Rivaroxaban Stada

Package Leaflet: Information for the User

Rivaroxaban STADA, 15 mg, hard capsules

Rivaroxaban STADA, 20 mg, hard capsules

Rivaroxabanum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Rivaroxaban STADA is and what it is 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 pack and other information

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

Rivaroxaban STADA contains the active substance rivaroxaban.
Rivaroxaban STADA is used in adults to

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heartbeat called atrial fibrillation not caused by heart valve problems
• treat blood clots in the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent new blood clots from forming in the blood vessels of the legs and/or lungs.

Rivaroxaban STADA is used in children and adolescents under 18 years of age and weighing 30 kg or more, to

• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban STADA contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban STADA

When not to take Rivaroxaban STADA

• 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 an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery)
• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery
• if you have liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban STADA, and inform your doctorif you think any of the above conditions apply to you.

Warnings and precautions

Before taking Rivaroxaban STADA, discuss this with your doctor or pharmacist.

When to be extra careful while taking Rivaroxaban STADA

• if you have 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 in the body o taking other medicines that prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) during switching of anticoagulant therapy or when heparin is given to maintain catheter patency in a vein or artery (see section "Rivaroxaban STADA and other medicines") o bleeding disorders o very high blood pressure that does not decrease with 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 gastroesophageal reflux disease (stomach acid flowing back into the esophagus) or tumors in the stomach, intestines, genital, or urinary system o vascular disease of the back of the eye (retinopathy) o lung disease where the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs
• in patients with artificial heart valves
• if you have a condition 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 your treatment
• if you have abnormal blood pressure or if a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, inform your doctor

before taking Rivaroxaban STADA. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding the intake of Rivaroxaban STADA at a specific time before or after surgery
• if you are to undergo a procedure where a catheter is inserted into an artery (e.g., for spinal or epidural anesthesia or pain relief): o it is very important to take Rivaroxaban STADA before and after the procedure or catheter removal at a specific time, as instructed by your doctor o you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder dysfunction, after the anesthesia has worn off, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban STADA capsules are not recommended for children under 30 kg.
There is limited data on the use of Rivaroxaban STADA in children and adolescents for the same indications as in adults.

Rivaroxaban STADA and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained 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 tablets (used to treat Cushing's syndrome, where 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 irregular heart rhythms o certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If you think any of the above conditions apply to you, inform

your doctorbefore taking Rivaroxaban STADA, as the effect of Rivaroxaban STADA may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor thinks you are at risk of developing stomach or intestinal ulcers, they may use a treatment to prevent ulcers.

• If you are taking: o certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital) o St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression o rifampicin, an antibiotic

If you think any of the above conditions apply to you, inform

your doctorbefore taking Rivaroxaban STADA, as the effect of Rivaroxaban STADA may be reduced. Your doctor will decide whether to use Rivaroxaban STADA and whether you should be closely monitored.

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 during treatment with Rivaroxaban STADA. If you become pregnant during treatment with 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 bicycle, or use tools or machines.

Rivaroxaban STADA contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Rivaroxaban STADA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially sodium-free.

3. How to take Rivaroxaban STADA

Always take Rivaroxaban STADA exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take Rivaroxaban STADA with food.
Swallow the capsule(s) whole, with water if possible.
If you have difficulty swallowing the capsule whole, 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 taking. After mixing, take the meal immediately. If necessary, your doctor may also give the contents of the capsule through a gastric tube.

How many capsules to take

• Adultso to prevent blood clots in the brain (stroke) and other blood vessels in the body The recommended dose is one 20 mg Rivaroxaban STADA capsule once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban STADA capsule once daily.

If you need a procedure to open up blocked blood vessels in the heart (called percutaneous coronary intervention, PCI, with stent placement), there is limited evidence to support a dose reduction to one 15 mg Rivaroxaban STADA capsule once daily (or one 10 mg Rivaroxaban STADA capsule once daily in case of kidney problems) in combination with an antiplatelet medicine such as clopidogrel.
o for the treatment of blood clots in the legs, blood clots in the lungs, and to prevent new blood clots The recommended dose is one 15 mg Rivaroxaban STADA capsule twice daily for the first 3 weeks.
After 3 weeks, the recommended dose is one 20 mg Rivaroxaban STADA capsule once daily.
After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with 10 mg rivaroxaban once daily or one 20 mg capsule once daily.
If you have kidney problems and are taking one 20 mg Rivaroxaban STADA capsule once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban STADA capsule once daily, if the risk of bleeding is higher than the risk of new blood clots.

