Roxan

Package Leaflet: Information for the User

Roxan, 15 mg, Film-Coated Tablets

Roxan, 20 mg, Film-Coated Tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see Section 4.

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

Contents of the pack and other information:

• 1. What Roxan is and what it is used for
• 2. What you need to know before you take Roxan
• 3. How to take Roxan
• 4. Possible side effects
• 5. How to store Roxan
• 6. Contents of the pack and other information

1. What Roxan is and what it is used for

Roxan contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation that is not caused by a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood clots in the lungs (pulmonary embolism) and prevent new blood clots from forming in the veins and/or lungs.

Roxan belongs to a group of medicines called anticoagulants. It works by blocking the factor Xa in the blood, which is involved in blood clotting.

2. What you need to know before you take Roxan

When not to take Roxan

• -if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in Section 6)
• -if you have active bleeding
• -if you have a disease or condition that increases the risk of serious bleeding, such as a stomach ulcer, bleeding in the brain, or recent surgery
• -if you are taking other medicines that prevent blood clotting, such as warfarin, dabigatran, apixaban, or heparin, except when switching to Roxan or when heparin is given to maintain a central venous or arterial catheter patency.

• -if you have liver disease that increases the risk of bleeding
• -if you are pregnant or breastfeeding.

Do not take Roxan, and inform your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking Roxan, talk to your doctor or pharmacist.

When to be extra careful while taking Roxan

• if you have an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of Roxan in your body;
• bleeding disorders;
• taking other medicines that prevent blood clotting (such as warfarin, dabigatran, apixaban, or heparin) when switching to Roxan or when heparin is given to maintain a central venous or arterial catheter patency (see Section "Roxan with other medicines");
• very high blood pressure that is not controlled with medication;
• stomach or intestinal disease that may cause bleeding, such as stomach or intestinal ulcers, or inflammation of the stomach or intestines;
• eye disease that affects the blood vessels in the retina (retinopathy);
• lung disease that causes the airways to widen and fill with pus (bronchiectasis) or previous bleeding from the lungs;
• if you have a prosthetic heart valve
• if you have a condition 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 your treatment;
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you think any of the above applies to you, inform your doctor

before taking Roxan. Your doctor will decide whether to prescribe Roxan and whether you need to be closely monitored.

If you need to have surgery:

• you must follow your doctor's instructions about taking Roxan before and after surgery,
• if you are scheduled for a procedure that involves inserting a catheter or puncturing the spine (such as spinal or epidural anesthesia),
• it is very important to take Roxan before and after the procedure, as instructed by your doctor
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems, or loss of bladder or bowel control after the procedure.

Children and adolescents

Roxan is not recommended for children under 18 years of age. There is limited data on the use of Roxan in children and adolescents.

Roxan with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• -If you are taking:
• certain medicines for fungal infections (such as fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin
• ketokonazole tablets (used to treat Cushing's syndrome, a condition where the body produces too much cortisol)
• certain medicines for bacterial infections (such as clarithromycin, erythromycin)
• certain antiviral medicines used to treat HIV or AIDS (such as ritonavir)
• other medicines that prevent blood clotting (such as enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medicines (such as naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat irregular heart rhythm
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think any of the above applies to you, inform your doctor

before taking Roxan, as the effect of Roxan may be increased if taken with these medicines. Your doctor will decide whether to prescribe Roxan and whether you need to be closely monitored.

• If you are taking:
• certain medicines for epilepsy (such as phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression
• rifampicin, an antibiotic.

If you think any of the above applies to you, inform your doctor

before taking Roxan, as the effect of Roxan may be decreased if taken with these medicines. Your doctor will decide whether to prescribe Roxan and whether you need to be closely monitored.

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 during treatment with Roxan. If you become pregnant during treatment with Roxan, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Roxan may cause dizziness (common side effect) and fainting (uncommon side effect) (see Section 4 "Possible side effects"). Patients who experience these side effects should not drive or use machines.

Roxan contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Roxan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

To prevent blood clots in the brain (stroke) and other blood vessels in the body:

• The recommended dose is one 20 mg tablet once daily.
• If you have kidney disease, your doctor may reduce the dose to one 15 mg tablet once daily.
• If you need a procedure to open up blocked blood vessels in the heart (percutaneous coronary intervention, PCI), there is limited evidence to support a dose reduction to one 15 mg tablet once daily (or one 10 mg tablet once daily in case of kidney disease) in combination with an antiplatelet medicine such as clopidogrel.
• To treat blood clots in the veins of the legs, blood clots in the lungs, and to prevent new blood clots from forming:
• The recommended dose is one 15 mg tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet once daily.
• After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney disease and are taking one 20 mg tablet once daily, your doctor may decide to reduce the dose to one 15 mg tablet once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of new blood clots.
• Swallow the tablet(s) with water. Take Roxan with food.
• If you have difficulty swallowing the tablet whole, 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, immediately before taking.

When to take Roxan

Take the tablet(s) every day until your doctor decides to stop treatment.

If you take more Roxan than you should

If you take more Roxan than you should, contact your doctor immediately. Taking too much Roxan increases the risk of bleeding.

If you forget to take Roxan

• If you take one 20 mg tablet or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet at the usual time the next day.
• If you take one 15 mg tablet twice daily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

If you stop taking Roxan

Do not stop taking Roxan without talking to your doctor first, as Roxan treats and prevents serious diseases.

4. Possible side effects

Like all medicines, Roxan can cause side effects, although not everybody gets them.

Side effects that may be a sign of bleeding:

Tell your doctor immediatelyif you experience any of the following side effects:

• prolonged or excessive bleeding
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding. Your doctor may decide to closely monitor you or change your treatment.

Side effects that may be a sign of a skin reaction

Tell your doctor immediatelyif you experience any of the following skin reactions:

• widespread, severe skin rash, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (may affect less than 1 in 10,000 people).
• drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (may affect less than 1 in 10,000 people).

Side effects that may be a sign of a severe allergic reaction

Tell your doctor immediatelyif you experience any of the following side effects:

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

Full list of side effects

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pale skin and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding into the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• blood in the sputum when coughing
• bleeding from the skin or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (which may be seen in tests performed by your doctor)
• fever
• stomach pain, nausea, vomiting, constipation, diarrhea
• low blood pressure (which may cause dizziness or fainting when standing up)
• general weakness and lack of energy (fatigue), headache, dizziness
• rash, itching
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or within the skull
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count)
• allergic reactions, including allergic skin reactions
• liver problems (which may be seen in tests performed by your doctor)
• blood test results may show increased levels of bilirubin, certain liver or pancreatic enzymes, or platelet count
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into the muscles
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• collection of blood (hematoma) in the groin as a complication of cardiac 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 after bleeding, which may cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding)

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Roxan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Medicines should not be disposed of 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 Roxan contains

• The active substance is rivaroxaban. One film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: 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 contents of the pack

Roxan 15 mg film-coated tablets are pink, round, biconvex, and have "15" engraved on one side.

The tablets are packaged in blisters, which are then packaged in cartons containing 10, 14, 28, 30, 42, 56, 90, 98, or 100 tablets.

Roxan 20 mg film-coated tablets are brown-red, round, biconvex, and have "20" engraved on one side.

The tablets are packaged in blisters, which are then packaged in cartons containing 10, 14, 28, 30, 42, 56, 90, 98, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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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