Runaplax

Leaflet attached to the packaging: patient information

Runaplax, 2.5 mg, 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 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 packaging and other information

1. What is Runaplax and what is it used for

The patient has been given Runaplax because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Runaplax reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Runaplax will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Runaplax reduces the risk of blood clots (atherothrombotic events) in adults. Runaplax will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin.

In some cases, if the patient is taking Runaplax after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
Runaplax 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 thereby reduce 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 of any 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 the patient is taking medicines that prevent blood clotting (i.e. warfarin, dabigatran, apixaban or heparin); exception is the period of change of anticoagulant treatment or when heparin is used to maintain the patency of a catheter in a vein or artery (see section "Runaplax and other medicines");
if the patient has been diagnosed with acute coronary syndrome and has had bleeding or blood clots in the brain (stroke),
if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small arteries supplying blood to the tissues in the deep structures of the brain (sinus thrombosis) or if the patient has had a blood clot in the brain (ischemic stroke) in the last month,
if the patient has liver disease that increases the risk of bleeding;
if the patient is pregnant or breastfeeding.
Do not take Runaplax and consult a doctorif any of these situations apply to the patient.

Warnings and precautions

Before starting to take Runaplax, the patient should discuss it with their doctor or pharmacist.
Runaplax should not be taken in combination with other medicines that prevent blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel or ticlopidine.

While taking Runaplax, the patient should be particularly careful

• if the risk of bleeding is increased, which may occur in situations such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works 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 catheter in a vein or artery (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 of the bronchi with pus (bronchiectasis) or previous bleeding from the lungs;
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure
• 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 their doctor, who will decide on possible changes to the treatment.

If any of these situations apply to the patient, they should consult their doctorbefore taking Runaplax. 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 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 the patient experiences numbness or weakness of the legs or disturbances of bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

It is not recommended to giveRunaplax to patients under 18 years of age.There is not enough information about its use in children and adolescents.

Runaplax and other medicines

The patient should tell their doctor or pharmacist about all medicines they 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
• ketoconazole 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, prasugrel and ticagrelor - see section "Warnings and precautions")
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin)
• 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 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

Runaplax should not be taken if the woman is 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 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 coated tablet, which is considered "sodium-free".

Runaplax contains azo dyes: orange yellow FCF, lake (E 110) and tartrazine.

These dyes may cause allergic reactions.

3. How to take Runaplax

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

How many tablets to take

The recommended dose is one tablet (2.5 mg) twice a day. Runaplax should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). The medicine can be taken with or without food.
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.
If necessary, the doctor may administer the crushed tablet of Runaplax through a gastric tube.
Runaplax will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. If the patient is taking Runaplax after acute coronary syndrome, the doctor may also instruct them to take clopidogrel or ticlopidine.
If the patient is taking Runaplax after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.
The doctor will tell the patient how much to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Runaplax

Treatment with Runaplax after acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the earliest 24 hours after hospitalization and when parenteral (by injection) anticoagulant treatment would normally be discontinued. The doctor will tell the patient when to start treatment with Runaplax if they have been diagnosed with coronary artery disease or peripheral arterial disease. The doctor will decide how long to continue treatment.

Taking a higher dose of Runaplax than recommended

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

Missing a dose of Runaplax

The patient should not take a double dose to make up for a missed dose. If the patient misses a dose, they should take the next dose at the scheduled time.

Stopping treatment with Runaplax

Runaplax should be taken regularly and for the time specified by the doctor.
The patient should not stop taking Runaplax without first consulting their doctor.
If the patient stops taking this medicine, the risk of another heart attack, stroke or death due to heart or blood vessel disease may increase.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Runaplax can cause side effects, although not everybody gets them.
Like other similar medicines with a similar action of reducing 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.

The patient should immediately inform their doctor if they 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. A serious medical emergency. Immediate medical attention is required!),
• prolonged or excessive bleeding
• extreme weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. The doctor may decide to subject the patient to close monitoring or change their treatment.
• Signs of severe skin reactions
• 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 reactions causing rash, fever, inflammation of internal organs, hematological 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; 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, gum bleeding
• 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 the results of tests 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 certain liver enzymes shown in blood tests

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

• 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 the blood clotting process)
• 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 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 flow obstruction (decreased 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 that 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 the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

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, blister and container after "EXP". The expiry date refers to the last day of the month.
No special instructions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Runaplax contains

The active substance of Runaplax is rivaroxaban. Each coated tablet contains 2.5 mg of rivaroxaban.
The other ingredients are lactose monohydrate, sodium lauryl sulfate, hypromellose (type 2910), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica
Opadry Yellow 04F520016 coating:hypromellose (type 2910), macrogol 3350, titanium dioxide (E 171), tartrazine (E 102), lake, indigo carmine (E 132), lake, orange yellow (E 110), lake.

What Runaplax looks like and what the pack contains

The tablets are round, biconvex, yellow, with the marking '2.5' on one side, 6 mm in diameter.
The coated tablets are available in transparent or matte PVC/PVDC/Aluminum blisters in a carton box
Pack sizes: 28 or 56 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
Sachsen-Anhalt, Barleben
39179
Germany

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. +48 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Runaplax
Estonia
Runaplax
Lithuania
Runaplax 2.5 mg film-coated tablets
Latvia
Runaplax 2.5 mg coated tablets
Poland
Runaplax
Slovenia
Runaplax 2.5 mg film-coated tablets
Date of last revision of the leaflet:03/2024
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