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

Rivaroxabanum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 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 section 4.

Contents of the pack and other information

• 1. What Rivaroxaban Medical Valley is and what it is used for
• 2. What you need to know before you take 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 Rivaroxaban Medical Valley is and what it is used for

The active substance is rivaroxaban. Rivaroxaban Medical Valley 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 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 blood clots from forming again in the legs and/or lungs.

Rivaroxaban Medical Valley 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 Medical Valley belongs to a group of medicines called anticoagulants. Its action is to prevent the formation of blood clots by blocking factor Xa, a protein involved in blood clotting.

2. What you need to know before you take Rivaroxaban Medical Valley

When not to take Rivaroxaban Medical Valley

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have bleeding that is not under control,
• if you have 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 brain or eye surgery),
• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to Rivaroxaban Medical Valley or when heparin is used 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 Medical Valleyand inform your doctor if you think any of the above applies to you.

Warnings and precautions

Before taking Rivaroxaban Medical Valley, discuss with your doctor or pharmacist.

When to be extra careful when taking Rivaroxaban Medical Valley

• 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,
• taking other medicines that prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin) when switching to Rivaroxaban Medical Valley or when heparin is used to maintain catheter patency in a vein or artery (see "Rivaroxaban Medical Valley with other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease with treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach and intestines or esophageal inflammation (e.g., due to gastroesophageal reflux disease),
• eye diseases (retinopathy),
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous lung bleeding,
• if you have 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 unstable blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

before taking Rivaroxaban Medical Valley. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• it is very important to take Rivaroxaban Medical Valley before or after surgery at the times specified by your doctor.
• if a catheter is to be inserted or a puncture is to be made in the spine (e.g., for spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Medical Valley before and after the procedure or catheter removal at the times specified by your doctor,

and tell your doctor immediately if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

• tell your doctor immediately if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia.

Children and adolescents

Rivaroxaban Medical Valley 10 mg tablets are not recommended for children under 30 kg. There is limited data on the use of rivaroxaban in children and adolescents for indications in adults.

Rivaroxaban Medical Valley with 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 for HIV or AIDS treatment (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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

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

before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley 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 increased risk of stomach or duodenal ulcers, they may prescribe a 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, an antibiotic.

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

before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be reduced. Your doctor will decide whether to use Rivaroxaban Medical Valley and whether you need to 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, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Medical Valley may cause dizziness (common 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 use 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 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. Take Rivaroxaban Medical Valley with food. Swallow the tablet(s) whole 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 the mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed Rivaroxaban Medical Valley tablet through a nasogastric tube.

How much to take

Adults

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

If you need a procedure to open up the 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 tablet of Rivaroxaban Medical Valley once daily (or one 10 mg tablet of Rivaroxaban Medical Valley once daily in case of kidney problems) in combination with an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the legs, lungs, and prevent new blood clots, the recommended dose is one 15 mg tablet of Rivaroxaban Medical Valley twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Medical Valley once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily. If you have kidney problems and are taking one 20 mg tablet of Rivaroxaban Medical Valley once daily, your doctor may decide to reduce the dose to one 15 mg tablet of Rivaroxaban Medical Valley 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 Medical Valley 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 tablet of Rivaroxaban Medical Valleyonce daily.
• The recommended dose for children and adolescents weighing 50 kg or moreis one 20 mgtablet of Rivaroxaban Medical Valleyonce daily.

Take each dose of Rivaroxaban Medical Valley with food, and drink a liquid (e.g., water or juice). Take the tablets at the same time every day. Consider setting an alarm to remind you. For parents or caregivers: observe the child to ensure they take the full dose. The dose of Rivaroxaban Medical Valley 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 divide the tabletto get a partial tabletdose. If a smaller dose is needed, other pharmaceutical forms, such as an oral suspension, may be more suitable. For children and adolescents who cannot swallow whole tablets, use a rivaroxaban-containing granule for oral suspension. If the oral suspension is not available, you can crush the Rivaroxaban Medical Valley tablet and mix it with water or apple sauce just before taking. After taking the mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed Rivaroxaban Medical Valley tablet through a nasogastric tube.

If you spit out or vomit the dose

• 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 the dose or have repeated vomiting after taking Rivaroxaban Medical Valley.

When to take Rivaroxaban Medical Valley

Take the tablet(s) 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. To prevent blood clots 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 Medical Valley at the time specified by your doctor.

If you take more Rivaroxaban Medical Valley than you should

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

If you forget to take 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) in one day. The next day, continue taking one 15 mg tablet twice a day.

If you stop taking 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 prevent blood clots, Rivaroxaban Medical Valley may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding is obvious or visible.

Tell your doctor immediately 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 consciousness, and stiffness in the neck. This is a serious medical emergency. Seek medical help 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 monitor you closely 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 (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).

Common side effects(may affect up to 1 in 10 people)

• reduced red blood cell count, which may cause paleness and be the reason for 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, gum bleeding,
• bleeding into the eye (including bleeding into the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• 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 may be seen in laboratory tests),
• fever,
• stomach pain, 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,
• increased activity of certain liver enzymes, which may be seen 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,
• low platelet count (thrombocytopenia),
• allergic reactions, including skin allergic reactions,
• liver problems (which may be seen in laboratory tests),
• blood test results may show increased bilirubin, certain liver or pancreatic 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 the muscles,
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local 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).

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, sensation changes, 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 Medical Valley 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 side effects(affect more than 1 in 10 patients)

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

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

• rapid heartbeat,
• blood test results may show increased bilirubin (a bile pigment),
• low platelet count (thrombocytopenia),
• excessive menstrual bleeding.

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

• blood test results may show increased direct bilirubin (a bile pigment).

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 that month. There are no special storage instructions for this medicine. 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, red iron oxide (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 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 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

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, Holland: 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 leaflet:

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