RIVAROXABAN MACLEODS PHARMA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Rivaroxaban Macleods

Do not take Rivaroxaban Macleods

• 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 or injury in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), except when switching from one anticoagulant treatment to another or when heparin is given through a vein or artery to keep it from getting blocked
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Macleods and inform your doctorif any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting Rivaroxaban Macleods.

Be extra careful with Rivaroxaban Macleods

• if you have an increased risk of bleeding, such as in the following situations:

• severe kidney problems, as kidney function can affect the amount of medicine that works in your body
• if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban, or heparin), when switching from one anticoagulant treatment to another or when receiving heparin through a vein or artery to keep it from getting blocked (see section "Other medicines and Rivaroxaban Macleods")
• bleeding disorders
• very high blood pressure that is not controlled by medical treatment
• stomach or intestinal diseases that can cause bleeding, such as stomach or intestinal inflammation, esophageal inflammation (e.g. due to gastroesophageal reflux disease), or tumors in the stomach, intestines, genital tract, or urinary tract
• a problem in the blood vessels of the back of your eyes (retinopathy)
• a lung disease where the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding in the lungs

• 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 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 Macleods. 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 Macleods before and after surgery, exactly at the times your doctor tells you.
• If your operation requires the 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 Macleods exactly at the times your doctor tells you.
• 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 Macleods 10 mg tablets are not recommended for children under 18 years. There is not enough information on its use in children and adolescents.

Other medicines and Rivaroxaban Macleods

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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, where 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 pain relievers (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine for treating irregular heartbeat
• certain medicines for treating depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs))

If any of these apply to you, tell your doctorbefore taking Rivaroxaban Macleods, as the effect of Rivaroxaban Macleods 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 thinks you are at a higher risk of developing stomach or intestinal ulcers, they will recommend that you also use a treatment to prevent ulcers.

• If you are taking

• any medicine for treating epilepsy (phenytoin, carbamazepine, phenobarbital)
• St. John's Wort (Hypericum perforatum), a herbal medicine for treating depression
• rifampicin, an antibiotic

If any of these apply to you, tell your doctorbefore taking Rivaroxaban Macleods, as the effect of Rivaroxaban Macleods may be reduced. Your doctor will decide if you should be treated with Rivaroxaban Macleods and if you should be kept under closer observation.

Pregnancy and breastfeeding

Do not take Rivaroxaban Macleods if you are pregnant or breastfeeding. If there is a possibility that you may become pregnant, use a reliable contraceptive while taking Rivaroxaban Macleods. 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 Macleods 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.

Rivaroxaban Macleods contains lactose and sodium

If your doctor has told you that you have an intolerance to some 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 Macleods

Follow exactly the instructions for taking 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 Rivaroxaban Macleods 10 mg 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 Macleods 10 mg once a day.

Swallow the tablet, preferably with water.

Rivaroxaban Macleods can be taken with or without food.

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

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

When to take Rivaroxaban Macleods

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

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

Your doctor will decide how long you should keep taking the 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 the operation.

If you have had major hip surgery, you will usually take tablets for 5 weeks.

If you have had major knee surgery, you will usually take tablets for 2 weeks.

If you take more Rivaroxaban Macleods than you should

Call your doctor immediately if you have taken too many Rivaroxaban Macleods tablets. Taking too much Rivaroxaban Macleods increases the risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Rivaroxaban Macleods

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 each day, as usual.

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

If you stop taking Rivaroxaban Macleods

Do not stop taking Rivaroxaban Macleods without talking to your doctor first, as Rivaroxaban Macleods prevents the development of a serious condition.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Macleods can cause side effects, although not everybody gets them.

Like other similar medicines to reduce blood clotting, Rivaroxaban Macleods can cause bleeding, which can be life-threatening. 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 side effects:

• Signs of bleeding

• bleeding in the brain or inside the skull (symptoms can include headache, weakness on one side of the body, vomiting, seizures, decreased level of consciousness, and stiffness in 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 modify your treatment.

• Signs of severe skin reactions

• intensive skin rashes that spread, 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).

• 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 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 gums
• bleeding in the eye (including bleeding in the white of the eye)
• bleeding into tissue or a 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 (can be seen in tests performed by your doctor)
• fever
• stomach pain, indigestion, dizziness or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms can 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 (can 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 where 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 stop working properly (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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rivaroxaban Macleods

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 carton and on each blister after "CAD". The expiry date is the last day of the month indicated.

Store below 30°C.

Crushed tablets

Crushed tablets are stable in water or apple sauce for up to 4 hours.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of cartons and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Rivaroxaban Macleods

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

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

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

Appearance and package contents of the product

Rivaroxaban Macleods 10 mg film-coated tablets are pink, round, biconvex, engraved with "J 8" on one side and smooth on the other.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Macleods Pharma España, S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial Sp. z o.o.

Rabowicka 15, Swarzedz,

62-020, Poland

Date of last revision of thisleaflet:

January 2024.

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