Rivaroxaban medical valley

Package leaflet: Information for the user

Rivaroxaban Medical Valley, 2.5 mg, coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

You have been prescribed Rivaroxaban Medical Valley because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain) and elevated levels of certain blood test markers related to the heart. Rivaroxaban Medical Valley reduces the risk of further heart attacks 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 medication. Your doctor will also prescribe you to take:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine. or
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaroxaban Medical Valley reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Medical Valley will not be given to you as the only medication. Your doctor will also prescribe you to take acetylsalicylic acid. In some cases, if you are receiving Rivaroxaban Medical Valley after a procedure to restore blood flow in a narrowed or blocked artery of the lower limb, your doctor may additionally prescribe clopidogrel for a short period alongside acetylsalicylic acid.

Rivaroxaban Medical Valley contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), 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 active bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery 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 switching anticoagulant therapy or if heparin is administered to maintain patency of a catheter in a vein or artery,
• if the patient has been diagnosed with acute coronary syndrome and previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and previously had bleeding in the brain (hemorrhagic stroke), blockage of small arteries supplying blood to tissues in deep brain structures (lacunar stroke), or if the patient had an ischemic stroke (non-lacunar) within the last month,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban Medical Valley, and inform your doctor
if the patient suspects any of the above-mentioned conditions.
Warnings and precautions
Before starting Rivaroxaban Medical Valley, discuss it with your doctor
or pharmacist.
Rivaroxaban Medical Valley should not be used in combination with other anticoagulant medicines besides acetylsalicylic acid, clopidogrel or ticlopidine, such as
prasugrel or ticagrelor.
When to exercise special caution when using Rivaroxaban Medical Valley

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain patency of a catheter in a vein or artery (see section "Rivaroxaban Medical Valley and other medicines"),
  • coagulation disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammatory bowel disease or gastritis, or esophagitis (inflammation of the esophagus and throat), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus), or tumors located in the stomach, intestines, genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated airways filled with pus (bronchiectasis) or previous lung bleeding,
  • if the patient is over 75 years old,
  • if the patient weighs less than 60 kg,
  • coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is needed.

If the patient suspects any of the above conditions, they should inform their doctor
before taking Rivaroxaban Medical Valley. The doctor will decide whether to use
this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• it is very important to take Rivaroxaban Medical Valley exactly at the times indicated by the doctor, before or after surgery.
• if during surgery a catheter is planned to be inserted or a spinal puncture is to be performed (e.g. for epidural or intrathecal anesthesia or for pain relief):
  • it is very important to take Rivaroxaban Medical Valley exactly at the times indicated by the doctor, before and after the puncture or catheter removal,
  • the patient should immediately inform the doctor if, after anesthesia ends, they experience numbness or weakness in the legs, or disturbances in bowel or bladder function, as immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban Medical Valley 2.5 mg tablets are not recommended for patients under 18 years of age.
There is insufficient data on the use of rivaroxaban in children and adolescents.
Rivaroxaban Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those
available without prescription.

• If the patient is taking:
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless used only topically on the skin,
  • ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
  • certain antibiotics (e.g. clarithromycin, erythromycin),
  • certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir),
  • other medicines used to 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 acetylsalicylic acid),
  • dronedarone, a medicine used to treat heart rhythm disorders,
  • certain antidepressants (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects any of the above conditions, they should inform their doctor
before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be enhanced. The doctor will decide whether to use this medicine and whether
the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking:
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
  • St. John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
  • rifampicin, which belongs to the group of antibiotics.

If the patient suspects any of the above conditions, they should inform their doctor
before 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 requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Medical Valley if the patient is pregnant or breastfeeding.
If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Medical Valley. If the patient becomes pregnant while taking this medicine, they should immediately inform their doctor, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Medical Valley may cause dizziness (common adverse effect) or fainting (uncommon adverse effect) (see section 4, "Possible side effects").
If the patient experiences these adverse effects, they should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Medical Valley contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Medical Valley

This medicine should always be taken as directed by the physician. In case of doubt, consult the
physician or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaroxaban Medical Valley should be
taken approximately at the same time each day (for example, one tablet in the morning and one in
the evening). This medicine may be taken with or without food.
If the patient has difficulty swallowing the whole tablet, discuss alternative ways of taking
Rivaroxaban Medical Valley with the physician. The tablet may be crushed and mixed with water or
apple puree immediately before administration.
If necessary, the physician may administer crushed Rivaroxaban Medical Valley tablets via a
gastric tube.
Rivaroxaban Medical Valley will not be given to the patient as the only medication.
The physician will prescribe acetylsalicylic acid for the patient. If the patient is receiving
Rivaroxaban Medical Valley after an acute coronary syndrome, the physician may also prescribe
clopidogrel or ticlopidine.
If the patient is receiving Rivaroxaban Medical Valley after a procedure to restore blood flow by
clearing a narrowed or blocked artery in the lower limb, the physician may additionally prescribe
clopidogrel to be taken for a short period alongside acetylsalicylic acid.
The physician will inform the patient about the doses of these medications to take (usually 75–100 mg
of acetylsalicylic acid daily, or a daily dose of 75–100 mg acetylsalicylic acid plus a daily dose of
75 mg clopidogrel, or the standard daily dose of ticlopidine).
When to start taking Rivaroxaban Medical Valley
Treatment with Rivaroxaban Medical Valley after acute coronary syndrome should be initiated as
soon as possible after stabilization of the acute coronary syndrome, no earlier than 24 hours after
hospital admission and at the time when parenteral (by injection) anticoagulant treatment would
normally be discontinued.
The physician will inform the patient when to start treatment with Rivaroxaban Medical Valley if
coronary artery disease or peripheral arterial disease has been diagnosed.
The physician will decide how long treatment should continue.
Taking more than the recommended dose of Rivaroxaban Medical Valley
If the patient has taken more than the recommended dose of Rivaroxaban Medical Valley, contact
the physician immediately. Taking too high a dose of 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 the patient misses a dose, the next
dose should be taken at the usual time.
Stopping Rivaroxaban Medical Valley
Rivaroxaban Medical Valley should be taken regularly and for the duration recommended by the
physician. Do not stop taking Rivaroxaban Medical Valley without first consulting the physician.
If this medicine is discontinued, the risk of having another heart attack, stroke, or death due to
heart- or blood vessel-related disease may increase.
If there are any further questions about the use of this medicine, consult the physician or
pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Medical Valley may cause bleeding, which potentially can be life-threatening. Excessive
bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always
obvious or visible.
You should immediately inform your doctor if any of the following adverse reactions occur:
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 neck stiffness. A serious medical emergency. Seek immediate medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Signs of severe skin reactions:

• extensive, acute skin rash, formation of blisters or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions:

• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; 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 adverse reactions
Common adverse reactions (may occur in up to 1 in 10 people)

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding from the sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon adverse reactions (may occur in 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 function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dryness of the oral cavity,
• urticaria.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

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

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated month.
No special storage precautions are required.
Crushed tablets
Crushed tablets are stable in water or apple puree 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 in use. 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 2.5 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 (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 contained in blisters packed in cardboard cartons containing 20, 28, 56, 100, or 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer/Importer
Laboratorios LICONSA, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Denmark Rivaroxaban Medical Valley
Netherlands Rivaroxaban Xiromed 2.5 mg, filmomhulde tabletten
Iceland Rivaroxaban Medical Valley 2.5 mg filmuhúðaðar töflur
Germany Rivaroxaban AXiromed 2.5 mg Filmtabletten
Norway Rivaroxaban Medical Valley
Poland Rivaroxaban Medical Valley
Sweden Rivaroxaban Medical Valley 2.5 mg Filmdragerad tablett

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