Rivaroxaban Teva 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Teva 20 mg film-coated tablets PAG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rivaroxaban Teva is and what it is used for
2. What you need to know before taking Rivaroxaban Teva
3. How to take Rivaroxaban Teva
4. Possible side effects
5. How to store Rivaroxaban Teva
6. Contents of the pack and other information

1. What Rivaroxaban Teva is and what it is used for

This medicine contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a type of irregular heart rhythm 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 these blood clots from reoccurring in the blood vessels of the legs and/or lungs.

This medicine is used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, after an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa), thereby reducing the blood's tendency to form clots.

2. What you need to know before taking Rivaroxaban Teva

Do not take Rivaroxaban Teva

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or organ condition that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, or recent surgery on the brain or eyes)
• if you are taking medications to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or while receiving heparin through a venous or arterial catheter to prevent blockage
• if you have liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take this medicine and inform your doctor if any of these situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Take special care with Rivaroxaban Teva

• if you have an increased risk of bleeding, such as in the following situations:

• severe renal impairment in adults or moderate to severe renal impairment in children and adolescents, as kidney function may affect the amount of medicine active in your body

• if you are taking other medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter to prevent blockage (see section “Other medicines and Rivaroxaban Teva”)

• bleeding disorders

• very high blood pressure not controlled by medical treatment

• stomach or intestinal diseases that could cause bleeding, such as inflammation of the stomach or intestine, inflammation of the esophagus (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid rises up into the esophagus]) or tumors in the stomach, intestines, genital or urinary tract

• a problem in the blood vessels at the back of your eyes (retinopathy)

• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis), or if you have previously had bleeding in the lungs

• if you have a heart valve prosthesis

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether your treatment needs to be adjusted

• if your doctor determines that your blood pressure is unstable or if you are scheduled to receive another treatment or undergo a surgical procedure to remove a blood clot from your lungs

Inform your doctor if any of these situations apply to you before taking this medicine. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If you need surgery:

• It is very important to take rivaroxaban before and after surgery exactly at the times specified by your doctor.

• If your surgery requires placement of a catheter or injection into your spine (e.g., for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban before and after the injection or catheter removal exactly at the times specified by your doctor.

• Inform your doctor immediately if you experience numbness or weakness in your legs or problems with your bowel or bladder after anesthesia, as urgent medical attention is required.

Children and adolescents

Rivaroxaban 20 mg tablets are not recommended in children weighing less than 30 kg. There is insufficient information on the use of rivaroxaban in children and adolescents for adult indications.

Other medicines and Rivaroxaban Teva in patients under 18 years

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

• If you are taking:

• any medicine for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except when applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces excess cortisol)

• any medicine for bacterial infections (e.g., clarithromycin, erythromycin)

• any antiviral medicine for HIV/AIDS (e.g., ritonavir)

• other medicines to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol)

• anti-inflammatory and pain-relief medicines (e.g., naproxen or acetylsalicylic acid)

• dronedarone, a medicine used to treat irregular heartbeat

• certain medicines for depression (selective serotonin reuptake inhibitors [SSRIs] or serotonin-norepinephrine reuptake inhibitors [SNRIs])

If any of the above apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be increased. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

If your doctor considers you to be at higher risk of developing a stomach or intestinal ulcer, they may recommend additional preventive treatment.

• If you are taking:

• any medicine for epilepsy (phenytoin, carbamazepine, phenobarbital)

• St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression

• rifampicin, an antibiotic

If any of the above apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking rivaroxaban, inform your doctor immediately. Your doctor will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). You should not drive, ride a bicycle, or operate tools or machinery if you are affected by these symptoms.

This medicine contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Rivaroxaban Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

You should take this medicine with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before administration. Then, take food.

If necessary, your doctor may also administer the crushed rivaroxaban tablet through a gastric tube.

What dose to take

Adults

• To prevent the formation of blood clots in the brain (stroke) and other blood vessels in your body:

The recommended dose is one 20 mg rivaroxaban tablet once daily.

If you have kidney problems, the dose may be reduced to one 15 mg rivaroxaban tablet once daily.

If you need a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence supporting reducing the dose to one 15 mg rivaroxaban tablet once daily (or to one 10 mg rivaroxaban tablet once daily if your kidneys are not functioning properly), in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent recurrence of blood clots:

The recommended dose is one 15 mg rivaroxaban tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once daily.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.

If you have kidney problems and are taking a 20 mg rivaroxaban tablet once daily, your doctor may decide to reduce your treatment dose to one 15 mg rivaroxaban tablet once daily after 3 weeks if your risk of bleeding is higher than the risk of having another blood clot.

Children and adolescents

The dose of rivaroxaban depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one 15 mg rivaroxaban tablet once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg rivaroxaban tablet once daily.

Take each dose of rivaroxaban with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to help you remember.

For parents or caregivers: observe the child to ensure they take the full dose.

Since the dose of rivaroxaban is based on body weight, it is important to attend scheduled visits with your doctor, as the dose may need to be adjusted as body weight changes. Never adjust the rivaroxaban dose on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to obtain a fraction of the tablet dose. If a lower dose is required, please use another available alternative formulation of rivaroxaban.

For children and adolescents who cannot swallow the tablets whole, please use another available alternative formulation of rivaroxaban.

If another alternative formulation of rivaroxaban is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before administration. Take food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a tube inserted into the stomach.

If you spit out or vomit the dose

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

Call your doctor if you repeatedly spit out or vomit the dose after taking rivaroxaban.

When to start treatment with Rivaroxaban Teva

Take the tablets every day until your doctor tells you otherwise.

Try to take the tablets at the same time each day to help you remember when to take them.

Your doctor will decide how long you should continue treatment.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If a procedure called cardioversion is needed to normalize your heart rhythm, take rivaroxaban at the times indicated by your doctor.

If you forget to take Rivaroxaban Teva

Adults, children and adolescents:

• If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day and then continue taking one tablet daily.

Adults:

• If you are taking one 15 mg tablet twice daily and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you missed a dose, you may take two 15 mg tablets at once to obtain a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you take more Rivaroxaban Teva than you should

Contact your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much rivaroxaban increases the risk of bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Rivaroxaban Teva

Do not stop treatment with rivaroxaban without first talking to your doctor, because rivaroxaban treats and prevents serious conditions.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding that may be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Tell your doctor immediately if you experience any of the following symptoms:

• Signs of bleeding:

• bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical attention!)

• prolonged or excessive bleeding

• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, as these may be signs of bleeding.

Your doctor will decide whether to keep you under closer monitoring or change your treatment.

• Signs of serious skin reactions

• severe skin rashes that spread, blisters, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

• drug reaction causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

The frequency of these adverse effects is very rare (up to 1 in 10,000 people).

• Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; difficulty breathing; sudden drop in blood pressure.

The frequencies of serious allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible adverse effects reported in adults, children, and adolescents:

Common (may affect up to 1 in 10 patients):

• stomach or intestinal bleeding, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into tissue or body cavity (bruising, hematoma)
• coughing up blood
• bleeding of or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• fever
• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or faintness upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• impaired kidney function (may be detected in tests performed by your doctor)
• blood tests may show increased levels of certain liver enzymes

Uncommon (may affect up to 1 in 100 patients):

• bleeding in the brain or within the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• fainting
• feeling unwell
• dry mouth
• increased heart rate
• allergic reaction, including skin allergic reaction
• hives
• impaired liver function (may be detected in tests performed by your doctor)
• blood tests may show increased bilirubin, certain pancreatic or liver enzymes, or platelet count

Rare (may affect up to 1 in 1,000 patients):

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including hepatocellular liver injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery involving catheter insertion into the leg artery (pseudoaneurysm)

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

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

Frequency not known (frequency cannot be estimated from available data):

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

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar in type to those seen in adults, and their severity was mainly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

Very common (may affect more than 1 in 10 people):

• headache
• fever
• nosebleeds
• vomiting

Common (may affect up to 1 in 10 people):

• increased heart rate
• blood tests may show increased bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people):

• blood tests may show increased levels in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on each blister after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Teva

• The active substance is rivaroxaban. Each tablet contains 20 mg of rivaroxaban.
• The other components are:

Tablet core: sodium lauryl sulfate, lactose monohydrate, hypromellose, sodium croscarmellose and magnesium stearate.

Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), macrogol 3350, talc (E553b) and red iron oxide (E172).

Appearance of the product and contents of the pack

Rivaroxaban Teva 20 mg film-coated tablets are red, round tablets, approximately 8 mm in diameter, marked with "T" on one side and "7R" on the other.

They are available in:

• unit dose blisters of 10x1, 14x1, 28x1, 30x1, 90x1, 98x1, 100x1 or 112x1 film-coated tablets.
• bottles containing 100 or 200 (2x100) film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva GmbH

Graf-Arco-Str. 3

Ulm, 89079

Germany

Manufacturer

Balkanpharma - Dupnitsa AD

3, Samokovsko Shosse Str.

BG-2600 DUPNITSA

Bulgaria

or

Actavis Group PTC ehf,

Dalshraun 1, Hafnarfjoerdur,

220, Iceland

Local representative

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85820/P_85820.html