Rivaroxaban Tarbis 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rivaroxaban Tarbis 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, and you should not give it to others, 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 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 and is used in adults for:

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you have a higher risk of developing blood clots after surgery.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from reoccurring in the blood vessels of the legs and/or lungs.

Rivaroxaban Tarbis 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 Tarbis

Do not take Rivaroxaban Tarbis

• if you are allergic to rivaroxaban or to 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 medicines 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 it from becoming blocked
• if you have 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 starting rivaroxaban.

Take special care with Rivaroxaban Tarbis

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

• moderate or severe kidney 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”)

• 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 oesophagus (gullet), for example due to gastroesophageal reflux disease (a condition where stomach acid rises up into the oesophagus)

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

• a lung disease where 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 so they can decide whether treatment adjustment may be necessary

• if your doctor determines that your blood pressure is unstable or 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 closer monitoring is required.

If you need surgery:

• It is very important to take rivaroxaban before and after surgery exactly as directed by your doctor.

• If your operation requires placement of a catheter or injection into the spinal column (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 needed.

Children and adolescents

Rivaroxaban is not recommended in individuals under 18 years of age. There is insufficient information on its use in children and adolescents.

Other medicines and Rivaroxaban Tarbis

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., ketoconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin
• ketoconazole tablets (used to treat Cushing's syndrome, a condition 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 acenocumarol)
• anti-inflammatory and pain-relieving medicines (e.g., naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat irregular heartbeat
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs))

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

If your doctor considers you to be at higher risk of developing stomach or intestinal ulcers, they may recommend that you also receive preventive ulcer 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 situations apply to you, inform your doctor before taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide whether you should be treated with rivaroxaban and whether closer monitoring is required.

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, who will decide on the appropriate course of treatment.

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.

Rivaroxaban contains lactose and sodium.

If your doctor has told 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; essentially “sodium-free”.

3. How to take Rivaroxaban Tarbis

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

What dose to take

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

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

Swallow the tablet, preferably with water.

Rivaroxaban can 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.

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

When to take Rivaroxaban Tarbis

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 the formation of 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rivaroxaban Tarbis

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

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

If you stop taking Rivaroxaban Tarbis

Do not stop treatment with 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 can cause adverse effects, although not everyone experiences them.

Like other similar medicines (antithrombotics), 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 inside 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

Your doctor will decide whether to monitor you more closely or adjust 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), causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.

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

• Signs of serious allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; breathing difficulties; 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

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• bleeding in the brain or inside 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)
• allergic reaction, including skin allergic reactions
• impaired liver function (may be detected in blood tests performed by your doctor)
• blood tests may show increased bilirubin, increased pancreatic or liver enzymes, or increased platelet count
• fainting
• feeling unwell
• increased heart rate
• dry mouth
• hives

Rare (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 as a complication after heart surgery involving insertion of a catheter into the leg artery (pseudoaneurysm)

Frequency not known (cannot be estimated from available data)

• kidney 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 due to hemorrhage)

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 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 Tarbis

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, following "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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Rivaroxaban Tarbis

The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.

The other components are:

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

Film coating: hypromellose (2910), titanium dioxide (E171), macrogol (E1521), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

The 10 mg film-coated tablets are orange, round, biconvex film-coated tablets with an approximate diameter of 8.1 mm, engraved with “R21” on one side and “H” on the other.

Transparent PVC/PVDC-aluminum blisters in packs of 10, 30, 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 for manufacturing

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 authorised in the European Economic Area member states under the following names:

Germany: Rivaroxaban Amarox 10 mg Filmtabletten

Spain: Rivaroxaban Tarbis 10 mg film-coated tablets EFG

Netherlands: Rivaroxaban Amarox 10 mg, filmomhulde tabletten

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/