Runaplax

Package leaflet: Information for the patient

Runaplax, 2.5 mg, film-coated tablets
Rivaroxabanum
Read the entire leaflet before starting treatment, as it contains important information for the patient.
Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:

1. What Runaplax is and what it is 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 Runaplax is and what it is used for

You have been prescribed Runaplax because

• you have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of cardiac biomarkers have been confirmed. Runaplax reduces the risk of subsequent heart attack or the risk of cardiovascular death in adults. Runaplax will not be given to you as a single treatment. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.

or

• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease causing symptoms. Runaplax reduces the risk of blood clots (atherosclerotic thrombotic events) in adults. Runaplax will not be given to you as a single treatment. Your doctor will also prescribe you to take acetylsalicylic acid.

In certain cases, if you are receiving Runaplax after a procedure to unblock a narrowed or blocked artery in the lower limb to restore blood flow, your doctor may also prescribe clopidogrel to be taken in addition to acetylsalicylic acid for a short period.
Runaplax 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 to form blood clots.

2. Important information before using Runaplax

When not to use 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 heavily;
if the patient has a disease or condition affecting any organ that increases the risk of
serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent
surgery within the brain or eye);
if the patient is taking anticoagulant medicines (i.e. warfarin, dabigatran, apixaban,
or heparin); the exception is during transition between anticoagulant treatments or when
administering heparin to maintain catheter patency in a vein or artery;
if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously experienced brain bleeding (stroke) or occlusion of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had an ischemic non-lacunar stroke within the past 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 doctor if any of these situations apply to
the patient.

Warnings and precautions
Discuss use of Runaplax with your doctor or pharmacist before starting treatment.
Runaplax should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
Special caution is required while taking Runaplax

• if the patient has an increased risk of bleeding, which may occur in situations such as:
• severe kidney disease, as kidney function may affect the amount of active drug in the patient’s body;
• taking other anticoagulant medicines (i.e. warfarin, dabigatran, apixaban or heparin) during transition between anticoagulant therapies or when using heparin to maintain catheter patency in a vein or artery (see section “Runaplax with other medicines”);
• coagulation disorders;
• very high blood pressure not controlled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. gastrointestinal inflammation or ulcers, oesophagitis (e.g. due to gastroesophageal reflux disease, in which acidic stomach fluid flows back into the oesophagus), or tumours in the stomach, intestines, genital or urinary tract;
• retinal vascular disease (retinopathy);
• lung disease with bronchiectasis and pus-filled airways (bronchiectasis) or previous pulmonary haemorrhage;
• if the patient is over 75 years of age,
• 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 condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

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

If the patient needs surgery

• It is very important to take Runaplax exactly as scheduled by the doctor before and after surgery.
• If spinal catheterization or puncture (e.g. for epidural or spinal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Runaplax exactly as directed by the doctor,
• immediately inform the doctor if, after anaesthesia, the patient experiences numbness or weakness in the legs or problems with bowel or bladder control, as immediate treatment may be necessary.

Children and adolescents
Runaplax is not recommended for patients under 18 years of age. There is
insufficient information on its use in children and adolescents.

Runaplax with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, and any medicines planned for use, including over-the-counter medicines.

If the patient is taking:

• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin;
• oral ketoconazole (used in treatment of Cushing’s syndrome when the body produces too much cortisol);
• certain antibiotics (e.g. clarithromycin, erythromycin);
• certain antiviral medicines for HIV/AIDS (e.g. ritonavir);
• other anticoagulant medicines (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 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 any of the above apply, inform the doctor before 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 is required.
If the doctor considers the patient to be at increased risk of stomach or intestinal ulcers, they may also prescribe medicines 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 any of the above apply, inform the doctor before 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 is required.

Pregnancy and breastfeeding
Do not use Runaplax if the woman is pregnant or breastfeeding. Women of childbearing potential should use effective contraception while taking Runaplax. If a woman becomes pregnant during treatment, she should immediately inform the doctor, who will decide on further management.

Driving and operating machinery
Runaplax may cause dizziness (a commonly occurring side effect) or fainting (a less commonly occurring 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 machinery.

Runaplax contains lactose
If the patient has previously been diagnosed with intolerance to certain 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 coated tablet, meaning it is considered “sodium-free”.

Runaplax contains azo dyes: Orange Yellow FCF, lac (E 110), and tartrazine.
These dyes may cause allergic reactions.

