Rixacam 15 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rixacam 15 mg hard capsules EFG

rivaroxaban

Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

1. What Rixacam is and what it is 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 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.

Rixacam 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 to 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 taking 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 are bleeding excessively
• if you have a disease or organ problem in your body that increases the risk of serious 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 from one anticoagulant treatment to another or while receiving heparin through a venous or arterial catheter to prevent blockage
• if you have a liver disease that could increase the risk of bleeding
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 Rixacam”)

• bleeding disorders

• very high blood pressure not controlled by medical treatment

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

• a blood vessel problem 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 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 needed

• if your doctor determines your blood pressure is unstable or you are scheduled for another treatment or 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 exactly at the times your doctor tells you, both before and after surgery.

• If your procedure 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 exactly at the times your doctor has instructed, both before and after the injection or catheter removal.

• 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

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

There is insufficient information on the use of this medicine 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 need to take any other medicines, including those obtained without a prescription.

• If you are taking

• any medicine for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin

• ketoconazole tablets (used to treat Cushing's syndrome, where 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 medicines and pain relievers (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 gastric 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

Do not take this medicine if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable contraceptive method while taking this medicine. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on the appropriate course of treatment.

Driving and use of machines

This medicine may cause dizziness (a common side effect) or fainting (an uncommon side effect) (see section 4, “Possible side effects”). You must not drive, ride a bicycle, or operate tools or machinery 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 them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Rixacam

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

You should take this medicine with food.

Swallow the capsule whole, preferably with water.

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

This mixture must be followed immediately by a meal.

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 in the body.

The recommended dose is one 20 mg rivaroxaban capsule once daily.

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

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 supporting reducing the dose to one 15 mg rivaroxaban capsule once daily (or one 10 mg rivaroxaban capsule once daily if your kidneys do not function properly), in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the leg veins and in the blood vessels of the lungs, and to prevent blood clots from recurring.

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

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once daily or one 20 mg capsule once daily.

If you have kidney problems and are taking one 20 mg rivaroxaban capsule once daily, your doctor may decide to reduce your treatment dose to one 15 mg rivaroxaban capsule once daily after 3 weeks, if your 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 kg is one Rixacam 15 mg capsule once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rixacam 20 mg capsule once daily.

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 help you remember. For parents or caregivers: observe the child to ensure they take the full dose.

Since the dose of Rixacam 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 Rixacam on your own. Your doctor will adjust the dose if necessary.

Do not pour out the capsule contents in an attempt to give a fraction of the capsule dose. If you need a lower dose, use the alternative product containing rivaroxaban in the form of granules for oral suspension.

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

If the oral suspension is not available, you may empty the contents of the Rixacam capsule and mix them with water or apple puree immediately before taking. Take some food after taking this mixture. If necessary, your doctor may also administer the sprinkled 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 not take a new dose. In this case, take the next dose of this medicine at the usual time.

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

When to take Rixacam

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

Try to take the capsules 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 becomes necessary to normalize your heart rhythm using 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 rivaroxaban increases the risk of bleeding.

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

If you forget to take Rixacam

• Adults, children and adolescents:

If you are taking one 15 mg capsule once daily and you forget a dose, take it as soon as you remember. Do not take more than one capsule in a single day to make up for a missed dose. Take the next capsule the following day, and then continue taking one capsule each day.

• Adults:

If you are taking one 15 mg capsule twice daily and you forget a dose, take it as soon as you remember. Do not take more than two 15 mg capsules in a single day. If you forget a dose, you may take two 15 mg capsules at the same time to obtain a total of two capsules (30 mg) in one day. The following day, resume taking one 15 mg capsule twice daily.

If you stop taking Rixacam

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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Like other similar medicines used to reduce blood clot formation, this medicine may cause bleeding that could be life-threatening. Excessive bleeding may lead to 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 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 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, causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

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; difficulty breathing; 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 reported 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
• bleeding from the stomach or intestines, urogenital hemorrhage (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the 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
• bleeding from or under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of the limbs
• limb pain
• impaired kidney function (may be detected in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting upon standing)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, itchy skin
• 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, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• impaired liver function (may be detected in tests performed by your doctor)
• blood tests may show increased levels of bilirubin, certain 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 (reduced bile flow), hepatitis, including hepatocellular liver injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• blood accumulation (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 cell 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 after 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 seen 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 clotting)
• 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 effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Rixacam

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

Do not use this medicine after the expiry date stated on the blister pack and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

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

Al/Al blisters: No special storage conditions required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rixacam

• The active substance 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 coating.

Nature of the product and pack contents

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

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 medicinal product is authorized in the European Economic Area member states under the following names:

Member State	Name of the medicinal product
Poland	RIXACAM
Czech Republic	RIXACAM
Spain	Rixacam 15 mg hard capsules EFG

Date of the most recent review of this leaflet: February 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.