Rivaroxaban Medreg

Package Leaflet: Information for the Patient

Rivaroxaban Medreg, 15 mg, Film-Coated Tablets

Rivaroxaban Medreg, 20 mg, Film-Coated Tablets

Rivaroxaban

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package and other information

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

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Medreg 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 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 administered to maintain the patency of a vein or artery catheter
• 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 treatment with Rivaroxaban Medreg, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Medreg

• if the patient has an increased risk of bleeding, in such conditions 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 acting in the patient's body
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is administered 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 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 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 eyeballs (retinopathy)
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• 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 may be necessary
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

before taking Rivaroxaban Medreg. The doctor will decide whether the patient should be treated with this medicine and whether they should be subject to closer monitoring.

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 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 Medreg before and after injection or removal of the catheter exactly at the time recommended by the doctor
• the doctor should be informed immediately if, after the anesthesia is completed, numbness or weakness of the legs occurs, or disturbances of bowel or bladder function, as immediate help is necessary.

Children and adolescents

Rivaroxaban Medreg 15 mg and 20 mg tablets are not recommended for use in children and adolescents under 18 years of agedue to the inadequacy of this pharmaceutical form. In children under 18 years of age, alternative rivaroxaban-containing medicines should be used.

Rivaroxaban Medreg and other medicines

The patient should inform 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 topically on the skin
• ketokonazole in 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 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 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 inform their doctor

before taking Rivaroxaban Medreg, as the action of Rivaroxaban Medreg may be enhanced. The doctor will decide whether the patient should be treated with Rivaroxaban Medreg and whether they should be subject to closer monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment to prevent ulcers.

• 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 inform their doctor

before taking Rivaroxaban Medreg, as the action of Rivaroxaban Medreg may be reduced. The doctor will decide whether the patient should be treated with Rivaroxaban Medreg and whether they should be subject to closer monitoring.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should ask their doctor or pharmacist for advice before taking this medicine.
Rivaroxaban Medreg should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception during treatment with 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) or fainting (uncommon side effect) (see section 4 "Possible side effects"). If these symptoms occur, the patient should not drive vehicles, ride a bicycle, or operate any 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 orange yellow S

It 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 directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Rivaroxaban Medreg should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the tablet whole, they should discuss other ways of taking Rivaroxaban Medreg with their doctor. The tablet can be crushed and mixed with water or apple sauce, just before taking. After such a mixture, the patient should take their meal immediately.
If necessary, the doctor may administer a crushed Rivaroxaban Medreg tablet through a gastric tube.

How many tablets to take

Adults

• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one 20 mg Rivaroxaban Medreg tablet once a day. If the patient has kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Medreg tablet once a day.

If the patient needs a procedure to restore normal heart rhythm, called cardioversion, they should take Rivaroxaban Medreg at the time recommended by their doctor.

When to take Rivaroxaban Medreg

The tablets should be taken daily, until the doctor recommends stopping treatment.
The patient should take the tablet(s) daily at the same time, to make it easier to remember.
The doctor will decide how long the treatment should be continued.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If cardioversion is necessary to restore normal heart rhythm, the patient should take Rivaroxaban Medreg at the time recommended by their doctor.

Taking more Rivaroxaban Medreg than recommended

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

Missing a dose of Rivaroxaban Medreg

If the patient takes one 20 mg or one 15 mg tablet oncea day and misses a dose, they should take it as soon as possible. They should not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then the patient should continue taking one tablet once a day.
If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as possible. They should not take more than two 15 mg tablets in one day. If a dose is missed, they can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Stopping treatment with Rivaroxaban Medreg

The patient should not stop taking Rivaroxaban Medreg without consulting their doctor first, as Rivaroxaban Medreg prevents a serious disease.
In case of any further doubts about taking this medicine, the patient 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 that reduce blood clotting, Rivaroxaban Medreg may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

The patient should inform 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, sudden medical condition. Immediate medical help is necessary!
• 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 very closely or change the treatment.

• Signs of severe skin reactions:
• widespread, acute skin rash, blisters, or changes on mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)
• a drug reaction that causes rash, fever, inflammation of internal organs, blood disorders, and systemic disease (DRESS syndrome). The frequency of these side effects is very rare (may occur in up to 1 in 10,000 patients).
• 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 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 occur in 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 intestine, bleeding from the urinary or reproductive 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 wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (can be observed in tests performed by the doctor)
• fever
• abdominal pain, nausea, vomiting, or 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
• blood tests may show increased activity of certain liver enzymes

Uncommon(may occur in 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 problems (can be observed in tests performed by the doctor)
• blood test results may show increased bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may occur in 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)
• localized 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 occur in less than 1 in 10,000 patients):

• accumulation of eosinophils, a type of white granular blood cell that causes 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 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 side effects occur, including those not listed in this package leaflet, the patient should inform 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.
Reporting side effects will help gather more information 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 storage instructions for 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 package and other information

What Rivaroxaban Medreg contains

• The active substance of Rivaroxaban Medreg is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are:

Tablet core: lactose monohydrate, sodium lauryl sulfate, hypromellose (type 2910), croscarmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica
Coating:
Rivaroxaban Medreg, 15 mg:
Opadry Orange 04F530006 (hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350 (E 1521), orange yellow S, aluminum lake (E 110), and iron oxide red (E 172))
Rivaroxaban Medreg, 20 mg:
Opadry Orange 04F530010 (hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350 (E 1521), orange yellow S, aluminum lake (E 110), iron oxide red (E 172), iron oxide yellow (E 172), and iron oxide black (E 172))

What Rivaroxaban Medreg looks like and contents of the pack

Rivaroxaban Medreg, 15 mg:
Light orange, round, biconvex, film-coated tablets with a diameter of about 6 mm, with the marking "15" on one side.
Package sizes: 10, 14, 28, 30, 42, 98, or 100 film-coated tablets.
Not all package sizes may be marketed.
Rivaroxaban Medreg, 20 mg:
Orange, round, biconvex, film-coated tablets with a diameter of about 7 mm, with the marking "20" on one side.
Package sizes: 10, 14, 28, 30, 98, or 100 film-coated tablets.
Not all package sizes may be marketed.
The film-coated tablets are provided in PVC/PVDC/Aluminum blisters in a cardboard box.

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 15 mg
Rivaroxaban Medreg 20 mg
Czech Republic:
Rivaroxaban Medreg
Poland:
Rivaroxaban Medreg
Romania:
Rivaroxaban Gemax Pharma 15 mg film-coated tablets
Rivaroxaban Gemax Pharma 20 mg film-coated tablets

Date of last revision of the package leaflet: