Rivaroxaban Olimp

Package Leaflet: Information for the User

Rivaroxaban OLIMP, 15 mg, Film-Coated Tablets

Rivaroxaban OLIMP, 20 mg, Film-Coated Tablets

Rivaroxabanum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Rivaroxaban OLIMP and what is it used for

Rivaroxaban OLIMP contains the active substance rivaroxaban.
Rivaroxaban OLIMP is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban OLIMP is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent the recurrence of blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

Rivaroxaban OLIMP belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban OLIMP

When not to take Rivaroxaban OLIMP

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medication (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, injury or bleeding into the brain, recent brain or eye surgery)
• if the patient is taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter
• if the patient has liver disease that leads to an increased risk of bleeding
• if the patient is pregnant or breastfeeding. Do not take Rivaroxaban OLIMP, and inform your doctor if you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rivaroxaban OLIMP, discuss it with a doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban OLIMP

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, in adults, and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medication acting in the patient's body
• taking other medications that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Rivaroxaban OLIMP and other medications")
• bleeding disorders
• very high blood pressure that does not decrease despite taking medications
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or esophagus (e.g., due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital, or urinary system
• vascular disease in the back of the eye (retinopathy)
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous pulmonary bleeding
• in patients with prosthetic valves
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform the doctor, who will decide on possible changes to the treatment
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban OLIMP. The doctor will decide whether to administer this medication and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery

• it is essential to follow the doctor's instructions regarding the intake of Rivaroxaban OLIMP at a specific time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is crucial to take Rivaroxaban OLIMP before and after the puncture or catheter removal, according to the doctor's instructions
• due to the need for particular caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders, or other symptoms occur after the anesthesia has ended.

Children and adolescents

Rivaroxaban OLIMP is not recommended for children with a body weight below 30 kg.
There is a lack of sufficient data on the use of this medication in children and adolescents for indications in adults.

Rivaroxaban OLIMP and other medications

Inform the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take, including those available without a prescription.

• If the patient is taking:
• certain medications used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain medications used to treat bacterial infections (e.g., clarithromycin, erythromycin)
• certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir)
• other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medication used to treat heart rhythm disorders
• certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban OLIMP, as the action of Rivaroxaban OLIMP may be enhanced. The doctor will decide whether to administer this medication and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent ulcers.

• If the patient is taking:
• certain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban OLIMP, as the action of Rivaroxaban OLIMP may be reduced. The doctor will decide whether to administer Rivaroxaban OLIMP and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Do not take Rivaroxaban OLIMP 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 OLIMP. If the patient becomes pregnant during treatment with this medication, they should inform their doctor immediately, who will decide on further treatment.

Driving and operating machinery

Rivaroxaban OLIMP may cause dizziness (a common side effect) or fainting (an 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 machinery.

Rivaroxaban OLIMP contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medication.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Rivaroxaban OLIMP

This medication should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
Rivaroxaban OLIMP should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Rivaroxaban OLIMP with their doctor. The tablet can be crushed and mixed with water or apple sauce, immediately before intake. After such a mixture, a meal should be consumed immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg tablet of Rivaroxaban OLIMP once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban OLIMP once daily.

If the patient requires a procedure to clear blood vessels in the heart (called percutaneous coronary intervention (PCI) with stent placement), there is limited evidence to support a dose reduction to one 15 mg tablet of Rivaroxaban OLIMP once daily (or one 10 mg tablet of Rivaroxaban OLIMP once daily in case of kidney function impairment) in combination with an antiplatelet medication such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent the recurrence of blood clots. The recommended dose is one 15 mg tablet of Rivaroxaban OLIMP twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban OLIMP once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one 20 mg tablet of Rivaroxaban OLIMP once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg tablet of Rivaroxaban OLIMP once daily, if the risk of bleeding is greater than the risk of recurrent blood clots.
• Children and adolescents

The dose of Rivaroxaban OLIMP depends on body weight and will be calculated by the doctor.

• For children and adolescents with a body weight of 30 kg to less than 50 kg, the recommended dose is one 15 mg tablet of Rivaroxaban OLIMP once daily.
• For children and adolescents with a body weight of 50 kg or more, the recommended dose is one 20 mg tablet of Rivaroxaban OLIMP once daily. Each dose of Rivaroxaban OLIMP should be taken with food, preferably with a drink (e.g., water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: observe the child to ensure they have taken the entire dose. The dose of Rivaroxaban OLIMP is dependent on body weight, so it is essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes. Never adjust the dose of Rivaroxaban OLIMP yourself.If necessary, the doctor will adjust the dose.

