Rivaroxaban polpharma: detailed information

Package leaflet: Information for the patient

Rivaroxaban Polpharma 15 mg coated tablets
Rivaroxaban Polpharma 20 mg coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine because 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 them even if their symptoms are the same.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Rivaroxaban Polpharma is and what it is used for
Important information before taking Rivaroxaban Polpharma
How to take Rivaroxaban Polpharma
Possible side effects
How to store Rivaroxaban Polpharma
Contents of the pack and other information

1. What Rivaroxaban Polpharma is and what it is used for

Rivaroxaban Polpharma contains the active substance rivaroxaban.
Rivaroxaban Polpharma is used in adults:

to prevent blood clots in the brain (stroke) and in other blood vessels of the body in patients who have an irregular heart rhythm called non-valvular atrial fibrillation;
to treat blood clots in the deep 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 and/or lungs. Rivaroxaban Polpharma 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 to 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 Polpharma 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 using Rivaroxaban Polpharma

When not to use Rivaroxaban Polpharma:

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., gastric 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 liver disease that leads to an increased risk of bleeding,
if the patient is pregnant or breastfeeding. Do not use Rivaroxaban Polpharma, and inform your doctor if you suspect any of the above conditions apply.

Warnings and precautions
Before starting Rivaroxaban Polpharma, discuss it with your doctor or pharmacist.
Exercise special caution when using Rivaroxaban Polpharma:

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, as kidney function may affect the amount of medicine acting in the patient’s body,
- taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section “Rivaroxaban Polpharma with other medicines”),
- blood clotting disorders,
- very high blood pressure that does not decrease despite treatment with medicines,
- diseases of the stomach or intestines that may cause bleeding, e.g., inflammation of the intestines and stomach or oesophagus (throat and oesophagus), e.g., due to gastro-oesophageal reflux disease (acid reflux from the stomach into the oesophagus), or tumours located in the stomach, intestines, genital or urinary system,
- blood vessel disease in the back of the eye (retinopathy),
- lung disease with dilated bronchi filled with pus (bronchiectasis) 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 a change in treatment is necessary,
if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary embolism is planned. If the patient suspects any of the above conditions apply, inform the doctor before using Rivaroxaban Polpharma. 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 when to take Rivaroxaban Polpharma before and 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 Polpharma before and after the puncture or catheter removal exactly as directed by the doctor,
due to the need for special caution, immediately inform the doctor if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
Rivaroxaban Polpharma tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban Polpharma in children and adolescents for adult indications.

Rivaroxaban Polpharma with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use, 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, oral ketoconazole (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 medicines (e.g., naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, inform the doctor before using Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma 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 stomach or intestinal ulcers, they may prescribe preventive treatment.

If the patient is taking: certain antiepileptic medicines (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 the patient suspects any of the above conditions apply, inform the doctor before using Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. The doctor will decide whether to use Rivaroxaban Polpharma and whether the patient requires particularly close monitoring.

Pregnancy and breastfeeding
Do not use Rivaroxaban Polpharma 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 Polpharma. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.

Driving and operating machinery
Rivaroxaban Polpharma may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 “Possible side effects”). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.

Rivaroxaban Polpharma contains lactose and sodium
If the patient has previously been diagnosed with an 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 it is essentially “sodium-free”.

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban Polpharma 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 discuss alternative methods of taking Rivaroxaban Polpharma with their doctor. The tablet may be crushed and mixed with water or apple purée immediately before administration. After taking this mixture, the patient should promptly eat a meal.
If necessary, a doctor may administer crushed Rivaroxaban Polpharma tablets via 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 Polpharma 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one Rivaroxaban Polpharma 15 mg tablet once daily. If the patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Polpharma 15 mg tablet once daily (or one Rivaroxaban Polpharma 10 mg tablet once daily if renal impairment is present), in combination with an antiplatelet medicine such as clopidogrel.
- For treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban Polpharma 15 mg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one Rivaroxaban Polpharma 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 Polpharma 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Polpharma 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.
Children and adolescents The dose of Rivaroxaban Polpharma 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 below 50 kg is one Rivaroxaban Polpharma 15 mg tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Polpharma 20 mg tablet once daily.

Each dose of Rivaroxaban Polpharma 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 Polpharma is based on body weight, so it is important to attend scheduled doctor appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose of Rivaroxaban Polpharma on your own. If necessary, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, other formulations such as granules for oral suspension should be used.
For children and adolescents who are unable to swallow whole tablets, alternative formulations such as granules for oral suspension should be used.
If oral suspension is not available, the Rivaroxaban Polpharma tablet may be crushed and mixed with water or apple purée immediately before administration. After taking this mixture, a meal should be consumed. 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 Polpharma, take a new dose.
More than 30 minutes after taking Rivaroxaban Polpharma, do not take a new dose. In this case, take the next dose at the usual time.

Contact your doctor if repeated vomiting or spitting out of the dose occurs after taking Rivaroxaban Polpharma.

When to take Rivaroxaban Polpharma
Take the tablet(s) 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.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure (cardioversion) is required to restore normal heart rhythm, take the tablet(s) at the time recommended by your doctor.

Missed dose of Rivaroxaban Polpharma

Adults, children, 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 a single 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 a single day. If the patient forgot to take 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, resume taking one 15 mg tablet twice daily.

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

Stopping Rivaroxaban Polpharma
Do not stop taking Rivaroxaban Polpharma without first consulting your doctor, as this medicine helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Like other medicines with a similar mechanism of action that reduce blood clot formation,
Rivaroxaban Polpharma may cause bleeding, which potentially could be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Bleeding may not always
present with obvious or visible signs.
Contact your doctor immediately if any of the following adverse effects occur:

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 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. on the tongue 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 adverse effects is very rare (up to 1 in 10,000 people).
Signs of severe allergic reactions
- swelling of the face, lips, oral cavity, 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 effects in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

decrease 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, bleeding gums,
bleeding into the eye (including bleeding from the sclera),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
bleeding from the skin or under the skin,
postoperative bleeding,
oozing of blood or fluid from the surgical wound,
limb swelling,
limb pain,
kidney function disorders (may be observed in tests performed by the doctor),
fever,
stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
low 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 signs of bleeding above),
bleeding into a joint causing pain and swelling,
thrombocytopenia (low platelet count, platelets being blood cells involved in clotting),
allergic reactions, including allergic skin reactions,
liver function disorders (may be observed in tests performed by the doctor),
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.

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),
local swelling,
blood collection (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 (may occur in 1 out of 10,000 people)
accumulation of eosinophils, a type of granulocyte white blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from 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 (drug-induced nephropathy associated with anticoagulant medicines),
increased pressure within the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse effects in children and adolescents
In general, adverse effects 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 effects 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 platelet count, platelets being cells that help 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Polpharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and that following the abbreviation Lot/LOT indicates the batch number.
No special storage instructions apply.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
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 Polpharma contains

The active substance is rivaroxaban. Each coated tablet contains 15 mg or 20 mg of rivaroxaban.
Other components are: tablet core: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. See section 2 "Rivaroxaban Polpharma contains lactose and sodium".
Coating of the 15 mg tablet (Opadry II Pink 33G240024): hypromellose, titanium dioxide (E 171), monohydrate lactose, polyethylene glycol 3350, triacetin, red iron oxide (E 172), black iron oxide (E 172);
Coating of the 20 mg tablet (Opadry II Red 33G250007): hypromellose, titanium dioxide (E 171), monohydrate lactose, polyethylene glycol 3350, triacetin, red iron oxide (E 172), yellow iron oxide (E 172).

What Rivaroxaban Polpharma looks like and contents of the pack
Rivaroxaban Polpharma 15 mg are pink, round, biconvex coated tablets,
with the number "15" engraved on one side.
The tablets are contained in transparent blisters packed in cardboard boxes, containing
10, 14, 28, 42, 98 or 100 coated tablets.
Rivaroxaban Polpharma 20 mg are brownish-red, round, biconvex coated tablets,
with the number "20" engraved on one side.
The tablets are contained in transparent blisters packed in cardboard boxes, containing
10, 14, 28, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

Manufacturer
FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 and 15
08028 Barcelona, Spain