RIXACAM 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Rixacam 20 mg Hard Capsules EFG

rivaroxaban

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Rixacam and what is it used for

Rixacam contains the active substance rivaroxaban and 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 happening again in the veins and/or lungs.

Rixacam is used in children and adolescents under 18 years of age and with a body weight of 50 kg or more to:

• treat and prevent blood clots in the veins or in the blood vessels of the lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

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 you take Rixacam

Do not take Rixacam

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding problems
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, recent bleeding or lesions 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 from one anticoagulant treatment to another or when heparin is given through a vein or artery to keep it from getting blocked
• if you have liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be particularly careful with this medicine

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

• severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may affect the amount of medicine that works in your 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 vein or artery to keep it from getting blocked (see section "Other medicines and Rixacam")
• bleeding disorders
• very high blood pressure that is not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the stomach or intestines, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), or tumors in the stomach, intestines, genital tract, 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 have had a previous bleeding in the lungs

(bronchiectasis) or have had a previous bleeding in the lungs

• if you have a heart valve replacement
• if you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), 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 if you are scheduled to receive another treatment or undergo surgery to remove a blood clot from your lungs.

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

If you need to have surgery

• It is very important to take this medicine before and after the operation, exactly at the times your doctor indicates.
• If your operation requires the placement of a catheter or injection in the spine (e.g. for epidural or spinal anesthesia, 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 indicated.
• Tell your doctor immediately if you experience numbness or weakness in your legs or problems with your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

Rixacam 20 mg capsules are not recommended in children with a body weight below 50 kg. There is not enough information on its use in children and adolescents for adult indications.

Other medicines and Rixacam

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 it is only applied to the skin
• tablets with 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 prevent 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 for treating irregular heartbeat
• certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If any of these circumstances apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine 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 stomach or intestinal ulcers, they may recommend that you also use a treatment to prevent ulcers.

• 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 these circumstances apply to you, tell your doctorbefore taking this medicine, as the effect of this medicine 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 this medicine if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

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"). Do not drive, ride a bicycle, or use tools or machines if you are affected by these symptoms.

Rixacam contains lactose monohydrate (a type of sugar) and sodium

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

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

3. How to take Rixacam

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

You must take Rixacam with a meal.

Swallow the capsule preferably with water.

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

This mixture should be followed immediately by food.

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

What dose to take

Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels.

The recommended dose is one rivaroxaban 20 mg capsule once a day.

If you have kidney problems, the dose may be reduced to one rivaroxaban 15 mg capsule once a day.

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 to reduce the dose to one rivaroxaban 15 mg capsule once a day (or to one rivaroxaban 10 mg capsule once a day if your kidneys do not work properly) in addition to an antiplatelet medicine like 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 happening again.

The recommended dose is one Rixacam 15 mg capsule twice a day for the first 3 weeks.

For treatment after 3 weeks, the recommended dose is one Rixacam 20 mg capsule once a day.

After at least 6 months of anticoagulant treatment, your doctor may decide to continue treatment with one 10 mg capsule once a day or one 20 mg capsule once a day.

If you have kidney problems and are taking one Rixacam 20 mg capsule once a day, your doctor may decide to reduce the dose of treatment after 3 weeks to one Rixacam 15 mg capsule once a day if the risk of bleeding is greater than the risk of another blood clot.

Children and adolescents

The dose of Rixacam 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 kgis one Rixacam 15 mgcapsule once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rixacam 20 mgcapsule once a day.

Take each dose of Rixacam with a drink (e.g. water or juice) during a meal. Take the capsules 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 entire dose.

Since the dose of Rixacam is based on body weight, it is important to attend scheduled visits with the doctor, as it may be necessary to adjust the dose as weight changes.

Never adjust the dose of Rixacam on your own. Your doctor will adjust the dose if necessary.

Do not pour out the contents of the capsule to try to obtain a fraction of the dose of the capsule. If a smaller dose is required, please use the alternative presentation that contains rivaroxaban in the form of oral suspension granules.

In children and adolescents who cannot swallow the capsules whole, please use products that contain rivaroxaban in the form of oral suspension granules.

If the oral suspension is not available, you can pour out the contents of the Rixacam capsule 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 contents of the Rixacam capsule through a gastric tube.

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 nottake a new dose. In this case, take the next dose of this medicine at the usual time.

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

When to take Rixacam

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

Try to take the capsule at the same time every day, to help you remember.

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

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels:

If it is necessary to normalize your heartbeat through a procedure called cardioversion, take this medicine at the times your doctor has indicated.

If you take more Rixacam than you should

Call your doctor immediately if you have taken too many capsules of this medicine. Taking too much Rixacam increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rixacam

Adults, children, and adolescents:

• If you are taking one 20 mg capsule oncea day and have forgotten to take a dose, take it as soon as you remember. Do not take more than one capsule per day to make up for the forgotten dose. Take the next capsule the next day and continue taking one capsule per day.

If you stop taking Rixacam

Do not stop taking this medicine without talking to your doctor first, as this medicine prevents the development of a serious condition.

If you have any further questions on 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 all people suffer from them.

Like other similar medicines to reduce blood clot formation, this medicine can cause bleeding, which can endanger the patient's life. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Tellyour doctor immediately if you or the child suffer from 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 stiffness of the neck. This is a serious medical emergency. Go to the doctor immediately!).
• prolonged or excessive bleeding.
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina.

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

• Signs of severe skin reactions

• intense skin rashes that spread, 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 adverse 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 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 found in adults, children, and adolescents

Frequent(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 hemorrhage (including blood in the 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 cavity of the body (hematoma, bruising)
• bloody cough
• 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
• 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 be dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness

• rash, skin itching
• 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 of discomfort
• increased heart rate
• dry mouth
• hives.

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

• bleeding into a muscle
• cholestasis (decrease in bile flow), hepatitis, including traumatic hepatocellular injury (inflammation or liver damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (hematoma) in the groin as a complication after heart surgery in which a catheter is inserted into the leg artery (pseudoaneurysm).

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

• accumulation of eosinophils, a type of granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

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

• renal failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (anticoagulant-related nephropathy)
• increase in pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Adverse effects in children and adolescents

In general, the adverse effects observed in children and adolescents treated with rivaroxaban were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed 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)

• acceleration of heartbeats
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rixacam

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

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

PVC/PVdC/Al blisters: Do not store above 30°C. Store in the original packaging to protect from moisture.

Al/Al blisters: No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rixacam

• The active ingredient is rivaroxaban. Each capsule contains 20 mg of rivaroxaban.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, and magnesium stearate in the capsule content; gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172) in the capsule shell.

Appearance of the product and package contents

Rixacam hard capsules 20 mg are a white to off-white powder packaged in size "0" (approximately 22 mm long) capsules with opaque brown caps and bodies.

The hard capsules are packaged in PVC/PVdC/Al or Al/Al blisters.

Rixacam 20 mg is available in packages of 14, 28, or 98 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. marsz J. Pilsudskiego 5, Pabianice, 95-200

Poland

or

Zentiva S.A.

B-dul Theodor Pallady nr. 50, sector 3, Bucharest, 032266 Romania

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

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

Date of the last revision of this leaflet: February 2024

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.

package and additional information