Rixacam

Package Leaflet: Information for the Patient

RIXACAM, 20 mg, Hard Capsules

Rivaroxaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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

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 patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems.
• 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 weighing 50 kg or more to:

• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medications used to treat blood clots.

RIXACAM belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus 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 medications that prevent 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 heparin is administered to maintain the patency of a vein or artery catheter,

• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take RIXACAM, and inform your doctorif you suspect that any of the above conditions apply to you.

Warnings and precautions

Before starting to take RIXACAM, consult your doctor or pharmacist.

When to be particularly careful when taking RIXACAM

• if you have an increased risk of bleeding, such as in cases of severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medication in the patient's body, taking other medications that prevent 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 medications"), bleeding disorders, very high blood pressure that does not decrease despite medication, 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) due to gastroesophageal reflux disease (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 artificial heart valves,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide on possible changes to the treatment,
• if you have abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

If you suspect that any of the above conditions apply to you, inform

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

If you need to undergo surgery:

• it is very important to take RIXACAM exactly as directed by your doctor before and 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 exactly as directed by your doctor before and after the puncture or catheter removal; you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction, as immediate treatment may be necessary.

Children and adolescents

RIXACAM 20 mg capsules are not recommended for children with a body weight below 50 kg.There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for adult indications.

RIXACAM and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those available without a prescription.

• If you are takingcertain medications used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medications used to treat bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medications used to treat HIV or AIDS (e.g., ritonavir), other medications used to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain medications (e.g., naproxen or acetylsalicylic acid), dronedarone, a medication used to treat heart rhythm disorders, certain medications used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that any of the above applies to you, inform

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

• If you are takingcertain medications used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort (Hypericum perforatum), a herbal remedy used to treat depression, rifampicin, which belongs to a group of antibiotics.

If you suspect that any of the above conditions apply to you, inform

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 effective contraception during RIXACAM treatment. If you become pregnant while taking RIXACAM, 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 bicycle, or operate tools or machines.

RIXACAM 20 mg contains lactose monohydrate (a type of sugar) and sodium.

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

3. How to take RIXACAM

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
RIXACAM should be taken with food.
Swallow the capsule(s) whole with water.
If you have difficulty swallowing whole capsules, you should talk to your doctor about other ways to take RIXACAM. The contents of the capsule can be mixed with water or apple sauce just before taking. After such a mixture, you should take a meal immediately. If necessary, your doctor may also administer the contents of the RIXACAM capsule through a gastric tube.

How many capsules 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 capsule once daily.
If you have kidney problems, the dose may be reduced to one RIXACAM 15 mg capsule once daily.
If you need a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one RIXACAM 15 mg capsule once daily (or one RIXACAM 10 mg capsule once daily in case of kidney function impairment) in combination with an antiplatelet medication such as clopidogrel.

In treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots

The recommended dose is one RIXACAM 15 mg capsule twice daily for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one RIXACAM 20 mg capsule once daily.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily.
If you have kidney problems and are taking one RIXACAM 20 mg capsule once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one RIXACAM 15 mg 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 your doctor.

• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one RIXACAM 15 mgcapsule once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one RIXACAM 20 mgcapsule once daily.

Each RIXACAM dose should be taken with food, with a drink (e.g., water or juice). Capsules 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: you should observe the child to ensure they take the entire dose.
The dose of RIXACAM depends 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 of RIXACAM yourself. If necessary, your doctor will adjust the dose.
Do not sprinkle the contents of the capsule to obtain a partial dose. If a smaller dose is needed, you should use a different rivaroxaban medication in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole capsules, you should use a rivaroxaban medication in the form of granules for oral suspension.
If the oral suspension is not available, you can sprinkle the contents of the RIXACAM capsule and mix it with water or apple sauce just before taking. After such a mixture, you should take a meal immediately. If necessary, your doctor may also administer the sprinkled contents of the RIXACAM capsule through a gastric tube.

If you spit out a dose or vomit

• less than 30 minutes after taking RIXACAM, you should take a new dose.
• more than 30 minutes after taking RIXACAM, do not takea new dose. In this case, take the next dose of RIXACAM at the usual time.

You should consult your doctor if you spit out a dose or vomit repeatedly after taking RIXACAM.

When to take RIXACAM

Take the capsule(s) every day until your doctor decides to stop the treatment.
It's best to take the capsule(s) at the same time each day, as it will be easier to remember.
Your 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, you should take RIXACAM as directed by your doctor.

Taking more RIXACAM than prescribed

If you have taken more RIXACAM than prescribed, you should immediately consult your doctor. Taking too much RIXACAM increases the risk of bleeding.

Missing a dose of RIXACAM

Adults, children, and adolescents:
If you take one 20 mg capsule oncedaily and miss a dose, you should take it 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 at the usual time the next day, and then continue taking one capsule once daily.

Stopping RIXACAM treatment

You should not stop taking RIXACAM without first consulting your doctor, as RIXACAM treats and prevents serious diseases.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, RIXACAM can cause side effects, although not everybody gets them.
Like other medications with similar effects that reduce blood clotting, RIXACAM can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all signs of bleeding will be obvious or visible.

You should immediately inform your doctor if you or your child 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. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering, or changes to the mucous membranes, such as 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; difficulty swallowing; 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 and allergic edema 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 pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, 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 part of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum when coughing (hemoptysis),
• 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, 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,
• 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 inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• low platelet count (thrombocytopenia),
• 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, certain liver or pancreatic 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,
• blood accumulation (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 blood cell, 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 medications),
• 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 rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased levels of a subtype of bilirubin (direct bilirubin).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product 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 medication.

5. How to store RIXACAM

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after EXP or expiry date. The expiry date refers to the last day of the month stated.
PVC/PVdC/Aluminum blisters: Store in a temperature below 30°C.
Store in the original package to protect from moisture.
Aluminum/OPA/Aluminum/PVC blisters: No special storage precautions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications 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 is rivaroxaban. Each capsule contains 20 mg of rivaroxaban.
• The other ingredients are: capsule contents:lactose monohydrate, 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 packaged in PVC/PVdC/Aluminum or Aluminum/OPA/Aluminum/PVC blisters and a carton box.
RIXACAM 20 mg capsules: available in packs of 14, 28, or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Poland: RIXACAM
Spain: RIXACAM 20 mg hard capsules

Date of last revision of the leaflet: