Rixacam

Package Leaflet: Information for the Patient

RIXACAM, 10 mg, hard capsules

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 doubts, consult 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 clot formation 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 veins 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 thereby 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 therapy or when heparin is given to maintain the patency of a venous or arterial 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 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, 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 therapy or when heparin is given to maintain the patency of a venous or arterial 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 esophageal inflammation), diseases of the blood vessels in the back of the eye (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 condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide whether to change your treatment,
• -if you have abnormal blood pressure or if surgery is planned to remove a blood clot from the lungs.

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

it is very important to take RIXACAM exactly as directed by your doctor before and after surgery;
if catheterization or lumbar 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 procedure;
• you should immediately inform your doctor if you experience numbness, weakness of the legs, bowel or bladder dysfunction, or other symptoms after anesthesia, as immediate treatment may be necessary.

Children and adolescents

RIXACAM 10 mg capsules 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

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

• - If you are takingcertain medicines for 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 medicines for bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir), other medicines that 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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that the above applies to you, 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 believes that you have an increased risk of stomach or intestinal ulcers, they may use a treatment to prevent stomach ulcers.

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

If you suspect that the above conditions exist, 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 while taking RIXACAM. If you become pregnant while taking this medicine, 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 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 medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that the medicine is considered "sodium-free".

3. How to take RIXACAM

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the capsule whole, preferably with water.
RIXACAM can be taken with or without food.
If you have difficulty swallowing the whole capsule, talk to your doctor about other ways to take RIXACAM. The contents of the capsule can be mixed with water or apple sauce immediately before taking it. If necessary, your doctor may administer the contents of the RIXACAM capsule through a gastric tube.

How many capsules to take

To prevent blood clots in the veins after hip or knee replacement surgery

The recommended dose is one RIXACAM 10 mg capsule taken once a day.

In the treatment of blood clots in the veins of the legs and 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 capsule once a day or one 20 mg capsule once a day. Your doctor has prescribed RIXACAM 10 mg once a day for you.

When to start treatment with RIXACAM

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

Taking a higher dose of RIXACAM than recommended

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

Missing a dose of RIXACAM

If you miss a dose, take it as soon as you remember. Take the next capsule the next day, and then take the capsules as usual, once a day.
Do not take a double dose to make up for the missed capsule.

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 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 a similar effect of reducing blood clot formation, RIXACAM can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible.

Tell your doctor immediately if 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, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina pectoris. The doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions:
• widespread, acute 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 disorders, 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 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 of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• appearance 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 dysfunction (may be observed in tests performed by your doctor)
• fever
• stomach pain, nausea, feeling of nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of 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 a 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.

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 white granulocytic blood cells that cause inflammation in the lungs (eosinophilic pneumonia).

Frequency not known(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 therapy),
• 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 the 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 month.
Blister packs: Store in a temperature below 30°C.
Store in the original package to protect from moisture.
Aluminum/OPA/Aluminum/PVC blister packs: No special storage precautions.
Likewise, do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What RIXACAM contains

• The active substance of RIXACAM is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• 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), black iron oxide (E 172).

What RIXACAM looks like and contents of the pack

RIXACAM 10 mg: beige, opaque, capsules filled with white or almost white powder, size "3" (approximately 16 mm in length).
Hard capsules are packaged in blister packs of PVC/PVdC/Alu or Aluminum/OPA/Aluminum/PVC and cardboard boxes.
Available packs of 10 or 30 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
This medicine is authorized in the Member States of the European Economic Area under the following names:
Czech Republic, Poland: RIXACAM
Spain: RIXACAM 10 mg hard capsules

Date of last revision of the leaflet: