Rivaroxaban Medreg

Package Leaflet: Information for the Patient

Rivaroxaban Medreg, 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, 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 leaflet, they should inform 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 pack and other information

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

Rivaroxaban Medreg 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. The doctor has prescribed this medicine to the patient because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and to 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 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial 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 to take 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, such as:
• 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 given to maintain the patency of a venous or arterial 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 (stomach acid flowing back 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
• in patients with artificial 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 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 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, during the surgical procedure, the patient is scheduled to undergo a lumbar puncture or insertion of a catheter into the spine (e.g., for epidural or spinal anesthesia or to reduce pain):
• the doctor's instructions regarding the intake of Rivaroxaban Medreg at a specific time must be followed very carefully
• the doctor should be informed immediately if, after the anesthesia, the patient experiences symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Medreg 10 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 taking, have recently taken, or plan to take, including those obtained without a prescription.

• If the patient is taking:
• certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain medicines used to treat bacterial infections (e.g., clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV or AIDS (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 (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

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

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

• 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 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 (a common side effect) or fainting (an uncommon side effect) (see section 4 "Possible side effects"). If these symptoms occur, the patient should not drive, 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 FCF

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 prescribed by the doctor. In case of doubts, the patient should consult their 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 Medreg 10 mg tablet 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 in the blood vessels of the legs and/or lungs. 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. The doctor has prescribed Rivaroxaban Medreg 10 mg once a day for the patient.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Medreg 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 apple sauce, just before taking it.
If necessary, the doctor may administer the crushed Rivaroxaban Medreg tablet through a gastric tube.

When to take Rivaroxaban Medreg

The patient should take one tablet every day until the 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.
The doctor will decide how long the treatment should be continued.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 6 to 10 hours after the surgical procedure.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks.
In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaroxaban Medreg

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

In case of a missed dose, the patient should take it as soon as possible. The next tablet should be taken the next day, and then the patient should continue taking one tablet a day at the usual time.
The patient should not take a double dose to make up for the missed tablet.

Stopping the 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 the use of 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. The patient should seek medical help immediately!
• prolonged or excessive bleeding
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. 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 (in 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):

• reduction in 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 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 disorders (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 decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• 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 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 granular 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 inform their 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 Warszawa, 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 gathered 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 pack and other information

What Rivaroxaban Medreg contains

• The active substance of Rivaroxaban Medreg is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: lactose monohydrate, sodium lauryl sulfate, hypromellose (type 2910), croscarmellose sodium, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica. Coating: Opadry Orange 04F530012 (hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), orange yellow FCF, aluminum lake (E 110), and iron oxide red (E 172))

What Rivaroxaban Medreg looks like and contents of the pack

Round, biconvex, orange-colored film-coated tablets with a diameter of about 6 mm, with the marking "10" on one side.
The film-coated tablets are supplied in PVC/PVDC/Aluminum blisters in a cardboard box.
Package sizes: 5, 10, 14, 28, 30, 98, or 100 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 10 mg
Czech Republic:
Rivaroxaban Medreg
Poland:
Rivaroxaban Medreg
Romania:
Rivaroxaban Gemax Pharma 10 mg film-coated tablets

Date of last revision of the leaflet: