Rivaroxaban medical valley

Package leaflet: Information for the user

Rivaroxaban Medical Valley, 10 mg, film-coated tablets
Rivaroxabanum
Please 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

• prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery.
• treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to 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. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

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 leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eye),
• 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 catheter patency in a vein or artery,
• if the patient has 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 conditions have occurred.
Warnings and precautions
Before starting to take Rivaroxaban Medical Valley, discuss this with your doctor or pharmacist.
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:
  • moderate or 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 if heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Medical Valley with other medicines"),
  • bleeding disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus), 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 and pus-filled airways (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed,
• if the patient has been diagnosed with unstable blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects any of the above conditions, they should inform the 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 spinal anesthesia or for pain relief):
  • it is very important to take Rivaroxaban Medical Valley exactly at the times indicated by the doctor,
  • the patient should immediately inform the doctor if, after the anesthesia wears off, numbness or weakness in the legs, or bowel or bladder dysfunction occurs, as immediate treatment will then be necessary.

Children and adolescents
Rivaroxaban Medical Valley 10 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 with other medicines
Inform 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 a prescription.

• If the patient is taking:
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are 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),
  • 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects any of the above conditions, they should inform the 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 the doctor
before taking Rivaroxaban Medical Valley, as the effect of Rivaroxaban Medical Valley may be reduced. The doctor will decide whether to use this medicine 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, she should immediately inform the doctor, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Medical Valley may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Medical Valley 10 mg 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 exactly as your doctor has told you. If you are unsure,
you should consult your doctor or pharmacist.
How many tablets to take

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

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Medical Valley may be taken with or without food.
If you have difficulty swallowing the whole tablet, speak to your doctor about other ways of taking
Rivaroxaban Medical Valley. The tablet can be crushed and mixed with water or apple puree immediately before administration.
If necessary, your doctor may administer crushed Rivaroxaban Medical Valley tablets via a gastric tube.
When to take Rivaroxaban Medical Valley
You should take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts for 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts for 2 weeks.
Taking more than the recommended dose of Rivaroxaban Medical Valley
If you have taken more than the prescribed dose of Rivaroxaban Medical Valley, contact your doctor immediately. Taking too high a dose of Rivaroxaban Medical Valley increases the risk of bleeding.
If you miss 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 following day, and then continue taking the tablets as usual, once daily. Do not take a double dose to make up for a forgotten tablet.
Stopping Rivaroxaban Medical Valley
Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor, as Rivaroxaban Medical Valley helps prevent a serious medical condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Medical Valley may cause bleeding, which could potentially 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 contact your doctor if any of the following adverse effects 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. Immediate medical help should be sought!),
  • 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:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, hematological and systemic disorders (DRESS syndrome). The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).
• Signs of serious allergic reactions:
  • swelling of the face, lips, mouth, 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 effects
Common adverse effects (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, gum bleeding,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• swelling of limbs,
• 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 loss of strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon adverse effects (may occur in up to 1 in 100 people)

• bleeding into the brain or inside the skull (see bleeding signs above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, blood 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 bilirubin levels, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

Rare adverse effects (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,
• blood collection (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 effects (may occur in up to 1 in 10,000 people)

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

Adverse effects with unknown frequency (frequency cannot be determined from available data)

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

Reporting of adverse effects
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 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 instructions are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, 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 contents of the pack
Rivaroxaban Medical Valley 10 mg film-coated tablets are round, pink, biconvex, approximately 6 mm in diameter, smooth on one side and marked with "10" on the other side.
The tablets are available in blister packs within cardboard cartons containing 10, 28, 30, 56, 98 or 100 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 in the member states of the European Economic Area under the following names:
Denmark Rivaroxaban Medical Valley
Netherlands Rivaroxaban Xiromed 10 mg, filmomhulde tabletten
Iceland Rivaroxaban Medical Valley 10 mg filmuhúðaðar töflur
Germany Rivaroxaban AXiromed 10 mg Filmtabletten
Norway Rivaroxaban Medical Valley
Poland Rivaroxaban Medical Valley
Sweden Rivaroxaban Medical Valley 10 mg Filmdragerad tablett

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