Rivaroxaban Medical Vallei

Package Leaflet: Information for the User

Rivaroxaban Medical Valley, 15 mg, film-coated tablets

Rivaroxaban Medical Valley, 20 mg, film-coated tablets

Rivaroxaban

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

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

Table of Contents of the Package Leaflet

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

1. What is Rivaroxaban Medical Valley and what is it used for

The medicine contains the active substance rivaroxaban. Rivaroxaban Medical Valley is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body, if the patient has a type of irregular heartbeat 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban Medical Valley is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat and prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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

2. Important information before taking Rivaroxaban Medical Valley

When not to take Rivaroxaban Medical Valley

• 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 an organ that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgical procedure on the brain or eyes),
• if the patient is taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter,
• if the patient has liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

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

Warnings and precautions

Before starting treatment with Rivaroxaban Medical Valley, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Medical Valley

• 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 body,
• taking other medicines that prevent the formation of blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban Medical Valley and other medicines"),
• bleeding disorders,
• 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,
• disease of the blood vessels 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 artificial heart 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 whether to change the treatment,
• if the patient has been found to have unstable 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 Medical Valley. 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 take Rivaroxaban Medical Valley before or after surgery at the times indicated by the doctor.
• if a catheter is to be inserted or a puncture is to be made in the spine (e.g., for spinal anesthesia or epidural anesthesia or to relieve pain):
• it is very important to take Rivaroxaban Medical Valley before and after the puncture or removal of the catheter, at the times indicated by the doctor,

and inform the doctor immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Medical Valley 10 mg tablets are 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 indications in adults.

Rivaroxaban Medical Valley and other medicines

Tell your doctor or pharmacist about all 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 topically on the skin,
• ketokonazole 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 used to treat HIV or AIDS (e.g., ritonavir),
• other medicines that 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 Medical Valley, as the effect of Rivaroxaban Medical Valley may be increased. The doctor will decide whether to use this medicine and whether the patient should be closely monitored. If the doctor considers that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent ulcers.

• 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 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 Medical Valley, as the effect of Rivaroxaban Medical Valley may be reduced. The doctor will decide whether to use Rivaroxaban Medical Valley and whether the patient should be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Medical Valley 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 Medical Valleycontains 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 (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Rivaroxaban Medical Valley

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Rivaroxaban Medical Valley 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 Medical Valley. The tablet can be crushed and mixed with water or apple sauce, just before taking. After taking this mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed Rivaroxaban Medical Valley tablet through a gastric tube.

How many tablets to take

Adults

• In the prevention of blood clots in the brain (stroke) and other blood vessels in the body, the recommended dose is one 20 mg Rivaroxaban Medical Valley tablet once a day. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Medical Valley tablet once a day.

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 15 mg Rivaroxaban Medical Valley tablet once a day (or one 10 mg Rivaroxaban Medical Valley tablet once a day in case of kidney disease) in combination with an antiplatelet 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 15 mg Rivaroxaban Medical Valley tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rivaroxaban Medical Valley tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney disease and are taking one 20 mg Rivaroxaban Medical Valley tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Medical Valley tablet once a day,

if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents

The dose of Rivaroxaban Medical Valley 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 less than 50 kgis one Rivaroxaban Medical Valley 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Rivaroxaban Medical Valley 20 mgtablet once a day.

Each dose of Rivaroxaban Medical Valley 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 recommended to set an alarm reminder. For parents or caregivers: observe the child to ensure they have taken the entire dose. The dose of Rivaroxaban Medical Valley is dependent on body weight, so it is essential 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, the doctor will adjust the dose. Do not divide the tabletto obtain a partial dose of the tablet. If a smaller dose is needed, other pharmaceutical forms, such as an oral suspension, may be more suitable. For children and adolescents who are unable to swallow whole tablets, a medicine containing rivaroxaban in the form of an oral suspension should be used. If the oral suspension is not available, the Rivaroxaban Medical Valley tablet can be crushed and mixed with water or apple sauce just before taking. After taking this mixture, eat a meal immediately. If necessary, the doctor may also give a crushed Rivaroxaban Medical Valley tablet through a gastric tube.

If a dose is spat out or vomited

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

Contact your doctor if you spit out or vomit a dose or have recurring vomiting after taking Rivaroxaban Medical Valley.

