Rivanoptim

Package leaflet: Information for the user

Rivanoptim, 10 mg, coated tablets
Rivaroxaban
Read this leaflet carefully before taking this medicine , because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Ask 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Rivanoptim is and what it is used for
2. What you need to know 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

Rivanoptim 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. Rivanoptim 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 is experiencing excessive bleeding
• if the patient has a disease or condition of an organ that increases the 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 liver disease that increases the risk of bleeding
• if the patient is pregnant or breastfeeding. Do not use Rivanoptim, and inform the doctor if the patient suspects any of the above conditions apply.

Warnings and precautions
Before starting Rivanoptim, consult a doctor or pharmacist.
When to exercise particular caution when using Rivanoptim

• 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
• 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 (see section "Rivanoptim with other medicines")
• blood coagulation disorders
• very high blood pressure that does not decrease despite medication
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system
• blood vessel disease in the back of the eye (retinopathy)
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• in patients with prosthetic heart valves
• 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 needs to be changed
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs

If the patient suspects any of the above conditions apply, they should inform the doctor before taking Rivanoptim. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient requires surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivanoptim before or after surgery.
• if during surgery the patient is scheduled to undergo lumbar puncture or spinal catheter placement (e.g. for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding the timing of taking Rivanoptim
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, difficulty passing stool or urinary problems, as immediate treatment will be necessary.

Children and adolescents
Rivanoptim 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.

Rivanoptim with 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 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 medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI))

If the patient suspects any of the above conditions apply, they should inform the doctor before taking Rivanoptim, because the effect of Rivanoptim may be increased when taken together with the above medicines. 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 intestinal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

• 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 the patient suspects any of the above conditions apply, they should inform the doctor before taking Rivanoptim, because the effect of Rivanoptim may be reduced when taken together with the above 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 the patient becomes pregnant while taking this medicine, they should immediately inform the doctor, who will decide on further treatment.

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, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivanoptim

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
How many tablets to take

• To prevent the formation of blood clots in veins following hip or knee replacement surgery: The recommended dose is one tablet of Rivanoptim
  10 mg once daily.

• For the treatment of blood clots in the leg veins, blood clots in 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. The doctor has prescribed Rivanoptim 10 mg once daily for the patient.

The tablet should be swallowed whole, preferably with water.
This medicine may be taken with food or independently of meals.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivanoptim with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. If necessary, the doctor may administer crushed Rivanoptim tablets via a gastric tube.
When to take Rivanoptim
Take one tablet every day until the 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.
The doctor will decide how long treatment should continue.
To prevent blood clots in leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Rivanoptim
If the patient has taken too many Rivanoptim tablets, contact the doctor immediately. Taking too high a dose of Rivanoptim increases the risk of bleeding.
Missing a dose of Rivanoptim
If the patient forgets to take a dose, take the tablet as soon as remembered. 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 Rivanoptim treatment
Do not stop taking Rivanoptim without first talking to the doctor, as Rivanoptim helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Rivanoptim may cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar action reducing 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.

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. 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

Your 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, including rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome)

The frequency of occurrence of these adverse reactions is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions:

• swelling of the face, lips, mouth, 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)

• reduction 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including conjunctival hemorrhage)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) during coughing
• bleeding from the skin or subcutaneous bleeding
• 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 a doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general loss of 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 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
• 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 collection (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 up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia)

Frequency not known (frequency cannot be determined from available data)

• kidney failure following severe bleeding
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (drug-induced nephropathy associated with anticoagulant medicines)
• 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 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 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 may 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 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, after: 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 required. 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 10 mg of rivaroxaban.
• The other ingredients are:

Tablet core: lactose monohydrate, 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 red (E 172).

What Rivanoptim looks like and contents of the pack
Rivanoptim 10 mg coated tablets are pink, round, biconvex (8 mm in diameter), with the imprint 'C02' on one side.
The tablets are contained:

• in blisters packed in cardboard cartons containing 5, 10 or 30 coated tablets, or
• in containers of 100 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
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 countries under the following names:
Iceland Rivaroxaban Coripharma
Poland Rivanoptim