Rivaroxaban farmak

Package leaflet: Information for the patient

Rivaroxaban Farmak, 2.5 mg, film-coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm others even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Rivaroxaban Farmak is and what it is used for
2. What you need to know before taking Rivaroxaban Farmak
3. How to take Rivaroxaban Farmak
4. Possible side effects
5. How to store Rivaroxaban Farmak
6. Contents of the pack and other information

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

You have been prescribed Rivaroxaban Farmak because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Rivaroxaban Farmak reduces the risk of subsequent heart attack and reduces the risk of death due to heart- or blood vessel-related disease in adults. Rivaroxaban Farmak will not be given to you as the only treatment. Your doctor will also prescribe you to take:
  • 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 arterial disease causing symptoms. Rivaroxaban Farmak reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Farmak will not be given to you as the only treatment. Your doctor will also prescribe you to take acetylsalicylic acid. In certain cases, if you are receiving Rivaroxaban Farmak after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken for a short period in addition to acetylsalicylic acid.

Rivaroxaban Farmak 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 to form blood clots.

2. Important information before using Rivaroxaban Farmak

When not to use Rivaroxaban Farmak:

• 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 leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery of 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 been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had a hemorrhagic stroke (bleeding in the brain) or occlusion of small arteries supplying blood to tissues in deep brain structures (sinus stroke), or if the patient had a blood clot in the brain (ischemic, non-sinus stroke) within the last month,
• 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 Farmak and inform your doctor if the patient
suspects that any of the above circumstances apply.
Warnings and precautions
Before starting treatment with Rivaroxaban Farmak, discuss this with your doctor or
pharmacist. Rivaroxaban Farmak should not be used in combination with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as
prasugrel or ticagrelor.
Exercise special caution when using Rivaroxaban Farmak:

• 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 patency of an intravenous or arterial catheter (see section "Rivaroxaban Farmak and other medicines"),
• disorders of blood coagulation,
• 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 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,
• retinal vascular disease (retinopathy),
• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary hemorrhage,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If the patient suspects any of the above conditions apply, inform the doctor
before taking Rivaroxaban Farmak. The doctor will decide whether to use this medicine and whether
the patient requires particularly close monitoring.
If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of Rivaroxaban Farmak administration before or after surgery,
• if during surgery a catheterization or spinal puncture is planned (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Farmak before and after the puncture or catheter removal, 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.

Children and adolescents
Rivaroxaban Farmak 2.5 mg is not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Farmak 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 antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin, oral ketoconazole (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol), certain antibacterial medicines (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 medicines (e.g. naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, or certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, inform the doctor
before taking Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak 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, they may prescribe preventive treatment.

• If the patient is taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression, or rifampicin, an antibiotic.

If the patient suspects any of the above conditions apply, inform the doctor
before taking Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak may be reduced. The doctor will decide whether to use Rivaroxaban Farmak and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Farmak 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 Farmak. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Farmak may cause dizziness (common side effects) or 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 Farmak contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the product is considered "sodium-free".

3. How to take Rivaroxaban Farmak

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Farmak 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, discuss alternative ways of taking Rivaroxaban
Farmak with the doctor. The tablet may be crushed and mixed with water or apple puree immediately
before administration.
If necessary, the doctor may administer crushed Rivaroxaban Farmak tablets via a gastric tube.
Rivaroxaban Farmak will not be given to the patient as the only medication.
The doctor will prescribe acetylsalicylic acid for the patient. If the patient is receiving Rivaroxaban
Farmak after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban Farmak after a procedure to open a narrowed or blocked artery
in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel to be taken for a short
period in addition to acetylsalicylic acid.
The doctor will inform the patient 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 Farmak
Treatment with Rivaroxaban Farmak after acute coronary syndrome should be initiated as soon as
possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after hospital
admission and at the time when parenteral (by injection) anticoagulant therapy would normally be
discontinued.
The doctor will inform the patient when to start treatment with Rivaroxaban Farmak if coronary
artery disease or peripheral artery disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of Rivaroxaban Farmak
If a patient has taken more than the recommended dose of Rivaroxaban Farmak, contact the doctor
immediately. Taking too high a dose of Rivaroxaban Farmak increases the risk of bleeding.
Missed dose of Rivaroxaban Farmak
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at
the scheduled time.
Stopping Rivaroxaban Farmak
Rivaroxaban Farmak should be taken regularly and for the duration recommended by the doctor.
Do not stop taking Rivaroxaban Farmak 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 disease.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation,
Rivaroxaban Farmak 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.

Possible side effects which may indicate bleeding
Contact your doctor immediately if you experience any of the following side effects:

• 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.

Possible side effects which may indicate severe skin reactions
Contact your doctor immediately if you experience any of the following side effects:

• Widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this adverse reaction is very rare (up to 1 in 10,000 people),
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of this adverse reaction is very rare (up to 1 in 10,000 people).

Possible side effects which may indicate severe allergic reactions
Contact your doctor immediately if you experience any of the following side effects:

• Swelling of the face, lips, mouth, tongue or throat; 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

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 genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• Bleeding into the eye (including conjunctival bleeding)
• Bleeding into tissues or body cavities (hematoma, bruising)
• Presence of blood in sputum (hemoptysis) during coughing
• Bleeding from or under the skin
• Postoperative bleeding
• Oozing of blood or fluid from the surgical wound
• Swelling of limbs
• Limb pain
• Kidney function disorders (may be observed in tests performed by a doctor)
• Fever
• Stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• Generalized weakness and fatigue, headache, dizziness
• Rash, itching of the skin
• Increased activity of certain liver enzymes, which may be evident in blood test results

Uncommon (may occur in up to 1 in 100 patients)

• Bleeding into the brain or inside the skull (see bleeding signs above)
• Bleeding into a joint causing pain and swelling
• Thrombocytopenia (low platelet count, the blood cells involved in 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, increased activity of certain pancreatic or liver enzymes, or increased platelet count
• Fainting
• Malaise
• Rapid heartbeat
• Dry mouth
• Urticaria

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

• Bleeding into muscles
• Cholestasis (bile stasis), hepatitis including liver cell damage
• Yellowing of the skin and eyes (jaundice)
• Localized swelling
• Blood collection (hematoma) in the groin area as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm)

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

• Kidney failure following severe bleeding
• Increased pressure in the muscles of arms and legs after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, 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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Farmak

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. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater 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 packaging and other information

What Rivaroxaban Farmak contains

• The active substance is rivaroxaban. Each coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2, "Rivaroxaban Farmak contains lactose and sodium".
  Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172).

What Rivaroxaban Farmak looks like and contents of the pack
Rivaroxaban Farmak 2.5 mg are light yellow, round, biconvex coated tablets (6 mm in diameter), embossed with "2.5" on one side and smooth on the other.
The tablets are packed in transparent PVC/PVDC/Aluminium blisters, contained in a cardboard box with 28 coated tablets.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65
00-667 Warsaw
Poland
Tel. +48 22 822 93 06

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec, Slovakia

Alvogen Malta (Out-Licensing) Ltd. / AMOL Ltd.
Malta Life Sciences Park, Building 1, Level 4
San Ġwann, SĠN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Lithuania Rivaroxaban Farmak 2.5 mg plėvele dengtos tabletės
Poland Rivaroxaban Farmak