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 this leaflet carefully before taking this medicine, as it contains important information for you.

You should keep this leaflet, so you can read it again later if you need to. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, please inform your 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. Contents of the pack 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 weighing 30 kg or more to:

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

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 you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6);

if you have severe bleeding;

if you have a disease or disorder affecting an organ that 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 you are 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 you have liver disease that increases the risk of bleeding;

if you are pregnant or breastfeeding.

If any of these situations apply to you, do not take Runaplax and consult your 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 your 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, intestines, genital, or urinary system; disease of the blood vessels in the back of the eyeballs (retinopathy); lung disease with bronchiectasis and filling with pus (bronchiectasis) or previous bleeding from the lungs;
• if you have a heart valve prosthesis;
• if you have a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide on possible changes to your treatment;
• if your doctor has determined that your blood pressure is unstable or if you are scheduled to undergo surgery or other treatment to remove a blood clot from the lungs.

If any of these situations apply to you, before taking Runaplax, you should consult your doctor. Your doctor will decide whether you should take this medicine and whether close monitoring of your condition is necessary.

If you need to have surgery

• It is very important to take Runaplax before and after surgery at a time specified by your doctor.
• If catheterization or spinal puncture is planned during surgery (e.g., for spinal anesthesia or to relieve pain):
• it is very important to strictly follow your doctor's instructions regarding the intake of Runaplax at a specified time before or after spinal puncture or catheter removal
• you should immediately inform your doctor if you experience numbness or weakness in your legs or problems with bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Runaplax is not recommended for children under 30 kg. There is not enough information on its use in children and adolescents for adult indications.

Runaplax and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

If you are taking:

• certain medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole 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 applies to you

you should tell your doctorbefore taking Runaplax, as it may increase the effect of the medicine. Your doctor will decide whether you should take Runaplax and whether close monitoring of your condition is necessary. If your doctor believes that you have an increased risk of stomach or intestinal ulcers, they may also prescribe medicines to prevent the development of ulcers.

If you are 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 applies to you

you should tell your doctorbefore taking Runaplax, as it may reduce the effect of the medicine. Your doctor will decide whether you should take Runaplax and whether close monitoring of your condition is necessary.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, you should not take Runaplax. Women of childbearing age should use effective contraception while taking Runaplax. If you become pregnant during treatment, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Runaplax may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If you experience such symptoms, you should not drive, ride a bike, or operate tools or machines.

Runaplax contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your 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 colorant Sunset Yellow FCF (E 110)

This colorant may cause allergic reactions.

3. How to take Runaplax

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist. Runaplax should be taken with food. The tablet(s) should be swallowed, preferably with water. If you have difficulty swallowing the tablet whole, you should discuss this with your doctor, who may recommend alternative ways of taking Runaplax. The tablet can be crushed, mixed with water or apple sauce, and taken immediately. Then, you should eat a meal. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and in other blood vessels, the recommended dose is one 20 mg tablet once daily. In patients with kidney function disorders, your doctor may reduce the dose to one 15 mg tablet once daily.

If a procedure to widen blocked arteries supplying the heart (so-called percutaneous coronary intervention with stent implantation) is necessary, limited data suggest a dose reduction to one 15 mg Runaplax tablet once daily (or to one 10 mg Runaplax tablet once daily in patients with impaired kidney function), in addition to an antiplatelet medicine, such as clopidogrel.

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

The dose of Runaplax is based on body weight, so it is essential to attend scheduled doctor's appointments, as it may be necessary to adjust the dose based on changes in body weight. Never adjust the dose of Runaplax yourself. If necessary, your doctor will adjust the dose. Do not split the tablet to get a partial dose. If a smaller dose is necessary, you should use a different form of rivaroxaban - an oral suspension. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of an oral suspension. If the oral suspension is not available, you can crush the Runaplax tablet and mix it with water or apple sauce immediately before taking it. Then, you should eat a meal. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If you spit out the dose or vomit

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

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Runaplax.

When to take Runaplax

The tablet(s) should be taken daily until your doctor advises you to stop taking the medicine. It is best to take the tablet(s) at the same time every day, as this will help you remember. Your doctor will decide on the duration of treatment. Prevention of blood clot formation in the brain (stroke) and in other blood vessels: If your heart rhythm needs to be restored to normal through a procedure called cardioversion, you should take Runaplax at the time specified by your doctor.

Missing a dose of Runaplax

• Adults, children, and adolescents:
• - If you take one 20 mg or one 15 mg tablet once daily and miss a dose, you should take it as soon as you remember. Do not take more than one tablet on the same day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once daily.
• Adults:
• - If you take one 15 mg tablet twice daily and miss a dose, you should take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can 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, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Runaplax

If you take too many Runaplax tablets, you should immediately contact your doctor. Taking too much Runaplax increases the risk of bleeding.

Stopping treatment with Runaplax

You should not stop taking Runaplax without consulting your doctor, as this medicine treats serious conditions and prevents their recurrence. If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Runaplax can cause side effects, although not everybody gets them. As with other medicines of this type that reduce blood clot formation, Runaplax may 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. You should immediately inform your doctor 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. You should immediately seek medical help!),
• prolonged or excessive bleeding
• extreme weakness, fatigue, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina pectoris Your doctor may decide to closely monitor you or change your treatment.

Signs of severe skin reactions:

• skin reactions, such as widespread, intense rash, blistering, or changes in mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• drug reactions 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 severe allergic reactions

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 uncommon (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)

• reduced red blood cell count, which may cause paleness, 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)
• 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 test results ordered by your doctor)
• fever
• stomach pain, nausea, vomiting, constipation, diarrhea
• low blood pressure (which may cause 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 test results ordered by your doctor)
• increased bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count shown 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 flow disorders (reduced bile flow), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• blood accumulation (hematoma) in the groin as a complication of heart catheterization 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 that cause inflammation in the lungs (eosinophilic pneumonia)

Frequency not known(cannot be estimated from 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, 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
• nosebleeds
• vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood test results showing 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 showing increased direct bilirubin levels

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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. By reporting side effects, you can help provide 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 stated. 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. Contents of the pack 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, Sunset Yellow FCF (E 110), lake, iron oxide red (E 172). Runaplax 20 mg Opadry Orange 04F530010: hypromellose, titanium dioxide (E 171), macrogol, Sunset 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 contents of the pack

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 or in transparent or matte PVC/PVDC/Aluminum blisters, in a carton box.

Package 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 or in transparent or matte single-dose PVC/PVDC/Aluminum blisters, in a carton box.

Package 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.

Package 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

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warszawa

tel. +48 22 209 70 00

Date of last revision of the leaflet:02/2025

Sandoz logo