Rivaroxaban polpharma: detailed information

Package leaflet: Information for the user

Rivaroxaban Polpharma, 15 mg, hard capsules
Rivaroxaban Polpharma, 20 mg, hard capsules
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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Rivaroxaban Polpharma is and what it is used for
What you need to know 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 a type of irregular heartbeat called non-valvular atrial fibrillation.
to 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 Polpharma is used in children and adolescents under 18 years of age and weighing 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 taking Rivaroxaban Polpharma

When not to take 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 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 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 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.

Rivaroxaban Polpharma must not be used, and the patient should inform their doctor if they suspect any of the above-mentioned circumstances apply.

Warnings and precautions

Before starting Rivaroxaban Polpharma, discuss this with your doctor or pharmacist.

When to exercise special caution when taking 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 clots (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"),
- bleeding disorders,
- very high blood pressure that does not decrease despite treatment with medication,
- diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the stomach and intestines or oesophagus (e.g. due to gastro-oesophageal reflux disease (acid reflux into the oesophagus) or tumours located in the stomach, intestines, reproductive or urinary system),
- disease of blood vessels at the back of the eye (retinopathy),
- lung disease where the 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 an increased risk of blood clots), the patient should inform their doctor, who will decide whether a change in treatment is needed,
if the patient has unstable blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions apply, they should inform their doctor before taking Rivaroxaban Polpharma. The doctor will decide whether to use this medicine and whether the patient needs particularly close monitoring.

If the patient needs surgery:

it is essential to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Polpharma before or after surgery,
if a lumbar puncture or placement of a spinal catheter is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):
- it is very important to take Rivaroxaban Polpharma before and after the puncture or removal of the catheter exactly as directed by the doctor and at the specified times,
- the patient should immediately inform the doctor if, after the anaesthesia ends, they experience numbness or weakness in the legs, or disturbances in bowel or bladder function, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Polpharma capsules are not recommended for children weighing less than 30 kg. There is insufficient data on the use of rivaroxaban in children and adolescents for the indications approved in adults.

Rivaroxaban Polpharma 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,
- 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 treatment of 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 (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions apply, they should inform their doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be enhanced. The doctor will decide whether to use this medicine and whether the patient needs particularly close monitoring.

If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, 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, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions apply, they should inform their doctor before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced. The doctor will decide whether to use Rivaroxaban Polpharma and whether the patient needs particularly close monitoring.

Pregnancy and breastfeeding

Do not take 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 Rivaroxaban Polpharma, they should inform their doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Polpharma 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 Polpharma contains lactose monohydrate 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 (23 mg) of sodium per capsule; this means the medicine is considered "sodium-free".

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Rivaroxaban Polpharma should be taken with food.
The capsule(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the entire capsule, they should discuss alternative
methods of taking Rivaroxaban Polpharma with their doctor. The contents of the capsule may be
mixed with water or apple puree immediately before administration. After taking this mixture,
a meal should be consumed promptly.
If necessary, a doctor may administer the dispensed contents of Rivaroxaban Polpharma capsules
via a gastric tube.

How many capsules to take
o Adults

For prevention of blood clots in the brain (stroke) and other blood vessels in the body
The recommended dose is one 20 mg Rivaroxaban Polpharma capsule once daily. If the patient has kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Polpharma capsule once daily.

If a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement) is required, there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Polpharma capsule once daily (or one 10 mg Rivaroxaban Polpharma capsule once daily in case of renal impairment), 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 15 mg Rivaroxaban Polpharma capsule twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one 20 mg Rivaroxaban Polpharma capsule once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily. If the patient has renal impairment and is taking one 20 mg Rivaroxaban Polpharma capsule once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Polpharma capsule once daily, if the risk of bleeding is greater than the risk of further blood clots.

o 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 from 30 kg to below 50 kg is one 15 mg Rivaroxaban Polpharma capsule once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Rivaroxaban Polpharma capsule once daily. Each dose of Rivaroxaban Polpharma should be taken with a meal, accompanied by a drink (e.g. water or juice). Capsules should be taken every day at approximately the same time. Setting an alarm as a reminder may be helpful. For parents or caregivers: observe the child to ensure they have taken the full dose.

The dose of Rivaroxaban Polpharma depends on body weight, so it is important to attend scheduled appointments with the doctor, as dose adjustments may be necessary due to changes in weight.
Never adjust the dose independently. If necessary, the doctor will adjust the dose.
Do not split the capsule contents to obtain a partial dose. If a lower dose is required, an alternative medicine containing rivaroxaban in the form of granules for oral suspension should be used.
For children and adolescents who are unable to swallow the entire capsule, a medicine containing rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the contents of the Rivaroxaban Polpharma capsule may be sprinkled and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, the doctor may also administer the dispensed capsule contents via a gastric tube.

If a dose is vomited or spit out

Within less than 30 minutes after 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 of Rivaroxaban Polpharma 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
The capsule(s) should be taken every day until the doctor decides to stop treatment.
It is best to take the capsule(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long the patient should continue treatment.
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 Polpharma should be taken as directed by the doctor.

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

Missing a dose of Rivaroxaban Polpharma

Adults, children and adolescents: If the patient takes one 20 mg capsule or one 15 mg capsule once daily and a dose is missed, take the capsule as soon as possible. Do not take more than one capsule in one day to make up for the missed dose. Take the next capsule the following day, then continue taking one capsule once daily.
Adults: If the patient takes one 15 mg capsule twice daily and a dose is missed, take the capsule as soon as possible. Do not take more than two 15 mg capsules in one day. If the patient forgets to take a dose, they may take two 15 mg capsules at the same time to achieve a total of two capsules (30 mg) taken within one day. The next day, continue taking one 15 mg capsule twice daily.

Stopping treatment with Rivaroxaban Polpharma
Do not stop taking Rivaroxaban Polpharma without first consulting your doctor, as Rivaroxaban Polpharma treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Polpharma 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.
Seek immediate medical advice if any of the following adverse reactions occur in an adult or child:

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, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. The 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 with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological and systemic disorders. The frequency of these adverse reactions is very rare (occurring in less than 1 in 10,000 patients).
Signs of severe allergic reactions:
- swelling of the face, lips, mouth, 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, occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema occur in less than 1 in 100 patients).

General list of possible adverse reactions in adults, children and adolescents
Common adverse reactions (occur in less than 1 in 10 patients)

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 white part of the eye),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
bleeding from the skin or under the skin,
bleeding after surgery,
oozing of blood or fluid from the surgical wound,
swelling of limbs,
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 seen in blood test results.

Uncommon adverse reactions (occur in less than 1 in 100 patients)

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, 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 levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
fainting,
malaise,
rapid heartbeat,
dry mouth,
urticaria.

Rare adverse reactions (occur in less than 1 in 1,000 patients)

bleeding into muscles,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
local swelling,
collection 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 adverse reactions (occur in less than 1 in 10,000 patients)

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

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

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

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban
Polpharma were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common adverse reactions (occur in more than 1 in 10 patients)

headache,
fever,
nosebleeds,
vomiting.

Common adverse reactions (occur in less than 1 in 10 patients)

rapid heartbeat,
blood tests may show increased levels of bilirubin (a bile pigment),
thrombocytopenia (low platelet count, blood cells that help in blood clotting),
excessive menstrual bleeding.

Uncommon adverse reactions (occur in less than 1 in 100 patients)

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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rivaroxaban Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
No special storage instructions apply for this medicine.
The capsule contents remain stable in water and 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Polpharma contains

The active substance is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
Other ingredients are: capsule contents: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose type 2910, magnesium stearate; capsule shell: gelatin, yellow iron oxide (E 172) (only in 15 mg capsules), red iron oxide (E 172); printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide, concentrated.

What Rivaroxaban Polpharma looks like and contents of the pack
Rivaroxaban Polpharma 15 mg: hard gelatin capsules with a yellow body and orange cap, printed with "15 mg", capsule size number 4; the capsule filling consists of white or almost white powder or slightly agglomerated masses.
The hard capsules are contained in blisters made of Aluminium/PVC/PVDC foil, packed in a cardboard box.
Rivaroxaban Polpharma 15 mg is available in packs containing 14, 28, 84 or 98 hard capsules.
Rivaroxaban Polpharma 20 mg consists of hard gelatin capsules with a red body and cap, printed with "20 mg" on the cap, capsule size number 3; the capsule filling consists of white or almost white powder or slightly agglomerated masses.
The hard capsules are contained in blisters made of Aluminium/PVC/PVDC foil, packed in a cardboard box.
Rivaroxaban Polpharma 20 mg is available in packs containing 14, 28, 84 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

This medicinal product is authorised in the European Economic Area under the following names:
BG: Ривароксабан Полфарма 15 mg твърди капсули, Ривароксабан Полфарма 20 mg твърди капсули
LV: Rivaroxaban Polpharma 15 mg cietās kapsulas, Rivaroxaban Polpharma 20 mg cietās kapsulas
LT: Rivaroxaban Polpharma 15 mg kietosios kapsulės, Rivaroxaban Polpharma 20 mg kietosios kapsulės
PL: Rivaroxaban Polpharma