blood clotting, Rivaroxaban Orion may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These signs of bleeding may not always be obvious or visible.

Tell your doctor immediately 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. Seek medical help immediately!)
• prolonged or excessive bleeding
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to keep you under close observation or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (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:

Common (may affect up to 1 in 10 people)

• reduced number of red blood cells, which may cause pale skin and be the reason for 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 into the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum when coughing
• bleeding from the skin or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (which can be seen in tests performed by your doctor)
• fever
• stomach pain, nausea, 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 of the skin
• increased activity of certain 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 problems (which can be seen in tests performed by your doctor)
• blood test results may show increased bilirubin, activity of certain pancreatic or liver enzymes, or 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 flow obstruction), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local 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 blood cell that causes inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy)
• 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)

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Orion

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. 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 Orion contains

• -The active substance is rivaroxaban. Each tablet contains 10 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

Rivaroxaban Orion 10 mg tablets are pink, round, biconvex, 6 mm in diameter, with the marking "10" on one side and smooth on the other. Rivaroxaban Orion 10 mg tablets are available in transparent PVC/PVDC/Aluminum blisters in cartons containing 5, 10, 14, 28, 30, 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 on this medicine, contact the local representative of the marketing authorization holder:

Date of last revision of the leaflet: