Rivaroxaban medreg

Package leaflet: Information for the patient

Rivaroxaban Medreg, 2.5 mg, film-coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

You have been prescribed Rivaroxaban Medreg because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, causing acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Medreg reduces the risk of subsequent heart attack and the risk of cardiovascular death in adults. Rivaroxaban Medreg will not be given to you as the only medication. Your doctor will also prescribe:
  • 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 Medreg reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Medreg will not be given to you as the only medication. Your doctor will also prescribe acetylsalicylic acid. In some cases, if you are receiving Rivaroxaban Medreg after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, your doctor may additionally prescribe clopidogrel to be taken for a short period alongside acetylsalicylic acid.

Rivaroxaban Medreg 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 for blood clots to form.

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 active bleeding
• if the patient has a disease or condition of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or intracranial bleeding, recent brain or eye surgery)
• if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain patency of a venous or arterial catheter
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke)
• if the patient has been diagnosed with ischemic heart disease or peripheral arterial disease and previously experienced intracranial bleeding (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (sinus stroke), or if the patient had an ischemic stroke (other than sinus) within the last month
• if the patient has liver disease that increases the risk of bleeding
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Medreg and inform your doctor if any of the above situations apply to the patient.
Warnings and precautions
Before starting Rivaroxaban Medreg, discuss this with your doctor or pharmacist.
Rivaroxaban Medreg should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, such as prasugrel or ticagrelor.
When to exercise particular 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
  • if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or if heparin is administered to maintain patency of a venous or arterial catheter (see section "Rivaroxaban Medreg and other medicines")
  • coagulation disorders
  • very high blood pressure that does not decrease despite medication
  • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine and stomach or esophagitis (throat and esophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid 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 dilated bronchi filled with pus (bronchiectasis) or previous pulmonary bleeding
  • if the patient is over 75 years of age
• if the patient has body weight below 60 kg
• coronary artery disease with severe symptomatic heart failure
  • 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 the doctor, who will decide whether a change in treatment may be necessary.

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 is scheduled for surgery:

• It is very important to take Rivaroxaban Medreg exactly at the times prescribed by the doctor, both before and after surgery.
• If during surgery a catheter or spinal 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 removal of the catheter, as directed by the doctor
  • due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anesthesia wears off, as immediate treatment may be necessary.

Children and adolescents
Rivaroxaban Medreg 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 Medreg and other medicines
Inform your doctor or pharmacist about all medicines currently used 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-norepinephrine reuptake inhibitors (SNRI)).

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 antiepileptic medicines (phenytoin, carbamazepine, phenobarbital)
  • St. John's wort (Hypericum perforatum), a herbal remedy used for depression
  • rifampicin, an antibiotic.

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 plans to become pregnant, she should consult a 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, an effective method of contraception should be used during treatment with Rivaroxaban Medreg. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and using machines
Rivaroxaban Medreg may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate 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 tartrazine and 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 as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Medreg 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 a patient has difficulty swallowing the whole tablet, they should discuss alternative ways of taking Rivaroxaban Medreg with their 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 Medreg tablets via a gastric tube.

Rivaroxaban Medreg will not be given to the patient as the only medication.

Your doctor will prescribe acetylsalicylic acid for you to take. If you are receiving Rivaroxaban Medreg after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.

If you are receiving Rivaroxaban Medreg after a procedure to restore blood flow through a narrowed or blocked artery in the lower limb, your doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.

Your doctor will inform you of the dose of these medications to take (usually 75–100 mg of acetylsalicylic acid per day, 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 start taking Rivaroxaban Medreg
Treatment with Rivaroxaban Medreg after an acute coronary syndrome should be initiated as soon as possible after stabilization of the acute coronary event, no earlier than 24 hours after hospital admission and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued.

Your doctor will inform you when to start treatment with Rivaroxaban Medreg if you have been diagnosed with coronary artery disease or peripheral arterial disease.

Your doctor will decide how long treatment should continue.

Taking more Rivaroxaban Medreg than prescribed
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
Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at the scheduled time.

Stopping Rivaroxaban Medreg
Rivaroxaban Medreg should be taken regularly and for the duration prescribed by your doctor.
Do not stop taking Rivaroxaban Medreg without first consulting your doctor. Discontinuing this medicine may increase the risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everyone will experience them.
Similarly to other medicines with a comparable action in reducing 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). Signs of bleeding are not always obvious or visible.
You should immediately inform your doctor 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, reduced level of consciousness, and neck stiffness). This is a serious, sudden 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 of the patient or a change in treatment is necessary.

  • Signs of severe skin reactions

• widespread, acute skin rash, blistering or mucosal changes, 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; 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 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 1 in 10 patients):

• decreased number of 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 loss of strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• blood tests may show increased activity of certain liver enzymes

Uncommon (may occur in 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
• urticaria

Rare (may occur in 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 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 in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (anticoagulant-related nephropathy)
• increased pressure in the muscles of the legs or arms after bleeding, leading to pain, swelling, sensory disturbances, numbness or paralysis (compartment syndrome following bleeding)

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Medreg contains

• The active substance is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: Lactose monohydrate, sodium lauryl sulfate, hypromellose (type 2910), sodium croscarmellose, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.
  Coating: Opadry Yellow 04F520016 (hypromellose (type 2910), titanium dioxide (E 171), macrogol 3350 (E 1521), tartrazine, aluminium lake (E 102), indigo carmine, aluminium lake (E 132), brilliant blue FCF, aluminium lake (E 110)).

What Rivaroxaban Medreg looks like and contents of the pack
Yellow, round, biconvex film-coated tablets with a diameter of approximately 6 mm, marked with "2.5" on one side.
The film-coated tablets are supplied in PVC/PVDC/Aluminium blister packs contained in a cardboard box.
Pack sizes: 14, 20, 28, 30, 56, 60, 98, 100, 168 or 196 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 member states 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