Runaplax

Leaflet accompanying the packaging: patient information

Runaplax, 10 mg, film-coated tablets

Rivaroxaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, 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 their symptoms are the same.
If the patient experiences any side effects, including those 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. 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 veins after hip or knee replacement surgery. The doctor has prescribed this medicine to the patient because of an increased risk of blood clots after surgery.
• to 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 veins of the legs and/or lungs.

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 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, discuss it with a doctor or pharmacist.

During treatment with Runaplax, special care should be taken

• if the patient's risk of bleeding is increased, which may occur in situations such as:
• mild or moderate kidney disease, 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 section "Runaplax and other medicines");
• bleeding disorders;
• very high blood pressure, uncontrolled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or stomach or inflammation of the esophagus (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);
• pulmonary 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 condition 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 or other treatment to remove 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 the time strictly specified by the doctor.
• If catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or to relieve pain):
• it is very important to take Runaplax at the time specified by the doctor,
• 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 giveRunaplax to patients under 18 years of age. There is not enough information on its use in children and adolescents.

Runaplax and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans 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 noradrenaline reuptake inhibitors [SNRIs])

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

tell their doctorbefore taking Runaplax, as the effect of the medicine may be enhanced. The doctor will decide whether the patient should take Runaplax and whether close monitoring of their condition is necessary.
If the doctor considers that the patient is at increased risk of stomach or intestinal ulcers, they may also prescribe medicines to 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 the effect of the medicine may be reduced. The doctor will decide whether the patient should take Runaplax and whether close monitoring of their condition is necessary.

Pregnancy and breastfeeding

Do not take Runaplax if you are pregnant or breastfeeding. Women of childbearing age should use effective contraception while taking Runaplax. If the patient becomes pregnant during treatment, they should immediately inform their 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 the patient experiences such symptoms, they should not drive, ride a bike, or operate tools or machines.

Runaplax contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact 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

Take this medicine always as directed by your doctor. In case of doubt, consult a doctor or pharmacist.

How many tablets to take

• In the prevention of blood clots in the veins after hip or knee replacement surgery: the recommended dose is one tablet (10 mg) once a day.
• In the treatment of blood clots in the veins of the legs and in the blood vessels of the lungs, as well as in the prevention of recurrence of blood clots, after at least 6 months of treatment for blood clots, the recommended dose is one tablet of 10 mg taken once a day or one tablet of 20 mg taken once a day. The doctor has prescribed Runaplax 10 mg tablets to be taken once a day.

Swallow the tablet with a glass of water.
The medicine can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways of taking Runaplax. The tablet can be crushed, mixed with water or apple sauce, and taken immediately.
If necessary, the doctor may administer the crushed Runaplax tablet through a gastric tube.

When to take Runaplax

Take the tablets every day until the doctor recommends stopping the medicine.
It is best to take the tablet at the same time every day, as it is easier to remember.
The doctor decides on the duration of treatment.
Prevention of blood clots in the veins after hip or knee replacement surgery
The first tablet should be taken 6 to 10 hours after surgery.
Patient after major hip surgery usually takes the medicine for 5 weeks, and patients after major knee surgery for 2 weeks.

Taking a higher dose of Runaplax than recommended

If the patient has taken more tablets than recommended, they should immediately contact their doctor due to the increased risk of bleeding.

Missing a dose of Runaplax

If the patient has forgotten to take a tablet, they should take it as soon as possible after remembering. The next dose should be taken the next day at the usual time and the prescribed dosing should be continued.
Do not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with Runaplax

Do not stop taking Runaplax without consulting a doctor, as this medicine prevents the development of serious disorders.
In case of any further doubts about taking 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 similar medicines with a similar anticoagulant effect, 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.

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

• Signs of bleeding
• 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. Immediate medical help is required!),
• 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).
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The mentioned 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; difficulty swallowing; 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:
Common(may occur in less than 1 in 10 patients)

• decrease in red blood cell count, which may cause pallor, weakness, or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding 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 test results ordered by the doctor)
• fever
• stomach pain, indigestion, nausea or 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 some liver enzymes shown in blood tests

Uncommon(may occur in less than 1 in 100 patients)

• bleeding into the brain or inside the skull (see above signs of bleeding)
• bleeding into the joint causing pain and swelling
• thrombocytopenia (low platelet count - cells involved in the blood clotting process)
• allergic reactions, including skin allergic reactions
• liver function disorders (which may be indicated by test results ordered by the doctor)
• increased bilirubin levels, increased activity of some pancreatic or liver enzymes, or increased platelet count shown in blood tests
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may occur in less than 1 in 1,000 patients)

• bleeding into the muscles
• bile duct obstruction (reduced bile flow), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes) hepatitis, including liver cell damage
• local swelling
• blood accumulation (hematoma) in the groin as a complication of cardiac catheterization involving the insertion of a catheter into an artery in the leg (pseudoaneurysm)

Very rare(may occur in less than 1 in 10,000 patients)

• accumulation of eosinophils, a type of white granular 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)
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)

Reporting side effects

If side effects occur, including those not listed in this leaflet, 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 the medicine.

5. How to store Runaplax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and container after "EXP". The expiry date refers to the last day of the month.
No special precautions for storage.
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 pack and other information

What Runaplax contains

The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
The other ingredients are lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica CoatingOpadry Orange 04F530012: hypromellose, titanium dioxide (E 171), macrogol, talc, orange yellow FCF (E 110), lake, iron oxide red (E 172).

What Runaplax looks like and contents of the pack

The tablets are round, biconvex, peach-colored, with the marking '10' on one side.
The film-coated tablets are available in blisters of OPA/Aluminum/PVC/Aluminum foil or in transparent or matte blisters of PVC/PVDC/Aluminum foil, in a carton box.
Pack sizes: 10, 20, 28, 30, 42, 50, 98, 100 film-coated tablets
The film-coated tablets are available in single-dose blisters of OPA/Aluminum/PVC/Aluminum foil or in transparent or matte single-dose blisters of PVC/PVDC/Aluminum foil, in a carton box
Pack sizes: 5x1, 10x1, 14x1 film-coated tablets.
The film-coated 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

For more information about the 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:03/2024
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