Rixacam 10 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rixacam 10 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 may 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 and is used in adults for:

• preventing the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of developing blood clots following surgery.
• treating blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and for preventing these blood clots from recurring 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 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 to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a disease or organ condition 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 medications 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:

• moderate or severe kidney impairment, 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 could cause bleeding, such as inflammation of the stomach or intestines, inflammation of the oesophagus (throat), for example due to gastro-oesophageal reflux disease (a condition in which stomach acid rises up into the oesophagus), or tumours in the stomach, intestines, genital tract, or urinary tract

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

• a lung disease in which the bronchi are widened and filled with pus (bronchiectasis), or if you have previously had bleeding in the lungs

• 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 necessary

• if your doctor determines that your blood pressure is unstable or if 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 exactly at the times your doctor tells you, both before and after surgery.

• 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 exactly at the times your doctor tells you.

• 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 10 mg capsules are not recommended for use in children and adolescents under 18 years of age. There is insufficient information on its use in this population.

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, itraconazol, voriconazole, posaconazole), unless applied only to the skin

• ketoconazole tablets (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 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 situations 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 to be at higher risk of developing stomach or intestinal ulcers, 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 situations 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 method of contraception 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 using machines

This medicine 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.

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

If your doctor has informed 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 use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Swallow the capsule preferably with water.

Rixacam may be taken with or without food.

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

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

What dose to take

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one 10 mg rivaroxaban capsule once daily.
• To treat blood clots in the legs and in the blood vessels of the lungs, and to prevent blood clots from recurring:

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed you Rixacam 10 mg once daily.

When to take Rixacam

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

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

Your doctor will decide how long you should continue treatment.

To prevent blood clots in the veins after hip or knee replacement surgery:

Take the first capsule 6 to 10 hours after surgery.

If you have undergone major hip surgery, you will usually take capsules for 5 weeks.

If you have undergone major knee surgery, you will usually take capsules for 2 weeks.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rixacam

If you forget to take a dose, take it as soon as you remember. Take the next capsule the following day and then continue taking one capsule each day as usual.

Do not take a double dose to make up for missed doses.

If you stop taking Rixacam

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

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 will experience them.

Like other similar medicines used to reduce blood clot formation, this medicine can cause bleeding, which may be life-threatening. Excessive bleeding may cause a sudden drop in blood pressure (shock). In some cases, bleeding may not be obvious.

Contact your doctor immediately if you 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, shortness of breath, chest pain, or angina.

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

• Signs of severe 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 (affecting 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

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 of the skin 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 blood tests performed by your doctor)

• fever

• stomach pain, indigestion, dizziness or feeling dizzy, constipation, diarrhea

• low blood pressure (symptoms may include dizziness or faintness upon standing)

• general decrease in strength and energy (weakness, fatigue), headache, dizziness

• skin rash, 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 inside the skull (see above, signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, the cells that help blood to clot)
• allergic reaction, including skin allergic reactions
• impaired liver function (may be detected in blood 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
• accumulation of blood (hematoma) in the groin as a complication after cardiac surgery involving catheter insertion 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 after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding).

Reporting of adverse effects

If you experience any adverse effect, talk to 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 containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 10 mg of rivaroxaban.
• The other components are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate and magnesium stearate in the capsule contents; 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 contents of the pack

Rixacam 10 mg capsules contain a white to almost white powder, presented in size "3" hard capsules (approximately 16 mm in length) with beige opaque caps and bodies.

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

Rixacam 10 mg is available in packs of 10 or 30 hard capsules.

Only certain 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 medicinal product is authorized in 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.