Rivaroxaban Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rivaroxaban Kern Pharma 10 mg film-coated tablets EFG

rivaroxaban

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, as 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.

Leaflet contents

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

1. What Rivaroxaban Kern Pharma 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 an increased 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 Kern Pharma

Do not take Rivaroxaban Kern Pharma

• 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 condition affecting an organ in the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain 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 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 Kern Pharma

• 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 Kern Pharma”)

• bleeding disorders

• uncontrolled high blood pressure despite medical treatment

• stomach or intestinal diseases that could cause bleeding, such as inflammation of the stomach or intestines, inflammation of the esophagus (e.g., due to gastroesophageal reflux disease [a condition in which stomach acid flows back up into the esophagus], or tumors located in the stomach, intestines, genital tract, or urinary tract)

• a blood vessel disorder 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, who will decide whether treatment adjustments 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 surgical 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 surgery requires 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 your doctor instructs.

• Inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after anesthesia, as urgent medical attention is required.

Children and adolescents

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

Other medicines and Rivaroxaban Kern Pharma

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)
• 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 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 closer monitoring is needed.

If your doctor considers you at higher risk of developing stomach or intestinal ulcers, they may recommend additional 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 closer monitoring is needed.

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. Your doctor 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.

This medicine contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

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

3. How to take Rivaroxaban Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If in 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 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.

Swallow the tablets whole, preferably with water.

Rivaroxaban may be taken with or without food.

If you have difficulty swallowing the tablet whole, consult your doctor about other ways of taking rivaroxaban. The tablet may be crushed and mixed with water or apple puree, immediately before administration.

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

When to take Rivaroxaban Kern Pharma

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

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

Your doctor will decide for 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 Kern Pharma 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, stating the medication and the amount ingested.

If you forget to take Rivaroxaban Kern Pharma

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 forgotten doses.

If you stop taking Rivaroxaban Kern Pharma

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, rivaroxaban may 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 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 within 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 closer monitoring or a change in treatment is necessary.

• 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 (up to 1 in 10,000 people).

• Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives; 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:

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

• 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 tissue or body cavities (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 blood tests performed by your doctor)

• fever

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

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

• 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 people):

• bleeding in the brain or within 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 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 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 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 cell causing lung inflammation (eosinophilic pneumonia).

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 within the muscles of the legs or arms following bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (hemorrhagic compartment syndrome)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Rivaroxaban Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging and on each blister, following "EXP" or "CAD". 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 containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rivaroxaban Kern Pharma

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

Tablet core: microcrystalline cellulose, lactose monohydrate, hypromellose, sodium croscarmellose, sodium lauryl sulfate (E 487), copovidone, magnesium stearate. See section 2 "Rivaroxaban Kern Pharma contains lactose and sodium".

Coating material: polyethylene glycol and poly(vinyl alcohol) grafted copolymer, talc, titanium dioxide (E 171), glycerol monocaprylocaprate, poly(vinyl alcohol), iron oxide red (E 172).

Appearance of the product and contents of the pack

Rivaroxaban Kern Pharma 10 mg film-coated tablets are round, pink, and have a diameter of 6 mm.

They are packaged in pre-cut single-dose blisters made of PVC/PVdC – aluminum foil, in packs of 10 or 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

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

Other sources of information

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