Rivaroxaban lek-am

Package leaflet: Information for the user

Rivaroxaban LEK-AM, 10 mg, film-coated tablets
Rivaroxabanum

Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Rivaroxaban LEK-AM is and what it is used for
2. What you need to know before taking Rivaroxaban LEK-AM
3. How to take Rivaroxaban LEK-AM
4. Possible side effects
5. How to store Rivaroxaban LEK-AM
6. Contents of the pack and other information

1. What Rivaroxaban LEK-AM is and what it is used for

Rivaroxaban LEK-AM contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots after surgery 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 to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban LEK-AM 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 LEK-AM

When not to take Rivaroxaban LEK-AM

• 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. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• 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 venous 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 LEK-AM and inform your doctor if you suspect that any of the above circumstances apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban LEK-AM.

When to exercise special caution with Rivaroxaban LEK-AM

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as 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 venous or arterial catheter (see section "Other medicines and Rivaroxaban LEK-AM"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach 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 or intestines or in the genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with bronchiectasis (enlarged bronchi filled with pus) or previous lung bleeding,
• 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 treatment should be changed,
• if the patient has 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 LEK-AM. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If the patient needs surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban LEK-AM before or after surgery,
• if during surgery a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
  • strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban LEK-AM,
  • immediately inform the doctor if, after completion of anaesthesia, the patient experiences symptoms such as numbness, weakness in the lower limbs, or disturbances in bowel or bladder function, as immediate treatment will be required.

Children and adolescents

Rivaroxaban LEK-AM 10 mg tablets are not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.

Rivaroxaban LEK-AM and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained 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-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 LEK-AM, as the effect of Rivaroxaban LEK-AM may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.

If your doctor believes you have an increased risk of developing a stomach 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,
  • rifampicin, an antibiotic.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Rivaroxaban LEK-AM, as the effect of Rivaroxaban LEK-AM may be reduced. The doctor will decide whether to use Rivaroxaban LEK-AM and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding

Do not take Rivaroxaban LEK-AM if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Rivaroxaban LEK-AM. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban LEK-AM 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 LEK-AM contains lactose and sodium.

If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take RIVAROXABAN LEK-AM

This medicine should always be taken as directed by the doctor. If in doubt, consult the 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 LEK-AM 10 mg tablet taken once daily.

• For the treatment of blood clots in the legs, 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 10 mg tablet once daily or one 20 mg tablet once daily.

Swallow the tablet whole, preferably with water.
Rivaroxaban LEK-AM may be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of administration of Rivaroxaban LEK-AM with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration.
If necessary, the doctor may administer crushed Rivaroxaban LEK-AM tablets via a gastric tube.

When to take Rivaroxaban LEK-AM
Take one tablet each day until the 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.
The doctor will decide how long treatment should continue.

To prevent blood clots in the legs after hip or knee replacement surgery:
The first tablet should be taken 6 to 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaroxaban LEK-AM
If a patient takes more than the recommended dose of Rivaroxaban LEK-AM, contact the doctor immediately. Taking too high a dose of Rivaroxaban LEK-AM increases the risk of bleeding.

Missing a dose of Rivaroxaban LEK-AM
If a patient forgets to take a dose, take the tablet as soon as remembered. 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 LEK-AM
Do not stop taking Rivaroxaban LEK-AM without first discussing it with the doctor, as this medicine helps prevent a serious condition.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Rivaroxaban LEK-AM may cause adverse reactions, although they do not occur in
everyone.
As with other medicines of similar action that reduce blood clot formation, Rivaroxaban LEK-AM
may cause bleeding, which potentially can be life-threatening. Excessive bleeding may lead to a sudden
drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following adverse reactions occur:

• Signs of bleeding:
  • Bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, 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 of the patient or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions You should inform your doctor immediately if the following adverse reactions occur:
  • 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 adverse reactions:
Common adverse reactions ( may occur in 1 out of 10 people )

• reduction in red blood cells which may cause pale skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) when coughing,
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the 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 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 adverse reactions ( may occur in 1 out of 100 people )

• bleeding into the brain or inside the skull (see bleeding signs 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,
• blood tests may show increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness in the mouth,
• urticaria,
• liver function disorders (may be observed in tests performed by a doctor).

Rare adverse reactions ( 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 as a complication of cardiac catheterization procedure, when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare adverse reactions ( may occur in 1 out of 10,000 people )

• accumulation of eosinophils, a type of white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia).

Adverse reactions with unknown frequency ( frequency cannot be estimated from the available data )

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis ( compartment syndrome following bleeding ).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
you should consult your doctor or pharmacist. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban LEK-AM

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 stated month.
There are no special storage instructions for this medicinal product.
Medicines must not be disposed of via the wastewater system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban LEK-AM contains

• The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulphate, magnesium stearate. See section 2 "Rivaroxaban LEK-AM contains lactose and sodium". Coating: hypromellose (type 2910), macrogol (type MW 3350), titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban LEK-AM looks like and contents of the pack
Rivaroxaban LEK-AM 10 mg coated tablets are pink, round, biconvex tablets.
The tablets are contained in blisters packed in cardboard boxes containing 10, 30 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
Ul. Ostrzykowizna 14 A
05-170 Zakroczym
Tel.: +48 22 785 27 60