Rivaroxaban Medreg

Leaflet accompanying the packaging: patient information

Rivaroxaban Medreg, 2.5 mg, film-coated tablets

Rivaroxaban

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The patient has been given Rivaroxaban Medreg because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Rivaroxaban Medreg reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Medreg will not be given to the patient as the only medicine. The doctor will also prescribe:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Medreg reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Medreg will not be given to the patient as the only medicine. The doctor will also prescribe aspirin. In some cases, if the patient is receiving Rivaroxaban Medreg after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for a short period in addition to aspirin.

Rivaroxaban Medreg contains the active substance rivaroxaban and 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 Medreg

When not to take Rivaroxaban Medreg:

• 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 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 the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter
• if the patient has been diagnosed with acute coronary syndrome and has previously had bleeding or a blood clot in the brain (stroke)
• if the patient has been diagnosed with ischemic heart disease or peripheral arterial disease and has previously had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the tissues in the deep structures of the brain (sinus thrombosis) or if the patient has had a blood clot in the brain (ischemic stroke, other than sinus thrombosis) in the last month
• 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 Medreg, and inform your doctorif any of the above situations apply to the patient.

Warnings and precautions

Before starting to take Rivaroxaban Medreg, discuss it with your doctor or pharmacist.
Rivaroxaban Medreg should not be taken in combination with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to be particularly careful when taking Rivaroxaban Medreg

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body
• if the patient is taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Medreg 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 genital or urinary system
• vascular disease of the back of the eye (retinopathy)
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• if the patient is over 75 years old
• if the patient weighs less than 60 kg
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves
• if the patient has a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), they should inform their doctor, who will decide whether a change in treatment is necessary.

If any of the above situations apply to the patient, they should tell their doctor

before taking Rivaroxaban Medreg. The doctor will decide whether the patient should be treated with this medicine and whether they should be monitored more closely.

If the patient is to undergo surgery:

• It is very important to take Rivaroxaban Medreg before and after surgery exactly at the time recommended by the doctor.
• If spinal or epidural puncture is planned (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Medreg before and after the puncture or catheter removal, as recommended by the doctor
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the anesthesia is completed, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Medreg 2.5 mg tablets 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 Medreg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 locally on the skin
• oral ketoconazole (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 that prevent blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel, and ticagrelor (see "Warnings and precautions"))
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or aspirin)
• 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 any of the above situations apply to the patient, they should tell their doctor

before taking Rivaroxaban Medreg, as the effect of Rivaroxaban Medreg may be increased. The doctor will decide whether to use this medicine and whether the patient should be monitored more closely.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment.

• If the patient is 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 any of the above situations apply to the patient, they should tell their doctor

before taking Rivaroxaban Medreg, as the effect of Rivaroxaban Medreg may be reduced. The doctor will decide whether to use Rivaroxaban Medreg and whether the patient should be monitored more closely.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not take Rivaroxaban Medreg if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Rivaroxaban Medreg. If the patient becomes pregnant while taking this medicine, they should inform their doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Medreg may cause dizziness (common side effect) and 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 Medreg contains lactose

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Rivaroxaban Medreg contains tartrazine and orange yellow FCF

May cause allergic reactions.

Rivaroxaban Medreg contains sodium

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 Medreg

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban Medreg should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Rivaroxaban Medreg. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it. If necessary, the doctor may administer the crushed Rivaroxaban Medreg tablet through a gastric tube.
Rivaroxaban Medreg will not be given to the patient as the only medicine.
The doctor will also prescribe aspirin. If the patient is receiving Rivaroxaban Medreg after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban Medreg after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for a short period in addition to aspirin.
The doctor will tell the patient what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rivaroxaban Medreg

Treatment with Rivaroxaban Medreg after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission, and when parenteral (injected) anticoagulant treatment would normally be discontinued.
The doctor will tell the patient when to start treatment with Rivaroxaban Medreg if they have been diagnosed with coronary artery disease or peripheral arterial disease.
The doctor will decide how long to continue treatment.

Taking more than the recommended dose of Rivaroxaban Medreg

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

Missing a dose of Rivaroxaban Medreg

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 treatment with Rivaroxaban Medreg

Rivaroxaban Medreg should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Rivaroxaban Medreg without consulting your doctor first. If the patient stops taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Medreg can cause side effects, although not everybody gets them.
Like other medicines with similar blood clotting-reducing effects, Rivaroxaban Medreg may 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.

The patient should tell their doctor immediately if they 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). A serious medical emergency. Immediate medical attention is required!

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 more closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• a drug reaction that causes rash, fever, inflammation of internal organs, hematological disorders, and systemic disease (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 patients).
• Signs of severe allergic reactions
• swelling of the face, lips, 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 up to 1 in 10,000 patients) and uncommon (angioedema and allergic edema; may occur in up to 1 in 100 patients).

General list of possible side effects:

Common(may affect up to 1 in 10 patients):

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestines, 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 conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (can be observed in tests performed by the doctor)
• fever
• abdominal pain, nausea, vomiting, or diarrhea, constipation
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• skin rash, itching
• blood tests may show increased activity of certain liver enzymes

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

• 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, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (can be observed in tests performed by the doctor)
• blood test results may show increased levels of bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 patients):

• bleeding into the muscles
• cholestasis (reduced bile flow), hepatitis, including liver damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of a cardiac procedure involving the insertion of a catheter into the leg artery (pseudoaneurysm)

Very rare(may affect up to 1 in 10,000 patients):

• accumulation of eosinophils, a type of white granulocytic 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 into 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 or arms after bleeding, leading to pain, swelling, sensory disturbances, numbness, or paralysis (compartment syndrome after bleeding)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly 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, more information can be collected on the safety of the medicine.

5. How to store Rivaroxaban Medreg

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Medreg contains

• The active substance of Rivaroxaban Medreg is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are: Tablet core: lactose monohydrate, sodium lauryl sulfate, hypromellose (type 2910), croscarmellose sodium, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica

Coating: Opadry Yellow 04F520016 (hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350 (E 1521), tartrazine, aluminum lake (E 102), indigo carmine, aluminum lake (E 132), orange yellow FCF, aluminum lake (E 110))

What Rivaroxaban Medreg looks like and contents of the pack

Yellow, round, biconvex film-coated tablets with a diameter of about 6 mm, with the inscription "2.5" on one side.
The film-coated tablets are supplied in PVC/PVDC/Aluminum blisters in a cardboard box.
Package sizes: 14, 20, 28, 30, 56, 60, 98, 100, 168, or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Importer:

Delorbis Pharmaceuticals Limited
Industrial Area
Athinon 17
2643 Ergates, Nicosia
Cyprus

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia:
Rivaroxaban Medreg 2.5 mg
Czech Republic:
Rivaroxaban Medreg
Poland:
Rivaroxaban Medreg
Romania:
Rivaroxaban Gemax Pharma 2.5 mg film-coated tablets

Date of last revision of the leaflet: