RIVAROXAB 15 mg + 20 Mg Hard Capsules

Contents of the leaflet

1. Introduction
2. What is Rivaroxaban Stada and what is it used for
3. What you need to know before taking Rivaroxaban Stada
4. How to take Rivaroxaban Stada
5. Possible side effects
6. Storage of Rivaroxaban Stada
7. Package Contents and Additional Information
8. Composition of Rivaroxaban Stada
9. Marketing Authorization Holder and Manufacturer

Introduction

Package Leaflet: Information for the User

Rivaroxaban Stada 15 mg + 20 mg Hard Capsules EFG

Starting Treatment Pack

Not for use in children.

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rivaroxaban Stada and what is it 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 further information

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

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

• 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 occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a factor involved in blood clotting (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before taking Rivaroxaban Stada

Do not take Rivaroxaban Stada

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have excessive bleeding
• if you have a disease or condition that increases the risk of severe bleeding (e.g. stomach ulcer, injury or bleeding in the brain or recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to anticoagulant treatment or while being administered heparin through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take rivaroxaban and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rivaroxaban.

Be particularly careful with Rivaroxaban Stada

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

• severe kidney failure, as kidney function may affect the amount of medicine that works in the body
• if you are taking other medicines to prevent blood clotting (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 it from becoming blocked (see section "Other medicines and Rivaroxaban Stada")
• bleeding disorder
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as intestinal or stomach inflammation, or inflammation of the esophagus (e.g. due to gastroesophageal reflux disease), or tumors located in the stomach, intestines, genital or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding

• if you have a heart valve prosthesis
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clotting), inform your doctor to decide if it may be necessary to modify the treatment.
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs

Tell your doctorif you have any of these conditionsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If you need surgery

• It is very important to take rivaroxaban before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia, or pain relief):

• It is very important to take rivaroxaban, before and after the injection or removal of the catheter, exactly at the times indicated by your doctor.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder at the end of anesthesia, as urgent attention is needed.

Children and adolescents

The starting treatment pack for rivaroxaban is not recommended for persons under 18 years of age,as it is specifically designed for starting treatment in adult patients and is not suitable for use in children and adolescents.

Other medicines and Rivaroxaban Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 it is only applied to the skin
• tablets containing ketoconazole (used to treat Cushing's syndrome, in which 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 or pain relievers (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for treating irregular heartbeat
• certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you, tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be increased. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

If your doctor considers that you have a higher risk of developing a stomach or intestinal ulcer, they may also recommend a preventive treatment.

• If you are taking

• any medicine for treating epilepsy(phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum),a herbal medicine for treating depression
• rifampicin,an antibiotic.

If any of the above circumstances apply to you,tell your doctorbefore taking rivaroxaban, as the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take rivaroxaban if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medicine, tell 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 use tools or machines if you are affected by these symptoms.

Rivaroxaban Stada contains lactose

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

Rivaroxaban Stada contains sodium

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

3. How to take Rivaroxaban Stada

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

You must take rivaroxaban with food.

Swallow the capsule(s) whole, preferably with water.

If you have difficulty swallowing the capsule whole, consult your doctor about other ways to take rivaroxaban. The contents of the capsule can be mixed with water or apple puree immediately before taking it. Then take food.

If necessary, your doctor may also administer the contents of the rivaroxaban capsule through a gastric tube.

What dose to take

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

This starting treatment pack for rivaroxaban 15 mg and 20 mg is only for the first 4 weeks of treatment.

Once this pack is finished, treatment will continue with rivaroxaban 20 mg once a day, as indicated by your doctor.

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

When to take Rivaroxaban Stada

Take the capsule(s) every day, until your doctor tells you to stop.

Try to take the capsule(s) at the same time every day to remember when to take them.

Your doctor will decide how long you should continue taking the treatment.

If you take more Rivaroxaban Stada than you should

Call your doctor immediately if you have taken too many rivaroxaban capsules. 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rivaroxaban Stada

• If you are taking one 15 mg capsule twice a day, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in one day. If you miss a dose, you can take two 15 mg capsules at the same time, for a total of two capsules (30 mg) in one day. The next day, you should continue taking one 15 mg capsule twice a day.

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

If you stop taking Rivaroxaban Stada

Do not stop taking rivaroxaban without consulting your doctor first, as 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines for reducing blood clotting, rivaroxaban can cause bleeding that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

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

• Signs of bleeding

• bleeding in the brain or inside the skull (symptoms may include headache, weakness on one side, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. This is a serious medical emergency. Go to the doctor immediately!)

• prolonged or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina

Your doctor may decide to keep you under closer observation or change your treatment.

• Signs of severe skin reactions

• severe skin rash that spreads, blisters, or lesions on the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome)

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

• Signs of severe allergic reactions

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

The frequency of severe allergic reactions is 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 side effects

Common(may affect up to 1 in 10 people)

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into a tissue or cavity of the body (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
• pain in the limbs
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, tiredness), headache, dizziness
• rash, itching of the skin
• blood tests may show an increase in some 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, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or 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 (decreased bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin after a complication in heart surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

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

• accumulation of eosinophils, a type of white blood cell granulocyte that causes inflammation in the lung (eosinophilic pneumonia)

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

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (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 after bleeding)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, 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 carton and blister after "EXP". The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

The dissolved content of the capsule is stable in water or apple sauce for up to 4 hours.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rivaroxaban Stada

• The active substance is rivaroxaban.
• Each hard capsule contains 15 mg or 20 mg of rivaroxaban, respectively.

• The other ingredients are:

Capsule Content

Pregelatinized corn starch

Lactose monohydrate

Sodium carboxymethyl starch (type A) (potato)

Sodium lauryl sulfate

Colloidal anhydrous silica

Magnesium stearate

Coating of the 15 mg Capsule

Erythrosine (E127)

Yellow iron oxide (E172)

Titanium dioxide (E171)

Gelatin

Coating of the 20 mg Capsule

Red iron oxide (E172)

Black iron oxide (E172)

Yellow iron oxide (E172)

Titanium dioxide (E171)

Gelatin

Appearance and Package Contents of the Product

Rivaroxaban Stada 15 mg: hard capsule, orange-red in color, containing white or almost white powder.

Rivaroxaban Stada 20 mg: hard capsule, brown in color, containing white or almost white powder.

Package Sizes

The starter pack for the first four weeks is available in blisters containing 49 hard capsules:

• 42 hard capsules of rivaroxaban 15 mg
• 7 hard capsules of rivaroxaban 20 mg

The starter pack for the first four weeks is available in perforated unit-dose blisters containing 49 x 1 hard capsules:

• 42 x 1 hard capsules of rivaroxaban 15 mg
• 7 x 1 hard capsules of rivaroxaban 20 mg

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

4814NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

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

Date of the last revision of this leaflet:November 2023

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