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.

You should read the leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 is Rivaroxaban APC and what is it 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 is Rivaroxaban APC and what is it 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 a heart valve problem.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent blood clots from forming again in the blood vessels of the legs 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 block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Before you take Rivaroxaban APC

When not to take Rivaroxaban APC

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in point 6),
• if you have excessive bleeding,
• if you have a disease or condition of an organ that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery,
• 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 conditions apply 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, in conditions 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 that works in the body, bleeding disorders, taking other medicines that prevent blood clots (e.g. warfarin, dabigatran etexilate, apixaban or heparin) when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban APC and other medicines"), very high blood pressure that does not decrease despite treatment, diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to gastroesophageal reflux disease (backflow of stomach acid 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), lung disease in which the airways are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• -in patients with prosthetic 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 treatment,
• -if you have abnormal blood pressure or are scheduled for surgery, or other treatment to remove a blood clot from the lungs.

If you think you have any of the above conditions, you should

tell your doctorbefore taking Rivaroxaban APC. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• -you must follow your doctor's instructions exactly regarding when to take Rivaroxaban APC before or after surgery,
• -if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia, or pain relief): it is very important to take Rivaroxaban APC before and after the puncture or catheter removal, as directed by your doctor, and due to the need for extra caution, you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivaroxaban APC tablets are not recommended for children under 30 kg.
There is not enough data on the use of Rivaroxaban APC in children and adolescents for adult indications.

Rivaroxaban APC and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available 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, in which the body produces too much cortisol), certain medicines for bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines for HIV infection or AIDS treatment (e.g. ritonavir), other medicines 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 for heart rhythm disorders, certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you think you have any of the above conditions, you should

tell your doctorbefore taking Rivaroxaban APC ,as the effect of Rivaroxaban APC may be increased. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor thinks you are at risk of developing stomach or duodenal ulcers, they may use a treatment to prevent this.

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

If you think you have any of the above conditions, you should

tell your doctorbefore taking Rivaroxaban APC ,as the effect of Rivaroxaban APC may be reduced. Your doctor will decide whether to use Rivaroxaban APC and whether you need to be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban APC may cause dizziness (frequent side effects) and fainting (uncommon side effects) (see point 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bike, or operate tools or machines.

Rivaroxaban APC contains lactose and sodium.

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

3. How to take Rivaroxaban APC

This medicine should always be taken exactly as directed by your doctor. If you are unsure, contact your doctor or pharmacist.
Rivaroxaban APC should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing whole tablets, you should 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, immediately before taking. After such a mixture, you should eat a meal immediately.
If necessary, your doctor may also give you a crushed Rivaroxaban APC tablet through a gastric tube.

How many tablets to take

Adults

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

The recommended dose is one Rivaroxaban APC 15 mg tablet twice daily for the first 3 weeks.

• After 3 weeks, the recommended dose is one Rivaroxaban APC 20 mg 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 Rivaroxaban APC 20 mg tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban APC 15 mg tablet once daily, if the risk of bleeding is higher than the risk of further 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 Rivaroxaban APC 15 mg tabletonce daily.
• The recommended dose for children and adolescents weighing 50 kg or moreis one Rivaroxaban APC 20 mg tabletonce daily.

Each Rivaroxaban APC dose should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time.
It is a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the whole dose.
The dose of Rivaroxaban APC is based on body weight, so it is important to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose. Do not split the tablet to get a partial dose. If a smaller dose is needed, you should use another rivaroxaban medicine in the form of granules for oral suspension. For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in the form of granules 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 immediately before taking. After this mixture, you should eat a meal. If necessary, your doctor may also give you a crushed Rivaroxaban APC tablet through a gastric tube.

If you spit out a dose or vomit

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

You should contact your doctor if you spit out a dose or vomit several times after taking Rivaroxaban APC.

When to take Rivaroxaban APC

The tablet(s) should be taken every day until your doctor decides to stop treatment. It is best to take the tablet(s) at the same time every day, as this will help you remember. Your doctor will decide how long you should continue treatment. 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, Rivaroxaban APC should be taken as directed by your doctor.

Missing a 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 one day to make up for a missed dose.
Take the next tablet the next day, and then take 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 one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Rivaroxaban APC

If you take too many Rivaroxaban APC tablets, contact your doctor immediately. Taking too much Rivaroxaban APC increases the risk of bleeding.

Stopping treatment with Rivaroxaban APC

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Rivaroxaban APC can cause bleeding, which can be life-threatening.
Excessive bleeding can lead to a sudden drop in blood pressure (shock). These signs of bleeding are not always obvious or visible.

You should 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 stiffness in the neck. This is a serious medical emergency. You should seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina .Your doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 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 less than 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 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 pallor 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 gums,
• bleeding into the eye (including bleeding into the white of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum when coughing,
• bleeding from the skin or bleeding under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a 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 (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching,
• increased activity of certain liver enzymes, which can be seen in blood test results.

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, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, certain liver or pancreatic enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localized swelling,
• blood accumulation (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

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

• kidney failure after severe bleeding,
• increased pressure in the muscles of the legs and arms, occurring 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 frequently 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 test results may show increased levels of bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• excessive menstrual bleeding

Uncommon(may affect up to 1 in 100 people)

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

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
email: website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 precautions for storing 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. This 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 appearance of Rivaroxaban APC

  What Rivaroxaban APC looks like and contents of the pack

  Rivaroxaban APC 15 mg film-coated tablets are pink, round, biconvex, with the number "15" embossed on one side.
  The tablets are packaged in blisters placed in a carton containing: 10, 14, 28, 30, 42, 56, 60, 98 or 100 film-coated tablets
  Rivaroxaban APC 20 mg film-coated tablets are reddish-brown, round, biconvex, with the number "20" embossed on one side.
  The tablets are packaged in blisters placed in a carton containing: 10, 14, 28, 30, 42, 56, 60, 98 or 100 film-coated tablets
  Not all pack sizes may be marketed.

  Marketing authorization 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 authorized in European Economic Area member states under the following names:
  Austria Rivaroxaban APC
  Bulgaria Rivaroxaban APC
  Croatia Rivaroksaban APC 15 mg film-coated tablets
  Cyprus Rivaroxaban APC
  France RIVAROXABAN APC 15 mg, film-coated tablet
  Greece Rivaroxaban APC
  Spain
  Rivaroxaban APC 15 mg film-coated tablets
  Germany
  Rivaroxaban APC 15 mg, film-coated tablet
  Poland
  Rivaroxaban APC
  Portugal Rivaroxaban APC
  Rivaroxaban APC 20 mg is authorized in European Economic Area member states under the following names:
  Austria Rivaroxaban APC
  Bulgaria Rivaroxaban APC
  Croatia Rivaroksaban APC 20 mg film-coated tablets
  Cyprus Rivaroxaban APC
  France RIVAROXABAN APC 20 mg, film-coated tablet
  Greece Rivaroxaban APC
  Spain
  Rivaroxaban APC 20 mg film-coated tablets
  Germany
  Rivaroxaban APC 20 mg, film-coated tablet
  Poland
  Rivaroxaban APC
  Portugal Rivaroxaban APC

  Date of last revision of the leaflet: