Rivaroxaban Medical Vallei

Leaflet attached to the packaging: information for the user

Rivaroxaban Medical Valley, 10 mg, coated tablets

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

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

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

Rivaroxaban Medical Valley contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins in 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 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 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 that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery 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 the patient suspects that any of the above circumstances apply to them.

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:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when switching to anticoagulant treatment or when heparin is administered to maintain the patency of a vein or artery catheter (see "Rivaroxaban Medical Valley and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment with medicines,
• 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 (stomach acid flowing back 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 dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), the patient should inform their 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 any of the above conditions apply to them, they should inform

their doctorbefore taking Rivaroxaban Medical Valley. The doctor will decide whether to prescribe this medicine and whether the patient should be monitored particularly closely.

If the patient needs to undergo surgery:

• it is very important to take Rivaroxaban Medical Valley before or after surgery at the exact times specified 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 pain relief):
• it is very important to take Rivaroxaban Medical Valley at the exact times specified by the doctor,
• the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder problems, or other symptoms occur after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Medical Valley 10 mg tablets are not recommended for people 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 plan to 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 in 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 prevent 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 noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects that any of the above conditions apply to them, they should inform

their doctorbefore taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be enhanced. The doctor will decide whether to prescribe this medicine and whether the patient should be monitored particularly closely.
If the doctor believes that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent stomach 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 the patient suspects that any of the above conditions apply to them, 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 prescribe this medicine and whether the patient should be monitored particularly closely.

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 while taking Rivaroxaban Medical Valley. If you become pregnant while taking this medicine, you should inform 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 operate tools or machines.

Rivaroxaban Medical Valley 10 mg contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the 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 Medical Valley

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one Rivaroxaban Medical Valley 10 mg tablet once a day.
• To treat blood clots in the veins in the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clotsAfter at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Medical Valley 10 mg once a day for you.

Swallow the tablet, preferably with water.
Rivaroxaban Medical Valley can be taken with or without food.
If you have difficulty swallowing the whole tablet, 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 administer the crushed Rivaroxaban Medical Valley tablet through a gastric tube.

When to take Rivaroxaban Medical Valley

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as it is easier to remember.
Your doctor will decide how long to continue treatment.
To prevent blood clots in the veins in the legs after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks for patients after major hip surgery.
Treatment usually lasts 2 weeks for patients after major knee surgery.

Taking a higher dose of Rivaroxaban Medical Valley than recommended

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

Missing a dose of Rivaroxaban Medical Valley

If you forget to take a dose, take the tablet as soon as you remember.
Take the next tablet the next day, and then take the tablets as usual, once a day. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Rivaroxaban Medical Valley

Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor, as Rivaroxaban Medical Valley prevents a serious condition.
If you have any further doubts about taking this medicine, consult 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 with similar anticoagulant effects, 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.

Inform 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 level of consciousness, and stiffness of the neck. A serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. Your doctor may decide to monitor you very closely or change your 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).
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 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 up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in up to 1 in 100 people).

General list of possible side effects

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

• decrease in 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),
• appearance 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 (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and 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 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 (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, 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 muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• local 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 (pseudoaneurysm).

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 inflammation in the lungs (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 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the 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 packaging and other information

What Rivaroxaban Medical Valley contains

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K30, pregelatinized 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 what the pack contains

Rivaroxaban Medical Valley 10 mg coated tablets are round, pink, biconvex, approximately 6 mm in diameter, smooth on one side, and marked with "10" on the other side.
Tablets are available in blisters, in cardboard boxes, containing 10, 28, 30, 56, 98, or 100 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 10 mg, film-coated tablets
Iceland
Rivaroxaban Medical Valley 10 mg film-coated tablets
Germany
Rivaroxaban AXiromed 10 mg film-coated tablets
Norway
Rivaroxaban Medical Valley
Poland
Rivaroxaban Medical Valley
Sweden
Rivaroxaban Medical Valley 10 mg film-coated tablets

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