Rivaroxaban Stada

Leaflet attached to the packaging: information for the user

Rivaroxaban STADA, 15 mg, hard capsules

Rivaroxaban STADA, 20 mg, hard capsules

Starting treatment 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 doubts, consult a doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

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

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

2. Important information before taking Rivaroxaban STADA

When not to take Rivaroxaban STADA

• 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 the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes)
• if the patient is taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter
• if the patient has liver disease that leads to an increased risk of bleeding
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban STADA, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rivaroxaban STADA, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban STADA

• if the patient has an increased risk of bleeding, such as: o severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body o taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran, apixaban or heparin) during a change in anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban STADA and other medicines") o bleeding disorders o very high blood pressure that does not decrease despite treatment o 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 (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system o vascular disease of the back of the eye (retinopathy) o lung disease in which the airways 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 that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible changes in treatment
• if the patient has been diagnosed with abnormal blood pressure or a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban STADA. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• it is very important to follow the doctor's instructions regarding the intake of Rivaroxaban STADA at a strictly specified time before or after surgery
• if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief): o it is very important to take Rivaroxaban STADA before and after the puncture or catheter removal at a strictly specified time, in accordance with the doctor's instructions o the doctor should be informed immediately if, after the end of anesthesia, numbness or weakness of the legs, bowel or bladder disorders, or other symptoms occur, as immediate treatment may be necessary.

Children and adolescents

The starting treatment packaging of Rivaroxaban STADA hard capsules is not recommended
for children under 18 years of age, as it is specifically intended for the treatment of adult patients and is not suitable for use in children and adolescents.

Rivaroxaban STADA and other medicines

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

• If you are taking:

o certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin o ketoconazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol) o certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin) o certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir) o other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol) o anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid) o dronedarone, a medicine used to treat heart rhythm disorders o certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs))

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban STADA, as the effect of Rivaroxaban STADA may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.
If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use treatment to prevent ulcers.

• If you are taking:

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban STADA, as the effect of Rivaroxaban STADA may be reduced. The doctor will decide whether to use Rivaroxaban STADA and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

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

Driving and using machines

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

Rivaroxaban STADA contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Rivaroxaban STADA contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that the medicine is considered "sodium-free".

3. How to take Rivaroxaban STADA

Rivaroxaban STADA should always be taken according to the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
Rivaroxaban STADA should be taken with food.
The capsule(s) should be swallowed, preferably with water.
If you have difficulty swallowing the whole capsule, you should talk to your doctor about other ways to take Rivaroxaban STADA. The contents of the capsule can be mixed with water or soft food, such as apple sauce, immediately before intake. After such a mixture, the meal should be consumed immediately. If necessary, the doctor may administer the dissolved contents of the Rivaroxaban STADA capsule through a gastric tube.

How many capsules to take

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

When to take Rivaroxaban STADA

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

Taking a higher dose of Rivaroxaban STADA than recommended

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

Missing a dose of Rivaroxaban STADA

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

Stopping treatment with Rivaroxaban STADA

Do not stop taking Rivaroxaban STADA without first consulting your doctor, as Rivaroxaban STADA treats and prevents a serious disease.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban STADA can cause side effects, although not everybody gets them.
Like other medicines with a similar anticoagulant effect, Rivaroxaban STADA may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Inform your doctor immediately if you experience any of the following side effects:

• Signs of bleedingo 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!) o prolonged or excessive bleeding o unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina Lekarz może zadecydować o konieczności bardzo dokładnej obserwacji pacjenta lub zmianie sposobu leczenia.
• Signs of severe skin reactionso widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis) o drug reaction causing rash, fever, inflammation of internal organs, hematological 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 reactionso swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; 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)

• decrease in 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 from the 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 the 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 decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• increased activity of some 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 the doctor)
• blood test results may show increased bilirubin levels, activity of some 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 stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• hematoma (collection of blood) 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 granular white blood cell that causes 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 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 side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rivaroxaban STADA

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
The dissolved contents of the capsule 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 STADA contains

The active substance of the medicine is rivaroxaban.
Rivaroxaban STADA 15 mg hard capsules
One hard capsule contains 15 mg of rivaroxaban.
Rivaroxaban STADA 20 mg hard capsules
One hard capsule contains 20 mg of rivaroxaban.
The other ingredients are:

• Capsule contents: cornstarch, lactose monohydrate, sodium carboxymethylcellulose (type A), sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.
• 15 mg capsule shell: erythrosine (E 127), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
• 171), gelatin.
• 20 mg capsule shell: red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.

What Rivaroxaban STADA looks like and what the packaging contains

Rivaroxaban STADA 15 mg are orange-red hard capsules, filled with white or almost white powder.
Rivaroxaban STADA 20 mg are brown hard capsules, filled with white or almost white powder.
The starting treatment packaging for the first 4 weeks of treatment contains 49 hard capsules in blisters located in a carton consisting of:

• 42 hard capsules of 15 mg rivaroxaban
• 7 hard capsules of 20 mg rivaroxaban.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Manufacturer/Importer:

STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Sweden:
Rivaroxaban ALIUD
Czech Republic:
Greece:
Croatia:
Rivaroxaban STADA
Rivaroxaban/ STADA
Rivaroksaban Stada
Hungary:
Poland:
Slovakia:
Rivaroxaban STADA
Rivaroxaban STADA
Rivaroxaban STADA

Date of last revision of the leaflet: