RIXACAM 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Rixacam 15 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. Storing 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.

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 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 blood vessels of the legs and/or lungs.

Rixacam is used in children and adolescents under 18 years of age and with a body weight of 30 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 medications used to treat blood clots.

Rivaroxaban belongs to a group of medicines called antithrombotic agents. It works by blocking a factor in the blood clotting process (factor Xa) and thus reduces the tendency of the 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 injury in the brain or recent brain or eye surgery)
• 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 when being administered heparin through a venous or arterial catheter to prevent blockage
• if you have a 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 starting this medicine.

Be particularly careful with this medicine

• if you have an increased risk of bleeding, such as 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 the 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 Rixacam")
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestine or stomach, 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 located 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

• if you have a heart valve prosthesis
• 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.

Inform 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 surgery, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection into 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 indicated by your doctor.
• Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestines or bladder after anesthesia, as urgent attention is needed.

Children and adolescents

Rixacam 15 mg is not recommended in children with a body weight below 30 kg.

There is not enough information about the use of this medicine in children and adolescents for the indications in adults.

Other medicines and Rixacam

Inform 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 reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for the treatment of irregular heartbeat
• certain medicines for the treatment of depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of the above circumstances apply to you, inform 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 a stomach or intestinal ulcer, they may recommend using a preventive treatment for ulcers in addition.

• If you are taking

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

If any of the above circumstances apply to you, inform 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, inform 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 administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You must take this medicine with food.

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 sprinkled 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 of the body.

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 insertion), 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 in case your kidneys do not function 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 these blood clots from happening again.

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

After at least 6 months of treatment for blood clots, 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 rivaroxaban 20 mg capsule once a day, your doctor may decide to reduce the treatment dose to one rivaroxaban 15 mg capsule once a day after 3 weeks if the risk of bleeding is higher than the risk of having 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 kg or moreis one Rixacam 20 mgcapsule once a day.

Take each dose of rivaroxaban 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 the contents of the capsule in an attempt to provide a fraction of the capsule dose. If you need a smaller dose, use the alternative product that contains rivaroxaban in the form of oral suspension granules.

For children and adolescents who cannot swallow the capsules whole, use a product that contains rivaroxaban in the form of oral suspension granules.

If you do not have the oral suspension, you can pour 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 sprinkled 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(s) every day, until your doctor tells you to stop.

Try to take the capsules at the same time every day to remember when to take them.

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 indicated by your doctor.

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 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, 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 15 mg capsule oncea day, and you forget to take a dose, take it as soon as you remember. Do not take more than one capsule in one day to make up for a forgotten dose. Take the next capsule the next day and, after that, continue taking one capsule every day.

• Adults:

If you are taking one 15 mg capsule twicea day, and you forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in one day. If you forget to take 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 stop taking Rixacam

Do not stop taking this medicine without talking to your doctor first, as this medicine treats and prevents serious conditions.

If you have any other 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 all people suffer from them.

Like other similar medicines to reduce blood clot formation, this medicine 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 evident.

Tellyour doctor immediately if you or your child 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 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 may decide 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 effectsfound 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), nasal bleeding, 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 up to 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 this medicine 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
• nasal bleeding
• vomiting

Frequent(may affect up to 1 in 10 people)

• accelerated 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 Monitoring System: 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 down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment

6. Package contents and additional information

Rixacam composition

• The active ingredient is rivaroxaban. Each capsule contains 15 mg of rivaroxaban
• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate in the capsule contents; gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and black iron oxide (E 172) in the capsule shell

Appearance of the product and package contents

Rixacam 15 mg hard capsules are a white to off-white powder presented in size "1" (approximately 19 mm long) capsules with opaque light brown cap and body

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

Rixacam 15 mg is available in packs of 14, 28, 42, or 98 hard capsules

Only some pack 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 last revision of this leaflet: February 2024

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