Rivaroxaban Sinoptis

Package Leaflet: Information for the Patient

Rivaroxaban Synoptis, 15 mg, film-coated tablets

Rivaroxaban Synoptis, 20 mg, film-coated tablets

Rivaroxabanum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

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

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

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

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Synoptis 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 blood vessels in the lungs, after at least 5 days of initial treatment with injectable anti-clotting medicines.

Rivaroxaban Synoptis belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Synoptis

When not to take Rivaroxaban Synoptis

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Synoptis, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rivaroxaban Synoptis, consult your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Synoptis

• if the patient has 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 patient's body,
• bleeding disorders,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Synoptis and other medicines"),
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible changes to the treatment,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Synoptis. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery

• it is very important to follow the doctor's instructions regarding the intake of Rivaroxaban Synoptis at a specified time 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 Synoptis before and after the puncture or catheter removal, according to the doctor's instructions,
• the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Synoptis is not recommended for children with a body weight below 30 kg.
There is a lack of sufficient data on the use of rivaroxaban in children and adolescents for adult indications.

Rivaroxaban Synoptis and other medicines

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

• If you are taking
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines used to treat bacterial infections (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used to treat HIV 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 heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Synoptis, as the effect of Rivaroxaban Synoptis may be enhanced when taken with the above medicines. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent stomach ulcers.

• If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Synoptis, as the effect of Rivaroxaban Synoptis may be reduced when taken with the above medicines. The doctor will decide whether to use Rivaroxaban Synoptis and whether the patient should be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

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

Rivaroxaban Synoptis contains lactose monohydrate and sodium

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

3. How to take Rivaroxaban Synoptis

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

How many tablets to take

• Adults
• In the prevention of blood clot formation in the brain (stroke) and other blood vessels in the body, the recommended dose is one tablet of Rivaroxaban Synoptis, 20 mg once daily. If you have kidney problems, the dose may be reduced to one tablet of Rivaroxaban Synoptis, 15 mg once daily.

If the patient requires a procedure to open up blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support a dose reduction to one tablet of Rivaroxaban Synoptis, 15 mg once daily (or one tablet of rivaroxaban, 10 mg once daily in case of kidney disease) in combination with an anti-platelet medicine such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots, the recommended dose is one tablet of Rivaroxaban Synoptis, 15 mg twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet of Rivaroxaban Synoptis, 20 mg once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one tablet of a medicine containing 10 mg of rivaroxaban once daily or one tablet of Rivaroxaban Synoptis, 20 mg once daily. If the patient has kidney disease and is taking one tablet of Rivaroxaban Synoptis, 20 mg once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one tablet of Rivaroxaban Synoptis, 15 mg once daily, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescentsThe dose of Rivaroxaban Synoptis depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one tablet of Rivaroxaban Synoptis , 15 mgonce daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one tablet of Rivaroxaban Synoptis , 20 mgonce daily.

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

If you spit out the dose or vomit

• less than 30 minutes after taking Rivaroxaban Synoptis, take a new dose.
• more than 30 minutes after taking Rivaroxaban Synoptis, do not takea new dose. In this case, take the next dose at the usual time.

Contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban Synoptis.

When to take Rivaroxaban Synoptis

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 it's easier to remember.
The doctor will decide how long you should continue the treatment.
Prevention of blood clot formation in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, take Rivaroxaban Synoptis as directed by your doctor.

Missing a dose of Rivaroxaban Synoptis

• Adults, children, and adolescents If you take one tablet of 20 mg or one tablet of 15 mg once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the next day, and then take one tablet once daily.
• Adults If you take one tablet of 15 mg twice daily and miss a dose, take it as soon as possible. Do not take more than two tablets of 15 mg in one day. If you miss a dose, you can take two tablets of 15 mg at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one tablet of 15 mg twice daily.

Taking more than the recommended dose of Rivaroxaban Synoptis

If you take more than the recommended dose of Rivaroxaban Synoptis, contact your doctor immediately. Taking too much Rivaroxaban Synoptis increases the risk of bleeding.

Stopping treatment with Rivaroxaban Synoptis

Do not stop taking Rivaroxaban Synoptis without consulting your doctor first, as Rivaroxaban Synoptis treats and prevents serious diseases.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Synoptis can cause side effects, although not everybody gets them.
Like other medicines with similar action to reduce blood clot formation, Rivaroxaban Synoptis may cause bleeding, which can be life-threatening.
Excessive bleeding can lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.
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 of the neck. This is a serious medical condition. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. The doctor may decide to monitor the patient closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute 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, hematological 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 or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum when coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the wound after surgery,
• swelling of the limbs,
• limb pain,
• kidney function disorders (can be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea, 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 of the skin,
• 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 the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (can be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, certain liver or pancreatic enzyme activity, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local swelling,
• accumulation of blood (hematoma) in the groin as a complication of heart catheterization, when the 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, 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

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly mild to moderate.
Side effects observed 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 bilirubin levels,
• 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 direct bilirubin levels.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rivaroxaban Synoptis

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
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 Synoptis contains

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose 2910, titanium dioxide (E 171), macrogol 4000, iron oxide red (E172).

What Rivaroxaban Synoptis looks like and contents of the pack

Rivaroxaban Synoptis, 15 mg: red, round, biconvex film-coated tablets with "15" engraved on one side and smooth on the other.
Rivaroxaban Synoptis, 20 mg: brown-red, round, biconvex film-coated tablets with "20" engraved on one side and smooth on the other.
Film-coated tablets are available in PVC/PCTFE/Aluminum blisters in a cardboard box.
Package sizes: 14, 28, 42 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Chanelle Medical Unlimited Company
Dublin Road, Loughrea
Co. Galway, H62 FH90
Ireland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Synoptis Pharma Sp. z o.o.
tel. +48 22 32 16 240

Date of last revision of the package leaflet: