Rivaroxaban medical valley

Package leaflet: Information for the user

Rivaroxaban Medical Valley, 15 mg, film-coated tablets
Rivaroxaban Medical Valley, 20 mg, film-coated tablets
Rivaroxabanum
Please read 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

This medicine contains the active substance rivaroxaban.
Rivaroxaban Medical Valley is used in adults to:

• prevent blood clots from forming in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins 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 blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the 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. 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 in the brain, recent surgery on the brain or eye),
• if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• if the patient has liver disease leading to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban Medical Valley, and inform your doctor
if you suspect any of the above-mentioned circumstances apply.
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:
  • severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, 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 the patency of a catheter in a vein or artery (see section "Rivaroxaban Medical Valley and other medicines"),
  • blood clotting 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 oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (acid from the stomach flowing back into the oesophagus), or tumours located in the stomach, intestines, reproductive 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,
• 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 treatment needs to be changed,
• if the patient has unstable blood pressure or if surgery or other treatment to remove a blood clot from the lungs is planned.

If you suspect any of the above-mentioned conditions, inform your 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 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 anaesthesia or for pain relief):

  • it is very important to take Rivaroxaban Medical Valley before and after the
    puncture or removal of the catheter exactly at the times indicated by the doctor,

• immediately inform the doctor if, after the anaesthesia ends, numbness or weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment will be required.

Children and adolescents
Rivaroxaban Medical Valley 10 mg tablets are not recommended for children weighing less than
30 kg. There is insufficient data on the use of rivaroxaban in children and adolescents for the indications approved in adults.
Rivaroxaban Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained 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-norepinephrine reuptake inhibitors (SNRI)).

If you suspect any of the above-mentioned conditions, inform your 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), an herbal medicine used for depression,
  • rifampicin, an antibiotic.

If you suspect any of the above-mentioned conditions, inform your 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, inform the doctor immediately, 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 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.
This 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 prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
Rivaroxaban Medical Valley should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative ways of taking Rivaroxaban Medical Valley with the doctor. The tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed promptly.
If necessary, the doctor may administer crushed Rivaroxaban Medical Valley tablets via a gastric tube.

How many tablets to take
Adults

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Medical Valley 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one Rivaroxaban Medical Valley 15 mg tablet once daily.

If the patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Medical Valley 15 mg tablet once daily (or one Rivaroxaban Medical Valley 10 mg tablet once daily in case of renal impairment), in combination with an antiplatelet agent such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrent blood clots: The recommended dose is one Rivaroxaban Medical Valley 15 mg tablet twice daily for the first 3 weeks. After 3 weeks of treatment, the recommended dose is one Rivaroxaban Medical Valley 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily. If the patient has renal impairment and is taking one Rivaroxaban Medical Valley 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Medical Valley 15 mg tablet once daily if the risk of bleeding is greater than the risk of further blood clots.

Children and adolescents
The dose of Rivaroxaban Medical Valley depends on body weight and will be calculated by the doctor.

• Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one Rivaroxaban Medical Valley 15 mg tablet once daily.
• Recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Medical Valley 20 mg tablet once daily.

Each dose of Rivaroxaban Medical Valley should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: Monitor the child to ensure the full dose has been taken.
Since the dose of Rivaroxaban Medical Valley is based on body weight, it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in weight.
Never adjust the dose independently. If necessary, the doctor will adjust the dose.
Do not split the tablet to obtain a partial dose of the tablet. If a lower dose is required, other pharmaceutical forms such as granules for oral suspension may be more suitable.
For children and adolescents unable to swallow whole tablets, a medicinal product containing rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban Medical Valley tablet may be crushed and mixed with water or apple puree immediately before administration. After taking this mixture, a meal should be consumed. If necessary, the doctor may also administer crushed Rivaroxaban Medical Valley tablets via a gastric tube.

If a dose is vomited or spat out

• Less than 30 minutes after taking Rivaroxaban Medical Valley, take a new dose.
• More than 30 minutes after taking Rivaroxaban Medical Valley, do not take a new dose. In this case, take the next dose at the usual time.

Contact your doctor if there are repeated episodes of vomiting or spitting out the dose after taking Rivaroxaban Medical Valley.

When to take Rivaroxaban Medical Valley
Take the tablet(s) every day until the doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
The doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If heart rhythm needs to be restored to normal through a cardioversion procedure, Rivaroxaban Medical Valley should be taken for the duration recommended by the doctor.

Taking more than the recommended dose of Rivaroxaban Medical Valley
If a patient takes more than the recommended dose of Rivaroxaban Medical Valley, contact the doctor immediately. Taking too high a dose of Rivaroxaban Medical Valley increases the risk of bleeding.

Missed dose of Rivaroxaban Medical Valley

• Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in a single day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in a single day. If a dose was forgotten, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Stopping Rivaroxaban Medical Valley
Do not stop taking Rivaroxaban Medical Valley without first consulting your doctor, as Rivaroxaban Medical Valley treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, 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 can 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 inform your doctor if any of the following adverse reactions occur in an adult or a child:
Signs of bleeding:

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious, acute medical emergency. Seek immediate 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 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 with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological disorders and systemic involvement. 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 in adults, children and adolescents
  Common adverse reactions (may occur in up to 1 in 10 people)

• reduction in red blood cells, which may cause skin pallor and lead to weakness or shortness of breath,

• gastrointestinal bleeding or bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,

• bleeding into the eye (including conjunctival hemorrhage),

• bleeding into tissues or body cavities (hematoma, bruising),

• presence of blood in sputum (hemoptysis) during coughing,

• bleeding from the skin or subcutaneous bleeding,

• postoperative bleeding,

• oozing of blood or fluid from a 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, skin itching,

• 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 above),
• joint bleeding 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 test results 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 reactions (may occur in up to 1 in 1,000 people)

• muscle bleeding,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• localized 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 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 nephropathy associated with anticoagulant medicines),
• 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).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with Rivaroxaban
Medical Valley were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common adverse reactions (occur in more than 1 in 10 patients)

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

Common adverse reactions (occur in less than 1 in 10 patients)

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

Uncommon adverse reactions (occur in less than 1 in 100 patients)

• blood test results may show increased levels of a bilirubin subcategory (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 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 to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on each blister labelled: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
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 you no longer 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 15 mg or 20 mg of rivaroxaban.
• 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". 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 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 packed 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, reddish-brown, biconvex, approximately 7 mm in diameter, smooth on one side and marked with "20" on the other side.
The tablets are packed 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 Authorisation Holder and Manufacturer
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 European Economic Area countries under the following names:
Denmark Rivaroxaban Medical Valley
Netherlands 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

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