Rivaroxaban polpharma

Package leaflet: Information for the patient

Rivaroxaban Polpharma 15 mg film-coated tablets
Rivaroxaban Polpharma 20 mg film-coated tablets
Starter pack
Not for use in children.
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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell 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

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 in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 is experiencing excessive 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, injury or bleeding into the brain, recent surgical procedure 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 catheter patency 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. Do not use Rivaroxaban Polpharma, and inform your doctor if you suspect any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Polpharma, discuss this 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, 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 and other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the stomach and intestines or oesophagitis (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 where the bronchi are dilated and 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 an 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 is scheduled for surgery or other treatment aimed at removing a pulmonary embolism. 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 Rivaroxaban Polpharma administration before and 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 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 numbness or weakness in the legs, or disturbances in bowel or bladder function occur after the anaesthesia wears off.

Children and adolescents
The starter pack of Rivaroxaban Polpharma is not recommended for patients under 18 years of age, as it is specifically designed for initiating treatment in adult patients and is not suitable for use in children and adolescents.

Rivaroxaban Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, 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 (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 for ulcer prevention.
• If the patient is taking certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital), St John's wort (Hypericum perforatum), an 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, inform the doctor immediately, who will decide on further management.

Driving and operating machinery
Rivaroxaban Polpharma may cause dizziness (common side effects) or 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 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, which essentially means it is "sodium-free".

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Rivaroxaban Polpharma should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If the patient has difficulty swallowing the whole tablet, discuss alternative methods of taking
Rivaroxaban Polpharma with your doctor. The tablet may be crushed and mixed with water
or apple puree immediately before administration. A meal should be taken immediately after
this mixture.
If necessary, your doctor may administer crushed Rivaroxaban Polpharma tablets via a
gastric tube.
How many tablets to take
The recommended dose is one 15 mg Rivaroxaban Polpharma tablet twice daily for the first
3 weeks.
For treatment after the first 3 weeks, the recommended dose is one 20 mg Rivaroxaban Polpharma tablet once daily.
The starter pack containing Rivaroxaban Polpharma 15 mg and Rivaroxaban Polpharma 20 mg
is intended only for the first 4 weeks of treatment.
After completing tablets from this pack, treatment will continue with Rivaroxaban
Polpharma 20 mg once daily, following consultation with your doctor.
If the patient has kidney problems, the doctor may decide to reduce the dose after 3 weeks of
treatment to one 15 mg Rivaroxaban Polpharma tablet once daily, if the risk of bleeding is
greater than the risk of developing further blood clots.
When to take Rivaroxaban Polpharma
The tablet(s) should be taken every day until the doctor decides to discontinue treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
Taking more than the recommended dose of Rivaroxaban Polpharma
If the patient has taken more than the recommended dose of Rivaroxaban Polpharma, contact
your doctor immediately. Taking too high a dose of Rivaroxaban Polpharma increases
the risk of bleeding.
Missed dose of Rivaroxaban Polpharma

• If the patient is taking one 15 mg tablet twice daily and a dose has been missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets within one 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, continue taking one 15 mg tablet twice daily.
• If the patient is taking one 20 mg tablet once daily and a dose has been 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, and then continue taking one tablet once daily.

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

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
As with 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). 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 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, 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 abnormalities and systemic involvement. The frequency of these adverse reactions is very rare (occurring in 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 reactions:
Common (may occur in up to 1 in 10 people)

• Decrease in red blood cells, which may cause pale 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 heavy menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including conjunctival hemorrhage),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) during coughing,
• Bleeding from the skin or subcutaneous bleeding,
• Postoperative bleeding,
• Oozing of blood or fluid from 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),
• Generalized weakness and lack of energy (fatigue, tiredness), headache, dizziness,
• Rash, skin itching,
• Increased activity of certain liver enzymes, which may be evident 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 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 (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,
• 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 up to 1 in 10,000 people)

• Eosinophilia, an accumulation of a type of white granulocytic 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 blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• Increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 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 carton and blister. 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. This 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 either 15 mg or 20 mg of rivaroxaban.
• Other ingredients 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, film-coated tablets,
with the number "15" engraved on one side.
Rivaroxaban Polpharma 20 mg are brown-red, round, biconvex, film-coated tablets,
with the number "20" engraved on one side.
Starting treatment pack for the first 4 weeks of therapy: each pack containing 49 film-coated tablets for the first 4 weeks of treatment includes:
42 film-coated tablets of Rivaroxaban Polpharma 15 mg and 7 film-coated tablets of Rivaroxaban Polpharma 20 mg.

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