Rixacam

Leaflet accompanying the packaging: patient information

RIXACAM, 2.5 mg, film-coated tablets

Rivaroxaban

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is RIXACAM and what is it 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 is RIXACAM and what is it used for

You have been given RIXACAM because

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of cardiac biomarkers. RIXACAM reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. RIXACAM will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin 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, which causes symptoms. RIXACAM reduces the risk of blood clots (atherothrombotic events) in adults. RIXACAM will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking RIXACAM after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

RIXACAM contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking RIXACAM

When not to take RIXACAM

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if you have had acute coronary syndrome and have had bleeding or blood clots in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the brain tissues (cerebral venous sinus thrombosis) or have had a blood clot in the brain (ischemic stroke) in the last month),
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding. Do not take RIXACAM, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take RIXACAM, you should talk to your doctor or pharmacist. RIXACAM should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be particularly careful when taking RIXACAM

• -if you have an increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine acting in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see section "RIXACAM and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors

located in the stomach or intestines or genital or urinary system,

• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• -in patients with artificial heart valves,
• -if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment.

If you suspect that you have any of the above conditions, you should

tell your doctorbefore taking RIXACAM. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• -you must strictly follow your doctor's instructions regarding the intake of RIXACAM at a precisely specified time before or after surgery,
• -if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take RIXACAM before and after the puncture or catheter removal, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

RIXACAM 2.5 mg tablets are not recommended for people under 18 years of age. There is not enough data on the use of the medicine in children and adolescents.

RIXACAM and other medicines

You should 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 that are available without a prescription.

• -If you are taking
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir),
• other medicines that prevent 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 aspirin),

or

• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, you should

tell your doctorbefore taking RIXACAM, as the effect of RIXACAM may be enhanced. Your doctor will decide whether to use this medicine and whether you should be under close observation.
If your doctor believes that you are at increased risk of stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• -If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, you should

tell your doctorbefore taking RIXACAM, as the effect of RIXACAM may be reduced. Your doctor will decide whether to use RIXACAM and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take RIXACAM if you are pregnant or breastfeeding.
If there is a risk that you may become pregnant, you should use an effective method of contraception while taking RIXACAM. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

RIXACAM may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients who experience these side effects should not drive, ride a bike or operate tools or machines.

RIXACAM contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take RIXACAM

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. RIXACAM should be taken at approximately the same time every day (e.g., one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways of taking RIXACAM. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may give you a crushed RIXACAM tablet through a nasogastric tube.
RIXACAM will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking RIXACAM after acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking RIXACAM after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you how much of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to take RIXACAM

Treatment with RIXACAM after acute coronary syndrome should be started as soon as possible after stabilization of acute coronary syndrome, at the latest 24 hours after hospitalization and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with RIXACAM if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking more RIXACAM than prescribed

If you have taken more RIXACAM than prescribed, you should immediately contact your doctor. Taking too much 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 you miss a dose, you should take the next dose at the scheduled time.

Stopping RIXACAM treatment

RIXACAM should be taken regularly and for the time prescribed by your doctor.
You should not stop taking RIXACAM without first discussing it with your doctor.
If you stop taking this medicine, you 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, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, RIXACAM can cause side effects, although not everybody gets them.
Like other medicines with similar blood clotting reducing effects, RIXACAM can cause bleeding, which can potentially be life-threatening.
Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

You should immediately inform your doctor if you experience any of the following side effects:

• • Signs of bleeding:
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiffness of the neck. A serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; hives and difficulty breathing; 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 affect up to 1 in 10 people)

• reduction in red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) while coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• 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,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above signs of bleeding),
• 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 (can be observed in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, activity of certain pancreatic or liver enzymes or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

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

Very rare(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• increased pressure in the muscles of the legs and arms occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RIXACAM

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry date and on each blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What RIXACAM contains

• The active substance of RIXACAM is rivaroxaban. One film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Tablet coating: hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide (E 171).

What RIXACAM looks like and contents of the pack

RIXACAM 2.5 mg film-coated tablets are white, round, biconvex, with the marking "2.5" on one side.
The tablets are packaged in blisters placed in a carton containing: 56, 60, 98, 100 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
Date of last revision of the leaflet:July 2024