Rixacam

Leaflet accompanying the packaging: patient information

RIXACAM, 10 mg, film-coated tablets

Rivaroxaban

Read the contents of this 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 further questions, ask your doctor or pharmacist. This medicine has been prescribed specifically for you. 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, tell your 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. 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 veins, after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clots is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

RIXACAM belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing 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 switching anticoagulant treatment or when heparin is given 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 also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with RIXACAM, consult your doctor or pharmacist.

When to be particularly careful when taking RIXACAM

• -if you have an increased risk of bleeding, in conditions such as: moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body, if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "RIXACAM and other medicines"), bleeding disorders, very high blood pressure that does not decrease despite treatment, 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 (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 eye (retinopathy), lung disease in which the bronchi 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 whether to change the treatment,
• -if you have been diagnosed with abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

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

If you need to have surgery:

• -you must follow your doctor's instructions exactly regarding the intake of RIXACAM at a strictly specified time before or after surgery,
• -if a lumbar puncture or spinal catheter insertion is planned during the surgical procedure
• -(e.g. for epidural or spinal anesthesia or to relieve pain):

you must follow your doctor's instructions exactly regarding the intake of RIXACAM at a strictly specified time.

• you should inform your doctor immediately if you experience symptoms such as numbness, weakness of the lower limbs, disorders of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

RIXACAM 10 mg tablets are not recommended for persons under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.

RIXACAM and other medicines

RIXACAMTell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 topically 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 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 you suspect that you have any of the above conditions, you should

inform your doctorbefore taking RIXACAM ,as the effect of RIXACAM may be enhanced. The doctor will decide whether to use this medicine and whether you should be under close observation.
If the doctor considers that you are at increased risk of developing stomach or duodenal ulcers, he may use treatment to prevent stomach 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

inform your doctorbefore taking RIXACAM ,as the effect of RIXACAM may be reduced. The 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 treatment with RIXACAM. If you become pregnant during treatment with this medicine, you should inform your doctor immediately, 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 contains lactose and sodium.

If you have been diagnosed with intolerance to certain 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 prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

How many tablets to take

To prevent blood clots in the veins after hip or knee replacement surgery
The recommended dose is one RIXACAM 10 mg tablet taken once a day.
In the treatment of 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.
After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed RIXACAM 10 mg once a day for you.
Swallow the tablet whole, preferably with water.
RIXACAM can be taken with or without food.
If you have difficulty swallowing the whole tablet, 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 sauce, immediately before taking it.
If necessary, your doctor may administer the crushed RIXACAM tablet through a gastric tube.

When to take RIXACAM

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as it is easier to remember. Your doctor will decide how long to continue treatment.
To prevent blood clots in the veins after hip or knee replacement surgery:
Take the first tablet 6 to 10 hours after surgery.
In patients after major hip surgery, treatment usually lasts 5 weeks.
In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking a higher dose of RIXACAM than recommended

If you have taken a higher dose of RIXACAM than recommended, contact your doctor immediately. Taking too much RIXACAM increases the risk of bleeding.

Missing a dose of RIXACAM

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with RIXACAM

Do not stop taking RIXACAM without consulting your doctor first, as RIXACAM prevents a serious disease.
If you have any further questions about the use of this medicine, 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 a similar effect of reducing 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). These may not always be obvious or visible signs of bleeding.
You should inform 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. A serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The doctor may decide to monitor you closely or change the treatment

approach.

• Signs of severe skin reactions:
• widespread, severe skin rash, blistering or changes to 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 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; 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 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)

• reduced red blood cell count, which may 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 gums,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) during 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, feeling of 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 may be visible 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 the joint causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,
• liver function disorders (can be observed in tests performed by the doctor).

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

• bleeding into the muscles,
• cholestasis (bile stasis), 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 granular white blood cell, which causes inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding,
• bleeding in the kidneys, 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 those not listed in this leaflet, 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

Keep the medicine 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 stated.
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. 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 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide (E 171), iron oxide red (E 172).

What RIXACAM looks like and contents of the pack

RIXACAM 10 mg film-coated tablets are light pink, round, biconvex, with the number "10" embossed on one side.
The tablets are packaged in blisters placed in a cardboard box containing: 10, 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 revision of the leaflet:July 2024