Runaplax

Package leaflet: Information for the patient

Runaplax, 10 mg, coated tablets
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet for future reference.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What Runaplax is and what it is used for
2. What you need to know 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

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

• to prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing 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), and also to prevent recurrence of blood clots in the legs and/or lungs.

Runaplax belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

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 disorder 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 a switch of anticoagulant therapy or when
administering 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.
Special caution is required when using Runaplax

• if the risk of bleeding is increased in the patient, which may occur in the following situations:
• moderate or 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 a switch of anticoagulant therapy or when using heparin to maintain patency of a venous or arterial catheter (see section "Runaplax and other medicines");
• bleeding disorders;
• very high blood pressure not controlled by medication;
• stomach or intestinal diseases that may cause bleeding, e.g. inflammatory bowel or stomach disease or oesophagitis (e.g. due to gastro-oesophageal reflux disease, where acidic gastric juice flows back into the oesophagus) or tumours located in the stomach, intestines, genital or urinary system;
• vascular disease of the posterior part of the eyeball (retinopathy);
• lung disease with bronchiectasis and pus-filled bronchi or previous lung bleeding;
• if the patient has a heart valve prosthesis; if the patient has a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of clot formation), the patient should inform the doctor, who will decide whether treatment adjustment 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 is necessary during treatment.

If the patient needs to undergo surgery

• It is very important to take Runaplax exactly as directed by the doctor before and after surgery.
• If catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or for pain relief) is planned during surgery:
• it is very important to take Runaplax exactly at the time recommended by the doctor,
• the patient should inform the doctor immediately if numbness or weakness in the legs or disturbances in bowel or bladder function occur after the anaesthesia, as immediate treatment may be required.

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 and 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 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
• ketoconazole tablets (used in the treatment of Cushing's syndrome when the body produces too much cortisol)
• certain antibiotics (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 antidepressants (selective serotonin reuptake inhibitors [SSRI] or serotonin-noradrenaline reuptake inhibitors [SNRI])

If any of the above situations apply, 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 is necessary.

If the doctor considers the patient to be at increased risk of stomach or intestinal ulceration, the doctor 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 to treat depression
• rifampicin (an antibiotic)

If any of the above situations apply, 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 is necessary.

Pregnancy and breastfeeding

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

Driving and operating machinery

Runaplax may cause dizziness (a common side effect) or fainting (an uncommon side effect), see section 4 "Possible side effects". If such symptoms occur, the patient should not drive, ride a bicycle or operate tools or machinery.

Runaplax contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Runaplax contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

Runaplax contains the colouring agent Orange Yellow FCF, lac (E 110)

This colouring agent may cause allergic reactions.

3. How to use Runaplax

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.

How many tablets to take

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

The tablet should be swallowed with water.
Runaplax can be taken with or without food.
If the patient has difficulty swallowing the whole tablet, the patient should discuss alternative methods 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.

When to take Runaplax

Tablets should be taken daily until the doctor advises stopping the medicine.
It is best to take the tablet 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 veins after hip or knee replacement surgery

The first tablet should be taken 6 to 10 hours after surgery.
Patients undergoing major hip surgery usually take the medicine for 5 weeks, and patients undergoing major knee surgery for 2 weeks.

Taking more Runaplax than prescribed

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

Missed dose of Runaplax

If the patient forgets to take a tablet, it should be taken as soon as remembered. The next dose should be taken the following day at the usual time, and the prescribed dosing schedule should be continued.
Do not take a double dose to make up for a missed dose.

Stopping Runaplax

Do not stop taking Runaplax without consulting the doctor, as this medicine helps prevent serious complications.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other similar medicines with a comparable action 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 reactions
  • 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 rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). These adverse reactions occur very rarely (in fewer than 1 in 10,000 patients).

Signs of serious allergic reaction:

• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure. Severe allergic reactions occur very rarely (anaphylactic reactions, including anaphylactic shock, may occur in fewer than 1 in 10,000 patients) and uncommonly (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)

• decreased number of 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, 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
• postoperative bleeding
• oozing of blood or fluid from a surgical wound
• limb swelling
• 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 (asthenia, 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 1000 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
• local 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 granulocytic white 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 (drug-induced anticoagulant-related nephropathy)
increased pressure in the muscles of legs and arms 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 adverse symptoms 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 Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect more information on the safety of the 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,
blister, and container after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the packaging and other information

What Runaplax contains
The active substance is rivaroxaban. Each coated tablet contains 10 mg of rivaroxaban.
The other ingredients are monohydrate lactose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide.
Coating: Opadry Orange 04F530012: hypromellose, titanium dioxide (E 171), macrogol, talc, sunset yellow (E 110), lac, iron oxide red (E 172).

What Runaplax looks like and contents of the pack
The tablets are peach-coloured, round, biconvex tablets, marked with ‘10’ on one side.
The coated tablets are available in blisters made of OPA/Aluminium/PVC/Aluminium foil or in transparent or opaque single-dose blisters made of PVC/PVDC/Aluminium foil, packed in a cardboard box.
Pack sizes: 10, 20, 28, 30, 42, 50, 98, 100 coated tablets.
Coated tablets are also available in single-dose blisters made of OPA/Aluminium/PVC/Aluminium foil or in transparent or opaque single-dose blisters made of PVC/PVDC/Aluminium foil, packed in a cardboard box.
Pack sizes: 5x1, 10x1, 14x1 coated tablets.
Coated 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 sizes: 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 medicine and its brand 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