Rivaroxaban farmak

Patient Information Leaflet

Rivaroxaban Farmak, 10 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Rivaroxaban Farmak is and what it is used for
2. Important information before taking Rivaroxaban Farmak
3. How to take Rivaroxaban Farmak
4. Possible side effects
5. How to store Rivaroxaban Farmak
6. Contents of the pack and other information

1. What Rivaroxaban Farmak is and what it is used for

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

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots 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 to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Farmak 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 using Rivaroxaban Farmak

When not to use Rivaroxaban Farmak:

• 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 anticoagulant medicines (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 use Rivaroxaban Farmak and inform your doctor if
the patient suspects that any of the above circumstances apply.
Warnings and precautions
Before starting to take Rivaroxaban Farmak, discuss this with your doctor or
pharmacist.
Exercise special caution when using Rivaroxaban Farmak:

• 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 anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain patency of an intravenous or arterial catheter (see section “Rivaroxaban Farmak and other medicines”),
• coagulation disorders,
• very high blood pressure that does not decrease despite medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease in the back of the eye (retinopathy),
• lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment needs to be changed,
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, inform the doctor
before using Rivaroxaban Farmak. The doctor will decide whether to use
this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Farmak before and after surgery,
• if during surgery catheterization or spinal puncture is planned (e.g. for epidural or spinal anaesthesia or pain relief):
• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Farmak,
• due to the need for special caution, immediately inform the doctor if numbness or weakness of the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Rivaroxaban Farmak 10 mg tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Farmak and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken by the patient,
as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking

some 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),
some antibacterial medicines (e.g. clarithromycin, erythromycin),
some 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,
some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).
If the patient suspects that any of the above conditions apply, inform the doctor
before using Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak may be enhanced. 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 stomach or intestinal ulcers, they may prescribe treatment to prevent ulcer formation.

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

If the patient suspects that any of the above conditions apply, inform the doctor
before using Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak may
be reduced. The doctor will decide whether to use Rivaroxaban Farmak and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Farmak 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 Rivaroxaban Farmak. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Farmak may cause dizziness (common adverse reactions) or fainting (uncommon adverse reactions) (see section 4 “Possible adverse reactions”).
Patients experiencing these adverse reactions should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Farmak contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the product is considered "sodium-free".

3. How to take Rivaroxaban Farmak

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.

How many tablets to take

• To prevent blood clots in veins after hip or knee replacement surgery: The recommended dose is one Rivaroxaban Farmak 10 mg tablet taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the lung blood vessels, 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 doctor has prescribed Rivaroxaban Farmak 10 mg once daily for the patient.

Swallow the tablet whole, preferably with water.
Rivaroxaban Farmak may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Farmak with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration. If necessary, the doctor may administer crushed Rivaroxaban Farmak tablets via a gastric tube.

When to take Rivaroxaban Farmak
Take one tablet every day until the doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
To prevent blood clots in 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 than the recommended dose of Rivaroxaban Farmak
If the patient has taken more than the recommended dose of Rivaroxaban Farmak, contact the doctor immediately. Taking too high a dose of Rivaroxaban Farmak increases the risk of bleeding.

Missing a dose of Rivaroxaban Farmak
If the patient forgets to take a dose, take the tablet as soon as remembered. Take the next tablet the following day, and then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed dose.

Stopping Rivaroxaban Farmak
Do not stop taking Rivaroxaban Farmak without first consulting the doctor, as Rivaroxaban Farmak helps prevent a serious medical condition.
If there are any further questions about the use of this medicine, consult the doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like other medicines with a similar action reducing blood clot formation,
Rivaroxaban Farmak may cause bleeding, which potentially could 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 side effects which may indicate bleeding
Contact a doctor immediately if any of the following side effects occur:

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris. The doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible side effects which may indicate severe skin reactions
Contact a doctor immediately if any of the following side effects occur:

• extensive, acute skin rash, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this side effect is very rare (up to 1 in 10,000 people),
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these side effects is very rare (up to 1 in 10,000 people).

Possible side effects which may indicate severe allergic reactions
Contact a doctor immediately if any of the following side effects occur:

• swelling of the face, lips, mouth, tongue or throat; urticaria and breathing difficulties; 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 occur in 1 out of 10 patients)

• reduction in red blood cell count, which may cause paleness of the skin and lead to weakness or breathlessness
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) when coughing
• bleeding from the skin or under the skin
• 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, diarrhoea
• low arterial blood pressure (symptoms may include dizziness or fainting upon standing)
• general reduction in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• increased activity of certain liver enzymes, which may be seen in blood test results

Uncommon (may occur in 1 out of 100 patients)

• bleeding into the brain or inside the skull (see bleeding signs above)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low platelet count, 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 bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count
• fainting
• malaise
• rapid heartbeat
• dryness of the mouth
• urticaria

Rare (may occur in 1 out of 1000 patients)

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

Frequency not known (frequency cannot be determined from available data)

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

Reporting of side effects
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Rivaroxaban Farmak

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
No special storage conditions are required 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 Rivaroxaban Farmak contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.

• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 "Rivaroxaban Farmak contains lactose and sodium".
  Tablet coating: hypromellose 2910, titanium dioxide (E 171), polyethylene glycol 3350, iron oxide red (E 172).

What Rivaroxaban Farmak looks like and contents of the pack
Rivaroxaban Farmak 10 mg are pink, round, biconvex coated tablets (6 mm in diameter), with "10" embossed on one side and smooth on the other.
The tablets are supplied in transparent PVC/PVDC/Aluminium blisters, packed in a cardboard box containing 10 coated tablets.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec, Slovakia
Alvogen Malta (Out-Licensing) Ltd. / AMOL Ltd.
Malta Life Sciences Park, Building 1, Level 4
San Ġwann, SĠN 3000, Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Lithuania Rivaroxaban Farmak 10 mg plėvele dengtos tabletės
Poland Rivaroxaban Farmak