Runaplax

Leaflet accompanying the packaging: patient information

Runaplax, 15 mg, film-coated tablets

Runaplax, 20 mg, film-coated tablets

Rivaroxaban

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Runaplax and what is it used for
• 2. Important information before taking Runaplax
• 3. How to take Runaplax
• 4. Possible side effects
• 5. How to store Runaplax
• 6. Package contents and other information

1. What is Runaplax and what is it used for

Runaplax contains the active substance rivaroxaban. The medicine is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients with a certain type of irregular heartbeat, called non-valvular atrial fibrillation;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the legs and/or lungs.

Runaplax is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

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

Runaplax belongs to a group of so-called anticoagulant medicines. 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 Runaplax

When not to take Runaplax

if the patient is allergic to rivaroxaban or to any of the other ingredients of this medicine (listed in section 6);
if the patient is bleeding profusely;
if the patient has a disease or disorder affecting any organ, which increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure in the brain or eyes);
if the patient is taking medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin); an exception is the period of changing anticoagulant treatment or the administration of heparin to maintain the patency of a vein or artery catheter;
if the patient has liver disease that increases the risk of bleeding;
if the patient is pregnant or breastfeeding.
If any of these situations apply to the patient, do not take Runaplax and consult a doctor.

Warnings and precautions

Before taking Runaplax, you should discuss it with your doctor or pharmacist.

While taking Runaplax, you should be particularly careful

• if the patient's risk of bleeding is increased, which may occur in situations such as: severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine working in the patient's body; taking other medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin) during the change of anticoagulant treatment or during the use of heparin to maintain the patency of a vein or artery catheter (see "Runaplax and other medicines"); bleeding disorders; very high blood pressure, uncontrolled by medication; stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines or stomach or esophageal inflammation (e.g. due to gastroesophageal reflux disease, in which acidic stomach juice flows back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system; disease of the blood vessels in the back of the eye (retinopathy); lung disease with bronchiectasis and filling with pus (bronchiectasis) or previous bleeding from the lungs;
• if the patient has a heart valve prosthesis;
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible changes to the treatment;
• if the doctor considers that the patient's blood pressure is unstable or if the doctor plans to perform surgery on the patient or other treatment aimed at removing a blood clot from the lungs.

If any of these situations apply to the patient, before taking Runaplax, consult a doctor. The doctor will decide whether the patient should take this medicine and whether close monitoring of their condition is necessary.

If the patient needs to undergo surgery

• It is very important to take Runaplax before and after surgery at a time strictly determined by the doctor.
• If, during surgery, catheterization or spinal puncture is planned (e.g. for epidural or spinal anesthesia or for pain relief):
• it is very important to strictly follow the doctor's recommendations regarding the intake of Runaplax at a specified time before or after lumbar puncture or catheter removal
• the doctor should be informed immediately if, after the anesthesia is completed, the patient experiences numbness or weakness of the legs or disorders of bowel or bladder function, as immediate treatment is then necessary.

Children and adolescents

It is not recommended to administerRunaplax to children with a body weight below 30 kg. There is not enough information on its use in children and adolescents for adult indications.

Runaplax 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 the patient is taking:

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

If any of the above cases apply to the patient, they should tell their

doctorbefore taking Runaplax, as it is possible to increase the effect of the medicine. The doctor will decide whether the patient should take Runaplax and whether close monitoring of their condition is necessary.
If, in the doctor's opinion, the patient is at increased risk of stomach or intestinal ulcers, they may also use medicines that prevent the development of ulcers.

If the patient is taking:

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

If any of the above cases apply to the patient, they should tell their

doctorbefore taking Runaplax, as it is possible to reduce the effect of the medicine.
The doctor will decide whether the patient should take Runaplax and whether close monitoring of their condition is necessary.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, she must not take Runaplax. Women of childbearing age should use effective contraception while taking Runaplax. If a patient becomes pregnant during treatment, she should immediately inform her doctor, who will decide on further treatment.

Driving and operating machinery

Runaplax may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If the patient experiences such symptoms, they should not drive vehicles, ride a bicycle, or operate tools or machines.

Runaplax contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Runaplax contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is considered "sodium-free".

Runaplax contains the dye orange yellow FCF, lake (E 110)

This dye may cause allergic reactions.

3. How to take Runaplax

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Runaplax should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, they should discuss other ways of taking Runaplax with their doctor. The tablet can be crushed, mixed with water or apple sauce, and taken immediately. Then, a meal should be eaten. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• The recommended dose is one 20 mg tablet once a day. In patients with kidney function disorders, the doctor may reduce the dose to one 15 mg tablet once a day.

If a procedure to widen blocked coronary arteries (so-called percutaneous coronary intervention with stent implantation) is necessary, limited data indicate a dose reduction to one 15 mg Runaplax tablet once a day (or in patients with impaired kidney function to 1 tablet of 10 mg Runaplax once a day), added to an antiplatelet agent, such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots The recommended dose is one 15 mg tablet twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet once a day. After completing at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet taken once a day or one 20 mg tablet taken once a day. In patients with kidney function disorders taking one 20 mg tablet once a day, the doctor may reduce the dose to one 15 mg tablet once a day after 3 weeks of treatment (if the risk of bleeding is greater than the risk of further blood clots).
• Children and adolescentsThe dose of Runaplax depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight from 30 kg to less than 50 kgis one 15 mg tabletonce a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one 25 mg tabletonce a day. Each dose of Runaplax should be taken with food, washed down with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It's a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they have taken the entire dose.

