Runaplax: detailed information

Package leaflet: Information for the patient

Runaplax, 15 mg, film-coated tablets
Runaplax, 20 mg, film-coated tablets
Rivaroxabanum
Please read the entire leaflet before taking this medicine, as it contains important information
for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please 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 the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:

What Runaplax is and what it is used for
Important information before taking Runaplax
How to take Runaplax
Possible side effects
How to store Runaplax
Contents of the pack and other information

1. What Runaplax is and what it is used for

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

preventing the formation of blood clots in the brain (stroke) and in other blood vessels throughout the body in patients with a certain type of irregular heart rhythm called non-valvular atrial fibrillation;
treating blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as for preventing the recurrence of blood clots in the veins of the legs and (or) lungs.

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

treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs, following at least 5 days of initial treatment with injectable anticoagulant medicines.

Runaplax belongs to a group of medicines known as 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, trauma 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 the period of switching anticoagulant therapy or administration of
heparin to maintain patency of a venous or arterial catheter;
if the patient has a 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 using Runaplax, discuss this with your doctor or pharmacist.
Be especially careful when using Runaplax

if the risk of bleeding is increased in the patient, 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 active drug in the patient's body; taking other anticoagulant medicines (i.e. warfarin, dabigatran, apixaban or heparin) during transition of anticoagulant therapy or while using heparin to maintain patency of a venous or arterial catheter (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. intestinal or gastric inflammation or oesophagitis (e.g. due to gastro-oesophageal reflux disease, in which acidic gastric juice flows back into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system; vascular disease of the posterior part of the eyeball (retinopathy); lung disease with bronchiectasis and pus-filled bronchi (bronchiectasis) or previous pulmonary haemorrhage;
if the patient has a heart valve prosthesis;
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether a change in treatment is necessary;
if the doctor considers the patient's blood pressure unstable or if surgery or other treatment to remove a pulmonary clot is planned.

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

It is very important to take Runaplax at the exact times prescribed by the doctor before and after surgery.
If spinal catheterisation or lumbar puncture is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):
it is very important to strictly follow the doctor's instructions regarding the timing of taking Runaplax before or after lumbar puncture or removal of the catheter
the doctor should be informed immediately if, after the anaesthesia ends, the patient experiences numbness or weakness in the legs or disturbances in bowel or urinary function, as immediate treatment will then be necessary.

Children and adolescents
Runaplax is not recommended for children weighing less than 30 kg. There is insufficient information on its use in children and adolescents for the indications approved in adults.
Runaplax with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 topically on the skin
ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
certain antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin)
certain antiviral medicines used to treat HIV/AIDS infection (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 antidepressants (selective serotonin reuptake inhibitors [SSRI] or serotonin-noradrenaline reuptake inhibitors [SNRI])

If any of the above situations apply to the patient, tell 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 of the patient's condition is necessary.
If the doctor considers that the patient has an increased risk of stomach or intestinal ulceration, the doctor may also prescribe medicines to prevent peptic ulcer disease.
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 situations apply to the patient, tell 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 of the patient's condition is necessary.
Pregnancy and breastfeeding
If a woman is pregnant or breastfeeding, she must not use Runaplax. Women of childbearing potential should use effective contraception while taking Runaplax. If a woman becomes pregnant during treatment, she should inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Runaplax may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect), see section 4 "Possible side effects". If the patient experiences such symptoms, do not drive, cycle or operate tools or machinery.
Runaplax contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the 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 the colouring agent Orange Yellow FCF, lake (E 110)
This colouring agent may cause allergic reactions.
3. How to use Runaplax
This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the 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, discuss other ways of taking Runaplax with the doctor. The tablet can be crushed, mixed with water or apple puree and taken immediately. A meal should be consumed directly afterwards. If necessary, the doctor may administer crushed Runaplax tablets via a gastric tube.
How many tablets to take

Adults
For prevention of blood clots in the brain (stroke) and in other blood vessels The recommended dose is one 20 mg tablet once daily. In patients with impaired kidney function, the doctor may reduce the dose to one 15 mg tablet once daily.

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

For treatment of blood clots in the leg veins, blood clots in the blood vessels of 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, the doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. In patients with impaired kidney function taking one 20 mg tablet once daily, the doctor may reduce the dose after 3 weeks of treatment to one 15 mg tablet once daily (if the risk of bleeding is greater than the risk of further clots).
Children and adolescents The 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 below 50 kg is one 15 mg tablet once daily.
The recommended dose for children and adolescents with a body weight of 50 kg or more is one 25 mg tablet once daily. Each dose of Runaplax should be taken with a meal, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder. For parents or caregivers: monitor the child to ensure the full dose is taken.

The dose of Runaplax depends on body weight, so it is important to attend scheduled appointments with the doctor, as dose adjustment may be necessary due to changes in body weight.
Never adjust the dose of Runaplax independently. If necessary, the doctor will adjust the dose.
Do not split the tablet to obtain partial doses. If a lower dose is required, use another formulation of rivaroxaban – granules for oral suspension. For children and adolescents unable to swallow whole tablets, rivaroxaban in the form of granules for oral suspension should be used. If the oral suspension is not available, the Runaplax tablet may be crushed and mixed with water or apple puree immediately before administration. A meal should be consumed after this mixture. If necessary, the doctor may also administer the crushed tablet via a gastric tube.
If a dose is vomited or expelled

within 30 minutes of taking Runaplax, take a new dose.
more than 30 minutes after taking Runaplax, do not take a new dose. In this case, take the next dose of Runaplax at the usual time.

