Roxan

Leaflet accompanying the packaging: information for the user

Roxan, 10 mg, film-coated tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.
You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicinal product has been prescribed to you specifically. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Roxan and what is it used for
• 2. Important information before taking Roxan
• 3. How to take Roxan
• 4. Possible adverse reactions
• 5. How to store Roxan
• 6. Contents of the packaging and other information

1. What is Roxan and what is it used for

Roxan 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 medicinal product 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 blood vessels of the legs and/or lungs.

Roxan 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 Roxan

When not to take Roxan

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicinal product (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 Roxan, and also inform your doctorif you suspect that you have become pregnant or are planning to become pregnant.

Warnings and precautionsBefore starting treatment with Roxan, you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Roxan

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicinal product acting in your body;
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Roxan 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 stomach and intestines or inflammation of the esophagus (throat and esophagus) e.g., due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus);
• disease of the blood vessels in the back of the eye (retinal vascular disease);
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with heart valve prostheses;
• 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 the treatment;
• if you have abnormal blood pressure or are planning 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 Roxan .The doctor will decide whether to use this medicinal product and whether you should be under close observation.

If you need to undergo surgery:

• you should follow your doctor's instructions carefully regarding the intake of Roxan at a specific time before or after surgery,
• if you are planning to undergo spinal puncture or insertion of a catheter into the spine (e.g., for epidural or spinal anesthesia or to relieve pain):
• you should follow your doctor's instructions carefully regarding the intake of Roxan at a specific time,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the legs, disorders of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Elderly patients

With age, the risk of bleeding may increase.

Children and adolescents

Roxan is not recommended for people under 18 years of age. There is a lack of sufficient data on the use of the medicinal product in children and adolescents.

Roxan and other medicines

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

• -If you are taking:
• certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol)
• certain medicines used to treat bacterial infections (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 norepinephrine reuptake inhibitors (SNRIs)).

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

your doctorbefore taking Roxan ,as the effect of Roxan may be increased if you take it with the above-mentioned medicines. The doctor will decide whether to use this medicinal product and whether you should be under close observation. If the doctor considers that you have an increased risk of developing stomach or duodenal ulcers, they 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 Roxan ,as the effect of Roxan may be reduced if you take it with the above-mentioned medicines. The doctor will decide whether to use Roxan and whether you should be under close observation.

Pregnancy and breastfeeding

Do not take Roxan if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Roxan. If you become pregnant while taking this medicinal product, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Roxan may cause dizziness (frequent adverse reactions) and fainting (uncommon adverse reactions) (see section 4 "Possible adverse reactions"). Patients who experience these adverse reactions should not drive or operate machinery.

Roxan contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicinal product.
The medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means that it is essentially "sodium-free".

3. How to take Roxan

This medicinal product should always be taken according to your doctor's instructions. If you have any doubts, you should ask 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 10 mg Roxan tablet taken once a day.
• For 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 Roxan 10 mg once a day for you.

The tablet should be swallowed whole, preferably with water. Roxan can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Roxan. The tablet can be crushed and mixed with water or soft food, such as apple sauce, just before taking it. If necessary, your doctor may give you a crushed Roxan tablet through a gastric tube.

When to take Roxan

You should take one tablet every day until your doctor decides to stop the 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 you should continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

The first tablet should be taken 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 more Roxan than prescribed

If you have taken more Roxan than prescribed, you should immediately contact your doctor. Taking too much Roxan increases the risk of bleeding. Do not take a double dose to make up for a missed dose.

Missing a dose of Roxan

If you have missed a dose, you should take the tablet as soon as you remember. The next tablet should be taken the next day, and then you should take the tablets as usual, once a day. Do not take a double dose to make up for a missed tablet.

Stopping Roxan treatment

You should not stop taking Roxan without first talking to your doctor, as Roxan prevents a serious disease.
If you have any further questions about the use of this medicinal product, you should ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Roxan can cause adverse reactions, although not everybody gets them.
Like other medicines with similar effects (anticoagulants), Roxan can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Adverse reactions that may be a sign of bleeding:

You should immediately inform your doctorif you experience any of the following adverse reactions:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina ,which may be signs of bleeding. The doctor may decide to monitor you closely or change the treatment.

Adverse reactions that may be a sign of a skin reaction:

You should immediately inform your doctorif you experience the following skin reactions, such as:

• widespread, severe skin rash, blistering or changes to the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions is very rare (they may occur in less than 1 in 10,000 patients),
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these adverse reactions is very rare (they may occur in less than 1 in 10,000 patients).

Adverse reactions that may be a sign of a severe allergic reaction You should

immediately inform your doctorif you experience the following adverse reactions:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing, hives, and difficulty breathing; sudden drop in blood pressure. The frequency of these adverse reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible adverse reactions:

Common(may occur in 1 in 10 patients)

• decrease in 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 reproductive 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) while 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 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 occur in 1 in 100 patients)

• bleeding into the brain or inside the skull
• 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
• liver function disorders (can be observed in tests performed by the doctor)

Rare(may occur in 1 in 1,000 patients)

• bleeding into the muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes)
• local swelling
• collection of blood (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm)

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

• kidney failure after severe bleeding
• 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 syndromeafter bleeding)

Reporting adverse reactions

If you experience any adverse reactions, including those not listed in this leaflet, you should tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to 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
e-mail: website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, you can help gather more information on the safety of the medicinal product.

5. How to store Roxan

The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after: Expiry date and on each blister or bottle after: EXP. The expiry date refers to the last day of the month stated.
There are no special requirements for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Roxan contains

• The active substance of Roxan is rivaroxaban. One film-coated tablet contains 10 mg of rivaroxaban.
• The medicinal product also contains: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose E5, sodium lauryl sulfate, magnesium stearate; Tablet coating. Aqua Polish P white: hydroxypropylcellulose, hypromellose E5, hypromellose E15, macrogol 8000, titanium dioxide (E 171), iron oxide red (E 172).

What Roxan looks like and what the packaging contains

Pale pink, round, biconvex film-coated tablets, with the number "10" embossed on one side.
The tablets are packaged in blisters, which are packed in cardboard boxes, containing 10, 14, 28, 30, 42, 56, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet:

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