When to take Rivaroxaban Medical Valley

Take the tablet(s) every day until the doctor decides to stop treatment. It is best to take the tablet(s) at the same time every day, as it will be easier to remember. The doctor will decide how long you should continue treatment. To prevent blood clots in the brain (stroke) and other blood vessels in the body: If your heart needs to be restored to a normal rhythm using a procedure called cardioversion, take Rivaroxaban Medical Valley at the time recommended by your doctor.

Taking more than the recommended dose of Rivaroxaban Medical Valley

If you have taken more than the recommended dose of Rivaroxaban Medical Valley, contact your doctor immediately. Taking too much Rivaroxaban Medical Valley increases the risk of bleeding.

Missing a dose of Rivaroxaban Medical Valley

• Adults, children, and adolescents: If you take one 20 mg or one 15 mg tablet oncea day 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 at the usual time the next day, and then continue taking one tablet once a day.
• Adults: If you take one 15 mg tablet twicea day 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) taken in one day. The next day, continue taking one 15 mg tablet twice a day.

Stopping treatment with Rivaroxaban Medical Valley

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

4. Possible side effects

Like all medicines, Rivaroxaban Medical Valley can cause side effects, although not everybody gets them. As with other medicines that have a similar effect of reducing blood clot formation, Rivaroxaban Medical Valley may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Immediately inform your doctor if 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 emergency. 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 closely monitor the patient 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, hematologic 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; difficulty swallowing; 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 less than 1 in 100 people).

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

Common side effects(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 intestine, 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 (hemoptysis),
• 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 disorders (may be observed in tests performed by the doctor),
• fever,
• stomach pain, nausea (nausea), vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of some liver enzymes, which may be visible in blood test results.

Uncommon side effects(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 disorders (may be observed in tests performed by the doctor),
• blood test results may show increased bilirubin levels, increased activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare side effects(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),
• local swelling,
• hematoma (collection of blood) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare side effects(may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white blood cell, which can cause lung inflammation (eosinophilic pneumonia).

Side effects with unknown frequency(frequency cannot be estimated from the available data)

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms after bleeding, which can cause pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects observed in children and adolescents treated with Rivaroxaban Medical Valley 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 side effects(occurring in more than 1 in 10 patients)

• headache,
• fever,
• nosebleeds,
• vomiting.

Common side effects(occurring in less than 1 in 10 patients)

• rapid heartbeat,
• blood test results may show increased bilirubin levels,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• heavy menstrual bleeding.

Uncommon side effects(occurring in less than 1 in 100 patients)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban Medical Valley

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 and on each blister after EXP. The expiry date refers to the last day of the month stated. There are no special storage instructions for this medicine. Crushed tablets: Crushed tablets are stable in water or apple sauce 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 Medical Valley contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, corn starch, crospovidone, sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban Medical Valley contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 4000, iron oxide red (E 172).

What Rivaroxaban Medical Valley looks like and contents of the pack

Rivaroxaban Medical Valley 15 mg film-coated tablets are round, red, biconvex, approximately 6 mm in diameter, smooth on one side, and marked with "15" on the other side. The tablets are packaged in blisters, which are packed in cardboard boxes containing 10, 28, 30, 42, 56, 98, 100, or 112 film-coated tablets. Rivaroxaban Medical Valley 20 mg film-coated tablets are round, brown-red, biconvex, approximately 7 mm in diameter, smooth on one side, and marked with "20" on the other side. The tablets are packaged in blisters, which are packed in cardboard boxes containing 10, 28, 30, 56, 98, 100, or 112 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden, email: safety@medicalvalley.se. Manufacturer/Importer: Laboratorios LICONSA, S.A., Avenida Miralcampo 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares, Guadalajara, Spain.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Rivaroxaban Medical Valley, Netherlands: Rivaroxaban Xiromed 15 mg, filmomhulde tabletten; Rivaroxaban Xiromed 20 mg, filmomhulde tabletten, Iceland: Rivaroxaban Medical Valley 15 mg filmuhúðaðar töflur; Rivaroxaban Medical Valley 20 mg filmuhúðaðar töflur, Germany: Rivaroxaban AXiromed 15 mg Filmtabletten; Rivaroxaban AXiromed 20 mg Filmtabletten, Norway: Rivaroxaban Medical Valley, Poland: Rivaroxaban Medical Valley, Sweden: Rivaroxaban Medical Valley 15 mg Filmdragerad tablet; Rivaroxaban Medical Valley 20 mg Filmdragerad tablett.

Date of last revision of the package leaflet:

Other sources of information: Detailed information on this medicine is available on the website: www.urpl.gov.pl.