Rivaroxaban Olimp

Package Leaflet: Information for the User

Rivaroxaban OLIMP, 10 mg, Film-Coated Tablets

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 and is used in adults to:

• prevent the formation of blood clots in the veins, after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation 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 prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Rivaroxaban OLIMP belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 the body 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 you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter
• if you have liver disease that leads to an increased risk of bleeding
• if you are pregnant or breastfeeding. Do not take Rivaroxaban OLIMP and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

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

When to be particularly careful when taking Rivaroxaban OLIMP

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the body
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) except when switching anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban OLIMP and other medicines")
• bleeding disorders
• very high blood pressure that does not decrease despite taking medicines
• 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 reflux disease of the esophagus (backflow of stomach acid into the esophagus), or tumors located in the stomach or intestines, or the genital or urinary system
• disease of the blood vessels in the back of the eye (retinopathy)
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with prosthetic heart valves
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change the treatment
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform your doctor

before 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 precisely specified time before or after surgery,
• if spinal puncture or catheter insertion into the spine is planned during surgery (e.g., for spinal or epidural anesthesia or pain relief):
• you must carefully follow your doctor's instructions regarding the intake of Rivaroxaban OLIMP at a precisely specified time
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban OLIMP tablets, 10 mg are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivaroxaban OLIMP and other medicines

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

• If you are taking:
• certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin)
• certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir)
• other medicines that 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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If any of the above situations apply to you, tell your doctor

before taking Rivaroxaban OLIMP, as the effect of Rivaroxaban OLIMP may be enhanced. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor considers that you have an increased risk of stomach or intestinal ulcers, he or she may use preventive treatment.

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

If you suspect that you have any of the above conditions, inform your doctor

before 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 immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban OLIMP may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4, "Possible side effects").
Patient 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 previously been diagnosed with 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 that the medicine is considered "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.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one Rivaroxaban OLIMP tablet, 10 mg taken once a day.
• For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban OLIMP, 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban OLIMP can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Rivaroxaban OLIMP. The tablet can be crushed and mixed with water or apple puree, just before taking it.
If necessary, your doctor may give you a crushed Rivaroxaban OLIMP tablet through a gastric tube.

When to take Rivaroxaban OLIMP

Take one tablet every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
Take the first tablet 6 to 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaroxaban OLIMP

If you have taken more than the recommended dose of Rivaroxaban OLIMP, contact your doctor immediately. Taking too much Rivaroxaban OLIMP increases the risk of bleeding.

Missing a dose of Rivaroxaban OLIMP

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Rivaroxaban OLIMP

Do not stop taking Rivaroxaban OLIMP without first talking to your doctor, as Rivaroxaban OLIMP prevents a serious disease.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately if you experience any of the following side effects:

• 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 stiffness of the neck. This is a serious medical emergency. Call for medical help immediately!)
• prolonged or excessive bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes to the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disease (DRESS syndrome). The frequency of these side effects is very rare (in 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

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 or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the white part of the eye)
• 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 (can be observed 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 of the skin
• 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 inside the skull (see above, signs of bleeding)
• bleeding into the joint causing pain and swelling
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (can be observed in tests performed by your doctor)
• blood test results may show increased bilirubin levels, 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 cell damage
• jaundice (yellowing of the skin and eyes)
• localized swelling
• blood accumulation (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 cells, which can cause inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(frequency cannot be estimated from the available data)

• renal failure after severe bleeding
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs) 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 film-coated tablet contains 10 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 10 mg film-coated tablets are orange, round, biconvex with the inscription "10" on one side and "RH" on the other side.
Transparent blisters of PVC/PVDC/Aluminum in a cardboard box.
Package sizes: 10 or 30 film-coated tablets.
Not all package 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: