Package leaflet: Information for the user

Rivaroxaban APC, 10 mg, film-coated tablets
Rivaroxabanum
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can also help by reporting any side effects that occur after using the medicine. To find out how to report side effects – see section 4.
Please read all of 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 other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet:

What Rivaroxaban APC is and what it is used for
Important information before taking Rivaroxaban APC
How to take Rivaroxaban APC
Possible side effects
How to store Rivaroxaban APC
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 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 the 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 recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban APC 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 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 has active 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 in 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 a catheter 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 you suspect that any of the above circumstances apply to you.
Warnings and precautions
Before starting to take 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 in the following conditions: moderate or severe kidney disease, because kidney function may affect the amount of medicine acting in the patient's body; 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 a catheter in a vein or artery (see section "Rivaroxaban APC with 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. inflammatory bowel disease or gastritis, 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, intestines, genital or urinary system; blood vessel disease of the posterior part of the eyeball (retinopathy); lung disease in which 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 a change in treatment is necessary,
if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery, or other treatment aimed at removing a blood clot from the lungs.

If you suspect that any of the above conditions apply to you, inform your doctor before taking 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 the surgical procedure the patient is scheduled to undergo
- lumbar puncture or placement of a catheter into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
- strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban APC,
- immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel or bladder function, as immediate treatment will be required in such a case.

Children and adolescents
Rivaroxaban APC 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.
Rivaroxaban APC with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

If the patient is taking
- certain medicines used to treat fungal infections (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 used to treat bacterial infections (e.g. clarithromycin, erythromycin),
- certain antiviral medicines used to treat HIV infection 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor before taking 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, he 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, which belongs to the group of antibiotics.
If you suspect that any of the above conditions apply to you, inform your doctor before taking 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 you are 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 pregnancy occurs during treatment with this medicine, inform your 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, the patient should consult a 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 as directed by the doctor. If in doubt,
consult your doctor or pharmacist.
How many tablets to take
To prevent the formation of blood clots in the veins after hip or knee replacement surgery:
The recommended dose is one tablet of Rivaroxaban APC 10 mg taken once daily.
For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots:
After at least 6 months of treatment for blood clots, the recommended dose is one tablet of 10 mg once daily or one tablet of 20 mg once daily. Your doctor has prescribed Rivaroxaban APC 10 mg once daily.
The tablet should be swallowed whole, preferably with water.
Rivaroxaban APC may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Rivaroxaban APC. The tablet can be crushed and mixed with water or soft food such as apple puree immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban APC tablets via a gastric tube.
When to take Rivaroxaban APC
Take one tablet every day until your 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. Your doctor will decide how long treatment should continue.
To prevent blood clots in the leg 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.
If you take more Rivaroxaban APC than recommended
If you take more Rivaroxaban APC than prescribed, contact your doctor immediately. Taking too much Rivaroxaban APC increases the risk of bleeding.
If you forget to take Rivaroxaban APC
If you forget to take a dose, take the tablet as soon as you remember.
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 tablet.
Stopping Rivaroxaban APC
Do not stop taking Rivaroxaban APC without first talking to your doctor, as Rivaroxaban APC helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban APC may cause bleeding, which could potentially be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Bleeding may not always present obvious or visible signs.
You should contact your doctor immediately 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, 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 close monitoring or a change in treatment is necessary.
Signs of severe skin reactions:
- widespread, acute skin rash, formation of blisters or mucosal lesions, 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 side effects is very rare (occurring in up to 1 in 10,000 people).
Signs of severe allergic reactions:
- swelling of the face, lips, oral cavity, tongue, or throat; difficulty swallowing; 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 up to 1 in 10 people )

reduced number of red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
gastrointestinal bleeding or intestinal bleeding, urinary or genital tract bleeding (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) during coughing,
bleeding from the skin or subcutaneous bleeding,
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, diarrhea,
low blood pressure (symptoms may include dizziness or fainting upon standing),
general loss of 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 up to 1 in 100 people )

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

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

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

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Email: website: https://smz.ezdrowie.gov.pl
Side effects may 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 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 after: Expiry and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban APC contains

The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
Other ingredients are:
Core of the tablet: microcrystalline cellulose, lactose monohydrate, 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 10 mg coated tablets are light pink, round, biconvex, with the number "10" embossed 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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 10 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 10 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain Rivaroxaban APC 10 mg comprimidos recubiertos con película
Germany Rivaroxaban APC 10 mg, Filmtablette
Poland Rivaroxaban APC
Portugal Rivaroxaban APC