Package leaflet: Information for the user

Rivaroxaban OLIMP, 15 mg, film-coated tablets
Rivaroxaban OLIMP, 20 mg, film-coated tablets
Rivaroxabanum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Rivaroxaban OLIMP is and what it is used for
What you need to know before taking Rivaroxaban OLIMP
How to take Rivaroxaban OLIMP
Possible side effects
How to store Rivaroxaban OLIMP
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 the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation.
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 veins and/or lungs.

Rivaroxaban OLIMP is used in children and adolescents under 18 years of age and with body weight of 30 kg or more to:

treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of 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. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency to form blood clots.

2. Information before using Rivaroxaban OLIMP

When not to use Rivaroxaban OLIMP

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, injury or bleeding in the brain, recent surgery on the brain or eyes)
if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery
if the patient has a liver disease that leads to an increased risk of bleeding
if the patient is pregnant or breastfeeding. Rivaroxaban OLIMP must not be used, and the doctor must be informed if the patient suspects that any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban OLIMP, discuss it with your doctor or
pharmacist.
When to exercise special caution when using Rivaroxaban OLIMP

if the patient has an increased risk of bleeding, such as in the following conditions:
- severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body
- taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section "Rivaroxaban OLIMP and 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 inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid from the stomach flowing back 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 bleeding from the lungs
in patients with prosthetic heart valves
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an 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 if surgery or another treatment to remove a blood clot from the lungs is planned. If the patient suspects that any of the above conditions apply, the patient must inform the doctor before using Rivaroxaban OLIMP. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery

it is essential to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban OLIMP before or after surgery
if during surgery a catheter is planned or a spinal puncture is to be performed (e.g. for epidural or intrathecal anaesthesia or pain relief):
- it is very important to take Rivaroxaban OLIMP before and after the puncture or removal of the catheter exactly as directed by the doctor
due to the need for special caution, the doctor must be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
Rivaroxaban OLIMP is not recommended for children weighing less than 30 kg.
There is insufficient data on the use of the medicine in children and adolescents for the indications
approved for adults.
Rivaroxaban OLIMP and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

If the patient is taking:
- certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are 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 that any of the above conditions apply, the patient must inform the doctor before using Rivaroxaban OLIMP, as the effect of Rivaroxaban OLIMP may be enhanced. 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 duodenal ulcers, preventive treatment for peptic ulcer disease may be prescribed.
If the patient is taking
- certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
- St John's wort ( Hypericum perforatum ), an herbal medicine used for depression
- rifampicin, which belongs to the group of antibiotics. If the patient suspects that any of the above conditions apply, the patient must inform the doctor before using Rivaroxaban OLIMP, as the effect of Rivaroxaban OLIMP may be reduced. The doctor will decide whether to use Rivaroxaban OLIMP and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use 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 must be used during treatment with Rivaroxaban OLIMP. If the patient becomes pregnant while taking this medicine, she must inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban OLIMP may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect) (see section 4, "Possible side effects").
Patients experiencing these adverse 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, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban OLIMP

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban OLIMP tablets should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban OLIMP with your doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed promptly.
If necessary, your doctor may administer crushed Rivaroxaban OLIMP tablets via a gastric tube.

How many tablets to take

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

If a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement) is required, there is limited evidence supporting dose reduction to one Rivaroxaban OLIMP tablet, 15 mg once daily (or one Rivaroxaban OLIMP tablet, 10 mg once daily in case of impaired kidney function), in combination with an antiplatelet medicine such as clopidogrel.