• Children and adolescentsThe dose of Rivaroxaban STADA depends on body weight and will be calculated by your doctor. o The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one 15 mg Rivaroxaban STADA capsule once daily. o The recommended dose for children and adolescents with a body weight of 50 kg or moreis one 20 mg Rivaroxaban STADA capsule once daily. Each dose of Rivaroxaban STADA should be taken with food, with a drink (e.g., water or juice). Capsules should be taken daily at approximately the same time. It is a good idea to set an alarm reminder. For parents or caregivers: you should observe the child to ensure they take the full dose.

The dose of Rivaroxaban STADA is based on body weight, so it is important to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself. If necessary, your doctor will adjust the dose.
If a smaller dose is needed or if the patient is unable to swallow the capsule whole, a different form of rivaroxaban should be used, e.g., granules for oral suspension. For children and adolescents who are unable to swallow whole capsules, rivaroxaban granules for oral suspension should be used.
If the oral suspension is not available, the contents of the Rivaroxaban STADA capsule can be mixed with water or apple sauce immediately before taking. After mixing, take the meal immediately. If necessary, your doctor may also give the contents of the capsule through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban STADA, take a new dose.
• more than 30 minutes after taking Rivaroxaban STADA, do not take a new dose. In this case, take the next dose of Rivaroxaban STADA at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban STADA.

When to take Rivaroxaban STADA

Take the capsule(s) every day until your doctor decides to stop the treatment.
It is best to take the capsule(s) at the same time every day, as this will help you to remember to take them.
Your doctor will decide how long you should continue to take Rivaroxaban STADA.
To prevent blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, take Rivaroxaban STADA as instructed by your doctor.

Missed dose of Rivaroxaban STADA

• Adults, children, and adolescents: If you are taking one 20 mg or one 15 mg capsule oncedaily and you miss a dose, take it as soon as possible. Do not take more than one capsule in one day to make up for a missed dose. Take the next capsule the next day, and then continue taking one capsule once daily.
• Adults: If you are taking one 15 mg capsule twicedaily and you miss a dose, take it as soon as possible. Do not take more than two 15 mg capsules in one day. If you miss a dose, you can take two 15 mg capsules at the same time to get a total of two capsules (30 mg) in one day. The next day, continue taking one 15 mg capsule twice daily.

Taking more than the recommended dose of Rivaroxaban STADA

If you take more Rivaroxaban STADA than you should, contact your doctor immediately. Taking more Rivaroxaban STADA than recommended may increase the risk of bleeding.

Stopping Rivaroxaban STADA treatment

Do not stop taking Rivaroxaban STADA without first talking to your doctor, as Rivaroxaban STADA treats and prevents serious diseases.
If you have any further questions on the use of this medicine, ask 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 that prevent blood clots, Rivaroxaban STADA may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding may be obvious or external.

Seek immediate medical attention if you experience any of the following side effects:

• Signs of bleedingo bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical attention immediately!) o prolonged or excessive bleeding o unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina
• Signs of severe skin reactionso widespread, severe skin rash, blistering, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis) o drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of severe allergic reactionso swelling of the face, lips, mouth, tongue, or throat; hives; difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible side effects in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause paleness and be the reason for weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds
• bleeding into the eye (including bleeding into the white of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from the skin or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from the wound after surgery
• swelling of the limbs
• limb pain
• kidney problems (which can be seen in blood tests performed by your doctor)
• fever
• stomach pain, nausea, vomiting, diarrhea, constipation
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (fatigue), headache, dizziness
• rash, itching
• increased activity of certain liver enzymes, which can be seen in blood tests

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or skull (see above signs of bleeding)
• bleeding into a joint, causing pain and swelling
• low platelet count (thrombocytopenia)
• allergic reactions, including skin allergic reactions
• liver problems (which can be seen in blood tests performed by your doctor)
• blood test results may show increased levels of bilirubin, certain liver or pancreatic 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 flow obstruction), liver inflammation, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling,
• blood accumulation (hematoma) in the groin as a complication of cardiac 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 blood cell, which causes inflammation in the lungs (eosinophilic pneumonia)

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

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

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with rivaroxaban were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results may show increased levels of bilirubin
• low platelet count (thrombocytopenia)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased levels of direct bilirubin

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban STADA contains

The active substance is rivaroxaban.
One hard capsule contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:

• capsule contents: cornstarch, lactose monohydrate, sodium carboxymethylcellulose (type A), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.
• 15 mg capsule shell: erythrosine (E 127), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
• 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 contents of the pack

Rivaroxaban STADA 15 mg are orange-red hard capsules, filled with white or almost white powder.
Available in blisters containing 10, 14, 15, 28, 30, 42, 45, 56, 98, and 100 hard capsules in a carton.
Rivaroxaban STADA 20 mg are brown hard capsules, filled with white or almost white powder.
Available in blisters containing 10, 14, 15, 28, 30, 42, 56, 98, and 100 hard capsules in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further 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 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 package leaflet: