Rivaroxaban Olimp

Package Leaflet: Information for the User

Rivaroxaban OLIMP, 15 mg, film-coated tablets

Rivaroxaban OLIMP, 20 mg, film-coated tablets

Rivaroxabanum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 signs of illness 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 OLIMP is and what it is 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 Rivaroxaban OLIMP is and what it is used for

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

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent new blood clots from forming 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 blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban OLIMP belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban OLIMP

When not to take Rivaroxaban OLIMP

• 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 of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgical procedure on the brain or eyes)
• if you are taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding. Do not take Rivaroxaban OLIMP, and inform your doctor if you think you may have any of the above conditions.

Warnings and precautions

Before taking Rivaroxaban OLIMP, discuss with your doctor or pharmacist.

When to be extra careful when taking Rivaroxaban OLIMP

• if you have 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 medicine in the body
• taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban OLIMP and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease with medication
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach or intestines or genital or urinary system
• vascular disease in the back of the eye (retinopathy)
• pulmonary disease with dilated bronchi and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with artificial heart valves
• 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 treatment
• if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you think you may have any of the above conditions, inform

your doctorbefore taking Rivaroxaban OLIMP. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery

• you must carefully follow your 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 spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban OLIMP before and after the puncture or removal of the catheter, as instructed by your doctor
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

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

Rivaroxaban OLIMP and other medicines

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

• If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain antibacterial medicines (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV or AIDS (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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you think you may have any of the above conditions, inform

your doctorbefore taking Rivaroxaban OLIMP, as the effect of Rivaroxaban OLIMP may be increased. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor thinks you are at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent stomach ulcers.

• If you are taking:
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression
• rifampicin, which belongs to a group of antibiotics.

If you think you may have any of the above conditions, inform

your doctorbefore taking Rivaroxaban OLIMP, as the effect of Rivaroxaban OLIMP may be reduced. Your doctor will decide whether to use Rivaroxaban OLIMP and whether you need to be closely monitored.

Pregnancy and breastfeeding

Do not take Rivaroxaban OLIMP if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Rivaroxaban OLIMP. If you become pregnant while taking this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban OLIMP may cause dizziness (frequent side effect) or 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 OLIMP contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Rivaroxaban OLIMP

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rivaroxaban OLIMP should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways to take Rivaroxaban OLIMP. The tablet can be crushed and mixed with water or apple sauce, just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clots 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 you have kidney problems, the dose may be reduced to one 15 mg tablet of Rivaroxaban OLIMP once daily.

If you need a procedure to open up 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 disease) in combination with an antiplatelet medicine such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the lungs, and to prevent new blood clots from forming. 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, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg tablet of Rivaroxaban OLIMP once daily, your doctor may decide to reduce the dose to one 15 mg tablet of Rivaroxaban OLIMP once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of new blood clots.
• Children and adolescents

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

• Recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one 15 mg tablet of Rivaroxaban OLIMP once daily.
• Recommended dose for children and adolescents with a body weight of 50 kg or moreis one 20 mg tablet of Rivaroxaban OLIMP once daily. Each dose of Rivaroxaban OLIMP should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose. The dose of Rivaroxaban OLIMP depends on body weight, so it's 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, your doctor will adjust the dose.

Do not divide the tablet to get a partial dose. If a smaller dose is needed, you should use a different form of Rivaroxaban OLIMP, an oral suspension.
For children and adolescents who are unable to swallow whole tablets, you should use a medicine containing rivaroxaban in the form of an oral suspension.
If the oral suspension is not available, you can crush the rivaroxaban tablet and mix it with water or apple sauce, just before taking. After such a mixture, you should eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

What to do if you vomit or spit up your dose

• if you vomit or spit up your dose less than 30 minutes after taking Rivaroxaban OLIMP, you should take a new dose.
• if you vomit or spit up your dose more than 30 minutes after taking Rivaroxaban OLIMP, do not take a new dose. In this case, take the next dose of Rivaroxaban OLIMP at the usual time.

You should contact your doctor if you vomit or spit up your dose repeatedly or have vomiting after taking Rivaroxaban OLIMP.

When to take Rivaroxaban OLIMP

Take the tablet(s) every day until your doctor decides to stop treatment.
It's best to take the tablet(s) at the same time every day, as it will be easier to remember.
Your doctor will decide how long you should continue treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, you should take Rivaroxaban OLIMP as instructed by your doctor.

Missed dose of Rivaroxaban OLIMP

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not takemore than one tablet in one day to make up for a missed dose. Take the next tablet the next day, and then take one tablet once daily.
• Adults:

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

Overdose of Rivaroxaban OLIMP

If you take too many tablets of Rivaroxaban OLIMP, contact your 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 talking to your doctor, as Rivaroxaban OLIMP treats and prevents serious diseases.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical help immediately if you or your child experience 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. Your doctor may decide to monitor you closely or change treatment.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g. on the tongue or eyes (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 (less 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 less than 1 in 10,000 people) and uncommon (angioedema and allergic edema; may occur in less 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):
• reduced red blood cell count, which can 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 from 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 problems (can be seen in tests performed by your doctor)
• fever
• stomach pain, nausea (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 some liver enzymes, which can be seen 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 problems (can be seen in tests performed by your doctor)
• blood test results may show increased bilirubin levels, increased activity of some 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 stasis), hepatitis, including liver damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• hematoma (collection of blood) 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 cells, which can cause 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

Overall, the side effects seen in children and adolescents treated with Rivaroxaban OLIMP were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen 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)
• excessive menstrual bleeding
• Uncommon(may affect up to 1 in 100 people)
• blood test results may show increased direct bilirubin levels (a subtype of bilirubin).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban OLIMP

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. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban OLIMP contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The 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 "15" engraved 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 "20" engraved 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: info@olimp-labs.com
{logo OLIMP Laboratories}

Manufacturer/Importer:

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

Date of last revision of the leaflet: