Rivaroxaban farmak

Package leaflet: Information for the patient

Rivaroxaban Farmak, 15 mg, coated tablets
Rivaroxaban Farmak, 20 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, 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 the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients who have a type of irregular heart rhythm called non-valvular atrial fibrillation;
• 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 recurrence of blood clots in the veins and/or lungs.

Rivaroxaban Farmak is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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 is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. peptic 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 the 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 treatment with Rivaroxaban Farmak, discuss this with your doctor or
pharmacist.
Exercise particular caution when using Rivaroxaban Farmak:

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
• concomitant use of other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the 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 treatment with medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (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 reproductive or urinary system,
• vascular disease of the posterior segment of the eyeball (retinopathy),
• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous pulmonary haemorrhage,
• in patients with prosthetic heart valves,
• 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 if surgery or other treatment to remove a pulmonary embolus 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 Rivaroxaban Farmak administration before and after surgery,
• if catheterization or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Rivaroxaban Farmak before and after the puncture or catheter removal, as directed by the doctor,
• 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 wears off.

Children and adolescents
Rivaroxaban Farmak tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban Farmak in children and adolescents for the indications approved in adults.
Rivaroxaban Farmak and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, 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 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 that any of the above conditions apply, inform the doctor
before using Rivaroxaban Farmak, because 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 gastric or intestinal ulcers,
he may prescribe treatment to prevent ulcer formation.

• If the patient is taking certain 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, because 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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take

• Adults
• For preventing blood clots in the brain (stroke) and in other blood vessels in the body: The recommended dose is one tablet of Rivaroxaban Farmak 20 mg once daily. If the patient has kidney problems, the dose may be reduced to one tablet of Rivaroxaban Farmak 15 mg once daily.

If the patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting reducing the dose to one tablet of Rivaroxaban Farmak 15 mg once daily (or one tablet of Rivaroxaban Farmak 10 mg once daily if the patient has impaired kidney function), in combination with an antiplatelet medicine such as clopidogrel.

• For treating blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and for preventing recurrence of blood clots: The recommended dose is one tablet of Rivaroxaban Farmak 15 mg twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one tablet of Rivaroxaban Farmak 20 mg once daily. After at least 6 months of treatment for blood clots, the 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 problems and is taking one tablet of Rivaroxaban Farmak 20 mg once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one tablet of Rivaroxaban Farmak 15 mg once daily, if the risk of bleeding is greater than the risk of developing further blood clots.

• Children and adolescents The dose of Rivaroxaban Farmak depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one tablet of Rivaroxaban Farmak 15 mg once daily.

• The recommended dose for children and adolescents with a body weight of 50 kg or more is one tablet of Rivaroxaban Farmak 20 mg once daily.

Each dose of Rivaroxaban Farmak should be taken with food, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: monitor the child to ensure the full dose has been taken.

The dose of Rivaroxaban Farmak depends on body weight; therefore, it is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to changes in weight.

Never adjust the dose on your own. Your doctor will adjust the dose if needed.

Do not split the tablet to achieve a partial dose. If a lower dose is required, other formulations of the medicine as granules for oral suspension should be used.

For children and adolescents who are unable to swallow whole tablets, other formulations of the medicine as granules for oral suspension should be used.

If the oral suspension is not available, the Rivaroxaban Farmak tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be consumed after this mixture.

If necessary, the doctor may administer the crushed tablet via a gastric tube.

The tablet(s) should be swallowed, preferably with water.

Rivaroxaban Farmak should be taken with food.

If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Farmak with the doctor. The tablet can be crushed and mixed with water or apple puree immediately before administration. A meal should be consumed immediately after this mixture.

If necessary, the doctor may administer the crushed Rivaroxaban Farmak tablet via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking Rivaroxaban Farmak, take a new dose.
• More than 30 minutes after taking Rivaroxaban Farmak, do not take a new dose. In this case, take the next dose of Rivaroxaban Farmak at the usual time.

Contact your doctor if the patient repeatedly spits out the dose or vomits after taking Rivaroxaban Farmak.

When to take Rivaroxaban Farmak

Take the tablet(s) every day until the 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. The doctor will decide how long treatment should continue.

For preventing blood clots in the brain (stroke) and in other blood vessels in the body:

If a procedure called cardioversion is required to restore normal heart rhythm, Rivaroxaban Farmak should be taken as directed by the doctor.

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 takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet 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 the following day, then continue taking one tablet once daily.
• If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Rivaroxaban Farmak

Do not stop taking Rivaroxaban Farmak without first consulting your doctor, as this medicine helps prevent serious illness.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

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

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, 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, shortness of breath, chest pain or angina. Your doctor may decide that careful monitoring or a change in treatment is necessary.

Possible side effects which may indicate severe skin reactions
Contact your doctor immediately if you experience any of the following side effects:

• widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue 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 abnormalities 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 your doctor immediately if you experience any of the following side effects:

• 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 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 urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding into the eye (including bleeding from the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence of blood in sputum (hemoptysis) during coughing
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• kidney function disorders (may be observed in tests performed by a doctor)
• fever
• stomach pain, indigestion, feeling of nausea (nausea) or vomiting, constipation, diarrhea
• low 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 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, platelets being blood cells involved in 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
• dryness of the mouth
• urticaria

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

• bleeding into muscles
• cholestasis (bile stasis), hepatitis including liver cell damage
• yellowing of the skin and eyes (jaundice)
• localised swelling
• blood collection (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 estimated from available data)

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

Reporting of side effects
If any adverse effects occur, including any adverse effects 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 authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Farmak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
No special storage conditions apply to 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 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, 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), macrogol 3350, iron oxide red (E 172).

What Rivaroxaban Farmak looks like and contents of the pack
Rivaroxaban Farmak 15 mg are red, round, biconvex coated tablets (with a diameter of 5.6 mm), imprinted with the number "15" on one side and smooth on the other.
Clear blisters made of PVC/PVDC/Aluminium in cardboard boxes containing 14 or 28 coated tablets.
Rivaroxaban Farmak 20 mg are dark red, round, biconvex coated tablets (with a diameter of 6.5 mm), imprinted with the number "20" on one side and smooth on the other.
Clear blisters made of PVC/PVDC/Aluminium in cardboard boxes containing 14 or 28 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 for marketing in the European Economic Area countries under the following names:
Lithuania Rivaroxaban Farmak 15 mg plėvele dengtos tabletės / Rivaroxaban Farmak 20 mg plėvele dengtos tabletės
Poland Rivaroxaban Farmak