Rivaroxaban apc

Package leaflet: Information for the user

Rivaroxaban APC, 15 mg, film-coated tablets
Rivaroxaban APC, 20 mg, film-coated tablets
Rivaroxabanum
This medicinal product will be subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience after using this medicine.
For information on how to report side effects - see section 4.
Please read the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet:

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

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

Rivaroxaban APC contains the active substance rivaroxaban.
Rivaroxaban APC is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body in patients who have an 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 recurrence of blood clots in the veins and/or lungs. Rivaroxaban APC 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 pulmonary blood vessels, after at least 5 days of initial treatment with injectable anticoagulant medicines.

Rivaroxaban APC 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 Rivaroxaban APC

When not to take Rivaroxaban APC

• 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 surgical procedure 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 catheter patency in a vein or artery,
• 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 APC and inform your doctor if
the patient suspects any of the above-mentioned conditions.
Warnings and precautions
Before starting Rivaroxaban APC, consult your doctor or
pharmacist.
When to exercise special caution when using Rivaroxaban APC

• if the patient has an increased risk of bleeding, such as: severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, since kidney function may affect the amount of drug acting in the patient's body, coagulation disorders, concomitant use of other anticoagulant medicines (e.g. warfarin, etexilate of dabigatran, apixaban or heparin) during transition of anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban APC and other medicines"), very high blood pressure that does not decrease despite medication, diseases of the stomach or intestines that may cause bleeding, e.g. inflammatory bowel disease and gastritis 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 genital or urinary system, vascular disease of the posterior part 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 is scheduled for surgery or other treatment aimed at removing a pulmonary embolism.

If the patient suspects any of the above-mentioned conditions, they should
inform the doctor before using Rivaroxaban APC. 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 APC before or after surgery,
• if during surgery spinal catheterization or spinal puncture is planned (e.g. for epidural or intrathecal anaesthesia, or pain relief): it is very important to take Rivaroxaban APC before and after the puncture or catheter removal, according to the doctor's instructions; due to the need for special caution, the doctor must be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
Rivaroxaban APC tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban APC in children and adolescents for indications approved in adults.
Rivaroxaban APC and other medicines
Tell your doctor or pharmacist about all medicines currently being taken
or recently taken, as well as any medicines the patient plans 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, oral ketoconazole (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, or certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)).

If the patient suspects any of the above-mentioned conditions, they should
inform the doctor before using Rivaroxaban APC, because the effect
of Rivaroxaban APC 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 duodenal ulcer, they may prescribe treatment to prevent 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, or rifampicin, an antibiotic.

If the patient suspects any of the above-mentioned conditions, they should
inform the doctor before using Rivaroxaban APC, because the effect
of Rivaroxaban APC may be reduced. The doctor will decide whether to use Rivaroxaban APC and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban APC 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 APC. If the patient becomes pregnant while taking Rivaroxaban APC, they should inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaroxaban APC 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, ride a bicycle, or operate tools or machinery.
Rivaroxaban APC contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban APC

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
please consult your doctor or pharmacist.
Rivaroxaban APC tablets should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, they should discuss alternative
administration methods with their doctor. The tablet may be crushed and mixed with
water or soft food such as apple puree immediately before administration. After taking
this mixture, a meal should be consumed promptly.
If necessary, a doctor may administer crushed Rivaroxaban APC tablets via a gastric tube.

How many tablets to take
Adults

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban APC 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one Rivaroxaban APC 15 mg tablet once daily.
  If a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement) is required, there is limited evidence supporting a reduced dose of one Rivaroxaban APC 15 mg tablet once daily (or one Rivaroxaban APC 10 mg tablet once daily in case of kidney impairment), in combination with an antiplatelet medicine such as clopidogrel.
  For treatment of blood clots in the leg veins (deep vein thrombosis), blood clots in the lung blood vessels (pulmonary embolism), and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban APC 15 mg tablet twice daily for the first 3 weeks.

• After 3 weeks of treatment, the recommended dose is one Rivaroxaban APC 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has kidney problems and is taking one Rivaroxaban APC 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban APC 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

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

• Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg: one Rivaroxaban APC 15 mg tablet once daily.
• Recommended dose for children and adolescents with a body weight of 50 kg or more: one Rivaroxaban APC 20 mg tablet once daily.