3. How to use Runaplax
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.

How many tablets to take
The recommended dose is one tablet (2.5 mg) twice daily. Runaplax should be taken at approximately the same time each 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, discuss alternative ways of taking Runaplax with the doctor. The tablet may be crushed, mixed with water or apple puree, and taken immediately.
If necessary, the doctor may administer crushed Runaplax tablets via a gastric tube.

Runaplax will not be given to the patient as the only medicine. The doctor will prescribe acetylsalicylic acid to be taken concurrently. If the patient is receiving Runaplax after acute coronary syndrome, the doctor may also prescribe clopidogrel or ticlopidine.
If the patient is receiving Runaplax after a procedure to open a narrowed or blocked artery in the lower limb to restore blood flow, the doctor may also prescribe clopidogrel for a short period in addition to acetylsalicylic acid.
The doctor will inform the patient of the dosage (usually 75–100 mg acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of 75 mg clopidogrel or the standard daily dose of ticlopidine).

When to start taking Runaplax
Treatment with Runaplax after acute coronary syndrome should be initiated as soon as possible after stabilization of the acute event, no earlier than 24 hours after hospital admission, and at the time when parenteral (injected) anticoagulant therapy would normally be discontinued. The doctor will inform the patient when to start Runaplax treatment if coronary artery disease or peripheral arterial disease has been diagnosed. The doctor will decide how long treatment should continue.

Taking more than the recommended dose of Runaplax
If the patient takes more Runaplax tablets than prescribed, contact a doctor immediately due to increased risk of bleeding.

Missing a dose of Runaplax
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the scheduled time.

Stopping Runaplax treatment
Runaplax should be taken regularly for the duration prescribed by the doctor.
Do not stop taking Runaplax without first consulting the doctor.
Discontinuing treatment may increase the risk of another heart attack, stroke, or death due to heart or vascular disease.
If there are any further questions about use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Runaplax may cause adverse reactions, although not everyone will experience them.
As with other similar medicines that have a comparable effect in reducing blood clot formation,
Runaplax may cause bleeding, which can even be life-threatening. Excessive bleeding
may lead to a sudden drop in blood pressure (shock). In some cases, bleeding may be invisible.
You should immediately inform your doctor if any of the following adverse reactions occur:

• 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 neck stiffness. A serious, sudden medical emergency. Seek immediate medical help!),
  • prolonged or excessive bleeding,
  • extreme weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to place you under close observation or change your treatment regimen.
• Signs of severe skin reaction
  • skin reactions such as widespread, intense rash, blistering, or lesions on mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, hematological disorders, and systemic symptoms (DRESS syndrome). These adverse reactions are very rare (occurring in fewer than 1 in 10,000 patients).

Signs of serious allergic reaction:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. Severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock, may occur in fewer than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in fewer than 1 in 100 patients).

General list of possible adverse reactions:
Common (may occur in fewer than 1 in 10 patients)

• reduction in red blood cells, which may cause pale skin, weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums
• bleeding into the eye (including bleeding from the white part of the eye)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood (hemoptysis)
• bleeding from the skin or under the skin
• postoperative bleeding
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• kidney function disorders (as indicated by test results ordered by your doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• increased activity of certain liver enzymes shown in blood tests

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

• bleeding into the brain or within the skull (see signs of bleeding above)
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low number of platelets – blood cells involved in the blood clotting process)
• allergic reactions, including skin allergic reactions
• liver function disorders (as 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
• rapid heartbeat
• dry mouth
• hives

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

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

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

• accumulation of eosinophils, a type of white granulocytic blood cells, causing lung inflammation (eosinophilic pneumonia)

Frequency not known (cannot be determined from available data):
renal failure following severe bleeding
bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy)
increased pressure in leg and arm muscles following bleeding, causing pain, swelling, sensory changes, numbness or paralysis (compartment syndrome following bleeding)

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Runaplax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blister pack, and container after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

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

What Runaplax looks like and contents of the pack
The tablets are round, biconvex, yellow in colour, with the imprint '2.5' on one side and a diameter of 6 mm.
The coated tablets are available in transparent or matte PVC/PVDC/Aluminium blisters packed in a cardboard box.
Pack sizes: 28 or 56 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, Barleben
Germany

Delorbis Pharmaceuticals Limited
17 Athinon Str, Ergates
Industrial Area,
Ergates, Lefkosia,
2643, Cyprus

Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana 1526
Slovenia

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. +48 22 209 70 00

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Netherlands Runaplax
Estonia Runaplax
Lithuania Runaplax 2.5 mg plėvele dengtos tabletės
Latvia Runaplax 2.5 mg apvalkotās tabletes
Poland Runaplax
Slovenia Runaplax 2.5 mg filmsko obložene tablete