Rixacam

Leaflet accompanying the packaging: patient information

RIXACAM, 15 mg, film-coated tablets

RIXACAM, 20 mg, film-coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor. 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. Package contents and other information

1. What is RIXACAM and what is it used for

RIXACAM contains the active substance rivaroxaban.
RIXACAM is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a form of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. RIXACAM is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:
• -treat blood clots and prevent the recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable blood clotting medicines.

RIXACAM belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

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 excessive bleeding,
• if the patient has 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 the patient is taking other medicines that prevent the formation of blood clots (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 the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is 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, consult your doctor or pharmacist.

When to be particularly careful when taking RIXACAM

• -if the patient has an increased risk of bleeding, in such conditions as: severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body, bleeding disorders, taking other medicines that prevent the formation of blood clots (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 "RIXACAM and other medicines"), very high blood pressure that does not decrease despite treatment, diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system, disease of the blood vessels in the back of the eyeballs (retinopathy), lung disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• -in patients with prosthetic valves,
• -if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their doctor, who will decide on possible changes to the treatment,
• -if the patient has been diagnosed with abnormal blood pressure or a surgical procedure is planned to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking RIXACAM. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• -they must strictly follow the 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, in accordance with the doctor's instructions, and due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia.

Children and adolescents

RIXACAM tablets are not recommended for children with a body weight below 30 kg.
There is insufficient data on the use of RIXACAM in children and adolescents for indications in adults.

RIXACAM and other medicines

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 available without a prescription.

• -If you are taking certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines used to 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 and noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking RIXACAM ,as the action of RIXACAM may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use 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 the patient suspects that they have any of the above conditions, they should

tell their doctorbefore taking RIXACAM ,as the action of RIXACAM may be reduced. The doctor will decide whether to use RIXACAM and whether the patient should be subject to particularly close monitoring.

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 effective contraception while taking RIXACAM. If you become pregnant while taking RIXACAM, you should inform your doctor immediately, who will decide on further treatment.

Driving and operating machinery

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 vehicles, ride bicycles, or operate tools or machines.

RIXACAM contains lactose and sodium.

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

3. How to take RIXACAM

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
RIXACAM should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take RIXACAM. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before administration. After such a mixture, the meal should be consumed immediately. If necessary, your doctor may also administer the crushed RIXACAM tablet through a gastric tube.

How many tablets to take

Adults

• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one RIXACAM 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one RIXACAM 15 mg tablet once a day.

If the patient needs a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent implantation), there is limited evidence to support a dose reduction to one RIXACAM 15 mg tablet once a day (or one RIXACAM 10 mg tablet once a day in case of kidney function impairment) in combination with an antiplatelet medicine such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and preventing the recurrence of blood clots. The recommended dose is one RIXACAM 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one RIXACAM 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one RIXACAM 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one RIXACAM 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents

The dose of RIXACAM depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one RIXACAM 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one RIXACAM 20 mgtablet once a day.

Each RIXACAM dose should be taken with food, washed down with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you.
For parents or caregivers: observe the child to make sure they have taken the entire dose.
The RIXACAM dose is dependent on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, the doctor will adjust the dose. Do not divide the tablet to obtain a partial dose. If a smaller dose is needed, use another rivaroxaban medicine in the form of granules for oral suspension. For children and adolescents who are unable to swallow whole tablets, use rivaroxaban in the form of granules for oral suspension. If the oral suspension is not available, you can crush the RIXACAM tablet and mix it with water or apple puree immediately before administration. After this mixture, the meal should be consumed immediately. If necessary, the doctor may also administer the crushed RIXACAM tablet through a gastric tube.

If a dose is spat out or vomited

• less than 30 minutes after taking RIXACAM, take a new dose.
• more than 30 minutes after taking RIXACAM, do nottake a new dose. In this case, take the next RIXACAM dose at the usual time.

Consult your doctor if you spit out or vomit a dose or vomit after taking RIXACAM several times.

When to take RIXACAM

Take the tablet(s) every day until your doctor decides to stop the treatment. It's best to take the tablet(s) at the same time every day, as it's easier to remember. The doctor will decide how long you should continue the treatment.
Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, take RIXACAM as directed by your doctor.

Missing a dose of RIXACAM

Adults, children, and adolescents:
If you take one 20 mg or one 15 mg tablet oncea day and miss a dose, take it as soon as possible. Do not take more than one tablet in a day to make up for the missed dose.
Take the next tablet at the usual time the next day, and then take one tablet once a day.
Adults:
If you take one 15 mg tablet twicea day and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in a day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in a day. The next day, continue taking one 15 mg tablet twice a day.

Taking more RIXACAM than prescribed

If you have taken too many RIXACAM tablets, contact your doctor immediately. Taking too much RIXACAM increases the risk of bleeding.

Stopping RIXACAM treatment

Do not stop taking RIXACAM without first consulting your doctor, as RIXACAM treats and prevents serious diseases.
If you have any further doubts about taking this medicine, consult 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 action to reduce blood clot formation, RIXACAM may cause bleeding, which can potentially be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
Tell your doctor immediatelyif you experience any of the following side effects:

• 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

stiffness of the neck. This is a serious medical emergency. Seek medical help immediately!),

• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina .The doctor may decide to monitor the patient closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute rash, blistering, or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 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 less than 1 in 10,000 people) and uncommon (angioedema may occur in 1 in 100 people).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause paleness and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) when 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 the doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of some liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• 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, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, activity of some 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 the 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 the catheter is inserted into an artery in the leg (pseudoaneurysm).

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).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with RIXACAM were similar in type to those observed in adults and were mainly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nasal bleeding, vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased bilirubin levels
• thrombocytopenia (low platelet count)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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

Keep the medicine out of the 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.
No special precautions for storage are necessary.
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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What RIXACAM contains

• The active substance of RIXACAM is rivaroxaban. One film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: hydroxypropylcellulose, macrogol, hypromellose, titanium dioxide (E 171),

iron oxide red (E 172).

What RIXACAM looks like and contents of the pack

RIXACAM 15 mg film-coated tablets are pink, round, biconvex, with the number "15" embossed on one side.
The tablets are packaged in blisters placed in a carton containing: 14, 28, 30, 42, 98, or 100 film-coated tablets.
RIXACAM 20 mg film-coated tablets are brown-red, round, biconvex, with the number "20" embossed on one side.
The tablets are packaged in blisters placed in a carton containing: 14, 28, 30, 98, or 100 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 update of the leaflet:November 2024