Rivaroxaban Apc

Package Leaflet: Information for the User

Rivaroxaban APC, 15 mg, Film-Coated Tablets

Rivaroxaban APC, 20 mg, Film-Coated Tablets

Rivaroxaban
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see point 4.

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See point 4.

Contents of the pack and other information:

• 1. What Rivaroxaban APC is and what it is used for
• 2. Before you take Rivaroxaban APC
• 3. How to take Rivaroxaban APC
• 4. Possible side effects
• 5. How to store Rivaroxaban APC
• 6. Contents of the pack and other information

1. What Rivaroxaban APC is and what it is used for

Rivaroxaban APC contains the active substance rivaroxaban.
Rivaroxaban APC is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood clots in the lungs (pulmonary embolism) and prevent new blood clots from forming in the veins and/or lungs. Rivaroxaban APC is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• -treat and prevent blood clots in the veins or lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban APC belongs to a group of medicines called anticoagulants. Its action is to prevent blood clots from forming by blocking factor Xa, which is involved in blood clotting.

2. Before you take Rivaroxaban APC

Do not take Rivaroxaban APC

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have bleeding problems or if you are bleeding heavily,
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes),
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to Rivaroxaban APC or when heparin is given to keep a line or device (e.g. a venous access device) open,
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban APC and inform your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking Rivaroxaban APC, tell your doctor or pharmacist.

When to be extra careful while taking Rivaroxaban APC

• -if you have an increased risk of bleeding, 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 medicine in the body, bleeding disorders, taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching to Rivaroxaban APC or when heparin is given to keep a line or device (e.g. a venous access device) open, very high blood pressure that does not decrease with treatment, stomach or intestinal diseases that may cause bleeding (e.g. inflammation of the stomach or intestines, or esophageal disease), vascular disease of the retina, lung disease with dilated airways filled with pus (bronchiectasis) or previous bleeding in the lungs,
• -in patients with artificial heart valves,
• -if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment,
• -if you have abnormal blood pressure or if a procedure to remove a blood clot from the lungs is planned.

If you think any of the above applies to you, tell your doctor

before taking Rivaroxaban APC. Your doctor will decide whether to give you this medicine and whether you need to be kept under closer medical supervision.

If you need to have an operation:

• -you must carefully follow your doctor's instructions about taking Rivaroxaban APC at a specific time before or after the operation,
• -if you are to have a procedure to widen narrowed blood vessels in the heart (called percutaneous coronary intervention, or PCI, with stent placement), it is very important to take Rivaroxaban APC before and after the procedure, as instructed by your doctor, and to be closely monitored for signs of bleeding.

Children and adolescents

Rivaroxaban APC tablets are not recommended for children under 30 kg.
There is limited experience with the use of Rivaroxaban APC in children and adolescents for the same indications as in adults.

Rivaroxaban APC with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• -If you are taking certain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, where the body produces too much cortisol), certain antibiotics (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV infection or AIDS (e.g. ritonavir), other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid), dronedarone, a medicine used to treat irregular heart rhythm, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think any of the above applies to you, tell your doctor

before taking Rivaroxaban APC, as the effect of Rivaroxaban APC may be increased. Your doctor will decide whether to give you this medicine and whether you need to be kept under closer medical supervision.
If your doctor thinks you are at increased risk of developing stomach or duodenal ulcers, they may prescribe a medicine to prevent this.

• -If you are taking certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, an antibiotic.

If you think any of the above applies to you, tell your doctor

before taking Rivaroxaban APC, as the effect of Rivaroxaban APC may be reduced. Your doctor will decide whether to give you Rivaroxaban APC and whether you need to be kept under closer medical supervision.

Pregnancy and breastfeeding

Do not take Rivaroxaban APC if you are pregnant or breastfeeding.
If there is a chance that you may become pregnant, you should use effective contraception during treatment with Rivaroxaban APC. If you become pregnant while taking Rivaroxaban APC, you must immediately inform your doctor, who will decide on the continuation of treatment.

Driving and using machines

Rivaroxaban APC may cause dizziness (common side effect) and fainting (uncommon side effect) (see point 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle or use machines.

Rivaroxaban APC contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Rivaroxaban APC

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Rivaroxaban APC should be taken with food.
Swallow the tablet(s) whole, with water.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Rivaroxaban APC. The tablet can be crushed and mixed with water or soft food such as apple puree, just before taking. After mixing, you should take the meal immediately. If necessary, your doctor may also give you the crushed tablet through a nasogastric tube.

How much to take

Adults

• In preventing blood clots in the brain (stroke) and other blood vessels in the body. The recommended dose is one 20 mg Rivaroxaban APC tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban APC tablet once daily.
  If you need a procedure to widen narrowed blood vessels in the heart (called percutaneous coronary intervention, or PCI, with stent placement), there is limited evidence to support the use of a reduced dose of one 15 mg Rivaroxaban APC tablet once daily (or one 10 mg Rivaroxaban APC tablet once daily in case of kidney problems) in combination with an antiplatelet medicine such as clopidogrel.

In treating blood clots in the legs, blood clots in the lungs and preventing new blood clots from forming:
The recommended dose is one 15 mg Rivaroxaban APC tablet twice daily for the first 3 weeks.

• After 3 weeks, the recommended dose is one 20 mg Rivaroxaban APC tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg Rivaroxaban APC tablet once daily, your doctor may decide to reduce the dose to one 15 mg Rivaroxaban APC tablet once daily after 3 weeks of treatment, if the risk of bleeding is higher than the risk of new blood clots.

Children and adolescents

The dose of Rivaroxaban APC depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents weighing 30 kg to less than 50 kgis one 15 mg Rivaroxaban APC tabletonce daily.
• The recommended dose for children and adolescents weighing 50 kg or moreis one 20 mg Rivaroxaban APC tabletonce daily.

Each Rivaroxaban APC dose should be taken with food, with a drink (e.g. water or juice). Tablets should be taken at the same time every day. It's a good idea to set an alarm reminder.
For parents or caregivers: you should check that the child has taken the whole dose.
The dose of Rivaroxaban APC is based on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted if the child's weight changes.
Never adjust the dose yourself. If necessary, your doctor will adjust the dose. Do not split the tablet to achieve a partial dose. If a smaller dose is needed, use another rivaroxaban medicine that comes in a granule form for oral suspension. For children and adolescents who cannot swallow whole tablets, use rivaroxaban in the granule form for oral suspension. If the oral suspension is not available, you can crush the Rivaroxaban APC tablet and mix it with water or apple puree just before taking. After mixing, you should take the meal immediately. If necessary, your doctor may also give you the crushed tablet through a nasogastric tube.

If you spit out or vomit the dose

• less than 30 minutes after taking Rivaroxaban APC, take a new dose.
• more than 30 minutes after taking Rivaroxaban APC, do nottake a new dose. In this case, take the next Rivaroxaban APC dose at the usual time.

Contact your doctor if you spit out or vomit the dose or have vomiting after taking Rivaroxaban APC.

When to take Rivaroxaban APC

Take the tablet(s) every day until your doctor decides to stop the treatment. It's best to take the tablet(s) at the same time every day, as this will help you to remember to take them. Your doctor will decide how long you should continue to take Rivaroxaban APC.
Preventing blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, take Rivaroxaban APC as instructed by your doctor.

Missed dose of Rivaroxaban APC

Adults, children and adolescents:
If you take one 20 mg or one 15 mg tablet oncedaily and miss a dose, take it as soon as possible. Do not take more than one tablet in a 24-hour period to make up for a missed dose. Take the next tablet at the usual time and then continue taking one tablet once daily.
Adults:
If you take one 15 mg tablet twicedaily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in a 24-hour period. If you miss a dose, you may take two 15 mg tablets at the same time to get a total daily dose of 30 mg. The next day, continue taking one 15 mg tablet twice daily.

