Rivaroxaban lek-am: detailed information

Package leaflet: Information for the user

Rivaroxaban LEK-AM, 15 mg, film-coated tablets
Rivaroxaban LEK-AM, 20 mg, film-coated tablets
Rivaroxabanum

Read the entire leaflet before taking this medicine, because it contains information important for the patient.

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

Leaflet contents:

What Rivaroxaban LEK-AM is and what it is used for
Important information before taking Rivaroxaban LEK-AM
How to take Rivaroxaban LEK-AM
Possible side effects
How to store Rivaroxaban LEK-AM
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.
Rivaroxaban LEK-AM is used in adults to:

prevent blood clots in the brain (stroke) and in other blood vessels in the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation.
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 veins of the legs and/or lungs.

Rivaroxaban LEK-AM is used in children and adolescents under 18 years of age and with body weight of 30 kg or more to:

treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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 to form blood clots.

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 organ condition leading to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or intracranial bleeding, recent surgery 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 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
the patient suspects any of the above circumstances apply.
Warnings and precautions
Before starting to take Rivaroxaban LEK-AM, discuss this with your doctor or
pharmacist.
When to exercise special caution with Rivaroxaban LEK-AM

if the patient has an increased risk of bleeding, such as in the following conditions:
- severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
- blood clotting disorders,
- taking other medicines that prevent blood clots (e.g. warfarin, edoxaban, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Other medicines and Rivaroxaban LEK-AM"),
- 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 oesophagitis (inflammation of the oesophagus), e.g. due to gastroesophageal reflux disease (acid reflux 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 (dilated bronchi filled with pus) 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 treatment adjustment is needed,
if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned.

If the patient suspects any of the above conditions apply, inform the
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 Rivaroxaban LEK-AM administration before or after surgery,
if catheterisation or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
it is very important to take Rivaroxaban LEK-AM before and after the puncture or catheter removal as directed by the doctor,
due to the need for special caution, immediately inform the doctor if symptoms such as numbness or weakness in the legs, or bowel or bladder dysfunction occur after the anaesthesia wears off.

Children and adolescents
Rivaroxaban LEK-AM tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban LEK-AM in children and adolescents for adult indications.
Rivaroxaban LEK-AM and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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,
- 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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, inform the
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 the doctor considers the patient to be at increased risk of developing gastric or duodenal ulceration, they may prescribe treatment to prevent peptic ulcer disease.

If the patient is taking
- certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
- St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
- rifampicin, an antibiotic.

If the patient suspects any of the above conditions apply, inform the
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 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 LEK-AM. If the patient becomes pregnant while taking Rivaroxaban LEK-AM, inform the doctor immediately so that they can decide on further treatment.
Driving and operating machinery
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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult 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 LEK-AM

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban LEK-AM 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 speak to their doctor about alternative ways of taking Rivaroxaban LEK-AM. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After taking this mixture, the patient should eat a meal promptly.
If necessary, a doctor may administer crushed Rivaroxaban LEK-AM tablets through 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 LEK-AM 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one Rivaroxaban LEK-AM 15 mg tablet once daily.
  
  If a patient requires a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban LEK-AM 15 mg tablet once daily (or one Rivaroxaban LEK-AM 10 mg tablet once daily in case of renal impairment), in combination with an antiplatelet medicine such as clopidogrel.
- For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots
  The recommended dose is one Rivaroxaban LEK-AM 15 mg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one Rivaroxaban LEK-AM 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 LEK-AM 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban LEK-AM 15 mg tablet once daily if the risk of bleeding is greater than the risk of developing further blood clots.
Children and adolescents

The dose of Rivaroxaban LEK-AM depends on body weight and will be calculated by the doctor.

The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kg is one Rivaroxaban LEK-AM 15 mg tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban LEK-AM 20 mg tablet once daily.

Each dose of Rivaroxaban LEK-AM should be taken with a meal and with a drink (e.g., water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: observe the child to ensure they have taken the full dose.
The dose of Rivaroxaban LEK-AM is based on body weight; therefore, it is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to changes in weight.
Never adjust the dose on your own. If needed, the doctor will adjust the dose.
Do not split the tablet. If a lower dose is required, use another formulation containing rivaroxaban (oral suspension granules). For children and adolescents who cannot swallow whole tablets, a rivaroxaban oral suspension granule formulation should be used.
If the oral suspension is not available, the Rivaroxaban LEK-AM tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, the patient should eat a meal. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

Within 30 minutes of taking Rivaroxaban LEK-AM, take a new dose.
More than 30 minutes after taking Rivaroxaban LEK-AM, do not take another dose. In this case, take the next dose at the usual time.

Contact your doctor if the patient repeatedly spits out doses or vomits after taking Rivaroxaban LEK-AM.

When to take Rivaroxaban LEK-AM
Take the tablet(s) every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your 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 LEK-AM should be taken as directed by your doctor.

Missed dose of Rivaroxaban LEK-AM

Adults, children and adolescents: If the 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 one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
Adults: If the 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 one day. If the patient forgets a dose, they 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 LEK-AM
If a patient takes too many Rivaroxaban LEK-AM tablets, they should contact their doctor immediately. Taking too high a dose of Rivaroxaban LEK-AM increases the risk of bleeding.

Stopping Rivaroxaban LEK-AM
Do not stop taking Rivaroxaban LEK-AM without first consulting your doctor, as Rivaroxaban LEK-AM treats and prevents serious medical conditions.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Rivaroxaban LEK-AM may cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar action of reducing blood clot formation, Rivaroxaban LEK-AM may cause bleeding, which potentially could 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. 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 of the patient or a change in treatment is necessary.
Signs of severe skin reactions
- widespread, acute skin rash, blistering or mucosal changes, e.g. on the tongue 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 (up to 1 in 10,000 people).
Signs of severe allergic reactions
- 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 in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

reduction in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including bleeding from the sclera),
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 surgical wound,
limb swelling,
limb pain,
kidney function disorders (may be observed in tests performed by a doctor),
fever,
stomach pain, indigestion, feeling of nausea or vomiting, constipation, diarrhea,
low arterial blood pressure (symptoms may include dizziness or fainting upon standing),
general decrease in strength and energy (weakness, fatigue), headache, dizziness,
rash, itching of the skin,
increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 out of 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 number of platelets, 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 bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
fainting,
malaise,
rapid heartbeat,
dry 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 as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

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

Frequency not known (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 inability of the kidneys to function properly (anticoagulant-associated 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).

Adverse reactions in children and adolescents
Generally, adverse reactions observed in children and adolescents treated with rivaroxaban 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 number of platelets, which are cells helping in blood clotting),
excessive menstrual bleeding.

Uncommon (may occur in 1 out of 100 people)

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

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, 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
Phone: +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 cardboard box and on each blister
after EXP:. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must 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 packaging and other information

What Rivaroxaban LEK-AM 15 mg, film-coated tablets contains

The active substance is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
Other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulfate, magnesium stearate. Coating: hypromellose (type 2910), titanium dioxide (E 171), macrogol (type MW400).

What Rivaroxaban LEK-AM 20 mg, film-coated tablets contains

The active substance is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
Other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulfate, magnesium stearate. Coating: hypromellose (type 2910), macrogol (type MW3350), iron oxide red (E 172), titanium dioxide (E 171).

What Rivaroxaban LEK-AM looks like and contents of the pack
Rivaroxaban LEK-AM 15 mg film-coated tablets are white, round, biconvex, with the number "15" engraved on one side.
The tablets are contained in blisters packed in cardboard boxes containing 14, 28, 98, or 100 film-coated tablets.
Rivaroxaban LEK-AM 20 mg film-coated tablets are red, round, biconvex, with the number "20" engraved on one side.
The tablets are contained in blisters packed in cardboard boxes containing 14, 28, 42, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
Ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60