Do not divide the tablet to obtain a partial dose. If a smaller dose is necessary, use a different form of Rivaroxaban OLIMP, a granule for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use a medication containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, the rivaroxaban tablet can be crushed and mixed with water or apple sauce, immediately before intake. After such a mixture, a meal should be consumed immediately. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

What to do if a dose is missed or vomited

• If the dose is missed or vomited less than 30 minutes after taking Rivaroxaban OLIMP, a new dose should be taken.
• If the dose is missed or vomited more than 30 minutes after taking Rivaroxaban OLIMP, do not take a new dose. In this case, the next dose of Rivaroxaban OLIMP should be taken at the usual time.

Contact the doctor in case of repeated vomiting or spitting up of the dose after taking Rivaroxaban OLIMP.

When to take Rivaroxaban OLIMP

The tablet(s) should be taken every day until the doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as it is easier to remember.
The doctor will decide how long the patient should continue the treatment.
To prevent blood clot formation in the brain (stroke) and other blood vessels in the body:
If the patient's heart rhythm needs to be restored to normal using a procedure called cardioversion, Rivaroxaban OLIMP should be taken as directed by the doctor.

Missing a dose of Rivaroxaban OLIMP

• Adults, children, and adolescents: If the patient takes one 20 mg or one 15 mg tablet once daily and misses a dose, they should take it as soon as possible. Do not takemore than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once daily.
• Adults:

If the patient takes one 15 mg tablet twice daily and misses a dose, they should take it as soon as possible. Do not takemore than two 15 mg tablets in one day. If the patient misses a dose, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day.
The next day, they should continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Rivaroxaban OLIMP

If the patient takes too many Rivaroxaban OLIMP tablets, they should contact their doctor immediately. Taking too much Rivaroxaban OLIMP increases the risk of bleeding.

Stopping treatment with Rivaroxaban OLIMP

Do not stop taking Rivaroxaban OLIMP without first consulting a doctor, as Rivaroxaban OLIMP treats and prevents serious diseases.
In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Rivaroxaban OLIMP can cause side effects, although not everybody gets them.
Like other medications with similar action to reduce blood clot formation, Rivaroxaban OLIMP may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Inform a doctor immediately if the patient or child experiences any of the following side effects:

• Signs of bleeding
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. Seek medical help immediately!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to monitor the patient closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., tongue or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (affects no more than 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; 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 no more than 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in no more than 1 in 100 people).

General list of possible side effects in adults, children, and adolescents

• Common(may affect up to 1 in 10 people):
• decrease in red blood cell count, which may cause pallor and be the cause of 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 into the eye (including bleeding into the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney function disorders (may be observed in tests performed by the 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
• increased activity of certain liver enzymes, which may be visible in blood test results

Uncommon(may affect up to 1 in 100 people):

• bleeding into the brain or 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 function disorders (may be observed in tests performed by the doctor)
• blood test results may show increased bilirubin levels, increased activity of certain liver or pancreatic 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 stasis), hepatitis, including liver damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• accumulation of blood (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 granular blood cell that causes inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(frequency 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 occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Rivaroxaban OLIMP were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:

• Very common(may affect more than 1 in 10 people)
• headache
• fever
• nosebleeds
• vomiting
• Common(may affect up to 1 in 10 people)
• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding
• Uncommon(may affect up to 1 in 100 people)
• blood test results may show increased direct bilirubin levels

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Rivaroxaban OLIMP

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the package and on each blister after: EXP. The expiration date refers to the last day of the specified month.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban OLIMP contains

• The active substance of Rivaroxaban OLIMP is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose 2910, magnesium stearate, sodium lauryl sulfate. Tablet coating: hypromellose 2910, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Rivaroxaban OLIMP looks like and contents of the pack

Rivaroxaban OLIMP 15 mg film-coated tablets are gray, round, biconvex with the inscription "15" on one side and "RH" on the other side.
Transparent blisters of PVC/PVDC/Aluminum in a cardboard box.
Pack sizes: 14, 28, or 42 film-coated tablets.
Rivaroxaban OLIMP 20 mg film-coated tablets are light gray, round, biconvex with the inscription "20" on one side and "RH" on the other side.
Transparent blisters of PVC/PVDC/Aluminum in a cardboard box.
Pack sizes: 14 or 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

OLIMP Laboratories Sp. z o.o.
Pustynia 84 F
39-200 Dębica
tel.: +48 14 690 32 02
e-mail: [email protected]
{logo OLIMP Laboratories}

Manufacturer/Importer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Date of last revision of the leaflet: