Rixacam

Package leaflet: Information for the patient

RIXACAM, 15 mg, hard capsules
Rivaroxabanum
Read the entire leaflet before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, ask 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 are the same.
• If you experience any adverse effects, including any possible adverse effects 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 should 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 in other blood vessels throughout the body in patients who have a type of irregular heart rhythm called 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 blood vessels of the legs and/or lungs.

RIXACAM is used in children and adolescents under 18 years of age and with body weight of 30 kg or more to:

• treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable 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, injury or bleeding in the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery,
• 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 the patient suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take RIXACAM, consult a doctor or pharmacist.
When to exercise special caution when using RIXACAM

• if the patient has an increased risk of bleeding, such as in the following conditions: severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of active drug in the patient's body, taking other medicines to prevent blood clots (e.g. warfarin, etexilate of 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"), coagulation 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 (acid reflux into the esophagus), or tumors located in the stomach or intestines or in the genital or urinary system, vascular disease of the posterior part of the eyeball (retinopathy), lung disease with dilated bronchi filled with pus (bronchiectasis), or previous pulmonary bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a pulmonary embolism is planned.

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

• it is very important to take RIXACAM exactly at the times scheduled by the treating doctor, both before and after surgery;
• if during surgery catheterization or a 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 scheduled by the treating doctor, both before and after the puncture or catheter removal; the doctor should be informed immediately 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 15 mg capsules are not recommended for children weighing less than 30 kg. There is
insufficient data on the use of rivaroxaban in children and adolescents for the indications approved for adults.
RIXACAM with other medicines
Tell your doctor or pharmacist about all medicines currently taken or 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 they are used only topically on the skin, oral ketoconazole (used in the treatment of Cushing's syndrome, a condition 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-norepinephrine reuptake inhibitors (SNRI)). If the patient suspects that any of the above apply, they should inform the doctor before using RIXACAM, as the effect of RIXACAM 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 gastric or duodenal ulceration, they may prescribe treatment to prevent peptic ulcer disease.
• If the patient is taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort ( Hypericum perforatum ), a herbal remedy used for depression, or rifampicin, an antibiotic.

If the patient suspects that any of the above conditions apply, they should inform the doctor
before using RIXACAM, as 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 use RIXACAM 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 RIXACAM, they should inform the doctor immediately, who will decide on further treatment.
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 15 mg contains monohydrate lactose (a type of sugar) and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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 directed by the doctor. If in doubt, consult 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, discuss alternative ways of taking RIXACAM with the doctor. The contents of the capsule may be mixed with water or apple puree immediately before administration. After such a mixture, a meal should be taken promptly. If necessary, the doctor may administer the contents of the RIXACAM capsule via 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 patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg RIXACAM capsule once daily (or one 10 mg RIXACAM capsule once daily in case of kidney impairment), 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 of treatment, 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 developing 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 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: monitor the child to ensure the full dose has been taken.
Since the dose of RIXACAM depends on body weight, 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. The doctor will adjust the dose if necessary.
Do not open the capsule and use part of its contents to achieve a lower dose. If a lower dose is required, use another medicine containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who cannot swallow whole capsules, use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, the contents of the RIXACAM capsule may be sprinkled and mixed with water or apple puree immediately before administration. After this mixture, a meal should be consumed. If necessary, the doctor may also administer the dispersed contents of the RIXACAM capsule via a gastric tube.

If a dose is vomited or expelled

• Within 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 the doctor if repeated vomiting or expulsion of the dose occurs after taking RIXACAM.

When to take RIXACAM
Capsules should be taken every day until the 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.
The doctor will decide how long the patient should continue treatment.

Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If heart rhythm needs to be restored to normal by a procedure called cardioversion, RIXACAM should be taken as directed by the doctor.

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.

Missed dose of RIXACAM
Adults, children and adolescents:
If the patient takes one 15 mg capsule once daily and a dose has been missed, take the capsule as soon as possible. Do not take more than one capsule in one day to make up for the missed dose. Take the next capsule the following day, then continue taking one capsule once daily.

Adults:
If the patient takes one 15 mg capsule twice daily and a dose has been missed, take the capsule as soon as possible. Do not take more than two 15 mg capsules in one day. If the patient forgot to take a dose, they may take two 15 mg capsules together, so that a total of two capsules (30 mg) are taken within one day. The next day, continue taking one 15 mg capsule twice daily.

Stopping RIXACAM treatment
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., on the tongue 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 disorders, 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 up to 1 in 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 bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• ocular bleeding (including bleeding from the conjunctiva),
• 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 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 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 up to 1 in 100 people)

• intracranial bleeding or bleeding within the skull (see signs of bleeding above),
• joint bleeding causing pain and swelling,
• thrombocytopenia (low platelet count, 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 up to 1 in 1,000 people)

• muscle bleeding,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• blood accumulation (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 up to 1 in 10,000 people)

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

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

• kidney failure following severe bleeding,
• kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-associated nephropathy),
• increased pressure within muscle compartments 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 mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common (may occur in up to 1 in 10 people)

• rapid heartbeat
• blood tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low number of platelets, cells that help blood clot)
• heavy menstrual bleeding

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

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

Reporting of adverse reactions
If any adverse reactions 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 of 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP or "expiry date". The expiry date refers to the last day of the stated month.
PVC/PVdC/Alu foil blisters: Store below 30°C.
Keep in the original packaging to protect from moisture.
Aluminium/OPA/Aluminium/PVC foil blisters: No special storage conditions required.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What RIXACAM contains

• The active substance is rivaroxaban. Each capsule contains 15 mg of rivaroxaban.
• The other components are: capsule contents: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What RIXACAM looks like and contents of the pack
RIXACAM 15 mg: light brown, opaque capsules filled with white or almost white powder, size “1” (approximately 19 mm in length).
The hard capsules are packed in blisters made of PVC/PVdC/Al or Aluminum/OPA/Aluminum/PVC foil and placed in a cardboard box.
RIXACAM 15 mg capsules: available pack sizes of 14, 28, 42 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 15 mg is authorized for marketing in the European Economic Area countries under the following names:
Czech Republic, Poland: RIXACAM
Spain: RIXACAM 15 mg cápsulas duras