Contact the doctor if multiple doses are vomited or if vomiting occurs after taking Runaplax.
When to take Runaplax
Tablets should be taken daily until the doctor advises stopping the medicine. It is best to take the tablet(s) at the same time each day, as this makes it easier to remember. The duration of treatment is determined by the doctor.
Prevention of blood clots in the brain (stroke) and in other blood vessels:
If heart function requires restoration of normal rhythm via cardioversion, Runaplax should be taken at the time prescribed by the doctor.
Missed dose of Runaplax

Adults, children and adolescents:
If the patient takes one 20 mg tablet or one 15 mg tablet once daily and misses a dose, the patient 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. Take the next tablet the following day, then continue taking one tablet once daily.
Adults:
If the patient takes one 15 mg tablet twice daily and misses a dose, the patient 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 achieve 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 the patient has taken too many Runaplax tablets, contact the doctor immediately.
Taking too high a dose of Runaplax increases the risk of bleeding.
Stopping Runaplax treatment
Do not stop taking Runaplax without consulting the doctor, as this medicine treats serious conditions and prevents their recurrence.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action reducing blood clot formation, Runaplax
can cause bleeding, which may even be life-threatening. Excessive bleeding may
lead to a sudden drop in blood pressure (shock). In some cases, bleeding
may be invisible.

Seek immediate medical attention if any of the following adverse reactions occur:

Signs of bleeding:
bleeding into the brain or within the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness and neck stiffness. A serious 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. The doctor may decide to place the patient under close observation or change the treatment regimen.

Signs of severe skin reaction:

skin reactions such as widespread, intense rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome or toxic epidermal necrolysis).
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. These adverse reactions are very rare (occurring in less than 1 in 10,000 patients).

Signs of serious allergic reaction
swelling of the face, lips, mouth, tongue or throat; hives and breathing difficulties; 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 common (angioedema and allergic edema may occur in less than 1 in 100
patients).

General list of possible adverse reactions in adults, children and adolescents:
Common (may occur in less than 1 in 10 people)

decreased number of red blood cells, which may cause pale skin, weakness or shortness of breath
gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding
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)
skin bleeding or subcutaneous bleeding
postoperative bleeding
oozing of blood or fluid from a surgical wound
limb swelling
limb pain
kidney function disorders (indicated by results of tests ordered by a 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 (asthenia, fatigue), headache, dizziness
rash, skin itching
increased activity of certain liver enzymes shown in blood tests

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

bleeding into the brain or within the skull (see signs of bleeding above)
bleeding into a joint causing pain and swelling
thrombocytopenia (low platelet count – cells involved in blood clotting)
allergic reactions, including skin allergic reactions
liver function disorders (indicated by results of tests ordered by a 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
urticaria (hives)

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

bleeding into muscles
cholestasis (reduced bile flow), hepatitis, including liver cell damage
yellowing of the skin and eyes (jaundice)
local swelling
blood accumulation (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 less than 1 in 10,000 people)

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

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

Adverse reactions in children and adolescents
Generally, adverse reactions observed in children and adolescents treated with Runaplax were
similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 people)
headache
fever
nosebleeds
vomiting
Common (may occur in less than 1 in 10 people)
rapid heartbeat
blood tests may show increased bilirubin levels (a bile pigment)
thrombocytopenia (low platelet count – cells that help in blood clotting)
excessive menstrual bleeding
Uncommon (may occur in 1 in 100 people):

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, 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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Runaplax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister labeled EXP. The expiry date refers to the last day of the stated month.
No special storage instructions 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. Such measures help protect the environment.

6. Contents of the pack and other information

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

Other ingredients: monohydrate lactose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Coating
Runaplax 15 mg Opadry Orange 04F530006: hypromellose, titanium dioxide (E 171), polyethylene glycol, sunset yellow (E 110), lac, iron oxide red (E 172).
Runaplax 20 mg Opadry Orange 04F530010: hypromellose, titanium dioxide (E 171), polyethylene glycol, sunset yellow (E 110), lac, 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
Tablets are round, light orange, biconvex, marked with ‘15’ on one side.
Runaplax 20 mg
Tablets are round, orange, biconvex, marked with ‘20’ on one side.
Tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium or in transparent or opaque PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 42, 50, 98, 100 coated tablets.
Tablets are also available in unit-dose blisters made of OPA/Aluminium/PVC/Aluminium or in transparent or opaque unit-dose blisters made of PVC/PVDC/Aluminium, packed in a cardboard box.
Pack sizes: 5x1, 10x1, 14x1 coated tablets.
Tablets are also available in HDPE bottles with PP screw caps containing a desiccant (silica gel), with child-resistant closure, packed in a cardboard box.
Pack size: 100 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
D-39179 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 further information about this medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. +48 22 209 70 00