Roxan

Package leaflet: Information for the user

Roxan, 15 mg, coated tablets
Roxan, 20 mg, coated tablets
Rivaroxabanum

This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. You, as a user of the medicine, can also help by
reporting any adverse reactions that occur after using the medicine. For information on how to
report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Roxan is and what it is used for
2. What you need to know before taking 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 the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heart rhythm called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to 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. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before taking Roxan

When not to take Roxan

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if the patient has excessive bleeding
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes)
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain patency of an intravenous or arterial catheter
• if the patient has a liver disease that leads to an increased risk of bleeding
• if the patient is pregnant or breastfeeding.

Do not take Roxan and inform your doctor if you suspect that any of the above-mentioned conditions apply to you.
Warnings and precautions
Discuss this with your doctor or pharmacist before starting to take Roxan.
When to exercise special caution when taking Roxan

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body;
• blood clotting disorders;
• taking other medicines that prevent blood clots (e.g. warfarin, edoxaban, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain patency of an intravenous or arterial catheter (see section "Roxan with other medicines");
• very high blood pressure that does not decrease despite treatment with medicines;
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the stomach and intestines or oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus);
• blood vessel disease of the back of the eye (retinopathy);
• lung disease with dilated airways filled with pus (bronchiectasis) or previous lung bleeding;
• in patients with heart valve prostheses
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects that any of the above-mentioned conditions apply, inform the doctor
before taking Roxan. The doctor will decide whether to use this medicine and whether the patient needs to be closely monitored.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Roxan before or after surgery;
• if catheterization or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Roxan before and after the puncture or catheter removal exactly as directed by the doctor;
• due to the need for special caution, inform the doctor immediately if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the anaesthesia wears off.

Children and adolescents
Roxan is not recommended for patients under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.
Roxan with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.

• If the patient is taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol)
• certain antibiotics (e.g. clarithromycin, erythromycin)
• certain antiviral medicines used in HIV infection or AIDS treatment (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 antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above-mentioned conditions apply, inform the doctor
before taking Roxan, because the effect of Roxan may be increased when taken together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient needs to be closely monitored. If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, he may prescribe preventive treatment for peptic ulcer disease.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above-mentioned conditions apply, inform the doctor
before taking Roxan, because the effect of Roxan may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Roxan and whether the patient needs to be closely monitored.
Pregnancy and breastfeeding
Do not take Roxan if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Roxan. If the patient becomes pregnant while taking Roxan, inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Roxan may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients experiencing these side effects should not drive or operate machinery.
Roxan contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which essentially means it is "sodium-free".

3. How to take Roxan

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
How many tablets to take
For the prevention of blood clots in the brain (stroke) and other blood vessels in the body:
The recommended dose is one tablet of Roxan 20 mg once daily.
If the patient has kidney disease, the dose may be reduced to one tablet of Roxan 15 mg once daily.
If the patient requires a procedure to open blocked blood vessels in the heart (called percutaneous
coronary intervention – PCI with stent placement), there is limited evidence supporting dose
reduction to one tablet of Roxan 15 mg once daily (or one tablet of Roxan 10 mg once daily in case
of renal impairment) in combination with an antiplatelet agent such as clopidogrel.
For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs,
and for the prevention of recurrence of blood clots:
The recommended dose is one tablet of Roxan 15 mg twice daily for the first 3 weeks. After 3 weeks
of treatment, the recommended dose is one tablet of Roxan 20 mg once daily.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment
with either one tablet of 10 mg once daily or one tablet of 20 mg once daily. If the patient has kidney
disease and is taking one tablet of Roxan 20 mg once daily, the doctor may decide to reduce the dose
after 3 weeks of treatment to one tablet of Roxan 15 mg once daily, if the risk of bleeding is greater
than the risk of further blood clots.
The tablet(s) should be swallowed whole, preferably with water. Roxan should be taken with food.
If the patient has difficulty swallowing the whole tablet, they should discuss alternative methods of
taking Roxan with their doctor. The tablet may be crushed and mixed with water or soft food, such
as apple puree, immediately before administration. A meal should be taken immediately after this
mixture. If necessary, the doctor may administer crushed Roxan tablets via a gastric tube.
When to take Roxan
The tablet(s) should be taken every day until your doctor decides to stop treatment. It is best to take
the tablet(s) at the same time each day, as this makes it easier to remember. Your doctor will decide
how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If restoration of normal heart rhythm is required by means of a cardioversion procedure, Roxan
should be taken as directed by your doctor.
Taking more Roxan than recommended
If you have taken more Roxan than recommended, contact your doctor immediately. Taking too
high a dose of Roxan increases the risk of bleeding.
If you miss a dose of Roxan

• If you are taking one tablet of 20 mg or one tablet of 15 mg once daily and you miss a dose, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• If you are taking one tablet of 15 mg twice daily and you miss a dose, take the tablet as soon as possible. Do not take more than two tablets of 15 mg in one day. If you forget to take a dose, you may take two tablets of 15 mg at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, resume taking one tablet of 15 mg twice daily. Stopping treatment with Roxan
  Do not stop taking Roxan without first consulting your doctor, as Roxan treats and prevents serious
  conditions.
  If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Roxan may cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar action (anticoagulants), Roxan may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Possible adverse reactions which may indicate bleeding:
Contact your doctor immediately if any of the following adverse reactions occur:

• 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. Your doctor may decide that close monitoring or a change in treatment is necessary.

Possible adverse reactions which may indicate a skin reaction:
Contact your doctor immediately if any of the following skin reactions occur:

• extensive, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).
• drug reaction with eosinophilia and systemic symptoms (DRESS) causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).

Possible adverse reactions which may indicate a serious allergic reaction:
Contact your doctor immediately if any of the following adverse reactions occur:

• swelling of the face, lips, mouth, tongue or throat, difficulty swallowing; urticaria and breathing difficulties; 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)

• reduced number of red blood cells, which may cause pale skin and lead to weakness or shortness of breath
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• ocular bleeding (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) during coughing
• skin bleeding or subcutaneous bleeding
• postoperative bleeding
• oozing of blood or fluid from a surgical wound
• limb swelling
• limb pain
• kidney function disorders (may be observed in tests performed by a doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing)
• general loss of strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 in 100 patients)

• intracranial or cerebral hemorrhage
• joint bleeding causing pain and swelling
• thrombocytopenia (low platelet count, blood cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (may be observed in tests performed by a doctor)
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• urticaria

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

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

Frequency unknown (frequency cannot be estimated from available data)

• kidney failure following severe bleeding
• increased pressure in the muscles of arms and legs after bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding)

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Roxan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton following:
Expiry date and on each blister or bottle after: EXP. The expiry date refers to the last day of the
stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Roxan contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose E5, sodium lauryl sulfate, magnesium stearate;
  Tablet coating: Aqua Polish P white coating: hydroxypropylcellulose, hypromellose E5, hypromellose E15, polyethylene glycol 8000, titanium dioxide (E 171), iron oxide red (E 172).

What Roxan looks like and contents of the pack
Roxan 15 mg coated tablets are pink, round, biconvex, with the number "15" engraved on one side.
Tablets are packed in blisters, packed into cartons containing 10, 14, 28, 30, 42, 56, 90, 98, or 100 tablets.
Roxan 20 mg coated tablets are brick-brown, round, biconvex, with the number "20" engraved on one side.
Tablets are packed in blisters, packed into 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
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