Rivaroxaban orion

Package leaflet: Information for the user

Rivaroxaban Orion, 10 mg, coated tablets
Rivaroxabanum
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the 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 recurrence of blood clots in the blood vessels of the legs and/or lungs. 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 take 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, trauma or bleeding in the brain, recent surgery on the brain or eyes)
• if the patient is taking other medicines that prevent blood clotting (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 inform your doctor immediately if you suspect any of the above conditions apply.

Warnings and precautions

Before starting Rivaroxaban Orion, consult your doctor or pharmacist.

When to exercise particular caution with Rivaroxaban Orion

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body
  • taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) during transition of anticoagulant therapy or if heparan is administered to maintain the patency of an intravenous or arterial catheter (see section "Rivaroxaban Orion with other medicines")
  • blood clotting disorders
  • very high blood pressure that does not decrease despite medication
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the 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 reproductive 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 a change in treatment is necessary
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary embolism is planned

If the patient suspects any of the above conditions, inform the doctor before taking 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 when to take Rivaroxaban Orion before or after surgery.
• if catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
  • strictly follow the doctor's instructions regarding the timing of Rivaroxaban Orion administration
  • immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as numbness, weakness in the lower limbs, or problems with bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Orion 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 Orion and 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 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 antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

If the patient suspects any of the above conditions, inform the doctor before taking 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 believes the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment for peptic ulcer disease may be prescribed.

• If the patient is taking:
  • certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital)
  • St John's wort (Hypericum perforatum), a herbal remedy used for depression
  • rifampicin, an antibiotic

If the patient suspects any of the above conditions, inform the doctor before taking 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 this medicine, inform the doctor immediately, who will decide on further management.

Driving and operating machinery

Rivaroxaban Orion 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 Orion contains lactose

This medicine contains 25.1 mg of lactose (as monohydrate lactose) per tablet. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their 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 your doctor has instructed. If you have any doubts, you should
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 Orion 10 mg taken 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 Orion 10 mg once daily for you.

The tablet should be swallowed whole, preferably with water.
This medicine can be taken with food or independently of meals.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Rivaroxaban Orion. 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 Orion tablets via a gastric tube.
When to take Rivaroxaban Orion
You should 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 legs after hip or knee replacement surgery:
The first tablet should be taken 6 to 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts for 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts for 2 weeks.
Taking more than the recommended dose of Rivaroxaban Orion
If you have taken too many Rivaroxaban Orion tablets, contact your doctor immediately. Taking too high a dose of Rivaroxaban Orion increases the risk of bleeding.
Missing a dose of Rivaroxaban Orion
If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping Rivaroxaban Orion
Do not stop taking Rivaroxaban Orion without first talking to your doctor, as Rivaroxaban Orion prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Rivaroxaban Orion may cause adverse effects, although not everyone experiences them.

As with other medicines with a similar mechanism of action that reduce 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 may not always be obvious or visible.

You should contact your doctor immediately 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 paralysis, vomiting, seizures, decreased 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 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 rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these adverse effects is very rare (up to 1 in 10,000 patients).
• Signs of serious 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 effects:
Common ( may affect up to 1 in 10 patients )

• decrease in red blood cells, which may cause pale skin and lead to weakness or shortness of breath
• gastrointestinal bleeding or intestinal bleeding, bleeding from the urogenital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) during coughing
• skin bleeding or subcutaneous bleeding
• postoperative bleeding
• 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 decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon ( may affect up to 1 in 100 patients )

• bleeding into the brain or within 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

• liver function disorders (may be observed in tests performed by a 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

• dry mouth

• urticaria.
  Rare ( may affect up to 1 in 1,000 patients )

• 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 when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare ( may affect up to 1 in 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 urine, leading to kidneys being unable to function properly (anticoagulant-related nephropathy)
• increased pressure within 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 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 provide more information on the safety of this 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 pack and on each blister. The expiry date refers to the last day of the stated month.
No special storage instructions apply 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 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), polyethylene glycol 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, with a diameter of 6 mm,
marked with "10" on one side and smooth on the other.
Rivaroxaban Orion 10 mg tablets are available in transparent PVC/PVDC/Aluminium blister packs in cardboard cartons containing 5, 10, 14, 28, 30, 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]