Rivaroxaban Teva 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Teva 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing blood clots after surgery.
• 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 recurring in the blood vessels of the legs and/or lungs.

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

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 severe 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 between anticoagulant treatments or while receiving heparin through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases 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, as may occur in the following situations:

• severe renal impairment, 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

• uncontrolled high blood pressure despite medical treatment

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

• a blood vessel problem at the back of the eyes (retinopathy)

• a lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding

• 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 treatment adjustment may be needed

• if your doctor determines your blood pressure is unstable or you are scheduled to receive another treatment or undergo a 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 as directed by your doctor.

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

• It is very important to take rivaroxaban exactly as directed by your doctor.

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

Children and adolescents

Rivaroxaban 10 mg tablets are not recommended for children and adolescents under 18 years of age. There is insufficient information on its use in this population.

Other medicines and Rivaroxaban Teva

Tell 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), unless 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 medicines and pain relievers (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 at higher risk of developing stomach or intestinal ulcers, they may recommend additional preventive ulcer treatment.

If you are taking:

• any medicine for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St John's wort (Hypericum perforatum), a herbal remedy for 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 this medicine, inform your doctor immediately. Your doctor will decide on the appropriate treatment.

Driving and using machines

This medicine 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 with them 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.

What dose to take

• To prevent blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one rivaroxaban 10 mg tablet once daily.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring.

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 10 mg once daily.

Swallow the tablet whole, preferably with water.

Rivaroxaban may be taken with or without food.

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

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

When to take Rivaroxaban Teva

Take the tablet every day, until your doctor tells you otherwise.

Try to take one tablet at the same time each day, to help you remember.

Your doctor will decide how long you should continue treatment.

To prevent blood clots in the veins after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.

If you have undergone major hip surgery, you will usually take tablets for 5 weeks.

If you have undergone major knee surgery, you will usually take tablets for 2 weeks.

If you take more Rivaroxaban Teva than you should

Call 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 Poison Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Rivaroxaban Teva

If you forget to take a dose, take it as soon as you remember. Take the next dose the following day at the usual time, and then continue taking one tablet daily as usual.

Do not take a double dose to make up for a missed dose.

If you stop taking Rivaroxaban Teva

Do not stop taking rivaroxaban without first talking to your doctor, because Rivaroxaban prevents the development of a serious condition.

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

4. Possible adverse effects

Like all medicines, rivaroxaban may cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, rivaroxaban can cause bleeding, which 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 adverse effects:

• Signs of bleeding

• bleeding in the brain or within the skull (symptoms may include headache, weakness on one side of the body, 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 modify your treatment.

• Signs of severe skin reactions

• severe skin rashes that spread, blisters, or mucosal lesions, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis). The frequency of this adverse effect is very rare (up to 1 in 10,000).

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

The frequency of this adverse effect is very rare (up to 1 in 10,000).

• Signs of severe allergic reactions

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

The frequencies of severe 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:

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

• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• stomach or intestinal bleeding, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from gums
• eye bleeding (including bleeding in the white part of the eye)
• bleeding into tissue or body cavity (hematoma, bruising)
• coughing up blood
• skin bleeding or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• fever
• stomach pain, indigestion, dizziness or feeling faint, 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 seen 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, the cells that help blood clot)
• fainting
• feeling unwell
• dry mouth
• increased heart rate
• allergic reaction, including skin allergic reaction
• hives
• impaired liver function (may be seen in tests performed by your doctor)
• blood tests may show increased bilirubin levels, increased pancreatic or liver enzymes, or increased platelet count

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

• muscle bleeding
• cholestasis (reduced bile flow), hepatitis, including hepatocellular liver injury (liver inflammation or damage)
• localized swelling
• yellowing of the skin and eyes (jaundice)
• accumulation of blood (hematoma) in the groin as a complication after cardiac surgery involving insertion of a catheter 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 (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 due to hemorrhage)
• kidney bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy)
• renal failure following severe bleeding.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly 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 which is stated on the pack 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 should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of any containers and medicines 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 10 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), titanium dioxide (E171), macrogol 3350, talc (E553b), carmine (E120), yellow iron oxide (E172) and red iron oxide (E172).

Nature of the product and contents of the pack

Rivaroxaban Teva 10 mg film-coated tablets are pink, round tablets, approximately 8 mm in diameter, marked with "T" on one side and "1R" on the other.

They are available in:

• unit dose blisters of 5x1, 10x1, 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85818/P_85818.html