Rivaroxaban Combix 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rivaroxaban Combix 10 mg Film-coated Tablets EFG

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

This medicine 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 higher risk of developing blood clots after 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.

This medicine 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 clot.

2. What you need to know before starting to take Rivaroxaban Combix

Do not take Rivaroxaban Combix

• 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 medicines to prevent blood clots (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching between anticoagulant treatments or while heparin is being administered through a venous or arterial catheter to prevent blockage
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breastfeeding

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Take special care with Rivaroxaban Combix

• 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 Rivaroxaban Combix”)
  • bleeding disorders
  • uncontrolled high blood pressure despite medical treatment
  • stomach or intestinal diseases that could cause bleeding, such as inflammation of the stomach or intestine, or inflammation of the esophagus (e.g., due to gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus)
  • a problem in the blood vessels at the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or a previous lung hemorrhage
• 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 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 rivaroxaban before and after surgery exactly at the times your doctor instructs.
• If your procedure requires 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 rivaroxaban exactly at the times your doctor instructs.
  • Inform your doctor immediately if you experience numbness or weakness in the legs or bowel or bladder problems after anesthesia, as urgent medical attention is required.

Children and adolescents

This medicine is not recommended for patients under 18 years of age. There is insufficient information on its use in children and adolescents.

Other medicines and Rivaroxaban Combix

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, in which the body produces excess cortisol)
  • any medicine for bacterial infections (e.g., clarithromycin, erythromycin)
  • antiviral medicines 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 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 situations apply to you, inform your doctor before taking this medicine, as the effect of rivaroxaban 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 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 rivaroxaban 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 rivaroxaban if you are pregnant or breastfeeding. If there is any possibility you could become pregnant, use a reliable method of contraception while taking rivaroxaban. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on the appropriate treatment.

Driving and use of machines

This medicine may cause dizziness (a common adverse effect) or fainting (an uncommon adverse 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.

Rivaroxaban Combix contains lactose and sodium

This medicine contains lactose. 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 tablet; this is essentially “sodium-free”.

3. How to take Rivaroxaban Combix

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

What dose to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery.

The recommended dose is one 10 mg rivaroxaban tablet once daily.

• To treat blood clots in the veins of 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 tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed you rivaroxaban 10 mg once daily.

You should take Rivaroxaban with food.

Swallow the tablets, preferably with water.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take Rivaroxaban. The tablet may be crushed and mixed with water or apple puree immediately before taking. Then take food.

If necessary, your doctor may also administer the crushed Rivaroxaban tablet through a gastric tube.

When to take RivaroxabanCombix

Take the tablet every day, for as long as your doctor instructs.

Try to take one tablet at the same time each day, to help you remember. Your doctor will decide how long you should continue treatment.

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

Take the first tablet 6 to 10 hours after surgery.

If you have undergone major hip surgery, you will usually take tablets for 5 weeks. If you have undergone major knee surgery, you will usually take tablets for 2 weeks.

If you take more Rivaroxaban Combix than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. 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, indicating the medicine and the amount ingested.

If you forget to take Rivaroxaban Combix

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

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

If you stop taking Rivaroxaban Combix

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, rivaroxaban can cause adverse effects, although not everyone experiences them.

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

Tell 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, difficulty breathing, chest pain, or angina.

Your doctor will decide whether to keep you under closer observation or modify 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 (DRESS syndrome), characterized by rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.

The frequency of this adverse effect 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:

Common (may affect up to 1 in 10 patients):

• decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• stomach or intestinal bleeding, 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 a tissue or body 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 dizzy, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or faintness when standing up)
• general decrease in strength and energy (weakness, fatigue), headache, dizziness
• rash, skin itching
• blood tests may show increased levels of certain liver enzymes

Uncommon (may affect up to 1 in 100 patients):

• 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 clot)
• 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 patients):

• bleeding into a muscle
• cholestasis (reduced bile flow), hepatitis, including traumatic hepatocellular injury (liver inflammation or damage)
• yellowing of the skin and eyes (jaundice)
• localized swelling
• accumulation of blood (hematoma) in the groin as a complication following cardiac surgery involving insertion of a catheter into the leg artery (pseudoaneurysm)

Frequency not known (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 (hemorrhagic compartment syndrome)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Rivaroxaban Combix Storage

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 packaging after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Combix

• The active substance is rivaroxaban. Each tablet contains 10 mg of rivaroxaban.
• The other components are:

Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.

Coating: hypromellose, macrogol, talc, iron oxide red (E172), titanium dioxide (E171).

Appearance of the medicinal product and contents of the container

Rivaroxaban Combix 10 mg is a film-coated, round, biconvex tablet, pink or light pink in colour, smooth on both sides. The tablet diameter is approximately 6.40 mm. The tablets are supplied in blisters contained in packs of 10 or 30 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

Or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)