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

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

The recommended dose for children and adolescents with a body weight of 30 kg to below 50 kg is one Rivaroxaban OLIMP tablet, 15 mg once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban OLIMP tablet, 20 mg once daily. Each dose of Rivaroxaban OLIMP should be taken with a meal and a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: observe the child to ensure the full dose has been taken. Since the dose of Rivaroxaban OLIMP depends on body weight, it is important to attend scheduled doctor visits, as dose adjustments may be needed due to changes in weight. Never adjust the dose of Rivaroxaban OLIMP on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet to achieve partial doses. If a lower dose is required, another formulation of Rivaroxaban OLIMP, namely granules for oral suspension, should be used.
For children and adolescents who are unable to swallow whole tablets, a rivaroxaban-containing medicine in the form of granules for oral suspension should be used.
If the oral suspension is not available, the rivaroxaban tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, your doctor may also administer the crushed tablet via a gastric tube.

In case of vomiting or spitting out the dose

Within 30 minutes of taking Rivaroxaban OLIMP, take a new 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.

Contact your doctor if there are repeated episodes of spitting out the dose or vomiting after taking Rivaroxaban OLIMP.

When to take Rivaroxaban OLIMP

Take the tablet(s) every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember. Your doctor will decide how long treatment should continue.

For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure (cardioversion) is needed to restore normal heart rhythm, Rivaroxaban OLIMP should be taken as directed by your doctor.

Missed dose of Rivaroxaban OLIMP

Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
Adults:

If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in a single day. If a dose was forgotten, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, resume taking one 15 mg tablet twice daily.

Taking more Rivaroxaban OLIMP than prescribed

If a patient has taken too many Rivaroxaban OLIMP tablets, contact a doctor immediately. Taking an excessive dose of Rivaroxaban OLIMP increases the risk of bleeding.

Stopping Rivaroxaban OLIMP

Do not stop taking Rivaroxaban OLIMP without first consulting your doctor, as Rivaroxaban OLIMP treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines of similar action that reduce blood clot formation, Rivaroxaban
OLIMP may cause bleeding, which potentially could be life-threatening. Excessive
bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding may not always be obvious or visible.
You should contact a doctor immediately if the patient or child experiences any of the
following adverse reactions:

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 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. The doctor may decide that close monitoring or a change in treatment is necessary.
Signs of severe skin reactions
- widespread, acute skin rash, blistering, or mucosal lesions, e.g., on the tongue 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 disorders, and systemic involvement. The frequency of these adverse reactions is very rare (occurring in no more than 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, oral cavity, tongue, or throat; difficulty swallowing; 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 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 adverse reactions in adults, children, and adolescents
Common (may occur in no more than 1 in 10 people):

decreased number of red blood cells, 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)
coughing up blood
bleeding from the skin 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 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 no more than 1 in 100 people):

bleeding into the brain or inside the skull (see above, signs of bleeding)
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 no more than 1 in 1,000 people):

bleeding into muscles
cholestasis (bile stasis), hepatitis including liver damage
yellowing of the skin and eyes (jaundice)
localized swelling
blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm)

Very rare (may occur in no more than 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 estimated from available data):

kidney failure following severe bleeding
bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy)
increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban
OLIMP were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)

headache
fever
nosebleeds
vomiting

Common (may occur in no more than 1 in 10 people)

rapid heartbeat
blood tests may show increased levels of bilirubin (a bile pigment)
thrombocytopenia (low platelet count, cells that help in blood clotting)
excessive menstrual bleeding

Uncommon (may occur in no more than 1 in 100 people)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps 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 stated on the carton and on each blister
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures 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.
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), iron oxide yellow (E 172), iron oxide red (E 172).

What Rivaroxaban OLIMP looks like and contents of the pack
Rivaroxaban OLIMP 15 mg coated tablets are grey, round, biconvex, with the imprint "15" on one side and "RH" on the other side.
Clear blisters made of PVC/PVDC/Aluminium in a cardboard box.
Pack sizes: 14, 28 or 42 coated tablets.
Rivaroxaban OLIMP 20 mg coated tablets are light grey, round, biconvex, with the imprint "20" on one side and "RH" on the other side.
Clear blisters made of PVC/PVDC/Aluminium in a cardboard box.
Pack sizes: 14 or 28 coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer/Importer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Rivaroxaban olimp