Rivaroxaban medreg

Package leaflet: Information for the patient

Rivaroxaban Medreg, 10 mg, coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of contents

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

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

• prevent the formation of blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots is increased after surgery.
• treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of 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. It works by blocking a clotting factor in the blood (factor Xa), 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 to 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, trauma or bleeding into the brain, recent surgery on the brain or eye)
• 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 the patency of a venous or arterial catheter
• 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 Medreg and inform your doctor if any of the above situations apply to you.
Warnings and precautions
Before starting to take Rivaroxaban Medreg, discuss this with your doctor or pharmacist.
When to exercise special caution when taking Rivaroxaban Medreg

• 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 the patency of a venous or arterial catheter (see section "Rivaroxaban Medreg and 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. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus), or tumours located in the stomach or intestines or in the genital or urinary system
  • blood vessel disease of the posterior part of the eyeball (retinopathy)
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• in patients with prosthetic heart valves
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder increasing the risk of blood clots), inform your 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 aimed at removing a blood clot from the lungs.

If any of the above situations apply to the patient, inform the doctor before taking Rivaroxaban Medreg. The doctor will decide whether the patient should be treated with this medicine and whether closer monitoring is required.
If the patient needs to undergo surgery:

• It is very important to take Rivaroxaban Medreg exactly at the time prescribed by the doctor, both before and after surgery.
• If during a surgical procedure the patient is scheduled to undergo lumbar puncture or spinal catheter placement (e.g. for epidural or intrathecal anaesthesia or for pain relief):
  • strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Medreg
  • immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, bowel or bladder dysfunction, as immediate treatment will be necessary.

Children and adolescents
Rivaroxaban Medreg 10 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 Medreg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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
  • 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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If any of the above situations apply to the patient, inform the 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 requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, preventive treatment may be prescribed.

• If the patient is taking
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St John's wort ( Hypericum perforatum ), a herbal remedy used for depression
  • rifampicin, which belongs to the group of antibiotics.

If any of the above situations apply to the patient, inform the 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 requires particularly close monitoring.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Do not use Rivaroxaban Medreg 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 Medreg. If the patient becomes pregnant while taking this medicine, she should immediately inform her doctor, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Medreg may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). If these symptoms occur, do not drive, ride a bicycle, or operate any tools or machinery.
Rivaroxaban Medreg contains lactose
If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Rivaroxaban Medreg contains sunset yellow FCF
May cause allergic reactions.
Rivaroxaban Medreg contains sodium
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 Medreg

This medicine should always be taken exactly as your doctor has told you. If you are not sure,
ask your 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 tablet of Rivaroxaban Medreg 10 mg once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Medreg 10 mg once daily for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban Medreg may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking
Rivaroxaban Medreg. The tablet may be crushed and mixed with water or apple puree immediately
before administration.
If necessary, your doctor may administer crushed Rivaroxaban Medreg tablets through a gastric
tube.
When to take Rivaroxaban Medreg
Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the legs after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
If you take more Rivaroxaban Medreg than you should
If you have taken too many Rivaroxaban Medreg tablets, contact your doctor immediately.
Taking too high a dose of Rivaroxaban Medreg increases the risk of bleeding.
If you forget to take Rivaroxaban Medreg
If you miss a dose, take it as soon as possible. Take the next tablet the following day at your
usual time, and then continue taking one tablet once daily as usual.
Do not take a double dose to make up for a missed tablet.
Stopping Rivaroxaban Medreg
Do not stop taking Rivaroxaban Medreg without first consulting your doctor, as Rivaroxaban Medreg prevents serious illness.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Similarly to other medicines that reduce blood clot formation, Rivaroxaban Medreg may cause bleeding,
which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood
pressure (shock). In some cases, bleeding may not be obvious.
You should contact your doctor immediately if any of the following side effects 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, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic illness (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring 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 breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock; may occur in 1 in 10,000 patients) and uncommon (angioedema and allergic edema; may occur in 1 in 100 patients).

General list of possible side effects:
Common (may occur in up to 1 in 10 patients):

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• bleeding into the eye (including bleeding from the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• 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
• abdominal pain, indigestion, nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• 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 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 number of platelets, 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, certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dryness in the mouth
• hives

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

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

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

• accumulation of eosinophils, a type of granular white blood cells, causing lung inflammation (eosinophilic pneumonia)

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

• kidney failure following severe bleeding or bleeding into the kidneys, sometimes with presence of blood in urine, leading to kidneys being unable to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms following bleeding, leading to pain, swelling, sensory disturbances, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie
181C, 02-222 Warsaw, phone: +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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Medreg

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 blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Rivaroxaban Medreg contains

• The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: monohydrate lactose, sodium lauryl sulfate, hypromellose (type 2910), sodium croscarmellose, 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, aluminium lake of sunset yellow (E 110), and red iron oxide (E 172)).

What Rivaroxaban Medreg looks like and contents of the pack
Round, biconvex, peach-coloured film-coated tablets with a diameter of approximately 6 mm, marked with "10" on one side.
The film-coated tablets are supplied in PVC/PVDC/Aluminium blister packs contained in a cardboard box.
Pack sizes: 5, 10, 14, 28, 30, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 medicinal product is authorised in 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