Rivaroxaban Medical Vallei

Package Leaflet: Information for the User

Rivaroxaban Medical Valley, 2.5 mg, Film-Coated Tablets

Rivaroxaban

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

• Keep this package leaflet, as 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 package 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

You have been given Rivaroxaban Medical Valley because:

• you have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, severe chest pain) and have elevated levels of certain blood tests related to the heart. Rivaroxaban Medical Valley reduces the risk of having another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Medical Valley will not be given to you as the only medicine. Your doctor will also prescribe you to take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.
• you have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Medical Valley reduces the risk of blood clots (thrombotic events) in adults. Rivaroxaban Medical Valley will not be given to you as the only medicine. Your doctor will also prescribe you to take aspirin. In some cases, if you are taking Rivaroxaban Medical Valley after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take for a short time in addition to aspirin.

Rivaroxaban Medical Valley contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action is to block the blood clotting factor (factor Xa) and thereby reduce the tendency to form blood clots.

2. Important information before taking 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 excessive bleeding,
• if you have 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 brain or eye surgery),
• if you are 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 you have been diagnosed with acute coronary syndrome and have had bleeding or a blood clot in the brain (stroke),
• if you have been diagnosed with coronary artery disease or peripheral arterial disease and have had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the tissues in the deep structures of the brain (sinus thrombosis) or if you have had a blood clot in the brain (ischemic stroke) in the last month,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are 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 to take Rivaroxaban Medical Valley, discuss it with your doctor or pharmacist. Rivaroxaban Medical Valley should not be taken with other medicines that reduce blood clotting, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

When to be careful when taking Rivaroxaban Medical Valley

• if you have an increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• 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 section "Rivaroxaban Medical Valley and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines or 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 of the back of the eye (retinopathy),
• pulmonary disease in which the bronchi are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you are over 75 years old,
• if you weigh less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• 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 the treatment.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Rivaroxaban Medical Valley. Your doctor will decide whether to use this medicine and whether you should 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 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 specified by your doctor,
• you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems, or back pain after the anesthesia has worn off, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Medical Valley 2.5 mg film-coated tablets are not recommended for persons under 18 years of age.
There is a lack of sufficient data on the use of rivaroxaban in children and adolescents.

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 that are 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,
• 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, prasugrel and ticagrelor (see section "Warnings and precautions")),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform

your doctorbefore 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 should be closely monitored.
If your doctor thinks that you are at increased risk of developing stomach or duodenal ulcers, he may use 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 to treat depression,
• rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform

your doctorbefore 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 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, you should use effective contraception during treatment with Rivaroxaban Medical Valley. If you become pregnant while taking this medicine, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban Medical Valley may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, "Possible side effects").
If you experience these side effects, do not drive, ride a bicycle, or use tools or machines.

Rivaroxaban Medical Valley 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 (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.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban Medical Valley should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food.
If you have difficulty swallowing whole tablets, you should 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 it.
If necessary, your doctor may give you a crushed Rivaroxaban Medical Valley tablet through a gastric tube.
Rivaroxaban Medical Valley will not be given to you as the only medicine.
Your doctor will also prescribe you to take aspirin. If you are taking Rivaroxaban Medical Valley after an acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine for you to take.
If you are taking Rivaroxaban Medical Valley after a procedure to open up a narrowed or blocked artery in your leg to restore blood flow, your doctor may prescribe clopidogrel for you to take for a short time in addition to aspirin.
Your doctor will tell you what doses of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rivaroxaban Medical Valley

Treatment with Rivaroxaban Medical Valley after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the latest 24 hours after hospital admission and when parenteral (by injection) anticoagulant treatment would normally be discontinued.
Your doctor will tell you when to start treatment with Rivaroxaban Medical Valley if you have been diagnosed with coronary artery disease or peripheral arterial disease.
Your doctor will decide how long to continue treatment.

Taking more than the recommended dose of Rivaroxaban Medical Valley

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

Missing a dose of Rivaroxaban Medical Valley

Do not take a double dose to make up for a missed dose. If you miss a dose, you should take the next dose at the usual time.

Stopping treatment with Rivaroxaban Medical Valley

Rivaroxaban Medical Valley should be taken regularly and for the duration recommended by your doctor.
Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor. If you stop taking this medicine, you may increase the risk of having another heart attack, stroke, or death due to heart or blood vessel disease.
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.
Like other medicines that reduce blood clotting, 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.

You should 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. A serious medical emergency. You should immediately seek medical help!),
• 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 the 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; difficulty swallowing; hives and difficulty breathing; a 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

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

• reduction in 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 genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) 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 problems (which can be seen in tests performed by your 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 certain liver enzymes, which can 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: signs of bleeding described above),
• 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, activity of certain 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 the muscles,
• cholestasis (bile stagnation), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localized swelling,
• collection of blood (hematoma) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg.

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

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

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

• kidney failure after severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant drugs),
• 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).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. 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
Phone: +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
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 that are no longer needed. 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 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, sodium starch glycolate, 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 (E 1521), yellow iron oxide (E 172).

What Rivaroxaban Medical Valley looks like and contents of the pack

Rivaroxaban Medical Valley 2.5 mg film-coated tablets are round, yellow, biconvex, approximately 6 mm in diameter, smooth on one side and marked with "2.5" on the other side.
The tablets are packaged in blisters, which are packed in cardboard boxes, containing 20, 28, 56, 100, or 196 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 2.5 mg, film-coated tablets
Iceland
Rivaroxaban Medical Valley 2.5 mg film-coated tablets
Germany
Rivaroxaban AXiromed 2.5 mg film-coated tablets
Norway
Rivaroxaban Medical Valley
Poland
Rivaroxaban Medical Valley
Sweden
Rivaroxaban Medical Valley 2.5 mg film-coated tablets

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