Rivaroxaban medreg

Package leaflet: Information for the patient

Rivaroxaban Medreg, 15 mg, coated tablets
Rivaroxaban Medreg, 20 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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.
Rivaroxaban Medreg is used in adults for:

• preventing blood clots in the brain (stroke) and other blood vessels in the body, in patients with a type of irregular heartbeat called non-valvular atrial fibrillation.
• treating blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and preventing 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 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 is experiencing 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 in the brain, recent surgery on the brain or eyes)
• 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 patency of an intravenous 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 take Rivaroxaban Medreg and inform your doctor if any of the
above situations apply to the patient.
Warnings and precautions
Before starting treatment with 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 in adults, or moderate to severe kidney disease in children and adolescents, because 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 patency of an intravenous or arterial catheter (see section "Rivaroxaban Medreg and other medicines")
  • coagulation 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 (backflow of stomach acid into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system
  • blood vessel disease in the back of the eye (retinopathy)
  • lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs
• 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 the patient has 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 times prescribed by the doctor, both before and after surgery
• If during surgery catheterisation or spinal puncture is planned (e.g. for epidural or intrathecal anaesthesia or pain relief):
  • it is very important to take Rivaroxaban Medreg exactly at the times prescribed by the doctor, both before and after injection or removal of the catheter
  • inform the doctor immediately if, after completion of anaesthesia, numbness or weakness of the legs, or disturbances in bowel or bladder function occur, as immediate medical help is required.

Children and adolescents
Rivaroxaban Medreg 15 mg and 20 mg tablets are not recommended for use in children and
adolescents under 18 years of age due to the unsuitability of this pharmaceutical form. In
children under 18 years of age, alternative medicines containing rivaroxaban should be used.
Rivaroxaban Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available 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 topically on the skin
  • ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
  • certain antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin)
  • certain antiviral medicines used to treat HIV infection 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-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 the patient should be treated with Rivaroxaban Medreg and whether closer monitoring is required.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, he may prescribe treatment to prevent ulcer formation.

• 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 the patient should be treated with Rivaroxaban Medreg and whether closer monitoring is required.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a child, 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 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 he or she has an intolerance to certain sugars, he or she should consult the 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 as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Rivaroxaban Medreg should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the tablet whole, they should discuss alternative methods of
taking Rivaroxaban Medreg with their doctor. The tablet may be crushed and mixed with water or
apple puree immediately before administration. After taking this mixture, the patient should
immediately eat a meal.
If necessary, a doctor may administer crushed Rivaroxaban Medreg tablets via a gastric tube.

How many tablets to take
Adults

• For prevention 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 daily. If the patient has impaired kidney function, the dose may be reduced to one 15 mg Rivaroxaban Medreg tablet once daily.

  If a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement) is required, there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Medreg tablet once daily (or one 10 mg Rivaroxaban Medreg tablet once daily if kidney function is impaired), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one 15 mg Rivaroxaban Medreg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one 20 mg Rivaroxaban Medreg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has impaired kidney function and is taking one 20 mg Rivaroxaban Medreg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Medreg tablet once daily, if the risk of bleeding is greater than the risk of forming further blood clots.

When to take Rivaroxaban Medreg
Tablets should be taken every day until the doctor advises stopping treatment.
The tablet(s) should be taken at the same time each day to help remember.
The doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If restoration of normal heart rhythm by a procedure called cardioversion is required, Rivaroxaban Medreg should be taken at the time prescribed by the doctor.

Taking more Rivaroxaban Medreg than prescribed
If a patient has taken too many Rivaroxaban Medreg tablets, they should contact their doctor immediately. Taking too high a dose of Rivaroxaban Medreg increases the risk of bleeding.

Missing a dose of Rivaroxaban Medreg
If a patient takes one 20 mg tablet or one 15 mg tablet once daily and misses a dose, they should take it as soon as possible. They should not take more than one tablet in a single day to make up for the missed dose. The next tablet should be taken the following day, and then continue taking one tablet once daily.

If taking one 15 mg tablet twice daily and a dose is missed, it should be taken as soon as possible. Do not take more than two 15 mg tablets in one day. If a dose is missed, two 15 mg tablets may be taken together to achieve a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Rivaroxaban Medreg
Do not stop taking Rivaroxaban Medreg without first consulting your doctor, as Rivaroxaban Medreg helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 immediately inform the doctor if the patient experiences any of the following
side effects:

• Signs of bleeding
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness). 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

The doctor may decide that the patient requires very close monitoring or a change in treatment.

• Signs of severe skin reactions:
  • widespread, acute skin rash, blisters or mucosal changes, e.g. in the mouth or eyes (Stevens-Johnson syndrome and/or toxic epidermal necrolysis)
  • a drug reaction causing rash, fever, internal organ inflammation, blood disorders and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (occurring in up to 1 in 10,000 patients).
• Signs of serious 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 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 intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the white of the eye)
• bleeding into tissues or body cavities (haematoma, 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 the doctor)
• fever
• abdominal pain, indigestion, nausea or vomiting, constipation, diarrhoea
• 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 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, the blood cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (may be observed in tests performed by the doctor)
• blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dryness of the mouth
• urticaria

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)
• localised swelling
• accumulation of blood (haematoma) 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 less than 1 in 10,000 patients):

• accumulation of eosinophils, a type of white granulocytic blood cells, causing inflammation in the lungs (eosinophilic pneumonia)

Frequency unknown (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 after bleeding)

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, you should inform 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, 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 responsible entity.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Medreg

Keep this medicine out of 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 apply 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Medreg contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 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:
Rivaroxaban Medreg, 15 mg:
Opadry Orange 04F530006 (hypromellose (type 2910), titanium dioxide (E 171), polyethylene glycol 3350
(E 1521), sunset yellow FCF, aluminium lake (E 110) and red iron oxide (E 172))
Rivaroxaban Medreg, 20 mg:
Opadry Orange 04F530010 (hypromellose (type 2910), titanium dioxide (E 171), polyethylene glycol 3350
(E 1521), sunset yellow FCF, aluminium lake (E 110), red iron oxide (E 172),
yellow iron oxide (E 172) and black iron oxide (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 approximately 6 mm, marked with "15" on one side.
Pack sizes: 10, 14, 28, 30, 42, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Rivaroxaban Medreg, 20 mg:
Orange, round, biconvex film-coated tablets with a diameter of approximately 7 mm, marked with "20" on one side.
Pack sizes: 10, 14, 28, 30, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Film-coated tablets are supplied in PVC/PVDC/Aluminium blister packs in cardboard cartons.

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 countries 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 comprimate filmate
Rivaroxaban Gemax Pharma 20 mg comprimate filmate