Rivaroxaban stada

Poland
Brand name Rivaroxaban stada
Form capsules, hard
Active substance / Dosage
rivaroxaban · 20 mg
Prescription type Prescription only
ATC code
B01AF01
Registration number 100456448
Manufacturer Stada AG

Table of Contents

Package leaflet: Information for the user

Rivaroxaban STADA, 15 mg, hard capsules
Rivaroxaban STADA, 20 mg, hard capsules
Rivaroxabanum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

  • Keep this leaflet for future reference.
  • If you have any questions, please consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

  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 the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation;
  • treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the veins 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 blood clots and prevent the recurrence of blood clots in veins or in the blood vessels of 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. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Information before using Rivaroxaban STADA

When not to use 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 active bleeding
  • if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes)
  • if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter
  • 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 STADA and inform your doctor if the patient suspects that any of the above conditions apply.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rivaroxaban STADA.
When to be especially careful with Rivaroxaban STADA

  • if the patient has an increased risk of bleeding, such as:
    • severe kidney disease in adults or moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body
    • use of other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) during a switch in anticoagulant therapy or when heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Rivaroxaban STADA with other medicines")
    • blood clotting disorders
    • very high blood pressure that does not decrease despite medication
    • stomach or intestinal disorders that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (inflammation of the 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 heart valve prostheses
  • 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 blood clot from the lungs is planned.

If the patient suspects any of the above conditions, inform the doctor before taking Rivaroxaban STADA. The doctor will decide whether to use this medicine and whether the patient needs to be closely monitored.
If the patient needs surgery:

  • strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban STADA before or after surgery
  • if catheterisation or spinal puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
    • it is very important to take Rivaroxaban STADA at the exact times before and after the puncture or catheter removal, as directed by the doctor
    • inform the doctor immediately if, after the anaesthesia wears off, numbness or weakness in the legs, or bowel or bladder dysfunction occurs, as immediate treatment will be necessary.

Children and adolescents
Rivaroxaban STADA capsules are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Rivaroxaban STADA in children and adolescents for adult indications.
Rivaroxaban STADA with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, 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
    • 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-relieving 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, inform the doctor before taking Rivaroxaban STADA, as the effect of Rivaroxaban STADA may be increased. The doctor will decide whether to use this medicine and whether the patient needs to be closely monitored.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

  • If the patient is taking:
    • certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital)
    • St. John's wort (Hypericum perforatum), a herbal remedy used for depression
    • rifampicin, an antibiotic

If the patient suspects any of the above conditions, inform the 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 needs to be closely monitored.
Pregnancy and breastfeeding
Do not use Rivaroxaban STADA 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 STADA. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further treatment.
Driving and using machines
Rivaroxaban STADA may cause dizziness (common side effect) and 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 STADA contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Rivaroxaban STADA contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban STADA

Rivaroxaban STADA must always be taken exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Rivaroxaban STADA should be taken with food.
The capsule(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the entire capsule, they should discuss alternative methods of taking Rivaroxaban STADA with their doctor. The contents of the capsule may be mixed with water or soft food such as apple puree immediately before administration. A meal should be consumed promptly after taking this mixture. If necessary, a doctor may administer the dissolved contents of the Rivaroxaban STADA capsule through a gastric tube.

How many capsules to take

  • Adults
    o For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
    The recommended dose is one Rivaroxaban STADA 20 mg capsule once daily. If the patient has impaired kidney function, the dose may be reduced to one Rivaroxaban STADA 15 mg capsule once daily.

    If a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention, PCI) with stent placement is required, there is limited evidence supporting dose reduction to one Rivaroxaban STADA 15 mg capsule once daily (or one Rivaroxaban STADA 10 mg capsule once daily if kidney function is impaired), in combination with an antiplatelet medicine such as clopidogrel.

    o For treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots:
    The recommended dose is one Rivaroxaban STADA 15 mg capsule twice daily for the first 3 weeks.
    After 3 weeks of treatment, the recommended dose is one Rivaroxaban STADA 20 mg capsule once daily.
    After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either 10 mg of rivaroxaban once daily or one 20 mg capsule once daily.
    If the patient has impaired kidney function and is taking one Rivaroxaban STADA 20 mg capsule once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban STADA 15 mg capsule once daily, if the risk of bleeding is greater than the risk of further blood clots.

  • Children and adolescents
    The dose of Rivaroxaban STADA depends on body weight and will be calculated by the doctor.
    o Recommended dose for children and adolescents with a body weight of 30 kg to below 50 kg is one Rivaroxaban STADA 15 mg capsule once daily.
    o Recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban STADA 20 mg capsule once daily.
    Each dose of Rivaroxaban STADA should be taken with a meal and with a drink (e.g. water or juice). Capsules should be taken every day at approximately the same time. Consider setting an alarm as a reminder.
    For parents or caregivers: observe the child to ensure they have taken the full dose.

