Rivaroxaban Polpharma

Leaflet attached to the packaging: patient information

Rivaroxaban Polpharma 15 mg film-coated tablets

Rivaroxaban Polpharma 20 mg film-coated tablets

Treatment initiation packaging

Do not use in children.

Rivaroxabanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivaroxaban Polpharma and what is it used for
• 2. Important information before taking Rivaroxaban Polpharma
• 3. How to take Rivaroxaban Polpharma
• 4. Possible side effects
• 5. How to store Rivaroxaban Polpharma
• 6. Contents of the packaging and other information

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

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

• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Polpharma belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Polpharma

When not to take Rivaroxaban Polpharma:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of the body 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 you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding. Do not take Rivaroxaban Polpharma, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaroxaban Polpharma, discuss it with your doctor or pharmacist.

Be particularly careful when taking Rivaroxaban Polpharma:

• if you have an increased risk of bleeding, in such conditions as:
• severe kidney disease, 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 treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Polpharma and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g., due to reflux disease of the esophagus (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Polpharma. The doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you must follow your doctor's instructions regarding the intake of Rivaroxaban Polpharma at a strictly defined time before and after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Polpharma before and after the puncture or catheter removal, according to your doctor's instructions
• due to the need for special caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder disorders after anesthesia.

Children and adolescents

The treatment initiation packaging of Rivaroxaban Polpharma is not recommended for persons under 18 years of age, as it is specifically designed for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

Rivaroxaban Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.

• If you are taking: certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines used to treat bacterial infections (e.g., clarithromycin, erythromycin), certain antiviral medicines used to treat HIV 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 (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma may be enhanced. The doctor will decide whether to use this medicine and whether you should be under close observation.
If the doctor believes that you are at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment to prevent ulcers.

• If you are taking certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma may be reduced. The doctor will decide whether to use Rivaroxaban Polpharma and whether you should be under close observation.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Polpharma may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Polpharma contains lactose and sodium

If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Rivaroxaban Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rivaroxaban Polpharma should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Rivaroxaban Polpharma. The tablet can be crushed and mixed with water or apple sauce, just before taking it. After such a mixture, you should immediately eat a meal.
If necessary, your doctor may administer the crushed Rivaroxaban Polpharma tablet through a gastric tube.

How many tablets to take

The recommended dose is one Rivaroxaban Polpharma 15 mg tablet twice a day for the first 3 weeks.
For treatment after 3 weeks, the recommended dose is one Rivaroxaban Polpharma 20 mg tablet once a day.
The treatment initiation packaging of Rivaroxaban Polpharma 15 mg and Rivaroxaban Polpharma 20 mg is intended only for the first 4 weeks of treatment.
After taking the tablets from this packaging, treatment will be continued with Rivaroxaban Polpharma 20 mg once a day after consulting your doctor.
If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Polpharma 15 mg tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

When to take Rivaroxaban Polpharma

Take the tablet(s) every day until your doctor decides to stop the treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue the treatment.

Taking a higher dose of Rivaroxaban Polpharma than recommended

If you have taken a higher dose of Rivaroxaban Polpharma than recommended, contact your doctor immediately. Taking too much Rivaroxaban Polpharma increases the risk of bleeding.

Missing a dose of Rivaroxaban Polpharma

• If you are taking one 15 mg tablet twice a day and you miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice a day.
• If you are taking one 20 mg tablet once a day and you miss a dose, take it 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 next day, and then take one tablet once a day.

Stopping treatment with Rivaroxaban Polpharma

Do not stop taking Rivaroxaban Polpharma without first consulting your doctor, as Rivaroxaban Polpharma prevents the occurrence of a serious disease.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Rivaroxaban Polpharma can cause side effects, although not everybody gets them.
Like other medicines with a similar action that reduces blood clot formation, Rivaroxaban Polpharma may cause bleeding, which can potentially be life-threatening.
Bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
Tell your doctor immediatelyif 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, decreased level of consciousness, and stiffness of the neck. A serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; a 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 affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) while coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 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 platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• hematoma (blood accumulation) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm). Very rare(may affect up to 1 in 10,000 people)
• accumulation of eosinophils, a type of white granular blood cells, which cause inflammation in the lungs (eosinophilic pneumonia).

Frequency not known(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• increased pressure in the muscles of the legs and arms, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Polpharma contains

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

What Rivaroxaban Polpharma looks like and contents of the packaging

Rivaroxaban Polpharma 15 mg are pink, round, biconvex film-coated tablets, with the number "15" embossed on one side.
Rivaroxaban Polpharma 20 mg are reddish-brown, round, biconvex film-coated tablets, with the number "20" embossed on one side.
The treatment initiation packaging for the first 4 weeks of treatment: each packaging with 49 film-coated tablets for the first 4 weeks of treatment contains:
42 film-coated tablets of Rivaroxaban Polpharma 15 mg and 7 film-coated tablets of Rivaroxaban Polpharma 20 mg.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Farmaprojects S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain
Date of last revision of the leaflet:October 2023