Rixacam

Package leaflet: Information for the patient

RIXACAM, 2.5 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as 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 pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What RIXACAM is and what it is used for

You have been prescribed RIXACAM 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. RIXACAM reduces the risk of subsequent heart attack or the risk of death due to heart- or blood vessel-related disease in adults. RIXACAM 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. RIXACAM reduces the risk of blood clots (atherothrombotic events) in adults. RIXACAM will not be given to you as the only treatment. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are receiving RIXACAM after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, your doctor may additionally prescribe clopidogrel for a short period alongside acetylsalicylic acid.

RIXACAM 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 RIXACAM

When not to take RIXACAM

• 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 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 the patency of a catheter in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and has previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral artery disease and previously had bleeding in the brain (hemorrhagic stroke), or blockage of small arteries supplying blood to tissues in deep brain structures (sinus vein thrombosis), or if the patient has had a blood clot in the brain (ischemic, non-sinus stroke) within the last month,
• if the patient has liver disease leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use RIXACAM, and you must inform your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting to take RIXACAM, consult your doctor or
pharmacist. RIXACAM must not be used in combination with medicines other than acetylsalicylic acid, clopidogrel or ticlopidine, which inhibit blood coagulation, such as prasugrel or ticagrelor.
When to exercise particular caution when taking RIXACAM

• 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 catheter in a vein or artery (see section "RIXACAM with other medicines"),

• blood clotting disorders,

• very high blood pressure that does not decrease despite medication,

• stomach or intestinal diseases that may cause bleeding, e.g., inflammatory bowel disease and gastritis 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 or intestines or in the genital or
  urinary system,

• posterior eye globe blood vessel disease (retinopathy),

• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary hemorrhage,

• if the patient is over 75 years of age,

• 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 clot formation), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If the patient suspects any of the above conditions apply, they should
inform the doctor before taking RIXACAM. The doctor will decide whether
to prescribe this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• it is essential to strictly follow the doctor's instructions regarding the timing of RIXACAM administration before or after surgery,
• if spinal catheterization or spinal puncture (e.g., for epidural or spinal anesthesia or pain relief) is planned during surgery:
• it is very important to take RIXACAM before and after the puncture or catheter removal, as directed by the doctor,
• due to the need for special caution, the doctor must be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anesthesia wears off.

Children and adolescents
RIXACAM 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.
RIXACAM with other medicines
Inform your doctor or pharmacist about all medicines currently taken or 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 used for bacterial infections (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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, they should
inform the doctor before taking RIXACAM, as the effect of RIXACAM may be enhanced. The doctor will decide whether to prescribe this medicine or 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 for ulcer prevention.

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

3. How to take RIXACAM

This medicine should always be taken as prescribed by the doctor. In case of doubts,
contact the doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. RIXACAM should be taken
approximately at 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 with the doctor
alternative ways of taking RIXACAM. 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 RIXACAM tablets via a gastric tube.
RIXACAM will not be given to the patient as the only medication.
The doctor will prescribe acetylsalicylic acid for the patient to take. If the patient is receiving
RIXACAM after an acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving RIXACAM following a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, the doctor may additionally prescribe clopidogrel for a short period alongside acetylsalicylic acid.
The doctor will inform the patient of the doses of these medications to take (usually 75–100 mg acetylsalicylic acid daily, 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 take RIXACAM
Treatment with RIXACAM 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 RIXACAM if coronary artery disease or peripheral arterial disease has been diagnosed.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of RIXACAM
If a patient has taken more than the recommended dose of RIXACAM, contact the doctor immediately.
Taking too high a dose of RIXACAM increases the risk of bleeding.
Missing a dose of RIXACAM
Do not take a double dose to make up for a missed dose. If a dose is missed, the patient should take the next dose at the scheduled time.
Stopping treatment with RIXACAM
RIXACAM should be taken regularly and for the duration prescribed by the doctor.
Do not stop taking RIXACAM without first consulting the doctor.
If treatment with this medicine is discontinued, the risk of a subsequent heart attack, stroke, or death due to heart- or blood vessel-related disease may increase.
If there are any further questions regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, RIXACAM may cause adverse reactions, although not
everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, RIXACAM 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.
Contact your doctor immediately if any of the following adverse reactions 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. 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 of the patient or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
  • swelling of the face, lips, oral cavity, 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 adverse reactions:
Common (may occur in 1 out of 10 people)

• decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including conjunctival hemorrhage),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• skin bleeding or subcutaneous hemorrhage,
• postoperative bleeding,
• 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,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general loss of strength and energy (weakness, 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 1 out of 100 people)

• bleeding into the brain or within the skull (see bleeding signs above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, 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, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• urticaria.

Rare (may occur in 1 out of 1,000 people)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• blood accumulation (hematoma) in the groin area as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people)

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

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

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store RIXACAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry date and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What RIXACAM contains

• The active substance is rivaroxaban. One coated tablet contains 2.5 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.
  Tablet coating: hypromellose, hydroxypropylcellulose, polyethylene glycol, titanium dioxide (E 171).

What RIXACAM looks like and contents of the pack
RIXACAM 2.5 mg coated tablets are white, round, biconvex, with an embossed mark "2.5" on one side.
The tablets are packed in blisters placed in a cardboard box containing: 56, 60, 98, 100 or 196 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer / Importer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice