Rivaroxaban Apc

Package Leaflet: Information for the User

Rivaroxaban APC, 2.5 mg, Film-Coated Tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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. You may need to read it again.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Rivaroxaban APC is and what it is used for
• 2. What you need to know before you take 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

You have been given Rivaroxaban APC because:

• you have been diagnosed with acute coronary syndrome (a condition where the blood flow to your heart is suddenly blocked) and have had elevated levels of cardiac biomarkers. Rivaroxaban APC reduces the risk of having another heart attack or reduces the risk of death from cardiovascular causes in adults. Rivaroxaban APC will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban APC reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban APC will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are given Rivaroxaban APC after a procedure to open up a blocked or narrowed artery in your leg to restore blood flow, your doctor may also prescribe you:

clopidogrel to take in addition to aspirin for a short period.
Rivaroxaban APC contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. What you need to know before you take 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),
• if you have bleeding disorders,
• if you have a disease or condition of an organ that increases the risk of major bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery),
• if you are taking other medicines to prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin), except when switching from one anticoagulant to another or when heparin is given to maintain patency of a venous or arterial catheter,
• if you have had acute coronary syndrome and have had bleeding or blood clot in the brain (stroke),
• if you have coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the tissues in the deep structures of the brain (cerebral venous sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month),
• 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 applies to you.

Warnings and precautions

Before taking Rivaroxaban APC, talk to your doctor or pharmacist. Rivaroxaban APC should not be taken with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

When to be extra careful while taking Rivaroxaban APC

• -if you have an increased risk of bleeding, in conditions such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin) when switching from one anticoagulant to another or when heparin is given to maintain patency of a venous or arterial catheter (see section "Rivaroxaban APC and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• -in patients with prosthetic 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 think you have any of the above conditions, you should

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 catheterization or spinal puncture is planned (e.g., for epidural, spinal or caudal anesthesia, or pain relief):
• it is very important to take Rivaroxaban APC before and after the puncture or catheter removal, as instructed by your doctor
• due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems, or pain after anesthesia.

Children and adolescents

Rivaroxaban APC 2.5 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 medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol),
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV or AIDS (e.g., ritonavir),
• other medicines that prevent blood clotting (e.g., enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or aspirin),
• dronedarone, a medicine used to treat irregular heart rhythm,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think you have any of the above conditions, you should

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 risk of developing stomach or intestinal ulcers, they may give you a medicine to prevent ulcers.

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

If you think you have any of the above conditions, you should

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 while taking Rivaroxaban APC. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban APC may cause dizziness (common 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 machinery.

Rivaroxaban APC contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it 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

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban APC should be taken at the same time each day (e.g., one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing whole tablets, you should talk to your doctor about other ways to take Rivaroxaban APC. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking it.
If necessary, your doctor may give you a crushed Rivaroxaban APC tablet through a nasogastric tube.
Rivaroxaban APC will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are given Rivaroxaban APC after acute coronary syndrome, your doctor may also prescribe you to take clopidogrel or ticlopidine.
If you are given Rivaroxaban APC after a procedure to open up a blocked or narrowed artery in your leg to restore blood flow, your doctor may prescribe you to take clopidogrel in addition to aspirin for a short period.
Your doctor will tell you how much of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel, or a standard daily dose of ticlopidine).

When to take Rivaroxaban APC

Treatment with Rivaroxaban APC after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission and when parenteral (given by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with Rivaroxaban APC if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long you should continue treatment.

If you take more Rivaroxaban APC than you should

If you take more Rivaroxaban APC than you should, contact your doctor immediately. Taking more Rivaroxaban APC than you should increases the risk of bleeding.

If you forget to take Rivaroxaban APC

Do not take a double dose to make up for a forgotten dose. If you forget a dose, take the next dose at the scheduled time.

If you stop taking Rivaroxaban APC

Rivaroxaban APC should be taken regularly and for the duration prescribed by your doctor.
Do not stop taking Rivaroxaban APC without first talking to your doctor. If you stop taking this medicine, you may increase your risk of having another heart attack, stroke or death from cardiovascular causes.
If you have any further questions on the use of this product, 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 prevent 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 signs of bleeding are not always obvious or visible.

You should immediately inform your doctor if you experience any of the following side effects:

• •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 stiffness of the neck. A serious and sudden medical condition. You should immediately seek medical help!),
• 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 peeling of the skin or 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, hematological 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; 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 up to 1 in 100 people).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• reduction in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum while coughing (hemoptysis),
• 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 problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea, vomiting, 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 can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people)

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

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

• bleeding into muscles,
• cholestasis (bile flow obstruction), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (collection of blood) 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, which can cause pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome due to bleeding).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide 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 which is stated on the carton after EXP. and on each blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree 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. These measures 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 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Tablet coating: hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E 171).

What Rivaroxaban APC looks like and contents of the pack

Rivaroxaban APC 2.5 mg film-coated tablets are white, round, biconvex, with "2.5" engraved on one side.
The tablets are packaged in blisters placed in a cardboard box containing: 10, 14, 28, 30, 42, 56, 60, 98, 100 or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

APC Institute Sp. z o.o.
Al. Jerozolimskie 146C
02-305 Warsaw

Manufacturer:

Adamed Pharma S.A.
ul. 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 2,5 mg film-coated tablets
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 2,5 mg, film-coated tablet
Greece Rivaroxaban APC
Spain
Rivaroxaban APC 2,5mg film-coated tablets
Germany
Rivaroxaban APC 2,5mg, film-coated tablet
Poland
Rivaroxaban APC
Portugal Rivaroxaban APC

Date of last revision of the leaflet: