Rivaroxaban Stada 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Stada 15 mg film-coated tablets EFG

Rivaroxaban Stada 20 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 may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Package leaflet contents

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

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

This medicine contains the active substance rivaroxaban.

Rivaroxaban 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 known as 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.

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.

Rivaroxaban 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 form clots.

2. What you need to know before starting to take Rivaroxaban Stada

Do not take Rivaroxaban

• 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 condition affecting an organ in your body that increases the risk of serious bleeding (for example, 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 liver disease that could increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Take special care with this medicine

• 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 Stada”)

• bleeding disorders

• very high blood pressure that is not controlled by medical treatment

• stomach or intestinal diseases that could cause bleeding, such as inflammatory bowel or stomach disease, oesophageal inflammation (e.g. due to gastro-oesophageal reflux disease (a condition where stomach acid moves up into the oesophagus), or tumours in the stomach, intestines, genital or urinary tract

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

• a lung disease where the bronchi are widened and filled with pus (bronchiectasis), or if you have previously had a lung bleed

• 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 your treatment needs to be adjusted

• 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 this medicine before and after surgery exactly at the times your doctor has instructed.

• 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 this medicine before and after the injection or removal of the catheter exactly at the times your doctor has instructed.

• 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

This medicine is not recommended for children weighing less than 30 kg.

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

Other medicines and Rivaroxaban Stada

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 a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin

• ketoconazole tablets (used to treat Cushing’s syndrome, where the body produces too much 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 painkillers (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 apply to you, inform your doctor before taking this medicine, as the effect of this medicine 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 you also use 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 apply to you, inform your doctor before taking this medicine, as the effect of this medicine may be reduced. Your doctor will decide whether you should be treated with this medicine and whether you need closer monitoring.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking this medicine. If you become pregnant while taking this medicine, inform your doctor immediately, who 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 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 Stada

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 this medicine with food.

Swallow the tablets whole, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take this medicine. The tablet may be crushed and mixed with water or apple puree immediately before administration. The mixture should be taken immediately, accompanied by food.

If necessary, your doctor may also administer this medicine via a crushed 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 require 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 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 beyond 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 your risk of bleeding is greater than the risk of developing 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 remind you. 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 doctor visits, as the dose may need to be adjusted as body weight changes.

Never adjust the dose of rivaroxaban 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 formulation of rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow the tablets whole, 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 some food after taking this mixture. If necessary, your doctor may also administer the crushed rivaroxaban tablet through a tube inserted into the stomach.

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If you spit out the dose or vomit

• less than 30 minutes after taking this medicine, take a new dose.
• more than 30 minutes after taking this medicine, do not take a new dose. In this case, take the next dose of this medicine at your usual time.

Call your doctor if, after taking this medicine, you repeatedly spit out the dose or vomit.

When to take Rivaroxaban Stada

Take the tablets every day, for as long as your doctor tells you to.

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 it is necessary to normalize your heart rhythm using a procedure called cardioversion, take this medicine at the times indicated by your doctor.

If you forget to take Rivaroxaban Stada

• Adults, children and adolescents:

If you are taking a 20 mg tablet or a 15 mg tablet once daily and you forget to take a dose, take it as soon as you remember. 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, and then continue taking one tablet each day.

• Adults:

If you are taking a 15 mg tablet twice daily and you forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forgot to take 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, you should continue taking the 15 mg tablet twice daily.

If you take more Rivaroxaban Stada than you should

Contact your doctor immediately if you have taken too many tablets of this medicine. 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 telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you stop treatment with Rivaroxaban Stada

Do not stop treatment with this medicine without first talking to your doctor, as this medicine 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, this medicine can cause bleeding that may be life-threatening. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Tell your doctor immediately if you or your child 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.

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 and 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 observed in adults, children, and adolescents

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, bleeding from gums
• bleeding in the eye (including bleeding in the white part of the eye)
• bleeding into body tissue or cavity (hematoma, bruising)
• coughing up blood
• skin bleeding or bleeding under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of limbs
• limb pain
• impaired kidney function (may be detected in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or lightheadedness, 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
• blood tests may show increased levels of certain liver enzymes.

Uncommon (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, cells that help blood clot)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be detected in tests performed by the doctor)
• blood tests may show increased levels of bilirubin, certain 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 traumatic 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).

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):

• 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 following 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 this medicine were similar in type to those observed in adults, and their severity was mostly mild to moderate.

Adverse effects observed more frequently in children and adolescents:

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

• headache
• fever
• nosebleeds
• vomiting

Frequent (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 clot)
• 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 reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Stada

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 blister and on the outer packaging after 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 purée for up to 4 hours.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Rivaroxaban Stada

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, povidone, pregelatinized starch (from maize), crospovidone, sodium lauryl sulfate, and magnesium stearate.

Tablet coating: hypromellose E464, titanium dioxide E171, macrogol 4000 E1521, and iron oxide red E172.

Appearance of the product and contents of the container

The 15 mg film-coated tablets are red, round, biconvex, with a diameter of approximately 6 mm.

They are packaged in blisters and unit-dose blisters, in cartons containing 10, 14, 15, 28, 30, 42, 45, 56, 98, and 100 film-coated tablets.

The 20 mg film-coated tablets are reddish-brown, round, biconvex, with a diameter of approximately 7 mm.

They are packaged in blisters and unit-dose blisters, in cartons containing 10, 14, 15, 28, 30, 42, 56, 98, and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

STADA Arzneimittel AG
Stadastrasse 2 - 18
61118 Bad Vilbel
Germany

or

STADA Arzneimittel GmbH
Muthgasse 36
1190 Wien
Austria

or

Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814NE Breda
The Netherlands

or

Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland

or

Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares - Guadalajara
Spain

or

Stada Nordic ApS
Marielundvej 46ª, Herlev
2730
Denmark

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State	Medicinal Product Name
Sweden	Rivaroxaban STADA 15 mg film-coated tablets Rivaroxaban STADA 20 mg film-coated tablets
Austria	Rivaroxaban STADA 15 mg Filmtabletten Rivaroxaban STADA 20 mg Filmtabletten
Belgium	Rivaroxaban EG 15 mg film-coated tablets Rivaroxaban EG 20 mg film-coated tablets
Germany	Rivaroxaban AL 15 mg Filmtabletten Rivaroxaban AL 20 mg Filmtabletten
Denmark	Rivaroxaban STADA 15 mg film-coated tablets Rivaroxaban STADA 20 mg film-coated tablets
Estonia	Rivaroxaban STADA
Greece	Rivaroxaban / Stada
Spain	Rivaroxaban STADA 15 mg film-coated tablets EFG Rivaroxaban STADA 20 mg film-coated tablets EFG
Finland	Rivaroxaban STADA 15 mg kalvopäällysteiset tabletit Rivaroxaban STADA 20 mg kalvopäällysteiset tabletit
France	RIVAROXABAN EG 15 mg, comprimé pelliculé RIVAROXABAN EG 20 mg, comprimé pelliculé
Hungary	Rivaroxaban STADA 15 mg filmtabletta Rivaroxaban STADA 20 mg filmtabletta
Ireland	Rivaroxaban Clonmel 15 mg film-coated tablets Rivaroxaban Clonmel 20 mg film-coated tablets
Iceland	Rivaroxaban STADA 15 mg film-coated tablets Rivaroxaban STADA 20 mg film-coated tablets
Lithuania	Rivaroxaban STADA 15 mg plevele dengtos tabletes Rivaroxaban STADA 20 mg plevele dengtos tabletes
Luxembourg	Rivaroxaban EG 15 mg film-coated tablets Rivaroxaban EG 20 mg film-coated tablets
Latvia	Rivaroxaban Stada 15 mg apvalkotas tabletes Rivaroxaban Stada 20 mg apvalkotas tabletes
Netherlands	Rivaroxaban CF 15 mg, filmomhulde tabletten Rivaroxaban CF 20 mg, filmomhulde tabletten
Norway	Rivaroxaban STADA
Portugal	Rivaroxaban Ciclum
Romania	Rivaroxaban STADA 15 mg film-coated tablets Rivaroxaban STADA 20 mg film-coated tablets
Sweden	Rivaroxaban STADA 15 mg film-coated tablets Rivaroxaban STADA 20 mg film-coated tablets

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

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