RIVAXA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Rivaxa 10 mg film-coated tablets EFG

rivaroxaban

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Rivaxa and what is it used for
2. What you need to know before you take Rivaxa
3. How to take Rivaxa
4. Possible side effects
5. Storage of Rivaxa

1. Contents of the pack and other information

1. What is Rivaxa and what is it used for

Rivaxa contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because after surgery you are at a higher risk of forming blood clots.
• 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.

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 reducing the tendency of the blood to form clots.

2. What you need to know before you take Rivaxa

Do not take Rivaxa

• 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 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 to a different anticoagulant treatment or when heparin is given through a venous or arterial catheter to prevent it from becoming blocked
• if you have a liver disease that increases the risk of bleeding
• if you are pregnant or breast-feeding

Do not take Rivaxa and inform your doctorif any of these conditions apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with rivaroxaban.

Be careful with Rivaxa

• if you have an increased risk of bleeding, such as in the following situations:
• • moderate or severe kidney problems, as kidney function may affect the amount of medicine that works in your body
  • if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), when switching to a different anticoagulant treatment or when receiving heparin through a venous or arterial catheter to prevent it from becoming blocked (see section "Other medicines and Rivaxa")
  • bleeding disorders
  • very high blood pressure that is not controlled by medical treatment
  • stomach or intestinal diseases that may cause bleeding, such as stomach or intestinal inflammation, inflammation of the esophagus (e.g. due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital or urinary tract
  • a problem in the blood vessels of the back of the eyes (retinopathy)
  • a lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding
• if you have a heart valve replacement
• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor to decide if treatment needs to be modified.
• 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 rivaroxaban. 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 rivaroxaban 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 spinal column (e.g. for epidural or spinal anesthesia, or pain relief):
• • It is very important to take rivaroxaban exactly at the times indicated by your doctor.
  • 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

Rivaroxaban 10 mg tablets are not recommended for children under 18 years of age.There is not enough information on their use in children and adolescents.

Other medicines and Rivaxa

Tell your doctor or pharmacist if you are using, have recently used or might use 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 medicines or painkillers (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 applies to you, tell your doctorbefore taking rivaroxaban, because the effect of rivaroxaban 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, he will recommend that you also use a treatment to prevent ulcers.

• 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 applies to you, tell your doctorbefore taking rivaroxaban, because the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with rivaroxaban and if you should be kept under closer observation.

Pregnancy and breast-feeding

Do not take rivaroxaban if you are pregnant or breast-feeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking rivaroxaban. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban 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 use tools or machines if you are affected by these symptoms.

Rivaxa contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with him 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 Rivaxa

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, 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 a day.

• 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.

After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed rivaroxaban 10 mg once a day.

Swallow the tablet, preferably with water. Rivaroxaban can be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways to take rivaroxaban. The tablet can be crushed and mixed with water or apple sauce, immediately before taking it.

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

When to take Rivaxa

Take one tablet every day, until your doctor tells you to stop.

Try to take one tablet at the same time each day, to help you remember. The 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 Rivaxa 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, consult your doctor or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rivaxa

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

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

If you stop taking Rivaxa

Do not stop taking rivaroxaban without talking to your doctor first, because rivaroxaban 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, rivaroxaban can cause bleeding that can put your life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be visible.

Tell your doctor immediately if you experience any of the following symptoms:

• 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, tiredness, 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.

?

• severe skin rash that spreads, 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 side effects is very rare (up to 1 in 10,000 people).

?

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is 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 side effects

Common(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 bleeding (including blood in the urine and heavy menstrual bleeding), nosebleeds
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into a tissue or cavity of the body (hematoma, bruising)
• coughing up blood
• bleeding from the skin or under the skin
• bleeding after surgery
• oozing of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• kidney function changes (may be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, tiredness), headache, dizziness
• rash, itching of the skin
• 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
• liver function changes (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some 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 (decreased 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 white blood cell granulocyte that causes inflammation in the lung (eosinophilic pneumonia).

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

• kidney failure after severe bleeding
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail (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 side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaxa

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 and blister after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Rivaxa Composition

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

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxa contains lactose and sodium".

Tablet film coating: hypromellose, titanium dioxide (E 171), macrogol, red iron oxide (E 172).

Product Appearance and Packaging Contents

Rivaxa 10 mg film-coated tablets are pink, round, biconvex (6 mm in diameter), marked with "10" on one side and smooth on the other side.

They are packaged in blisters, in packs of 5, 10, 28, 30, 45 or 98 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, Praha 4

140 78 Czech Republic

Manufacturer:

S.C. Labormed-Pharma S.A.

Bd. Theodor Pallady nr. 44B, sector 3

Bucharest cod 032266

Romania

Adalvo Ltd

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann

SGN 3000, Malta

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Rivaxa 10 mg Filmtabletten

Denmark Rivaxa

Spain Rivaxa 10 mg film-coated tablets EFG

Finland Rivaxa

Norway Rivaxa

Czech Republic Rivaxa 10 mg potahované tablety

Sweden Rivaxa

Date of Last Revision of this Leaflet: March 2024

Detailed 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/).