The dose of Runaplax depends on body weight, so it's essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose due to changes in body weight.
Never adjust the dose of Runaplax on your own.If necessary, the doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is necessary, another form of rivaroxaban should be used - an oral suspension granule. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension granule. If the oral suspension is not available, the Runaplax tablet can be crushed and mixed with water or apple sauce immediately before administration. After this mixture, a meal should be eaten. If necessary, the doctor may also administer the crushed tablet through a gastric tube.

In case of spitting out the dose or vomiting

• less than 30 minutes after taking Runaplax, a new dose should be taken.
• more than 30 minutes after taking Runaplax, a new dose should not be taken. In this case, the next dose of Runaplax should be taken at the usual time.

In case of repeated spitting out of the dose or vomiting after taking Runaplax, you should consult a doctor.

When to take Runaplax

The tablet(s) should be taken daily until the doctor recommends stopping the medicine. It's best to take the tablet(s) at the same time every day, as it's easier to remember.
The doctor decides on the duration of treatment.
Preventing the formation of blood clots in the brain (stroke) and in other blood vessels:
If the patient's heart rhythm needs to be restored to normal through a cardioversion procedure, Runaplax should be taken at the time recommended by the doctor.

Missing a dose of Runaplax

• Adults, children, and adolescents:
• -If the patient takes one 20 mg tablet or one 15 mg tablet once a day and misses a dose, they should take it as soon as they remember. Do not take more than one tablet on the same day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• Adults:
• -If the patient takes one 15 mg tablet twice a day and misses a dose, they should take it as soon as they remember. Do not take more than two 15 mg tablets in one day. If the patient forgets to take a dose, they may take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Runaplax

If the patient has taken too many Runaplax tablets, they should contact their doctor immediately.
Taking too much Runaplax increases the risk of bleeding.

Stopping Runaplax treatment

Do not stop taking Runaplax without consulting your doctor, as this medicine treats serious conditions and prevents their recurrence.
In case of any further doubts 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 everybody gets them.
Like other medicines with a similar anticoagulant effect, Runaplax can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may be invisible.
Tell your doctor immediately if you experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. Medical help should be sought immediately!),
• prolonged or excessive bleeding
• extreme weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris The doctor may decide to subject the patient to close monitoring or change their treatment.

Signs of a severe skin reaction:

• skin reactions, such as widespread, intense rash, blistering, or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). These side effects are very rare (less than 1 in 10,000 patients).

Signs of a severe allergic reaction

swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and not very common (angioedema and allergic edema may occur in less than 1 in 100 patients).
General list of possible side effects in adults, children, and adolescents:
Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor, 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 sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from the surgical wound
• swelling of the limbs
• limb pain
• kidney function disorders (which may be indicated by the results of tests ordered by the doctor)
• fever
• stomach pain, nausea, vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching
• increased activity of certain liver enzymes shown 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 the joint, causing pain and swelling
• thrombocytopenia (low platelet count - cells involved in blood clotting)
• allergic reactions, including skin allergic reactions
• liver function disorders (which may be indicated by the results of tests ordered by the doctor)
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count in blood tests
• fainting
• malaise
• dry mouth
• rapid heartbeat
• hives

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

• bleeding into the muscles
• bile stasis (reduced bile flow), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• formation of a blood collection (hematoma) in the groin as a complication of a heart catheterization procedure involving the insertion of a catheter 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 granulocytic blood cells, which cause inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(cannot be estimated from the available data):
renal failure after severe bleeding
bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs)
occurring after bleeding, increased pressure in the muscles of the legs and arms, causing pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding)

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with Runaplax were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)
headache
fever
nasal bleeding
vomiting
Common(may affect up to 1 in 10 people)
rapid heartbeat
blood test results may show increased bilirubin levels
thrombocytopenia (low platelet count - cells involved in blood clotting)
excessive menstrual bleeding
Uncommon(may affect up to 1 in 100 people):

• blood test results may show increased direct bilirubin levels.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 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 to gather more information on the safety of this medicine.

5. How to store Runaplax

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Runaplax contains

The active substance of Runaplax is rivaroxaban.
Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.

• The other ingredients are: lactose monohydrate, sodium lauryl sulfate, hypromellose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica CoatingRunaplax 15 mg Opadry Orange 04F530006: hypromellose, titanium dioxide (E 171), macrogol, orange yellow FCF (E 110), lake, iron oxide red (E 172). Runaplax 20 mg Opadry Orange 04F530010: hypromellose, titanium dioxide (E 171), macrogol, orange yellow FCF (E 110), lake, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172).

What Runaplax looks like and what the pack contains

Runaplax 15 mg
The tablets are round, light orange, biconvex, with the marking ‘15’ on one side.
Runaplax 20 mg
The tablets are round, orange, biconvex, with the marking ‘20’ on one side.
The tablets are available in blisters of OPA/Aluminum/PVC/Aluminum foil or in transparent or matte PVC/PVDC/Aluminum blisters, in a carton box.
Pack sizes: 10, 14, 20, 28, 30, 42, 50, 98, 100 film-coated tablets
The tablets are available in single-dose blisters of OPA/Aluminum/PVC/Aluminum foil or in transparent or matte single-dose PVC/PVDC/Aluminum blisters, in a carton box.
Pack sizes: 5x1, 10x1, 14x1 film-coated tablets.
The tablets are available in an HDPE container with a PP cap containing a desiccant (silica gel), with a child-resistant closure, in a carton box.
Pack sizes: 100 film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Importer
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
D-39179 Barleben, Germany