Each dose of Rivaroxaban APC should be taken with a meal and with 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: please observe the child to ensure they have taken the full dose.
Since the dose of Rivaroxaban APC is based on body weight, it is important to attend scheduled doctor visits, as dose adjustments may be needed due to weight changes.
Never adjust the dose independently. The doctor will adjust the dose if necessary.
Do not split the tablet to achieve a partial dose. If a lower dose is required, a different formulation containing rivaroxaban as granules for oral suspension should be used. For children and adolescents unable to swallow whole tablets, rivaroxaban granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban APC tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, a doctor may also administer crushed Rivaroxaban APC tablets via a gastric tube.

If a dose is vomited or spat out

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

Contact your doctor if repeated vomiting or spitting out of the dose occurs after taking Rivaroxaban APC.

When to take Rivaroxaban APC
Tablets should be taken every day until the doctor decides to stop treatment. It is best to take the tablets at the same time each day, as this makes it easier to remember. The doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, Rivaroxaban APC should be taken as directed by the doctor.

Missed dose of Rivaroxaban APC
Adults, children and adolescents:
If a 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 a single day to make up for the missed dose. Take the next tablet the following day and continue with one tablet once daily.

Adults:
If a 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 a single day. If a dose was forgotten, the patient 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.

Taking more than the recommended dose of Rivaroxaban APC
If a patient has taken too many Rivaroxaban APC tablets, contact a doctor immediately.
Taking too high a dose of Rivaroxaban APC increases the risk of bleeding.

Stopping Rivaroxaban APC
Do not stop taking Rivaroxaban APC without first consulting your doctor, as this medicine treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban APC may cause bleeding, which potentially could be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding may not always be obvious or visible.
You should contact your doctor immediately if you experience any of the following adverse reactions:

• Signs of bleeding:
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
  • prolonged or excessive bleeding,
  • unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.
• Signs of severe skin reactions
  • widespread, acute skin rash, blistering or mucosal changes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities and systemic involvement. The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
  • swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 adverse reactions in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

• reduction in red blood cell count, which may cause skin pallor and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including conjunctival hemorrhage),
• 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 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 reduction 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 out of 100 people)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint 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, 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 people)

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

Frequency not known (frequency cannot be estimated from the 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).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban APC were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

• headache
• fever
• nosebleeds, vomiting

Common (may occur in 1 out of 10 people)

• rapid heartbeat
• blood tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, platelets being cells that help blood to clot)
• excessive menstrual bleeding

Uncommon (may occur in 1 out of 100 people)

• blood tests may show increased levels of a bilirubin subfraction (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
E-mail: 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 this medicine.

5. How to store Rivaroxaban APC

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after: Expiry date and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
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 Rivaroxaban APC contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are:
  Core of the tablet: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose, hydroxypropylcellulose, polyethylene glycol, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban APC looks like and contents of the pack
Rivaroxaban APC 15 mg coated tablets are pink, round, biconvex, with the number “15” engraved on one side.
The tablets are packed in blisters placed in a cardboard box containing: 10, 14, 28, 30, 42, 56, 60, 98 or 100 coated tablets.
Rivaroxaban APC 20 mg coated tablets are brick-brown, round, biconvex tablets, with the number “20” engraved on one side.
The tablets are packed in blisters placed in a cardboard box containing: 10, 14, 28, 30, 42, 56, 60, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
APC Instytut Sp. z o.o.
Al. Jerozolimskie 146C
02-305 Warsaw, Poland

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice, Poland

Rivaroxaban APC 15 mg is authorised for marketing in the European Economic Area under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 15 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 15 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain Rivaroxaban APC 15 mg comprimidos recubiertos con película
Germany Rivaroxaban APC 15 mg, Filmtablette
Poland Rivaroxaban APC
Portugal Rivaroxaban APC

Rivaroxaban APC 20 mg is authorised for marketing in the European Economic Area under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 20 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 20 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain Rivaroxaban APC 20 mg comprimidos recubiertos con película
Germany Rivaroxaban APC 20 mg, Filmtablette
Poland Rivaroxaban APC
Portugal Rivaroxaban APC