The dose of Rivaroxaban STADA depends on body weight, so it is important to attend scheduled appointments with the doctor, as dose adjustments may be needed due to weight changes.
Never adjust the dose independently. If necessary, the doctor will adjust the dose.
If a lower dose is required or if the patient is unable to swallow the entire capsule, an alternative formulation of rivaroxaban should be used, such as granules for oral suspension. For children and adolescents who cannot swallow whole capsules, rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the contents of the Rivaroxaban STADA capsule may be mixed with water or apple puree immediately before administration. A meal should be consumed after taking this mixture. If necessary, a doctor may also administer the capsule contents through a gastric tube.

If a dose is vomited or spat out

  • 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. Take the next dose at the usual time.

Contact a doctor if there are repeated episodes of vomiting or spitting out the dose after taking Rivaroxaban STADA.

When to take Rivaroxaban STADA
Take the capsule(s) every day until the doctor decides to stop treatment. It is best to take the capsule(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure called cardioversion is needed to restore normal heart rhythm, Rivaroxaban STADA should be taken as directed by the doctor.

Missed dose of Rivaroxaban STADA

  • Adults, children, and adolescents: If the patient takes one 20 mg capsule or one 15 mg capsule once daily and a dose is missed, take the capsule as soon as possible. Do not take more than one capsule in a single day to make up for the missed dose. Take the next capsule the following day, then continue taking one capsule once daily.
  • Adults: If the patient takes one 15 mg capsule twice daily and a dose is missed, take the capsule as soon as possible. Do not take more than two 15 mg capsules in a single day. If a dose was forgotten, the patient may take two 15 mg capsules at the same time to achieve a total of two capsules (30 mg) taken within one day. The next day, resume taking one 15 mg capsule twice daily.

Taking more than the recommended dose of Rivaroxaban STADA
If a patient takes more than the recommended dose of Rivaroxaban STADA, contact a doctor immediately. Taking too high a dose of Rivaroxaban STADA increases the risk of bleeding.

Stopping Rivaroxaban STADA
Do not stop taking Rivaroxaban STADA without first consulting a doctor, as Rivaroxaban STADA treats and prevents serious medical conditions.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduces blood clot formation, Rivaroxaban
STADA 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 side effects occur:

  • Signs of bleeding
    o Bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!)
    o Prolonged or excessive bleeding
    o Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina
    Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
  • Signs of severe skin reactions
    o Widespread, acute skin rash, formation of blisters or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
    o Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement.
    The frequency of these side effects is very rare (up to 1 in 10,000 people).
  • Signs of severe allergic reactions
    o 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 side effects in adults, children and adolescents:
Common (may occur in 1 out of 10 patients)

  • Decrease in red blood cells, which may cause paleness of the skin and lead to weakness or shortness of breath
  • Gastrointestinal bleeding or 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 conjunctiva)
  • Bleeding into tissues or body cavities (hematoma, bruising)
  • Presence of blood in sputum (hemoptysis) during coughing
  • Bleeding from the skin or subcutaneous bleeding
  • Bleeding after surgery
  • Oozing of blood or fluid from a 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 arterial blood pressure (symptoms may include dizziness or fainting upon standing)
  • Generalized weakness and fatigue, headache, dizziness
  • Rash, itching of the skin
  • Increased activity of certain liver enzymes, which may be seen in blood test results

Uncommon (may occur in 1 out of 100 patients)

  • 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, 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 1 out of 1,000 patients)

  • 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 area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm)

Very rare (may occur in 1 out of 10,000 people)

  • Accumulation of eosinophils, a type of granulocyte white blood cells, causing inflammation in the lungs (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 the urine, leading to impaired kidney function (anticoagulant-related nephropathy)
  • Increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents
Generally, side effects observed in children and adolescents treated with rivaroxaban were
similar in type to those observed in adults and were mainly mild to moderate in severity.
Side effects observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 patients)

  • Headache
  • Fever
  • Nosebleeds
  • Vomiting

Common (may occur in 1 out of 10 patients)

  • Rapid heartbeat
  • Blood test results may show increased bilirubin levels (a bile pigment)
  • Thrombocytopenia (low platelet count, blood cells that help in blood clotting)
  • Excessive menstrual bleeding

Uncommon (may occur in 1 out of 100 patients)

  • Blood test results may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment)

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of 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 the 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 stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
The dissolved contents of the capsule remain 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 STADA contains
The active substance is rivaroxaban.
Each hard capsule contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:

  • Capsule contents: pregelatinized starch (maize), monohydrate lactose, sodium carboxymethyl starch (type A), sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.
  • Capsule shell 15 mg: erythrosine (E 127), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
  • Capsule shell 20 mg: 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 blister packs containing 10, 14, 15, 28, 30, 42, 45, 56, 98 and 100 hard capsules in a cardboard carton.
Rivaroxaban STADA 20 mg are brown hard capsules filled with white or almost white powder.
Available in blister packs containing 10, 14, 15, 28, 30, 42, 56, 98 and 100 hard capsules in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Sweden: Rivaroxaban ALIUD
Czech Republic: Rivaroxaban STADA
Greece: Rivaroxaban/ STADA
Croatia: Rivaroksaban Stada
Hungary: Rivaroxaban STADA
Poland: Rivaroxaban STADA
Slovakia: Rivaroxaban STADA