Rivaroxaban Tarbis 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Tarbis 15 mg film-coated tablets EFG

Rivaroxaban Tarbis 20 mg film-coated tablets EFG

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

• Keep this leaflet. 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 may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Rivaroxaban Tarbis contains the active substance rivaroxaban.

Rivaroxaban Tarbis 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 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 these blood clots from recurring in the blood vessels of the legs and/or lungs.

Rivaroxaban Tarbis 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 blood clots in the veins or in the blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Rivaroxaban Tarbis 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 Tarbis

Do not take Rivaroxaban Tarbis

• 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 medicines 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 a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rivaroxaban Tarbis.

Take special care with Rivaroxaban Tarbis

• 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 Tarbis”)

• bleeding disorders

• uncontrolled high blood pressure

• stomach or intestinal diseases that may cause bleeding, such as inflammatory bowel disease or stomach inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid flows back up into the esophagus]), or tumors in the stomach, intestines, genital tract, or urinary tract

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

• a lung disease in which the bronchi are widened and 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 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 Rivaroxaban Tarbis. 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 Tarbis 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 anaesthesia, or pain relief):

• It is very important to take Rivaroxaban Tarbis 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 the anaesthesia ends, as urgent medical attention is required.

Children and adolescents

Rivaroxaban Tarbis tablets are not recommended for children weighing less than 30 kg.

There is insufficient information on the use of Rivaroxaban Tarbis in children and adolescents for adult indications.

Other medicines and Rivaroxaban Tarbis

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

• medicines 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 too much cortisol)

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

• antiviral medicines 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 Rivaroxaban Tarbis, as the effect of Rivaroxaban Tarbis 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 a stomach or intestinal ulcer, they may recommend additional preventive treatment.

• If you are taking

• medicines 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 Rivaroxaban Tarbis, as the effect of Rivaroxaban Tarbis 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 Tarbis if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking Rivaroxaban Tarbis. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide on the appropriate course of treatment.

Driving and using machines

Rivaroxaban Tarbis 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.

Rivaroxaban Tarbis contains lactose and sodium

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

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

3. How to take Rivaroxaban Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

You should take Rivaroxaban Tarbis with food.

Swallow the tablets whole, 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 blood clots in the brain (stroke) or in other blood vessels of the 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 to undergo 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 blood clots from recurring

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 one 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 the risk of bleeding is greater than the risk of having another blood clot.

• Children and adolescents

The dose of Rivaroxaban Tarbis 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 dose of Rivaroxaban Tarbis 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 the alternative oral suspension granule formulation of rivaroxaban. For children and adolescents who cannot swallow whole tablets, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix it with water or apple puree immediately before taking it. 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 the dose or vomit

• less than 30 minutes after taking rivaroxaban, take a new dose.
• more than 30 minutes after taking rivaroxaban, do not take a new 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 Tarbis.

When to take Rivaroxaban Tarbis

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 blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heart rhythm using a procedure called cardioversion, take rivaroxaban at the times your doctor has indicated.

If you forget to take Rivaroxaban Tarbis

• Adults, children and adolescents:

If you are taking one 20 mg 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 each day.

• 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 Tarbis 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Rivaroxaban Tarbis

Do not stop treatment with rivaroxaban without first consulting 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, Rivaroxaban Tarbis may cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, Rivaroxaban Tarbis can cause bleeding that may be life-threatening. Excessive bleeding may 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, which may be signs of bleeding.

Your doctor may decide to monitor you more closely 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 with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.

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 observed in adults, children and adolescents

Common adverse effects (may affect up to 1 in 10 people)

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

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

• 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, platelets being cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, certain pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

Rare adverse effects (may affect up to 1 in 1,000 people)

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

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

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

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with Rivaroxaban Tarbis were of a similar type to those observed 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 an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, platelets being cells that help blood clotting)
• heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Tarbis

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

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

No special storage conditions are required.

In-use shelf life: 90 days after first opening the HDPE container.

Crushed tablets

Crushed tablets are stable in water or apple purée for up to 4 hours.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the Rivaroxaban Tarbis packaging

Composition of Rivaroxaban Tarbis

The active substance is rivaroxaban.

Rivaroxaban Tarbis 15 mg film-coated tablets

Each tablet contains 15 mg of rivaroxaban.

Rivaroxaban Tarbis 20 mg film-coated tablets

Each tablet contains 20 mg of rivaroxaban.

The other components are:

Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose (2910), sodium lauryl sulfate, magnesium stearate.

Film coating: hypromellose (2910), macrogol (E1521), titanium dioxide (E 171), iron oxide black (E172), iron oxide yellow (E172).

Appearance of the product and contents of the packaging

Rivaroxaban Tarbis 15 mg film-coated tablets

Biconvex, round, film-coated tablets, grey in colour, with an approximate diameter of 5.7 mm, engraved with "R22" on one side and "H" on the other.

Rivaroxaban Tarbis 20 mg film-coated tablets

Biconvex, round, film-coated tablets, light grey in colour, with an approximate diameter of 6.4 mm, engraved with "R23" on one side and "H" on the other.

Transparent PVC/PVDC-aluminium blisters in cartons containing 10, 14, 28, 42, 50, 98 and 100 film-coated tablets.

HDPE bottles with child-resistant plastic caps containing 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer responsible

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Rivaroxaban Amarox 15 mg/20 mg Filmtabletten

Spain: Rivaroxaban Tarbis 15 mg/20 mg film-coated tablets EFG

The Netherlands: Rivaroxaban Amarox 15 mg/20 mg, filmomhulde tabletten

Date of the most recent revision of this leaflet:

11/23

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/