Rivanoptim

Patient Information Leaflet: Information for the User

Rivanoptim, 2.5 mg, film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Rivanoptim is and what it is used for

You have been prescribed Rivanoptim because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed.
• Rivanoptim reduces the risk of another heart attack in adults and lowers the risk of death due to heart or blood vessel disease.
• Rivanoptim will not be given to you as a single treatment. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Rivanoptim reduces the risk of blood clots in adults (atherosclerotic thrombotic events). Rivanoptim will not be given to you as a single treatment. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are receiving Rivanoptim after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken for a short time in addition to acetylsalicylic acid.

Rivanoptim contains the active substance rivaroxaban and 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 Rivanoptim

When not to take Rivanoptim

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has 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 clotting (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 been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke)
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had bleeding in the brain (hemorrhagic stroke) or blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had a blood clot in the brain (ischemic, non-lacunar stroke) within the last month
• if the patient has liver disease that leads to an increased risk of bleeding
• if the patient is pregnant or breastfeeding

Do not use Rivanoptim, and inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions

Before starting Rivanoptim, consult your doctor or pharmacist. Rivanoptim should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.

When to exercise particular caution when taking Rivanoptim

• 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 clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivanoptim 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 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
• blood vessel disease in the back of the eyeball (retinopathy)
• lung disease where bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• if the patient is over 75 years of age
• if the patient weighs less than 60 kg
• coronary artery disease with severe symptomatic heart failure
• 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 treatment adjustment is necessary.

If you suspect any of the above conditions apply, inform your doctor
before taking Rivanoptim. 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 Rivanoptim administration before or after surgery.
• if spinal catheterization or spinal puncture (e.g. for epidural or intrathecal anesthesia or pain relief) is planned during surgery:
• it is very important to take Rivanoptim 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 bowel or bladder dysfunction occurs after the anesthesia wears off.

Children and adolescents
Rivanoptim 2.5 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.

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

• If the patient is taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless 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, prasugrel and ticagrelor (see section "Warnings and precautions"))
• 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 you suspect any of the above conditions apply, inform your doctor
before taking Rivanoptim, because the effect of Rivanoptim may be increased. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers there is an increased risk of stomach or intestinal ulceration, preventive treatment 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 remedy used for depression
• rifampicin, an antibiotic

If you suspect any of the above conditions apply, inform your doctor
before taking Rivanoptim, because the effect of Rivanoptim may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Rivanoptim and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use Rivanoptim if the patient is pregnant or breastfeeding. If there is a risk that the patient could become pregnant, an effective method of contraception should be used during treatment with Rivanoptim. If a patient becomes pregnant while taking this medicine, she must immediately inform her doctor, who will decide on further management.

Driving and operating machinery
Rivanoptim 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.

Rivanoptim contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Rivanoptim

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
contact your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivanoptim should be taken at approximately
the same time each day (for example, one tablet in the morning and one in the evening). This medicine
can be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Rivanoptim
with your doctor. 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 Rivanoptim tablets
through a gastric tube.
Rivanoptim will not be given to the patient as the only medication.
Your doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving
Rivanoptim after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Rivanoptim after a procedure to open a narrowed or blocked artery in the
lower limb to restore blood flow, the doctor may additionally prescribe clopidogrel for a short period
alongside acetylsalicylic acid.
Your doctor will inform the patient of the dose of these medications to take (usually 75–100 mg of
acetylsalicylic acid per day, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of
75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to take Rivanoptim
Treatment with Rivanoptim after an acute coronary syndrome should be initiated as soon as possible
after stabilization of the acute event, no earlier than 24 hours after hospital admission and at the
time when parenteral (injected) antithrombotic therapy would normally be discontinued.
Your doctor will advise the patient when to start treatment with Rivanoptim if coronary artery disease
or peripheral arterial disease has been diagnosed.
Your doctor will decide how long treatment should continue.
Taking more Rivanoptim than prescribed
If a patient has taken too many Rivanoptim tablets, contact a doctor immediately. Taking an excessive
dose of Rivanoptim increases the risk of bleeding.
Missing a dose of Rivanoptim
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the
scheduled time.
Stopping Rivanoptim treatment
Rivanoptim should be taken regularly and for the duration prescribed by your doctor.
Do not stop taking Rivanoptim without first discussing it with your doctor. Stopping treatment with
this medicine may increase the risk of another heart attack, stroke, or death due to heart- or blood
vessel-related disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Rivanoptim may cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivanoptim 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 contact your doctor immediately if any of the following adverse reactions occur:
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. 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 of the patient or a change in treatment is necessary.

Signs of severe skin reactions:

• extensive, acute skin rash, blister formation, 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 people).

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 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

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

• decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath
• gastrointestinal or intestinal bleeding, bleeding from the urogenital 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 (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 arterial blood pressure (symptoms may include dizziness or fainting upon standing)
• general decrease 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, blood cells involved in blood 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 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)
• localized swelling
• blood accumulation (hematoma) in the groin area as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm)

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

• accumulation of eosinophils, a type of granulocytic white 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 impaired kidney function (nephropathy associated with anticoagulant drugs)
• 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 adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, 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 provide more information on the safety of the medicine.

5. How to store Rivanoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on each blister or bottle: Expiry date (EXP). The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Rivanoptim contains

• The active substance is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: Monohydrate lactose, microcrystalline cellulose, crospovidone type A, crospovidone type B, copovidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate. See section 2 "Rivanoptim contains lactose and sodium".
  Tablet coating: Polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide yellow (E 172).

What Rivanoptim looks like and contents of the pack
Rivanoptim 2.5 mg film-coated tablets are yellow, round, biconvex (8 mm in diameter),
with the imprint 'C01' on one side.
The tablets are contained in:

• Blister packs within cardboard cartons containing 28, 56 or 100 film-coated tablets, or
• Bottles containing 100 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków 65 Street
02-255 Warsaw
Poland
Tel. 607 696 231
e-mail: [email protected]
Manufacturer
Coripharma ehf.
Reykjavikurvegur 78-80
220 Hafnarfjörður
Iceland
Email: [email protected]
Tel: +354 4206700
This medicinal product is authorised in the European Economic Area member states under the following names:
Iceland Rivaroxaban Coripharma
Poland Rivanoptim