Rivaroxaban Apc

Package Leaflet: Information for the User

Rivaroxaban APC, 10 mg, Film-Coated Tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. You can help by reporting any side effects you may experience. To find out more, see section 4.

You should read this leaflet carefully before taking this medicine, as it contains important information for you

• -You should keep this leaflet, so you can read it again later.
• -If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, tell your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet:

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

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

• prevent the formation of blood clots in the veins, after hip or knee replacement surgery. Your doctor has prescribed this medicine because after surgery, the risk of blood clots is increased.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Rivaroxaban APC belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban APC

When not to take Rivaroxaban APC

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),

or

• if you have excessive bleeding,
• if you have a disease or condition of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that increases the risk of bleeding,
• -if you are pregnant or breastfeeding.

Do not take Rivaroxaban APC, and inform your doctorif you think any of the above conditions apply to you.

Warnings and precautions

Before taking Rivaroxaban APC, tell your doctor or pharmacist.

When to be extra careful while taking Rivaroxaban APC

• -if you have an increased risk of bleeding, such as moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body, if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban APC and other medicines"), bleeding disorders, very high blood pressure that does not decrease despite treatment, stomach or intestinal diseases that may cause bleeding (e.g., inflammation of the intestines and stomach or inflammation of the esophagus), diseases of the blood vessels in the back of the eye (retinopathy), lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• -in patients with artificial heart valves,
• -if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment,
• -if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, you must

tell your doctorbefore taking Rivaroxaban APC .Your doctor will decide whether to give you this medicine and whether you need to be closely monitored.

If you need to have surgery:

• -you must follow your doctor's instructions exactly regarding when to take Rivaroxaban APC before or after surgery,
• -if spinal or epidural anesthesia is planned (e.g., for pain relief during childbirth or surgery):
• you must follow your doctor's instructions exactly regarding when to take Rivaroxaban APC,
• you must immediately inform your doctor if you experience any symptoms after anesthesia, such as numbness, weakness of the legs, difficulty urinating or defecating, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban APC 10 mg tablets are not recommended for people under 18 years of age. There is not enough data on the use of this medicine in children and adolescents.

Rivaroxaban APC and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• -If you are taking
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol),
• certain antibacterial medicines (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you think any of the above conditions apply to you, you must

tell your doctorbefore taking Rivaroxaban APC ,as the effect of Rivaroxaban APC may be increased. Your doctor will decide whether to give you this medicine and whether you need to be closely monitored.
If your doctor thinks you are at increased risk of developing stomach or duodenal ulcers, they may give you a medicine to prevent this.

• If you are taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression,

rifampicin, an antibiotic.

If you think any of the above conditions apply to you, you must

tell your doctorbefore taking Rivaroxaban APC ,as the effect of Rivaroxaban APC may be reduced. Your doctor will decide whether to give you Rivaroxaban APC and whether you need to be closely monitored.

Pregnancy and breastfeeding

Do not take Rivaroxaban APC if you are pregnant or breastfeeding.
If there is a risk that you may become pregnant, you should use effective contraception during treatment with Rivaroxaban APC. If you become pregnant during treatment with this medicine, you must immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban APC may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban APC contains lactose and sodium.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Rivaroxaban APC

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many tablets to take

To prevent blood clots in the veins after hip or knee replacement surgery
The recommended dose is one Rivaroxaban APC 10 mg tablet once a day.
For the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots.
After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban APC 10 mg once a day for you.
Swallow the tablet whole, preferably with water.
Rivaroxaban APC can be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Rivaroxaban APC. The tablet can be crushed and mixed with water or a soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may give you a crushed Rivaroxaban APC tablet through a gastric tube.

When to take Rivaroxaban APC

Take one tablet each day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as this will help you remember to take it. Your doctor will decide how long you should continue the treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks for patients after major hip surgery.
Treatment usually lasts 2 weeks for patients after major knee surgery.

Taking more Rivaroxaban APC than prescribed

If you have taken more Rivaroxaban APC than prescribed, contact your doctor immediately. Taking too much Rivaroxaban APC increases the risk of bleeding.

Missing a dose of Rivaroxaban APC

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day.
Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Rivaroxaban APC

Do not stop taking Rivaroxaban APC without talking to your doctor first, as this medicine prevents a serious disease.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban APC can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Rivaroxaban APC may cause bleeding, which can be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
You must immediately inform your doctorif you experience any of the following side effects:

• Bleeding signs:
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. You must immediately seek medical help!),

or

• prolonged or excessive bleeding,
• unusual weakness, tiredness, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives and difficulty breathing; 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 affect up to 1 in 10 people)

• reduced number of red blood cells, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or reproductive system (including blood in the 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) when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor)
• fever,
• stomach pain, nausea, vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be visible in blood test results.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above bleeding signs),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,
• liver function disorders (can be observed in tests performed by your doctor).

Rare(may affect up to 1 in 1,000 people)

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

Frequency not known(frequency cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rivaroxaban APC

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 on each blister after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing this medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should 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 pack and other information

What Rivaroxaban APC contains

• The active substance is rivaroxaban. One film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban APC looks like and contents of the pack

Rivaroxaban APC 10 mg film-coated tablets are light pink, round, biconvex, with the number "10" embossed on one side.
The tablets are packaged in blisters placed in a cardboard box containing: 10, 14, 28, 30, 42, 56, 60, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

APC Instytut Sp. z o.o.
Jerozolimskie Avenue 146C
02-305 Warsaw

Manufacturer:

Adamed Pharma S.A.
Marszałka J. Piłsudskiego 5
95-200 Pabianice
This medicine is authorized in the Member States of the European Economic Area under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 10 mg film-coated tablets
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 10 mg, film-coated tablet
Greece Rivaroxaban APC
Spain Rivaroxaban APC 10 mg film-coated tablets
Germany Rivaroxaban APC 10 mg, film-coated tablet
Poland Rivaroxaban APC
Portugal Rivaroxaban APC

Date of last revision of the package leaflet: