Rivaroxaban polpharma

Package leaflet: Information for the patient

Rivaroxaban Polpharma 10 mg film-coated tablets
Rivaroxabanum
Please read all of 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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., peptic ulcer, trauma or bleeding into the brain, recent surgical procedure on the brain or eye),
• if the patient is taking other anticoagulant medicines (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 leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Rivaroxaban Polpharma must not be used, and the doctor must be informed if the patient suspects any of the above conditions.

Warnings and precautions
Before starting Rivaroxaban Polpharma, discuss this with your doctor or
pharmacist.
Special caution is required when using Rivaroxaban Polpharma:

• 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,
  • 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 catheter patency in a vein or artery (see section "Rivaroxaban Polpharma with other medicines"),
  • coagulation disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g., inflammatory bowel disease or gastritis, or oesophagitis (inflammation of the throat and oesophagus), e.g., due to gastro-oesophageal reflux disease (acid reflux 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 airways 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 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, they should 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 to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Polpharma before or after surgery,
• if catheterization 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 exactly as directed by the doctor,
  • due to the need for special caution, the doctor must be informed immediately if numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia ends.

Children and adolescents
Rivaroxaban Polpharma 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 Polpharma with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 medicines (e.g., naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat heart rhythm disorders, certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions, they should 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 medicine used for depression, or rifampicin, an antibiotic.

If the patient suspects any of the above conditions, they should 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, she should immediately inform her doctor, 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 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.
How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery:

The recommended dose is one tablet of Rivaroxaban Polpharma 10 mg taken once daily.

• For the treatment of blood clots in the leg veins, 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. Your doctor has prescribed Rivaroxaban Polpharma 10 mg once daily.

Swallow the tablet whole, preferably with water.
Rivaroxaban Polpharma may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other
ways of taking Rivaroxaban Polpharma. The tablet may be crushed and mixed with water
or apple puree immediately before administration. If necessary, your doctor may administer
crushed Rivaroxaban Polpharma tablets through a gastric tube.
When to take Rivaroxaban Polpharma
Take one tablet 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.
To prevent blood clots in the veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 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 Rivaroxaban Polpharma than prescribed
If you have taken more Rivaroxaban Polpharma than prescribed, contact your doctor immediately.
Taking too high a dose of Rivaroxaban Polpharma increases the risk of bleeding.
If you forget to take Rivaroxaban Polpharma
If you forget to take a dose, take the tablet as soon as you remember. 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 dose.
Stopping Rivaroxaban Polpharma treatment
Do not stop taking Rivaroxaban Polpharma without first consulting your doctor, as this medicine prevents serious illness.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side 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 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 side 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. 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, blistering 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 side effects is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions:
  • swelling of the face, lips, mouth, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 occur in up to 1 in 10 people)

• reduction in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
• 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) when coughing,
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a 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 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 observed in blood test results.

Uncommon (may occur in up to 1 in 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, the blood cells involved in 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,
• dryness of the mouth,
• urticaria.

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized swelling,
• collection of blood (hematoma) in the groin area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm). Very rare (may occur in up to 1 in 10,000 people)
• • accumulation of eosinophils, a type of white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia).

Frequency not known (frequency cannot be determined from available data)

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

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects 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 carton and blister pack. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
No special storage conditions are required for this medicine.
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 pack and other information

What Rivaroxaban Polpharma contains

• The active substance is rivaroxaban. Each coated tablet contains 10 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 (Opadry II Pink 33G34170): hypromellose, titanium dioxide (E 171), lactose monohydrate, polyethylene glycol 3350, triacetin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172).

What Rivaroxaban Polpharma looks like and contents of the pack
Rivaroxaban Polpharma 10 mg are pink, round, biconvex, film-coated tablets, embossed with the number "10" on one side.
The tablets are contained in transparent blisters packed in cardboard boxes, containing 5, 10, 28, 30, 98 or 100 film-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