Package leaflet: Information for the user

Rivaroxaban APC, 2.5 mg, coated tablets
Rivaroxabanum
This medicinal product will be subject to additional monitoring. This will allow for
rapid identification of new safety information. You can also help by reporting any
adverse reactions observed after using the medicine.
For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, 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 similar.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Rivaroxaban APC is and what it is used for
Important information before taking Rivaroxaban APC
How to take Rivaroxaban APC
Possible adverse reactions
How to store Rivaroxaban APC
Contents of the pack and other information

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

You have been prescribed Rivaroxaban APC because:

You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban APC reduces the risk of subsequent heart attack and reduces the risk of death due to heart- or blood vessel-related disease in adults. Rivaroxaban APC will not be given to you as a single treatment. Your doctor will also prescribe you:
- acetylsalicylic acid, or
- acetylsalicylic acid and clopidogrel or ticlopidine.
  or
You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban APC reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Rivaroxaban APC will not be given to you as a single treatment. Your doctor will also prescribe you acetylsalicylic acid. In certain cases, if you are receiving Rivaroxaban APC after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.

Rivaroxaban APC contains the active substance rivaroxaban and 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. Important information before taking Rivaroxaban APC

When not to take Rivaroxaban APC

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 leads to an increased risk of serious bleeding (e.g., gastric ulcer, trauma or bleeding into the brain, recent brain or eye surgery),
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 been diagnosed with acute coronary syndrome and previously experienced bleeding or a blood clot in the brain (stroke),
if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had a brain hemorrhage (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had an ischemic stroke (non-lacunar) within the last month,
if the patient has a liver disease that leads to an increased risk of bleeding,
if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban APC, and also inform the doctor if the patient suspects any of the above circumstances apply.
Warnings and precautions
Before starting Rivaroxaban APC, consult a doctor or pharmacist. Rivaroxaban APC should not be used in combination with other anticoagulant medicines apart from acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Rivaroxaban APC

if the patient has an increased risk of bleeding, such as in the following conditions:
severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban APC with other medicines"),
blood clotting disorders,
very high blood pressure that does not decrease despite medication,
diseases of the stomach or intestines that may cause bleeding, e.g., inflammatory bowel disease or gastritis, or esophagitis (inflammation of the throat and esophagus), e.g., due to gastroesophageal reflux disease (acid reflux into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,
vascular disease of the posterior part of the eyeball (retinopathy),
lung disease with bronchiectasis (dilated bronchi filled with pus) or previous lung bleeding,
if the patient is over 75 years of age,
if the patient weighs less than 60 kg,
coronary artery disease with severe symptomatic heart failure,
in patients with heart valve prostheses,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment adjustment is needed.

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

strictly follow the doctor's instructions regarding the timing of Rivaroxaban APC administration before or after surgery,
if catheterization or spinal puncture (e.g., for epidural or spinal anesthesia or pain relief) is planned during surgery:
it is very important to take Rivaroxaban APC before and after the puncture or catheter removal 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 bowel or bladder dysfunction occur after anesthesia ends.

Children and adolescents
Rivaroxaban APC 2.5 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.
Rivaroxaban APC with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, 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 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, prasugrel, and ticagrelor (see section "Warnings and precautions")),
anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid),
dronedarone, a medicine used to treat heart rhythm disorders,
certain antidepressants (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 Rivaroxaban APC, as the effect of Rivaroxaban APC may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers the patient to be at increased risk of developing stomach or intestinal ulcers, preventive treatment may be initiated.

If the patient is taking
certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
St. John's wort (Hypericum perforatum), an herbal medicine used for depression,
rifampicin, an antibiotic.

If the patient suspects any of the above conditions apply, they should
inform the doctor before taking Rivaroxaban APC, as the effect of Rivaroxaban APC may be reduced. The doctor will decide whether to use Rivaroxaban APC and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Rivaroxaban APC must not be used 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 APC. If the patient becomes pregnant while taking this medicine, she must inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaroxaban APC may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban APC 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.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban APC

This medicine should always be taken as instructed by the doctor. If in doubt,
contact the doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban APC should
be taken at approximately the same time each day (for example, one tablet in the morning
and one in the evening). This medicine may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
Rivaroxaban APC 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 Rivaroxaban APC tablets via a gastric tube.
Rivaroxaban APC will not be given to the patient as the only medicine.
The doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving
Rivaroxaban APC after an acute coronary syndrome, the doctor may also prescribe
clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban APC after a procedure to open a narrowed or blocked
artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel
to be taken for a short additional period along with acetylsalicylic acid.
The doctor will inform the patient of the doses to take of these medicines (usually 75–100 mg
of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose
of 75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to take Rivaroxaban APC
Treatment with Rivaroxaban APC after an acute coronary syndrome should be started as soon
as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after
hospital admission and at the time when parenteral (by injection) anticoagulant therapy would
normally be discontinued.
The doctor will inform the patient when to start treatment with Rivaroxaban APC if coronary
artery disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more Rivaroxaban APC than prescribed
If the patient has taken more than the prescribed dose of Rivaroxaban APC, contact the doctor
immediately. Taking too high a dose of Rivaroxaban APC increases the risk of bleeding.
Missing a dose of Rivaroxaban APC
Do not take a double dose to make up for a missed dose. If the patient misses a dose,
they should take the next dose at the scheduled time.
Stopping Rivaroxaban APC
Rivaroxaban APC should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking Rivaroxaban APC without first consulting the doctor. Stopping this medicine
may increase the risk of another heart attack, stroke, or death due to heart or blood vessel disease.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Rivaroxaban APC may cause adverse reactions, although not
everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban APC 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. This is 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. Your 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. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- drug reaction with eosinophilia and systemic symptoms (DRESS) characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement.

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

swelling of the face, lips, oral cavity, 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 1 in 10 people)

reduction in 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 genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including bleeding from the sclera),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) when coughing,
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 decrease in strength and energy (weakness, fatigue), headache, dizziness,
rash, skin itching,
increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 in 100 people)

bleeding into the brain or inside the skull (see bleeding signs above),
joint bleeding causing pain and swelling,
thrombocytopenia (low platelet count, blood cells involved in 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 1 in 1,000 people)

muscle bleeding,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
local 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).

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

kidney failure following severe bleeding,
increased pressure in the muscles of arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions 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, 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
e-mail: website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban APC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after "Expiry date" and on each blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban APC contains

The active substance is rivaroxaban. One coated tablet contains 2.5 mg of rivaroxaban.
Other components are:
Core of the tablet: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.
Coating of the tablet: hypromellose, hydroxypropylcellulose, polyethylene glycol, titanium dioxide (E 171).

What Rivaroxaban APC looks like and contents of the pack
Rivaroxaban APC 2.5 mg coated tablets are white, round, biconvex, with an embossed mark "2.5" on one side.
The tablets are packed in blisters placed in a cardboard box containing: 10, 14, 28, 30, 42, 56, 60, 98, 100 or 196 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
APC Instytut Sp. z o.o.
Al. Jerozolimskie 146C
02-305 Warsaw
Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 2,5 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 2,5 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain Rivaroxaban APC 2.5mg comprimidos recubiertos con película
Germany Rivaroxaban APC 2,5mg, Filmtablette
Poland Rivaroxaban APC
Portugal Rivaroxaban APC