Overdose of Rivaroxaban APC

If you take more Rivaroxaban APC tablets than you should, contact your doctor immediately. Taking more Rivaroxaban APC tablets than recommended may increase the risk of bleeding.

Stopping Rivaroxaban APC treatment

Do not stop taking Rivaroxaban APC without first talking to your doctor, as Rivaroxaban APC treats and prevents serious conditions. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban APC can cause side effects, although not everybody gets them.
As with other medicines that prevent blood clots, Rivaroxaban APC may cause bleeding, which can be life-threatening in some cases.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding may be obvious or external.

Tell your doctor immediatelyif 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 stiff neck. This is a serious medical emergency. You should seek medical attention immediately!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina .Your doctor may decide to closely monitor you or change your treatment.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders and systemic symptoms (DRESS syndrome). The frequency of these side effects is very rare (may affect up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, mouth, tongue or throat; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema may occur in up to 1 in 100 people).

General list of possible side effects in adults, children and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause pale skin and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding into the conjunctiva),
• bleeding into tissues or body cavities (haematoma, bruising),
• presence of blood in the sputum when coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney problems (which can be seen in tests performed by your doctor),
• fever,
• stomach pain, nausea (feeling sick), vomiting, constipation, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, tiredness), headache, dizziness,
• rash, itching,
• increased activity of certain liver enzymes, which can be seen in blood tests.

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, which are cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood tests may show increased levels of bilirubin, certain liver enzymes or platelet count,
• fainting,
• feeling unwell,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may affect up to 1 in 1,000 people)

• bleeding into the muscles,
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localised swelling,
• collection of blood (haematoma) in the groin as a complication of a procedure to widen narrowed blood vessels in the heart, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Frequency not known(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects seen in children and adolescents treated with Rivaroxaban APC were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen more often in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache
• fever
• nosebleeds, vomiting

Common(may affect up to 1 in 10 people)

• rapid heartbeat
• blood tests may show increased levels of bilirubin (a bile pigment)
• low platelet count (thrombocytopenia, which are cells involved in blood clotting)
• heavy menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban APC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban APC contains

• The active substance is rivaroxaban. One film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide (E 171), iron oxide red (E 172).

The tablets are pink, round, biconvex, with "15" engraved on one side.
Rivaroxaban APC 15 mg film-coated tablets are available in packs of 10, 14, 28, 30, 42, 56, 60, 98 or 100 film-coated tablets.
The tablets are brown-red, round, biconvex, with "20" engraved on one side.
Rivaroxaban APC 20 mg film-coated tablets are available in packs of 10, 14, 28, 30, 42, 56, 60, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

APC Institute Sp. z o.o.
Al. Jerozolimskie 146C
02-305 Warsaw

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

Rivaroxaban APC 15 mg is authorised in the Member States of the European Economic Area under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 15 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 15 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain
Rivaroxaban APC 15 mg comprimidos recubiertos con película
Germany
Rivaroxaban APC 15 mg, Filmtablette
Poland
Rivaroxaban APC
Portugal Rivaroxaban APC

Rivaroxaban APC 20 mg is authorised in the Member States of the European Economic Area under the following names:
Austria Rivaroxaban APC
Bulgaria Rivaroxaban APC
Croatia Rivaroksaban APC 20 mg filmom obložene tablete
Cyprus Rivaroxaban APC
France RIVAROXABAN APC 20 mg, comprimé pelliculé
Greece Rivaroxaban APC
Spain
Rivaroxaban APC 20 mg comprimidos recubiertos con película
Germany
Rivaroxaban APC 20 mg, Filmtablette
Poland
Rivaroxaban APC
Portugal Rivaroxaban APC

Date of last revision of the leaflet: