Roxan

Package leaflet: Information for the user

Roxan, 10 mg, coated tablets
Rivaroxabanum

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

• 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Roxan is and what it is used for
2. Important information 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent 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 to form blood clots.

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 active 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 clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not use Roxan, and inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting treatment with Roxan, discuss this with your
doctor or pharmacist.
When to exercise particular caution when taking Roxan

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

If the patient suspects any of the above conditions apply, they should inform the
doctor before taking Roxan. The doctor will decide whether to use this medicine and whether
the patient requires particularly close monitoring.
If the patient needs surgery:

• strictly follow the doctor's instructions regarding taking Roxan at a specific time before or after surgery;
• if during the surgical procedure a lumbar puncture or placement of a spinal catheter is planned (e.g., for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding taking Roxan at a specific time;
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the legs, disturbances in bowel or bladder function, as immediate treatment may be required.

Elderly patients
The risk of bleeding may increase with age.
Children and adolescents
Roxan is not recommended for patients under 18 years of age. There is insufficient data on the use of this 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, as well as any medicines you plan to take, including those available 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 medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions apply, they should inform the
doctor before taking Roxan, as the effect of Roxan may be enhanced when taken together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring. If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcers, they 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, an antibiotic.

If the patient suspects any of the above conditions apply, they should inform the
doctor before taking Roxan, as 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 requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use 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 this medicine, they should immediately inform the doctor, 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, they should consult their 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 as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
How many tablets to take

• To prevent blood clots in the veins following hip or knee replacement surgery, the recommended dose is one tablet of Roxan 10 mg taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. The physician has prescribed the patient Roxan 10 mg once daily.

The tablet should be swallowed whole, preferably with water. Roxan may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Roxan with the physician. The tablet may be crushed and mixed with water or soft food such as apple puree, immediately before administration. If necessary, the physician may administer crushed Roxan tablets via a gastric tube.
When to take Roxan
One tablet should be taken every day until the physician decides to discontinue treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The physician will decide how long treatment should continue.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks. In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more Roxan than recommended
If the patient has taken more than the recommended dose of Roxan, contact the physician immediately. Overdosing on 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 the patient forgets to take a dose, take the tablet as soon as remembered. The next tablet should be taken the following day, and then continue taking tablets as usual, once daily. Do not take a double dose to make up for a missed tablet.
Stopping Roxan treatment
Do not stop taking Roxan without first discussing it with the physician, as Roxan helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar action (anticoagulant medicines), Roxan can cause bleeding,
which may 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 be signs of bleeding:
Immediately inform your doctor if any of the following adverse reactions occur:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding. The doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible adverse reactions which may be signs of skin reactions:
Immediately inform your doctor if the following skin reactions occur, such as:

• 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 causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).

Possible adverse reactions which may be signs of a serious allergic reaction.
Immediately inform your doctor if the following adverse reactions occur:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing, hives and breathing difficulties; sudden drop in blood pressure. The frequency of these 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)

• reduction in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• 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, feeling of nausea or vomiting, constipation, diarrhea,
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 in 100 patients)

• bleeding into the brain or within the skull,
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low number of platelets, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the mouth,
• urticaria (hives),
• liver function disorders (may be observed in tests performed by a doctor).

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

• bleeding into muscles,
• 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 when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Frequency unknown (frequency cannot be determined from available data)

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet,
you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
e-mail: website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the packaging after: Expiry and on each blister or bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage requirements apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 10 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose E5, sodium lauryl sulfate, magnesium stearate;
  Tablet coating: Aqua Polish P white coating: hydroxypropyl cellulose, hypromellose E5, hypromellose E15, macrogol 8000, titanium dioxide (E 171), iron oxide red (E 172).

What Roxan looks like and contents of the pack
Light pink, round, biconvex coated tablets, with the number "10" engraved on one side.
The tablets are contained in blisters packed in cardboard boxes 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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