Rixacam

Package leaflet: Information for the patient

RIXACAM, 20 mg, hard capsules
Rivaroxabanum
Please read the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms appear identical.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What RIXACAM is and what it is used for
2. What you need to know 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

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins of the legs and/or lungs.

RIXACAM is used in children and adolescents under 18 years of age and with body weight of 50 kg or more to:

• treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, following at least 5 days of initial treatment with injectable anticoagulant medicines used for treating blood clots.

RIXACAM 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 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 into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or

if heparin is administered to maintain patency of a venous 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 use RIXACAM and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Before starting RIXACAM, consult your doctor or pharmacist.
When to exercise special caution when taking RIXACAM

• if the patient has an increased risk of bleeding, such as: severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, since kidney function may affect the amount of active drug in the patient's body; taking other anticoagulant medicines (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain patency of a venous or arterial catheter (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 or gastritis, or esophagitis (inflammation of the 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; vascular disease of the posterior part of the eyeball (retinopathy); lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary hemorrhage,
• 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 has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolism.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking RIXACAM. The doctor will decide whether to use this medicine and whether the
patient requires particularly close monitoring.
If the patient requires surgery:

• it is very important to take RIXACAM exactly at the times prescribed by the attending physician, both before and after surgery;
• if during surgery spinal catheterization or spinal puncture (e.g. for epidural or intrathecal anesthesia or pain relief) is planned: it is very important to take RIXACAM exactly at the times prescribed by the attending physician, both before and after the procedure or catheter removal; immediately inform the doctor if, after anesthesia, numbness or weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment may be required.

Children and adolescents
RIXACAM 20 mg capsules are not recommended for children weighing less than 50 kg. There is
insufficient data on the use of rivaroxaban in children and adolescents for indications approved in adults.
RIXACAM with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

• If you are 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 (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); 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)). If you suspect that any of the above applies to you, inform your doctor before taking RIXACAM, because the effect of RIXACAM may be enhanced. The doctor will decide whether to use this medicine and whether particularly close monitoring is required. If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcers, preventive treatment for peptic ulcer disease may be prescribed.
• If you are taking certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression, or rifampicin, an antibiotic.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking RIXACAM, because the effect of RIXACAM may be reduced. The doctor will decide whether to use RIXACAM and whether the patient requires 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 an effective method of contraception during treatment with RIXACAM. If you become pregnant while taking RIXACAM, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
RIXACAM may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
RIXACAM 20 mg contains lactose monohydrate (a type of sugar) 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 of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to take RIXACAM

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should contact your doctor or pharmacist.
RIXACAM should be taken with food.
The capsule(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the entire capsule, they should speak to their doctor about alternative ways of taking RIXACAM. The contents of the capsule may be mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed promptly. If necessary, a doctor may administer the contents of the RIXACAM capsule through a gastric tube.

How many capsules should be taken
Adults

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
  The recommended dose is one 20 mg RIXACAM capsule once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg RIXACAM capsule 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 RIXACAM capsule once daily (or one 10 mg RIXACAM capsule 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 RIXACAM capsule twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg RIXACAM capsule once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily. If the patient has kidney problems and is taking one 20 mg RIXACAM capsule once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg RIXACAM capsule once daily 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 of 30 kg to below 50 kg is one 15 mg RIXACAM capsule once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg RIXACAM capsule once daily.

Each dose of RIXACAM should be taken with a meal and with a drink (e.g. water or juice). Capsules should be taken daily at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: you should observe the child to ensure they have taken the full dose.
The dose of RIXACAM depends on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose of RIXACAM on your own. If necessary, your doctor will adjust the dose.
Do not open the capsule and use part of its contents to achieve a lower dose. If a lower dose is required, a different medicine containing rivaroxaban in the form of granules for oral suspension should be used.
For children and adolescents who cannot swallow whole capsules, a medicine containing rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the contents of the RIXACAM capsule may be dispersed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, a doctor may also administer the dispersed contents of the RIXACAM capsule through a gastric tube.

If a dose is vomited or spit out

• Less than 30 minutes after taking RIXACAM, take a new dose.
• More than 30 minutes after taking RIXACAM, do not take another dose. In this case, take the next dose of RIXACAM at the usual time.

Contact your doctor if vomiting or spitting out the dose occurs repeatedly after taking RIXACAM.

When to take RIXACAM
Capsules should be taken every day until your doctor decides to stop treatment.
It is best to take the capsule(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long you should continue treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, RIXACAM should be taken as directed by your doctor.

Taking more than the recommended dose of RIXACAM
If a patient has taken more than the recommended dose of RIXACAM, they should contact their doctor immediately. Taking too high a dose of RIXACAM increases the risk of bleeding.

Missed dose of RIXACAM
Adults, children and adolescents:
If a patient takes one 20 mg capsule once daily and a dose is missed, take the capsule as soon as possible. Do not take more than one capsule in a single day to make up for the missed dose. Take the next capsule the following day, and then continue taking one capsule once daily.

Stopping treatment with RIXACAM
Do not stop taking RIXACAM without first consulting your doctor, as RIXACAM treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can 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 can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
Immediately contact a doctor if any of the following adverse reactions occur in an adult or child:

• 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, acute medical emergency. Immediate medical assistance must be sought!)
  • prolonged or excessive bleeding,
  • unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The 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), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions
  • swelling of the face, lips, oral cavity, 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 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 in adults, children and adolescents
Common (may occur in 1 out of 10 people)

• decreased number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal bleeding 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 during coughing (hemoptysis),
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from the 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 blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in 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 signs of bleeding above),
• 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 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 1 out of 1,000 people)

• 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 as a complication of cardiac catheterization 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 granulocytic white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency unknown (frequency cannot be estimated from available data)

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

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with rivaroxaban were
similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common (may occur in 1 out of 10 people)

• rapid heartbeat
• blood tests may show increased bilirubin levels (a yellow pigment)
• thrombocytopenia (low platelet count, the cells that help in blood clotting)
• heavy menstrual bleeding

Uncommon (may occur in 1 out of 100 people)

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a yellow pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 may 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following: EXP or expiry date. The expiry date refers to the last day of the stated month.
PVC/PVdC/Aluminium foil blisters: Store below 30°C.
Keep in the original packaging to protect from moisture.
Aluminium/OPA/Aluminium/PVC foil blisters: No special storage instructions required.
Medicines must not be disposed of via wastewater 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 RIXACAM contains

• The active substance is rivaroxaban. Each capsule contains 20 mg of rivaroxaban.
• The other ingredients are: capsule contents: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).

What RIXACAM looks like and contents of the pack
RIXACAM 20 mg: dark brown, opaque hard capsules filled with white or almost white powder, size "0" (approximately 22 mm in length).
The hard capsules are packed in blisters made of PVC/PVdC/Aluminum or Aluminum/OPA/Aluminum/PVC, and boxed in a cardboard carton.
RIXACAM 20 mg capsules: available pack sizes of 14, 28 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola
PLA3000
Malta
Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3,
Bucharest, 032266
Romania

RIXACAM 20 mg is authorised for sale in the European Economic Area countries under the following names:
Czech Republic, Poland: RIXACAM
Spain: RIXACAM 20 mg cápsulas duras