BLOMENSY 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Blomensy 15 mg film-coated tablets EFG

Blomensy 20 mg film-coated tablets EFG

rivaroxaban

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

1. What is Blomensy and what is it used for
2. What you need to know before you take Blomensy
3. How to take Blomensy
4. Possible side effects
5. Storing Blomensy
6. Contents of the pack and other information

1. What is Blomensy and what is it used for

Blomensy film-coated tablets contain the active substance rivaroxaban.

Blomensy 15 mg and 20 mg film-coated tablets are used in adults to:

• prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
• 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 veins and/or lungs.

Blomensy 15 mg and 20 mg film-coated tablets are used in children and adolescents under 18 years of age and with a body weight of 30 kg or more to:

• treat and prevent blood clots in the veins or in the blood vessels of the lungs after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Blomensy belongs to a group of medicines called antithrombotic agents. It works by blocking a factor involved in blood clotting (factor Xa) and thus reduces the tendency of blood to form clots.

2. What you need to know before you take Blomensy

Do not take Blomensy

• 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 injury or bleeding in the brain or recent surgery in 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 when being treated with heparin 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 Blomensy and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Blomensy.

Be careful with Blomensy

• if you have an increased risk of bleeding, as may occur in the following situations:
• • severe kidney problems in adults and moderate or severe kidney problems in children and adolescents, as kidney function may affect the amount of medicine that works in the 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 it from becoming blocked (see section "Other medicines and Blomensy");
  • bleeding disorders;
  • very high blood pressure, not controlled by medical treatment;
  • diseases of the stomach or intestines that may cause bleeding, such as inflammation of the intestines or stomach, inflammation of the esophagus (throat), e.g. due to gastroesophageal reflux disease (a disease in which stomach acid rises up into the esophagus), or tumors located 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 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 (a disorder of the immune system that increases the risk of blood clots), inform your doctor so that they can decide if it may be necessary to modify the treatment;
• 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 Blomensy. 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 Blomensy before and after surgery, exactly at the times indicated by your doctor.
• If your operation requires the insertion of a catheter or injection into the spine (e.g. for epidural or spinal anesthesia, or pain relief):
• • it is very important to take Blomensy before and after the injection or removal of the catheter, 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 at the end of anesthesia, as urgent attention is needed.

Children and adolescents

Blomensy film-coated tablets are not recommended in children with a body weight below 30 kg. There is not enough information on the use of Blomensy in children and adolescents for the indications in adults.

Other medicines and Blomensy

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

• If you are taking
• • any medicine for a fungal infection (e.g. fluconazole, itraconazole, voriconazole, posaconazole), except if only applied 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 medicines and 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 Blomensy, as the effect of Blomensy 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 a stomach or intestinal ulcer, they may recommend that you also take a preventive treatment.

• 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 Blomensy, as the effect of Blomensy may be reduced. Your doctor will decide if you should be treated with Blomensy and if you should be kept under closer observation.

Pregnancy and breast-feeding

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

Driving and using machines

Blomensy may cause dizziness (common side effect) or fainting (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.

Blomensy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Blomensy

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

You should take rivaroxaban 15 mg and 20 mg film-coated tablets with food.

Swallow the tablets, preferably with water.

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

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

What dose to take

Adults

• To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body.

The recommended dose is one Blomensy 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one Blomensy 15 mg tablet once a day.

If you need to undergo a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent insertion), there is limited evidence to reduce the dose to one Blomensy 15 mg tablet once a day (or to 10 mg once a day in case of impaired kidney function) in addition to an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the veins of the legs and in the blood vessels of the lungs, and to prevent blood clots from happening again.

The recommended dose is one Blomensy 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Blomensy 20 mg tablet once a day.

After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one Blomensy 10 mg tablet once a day or one Blomensy 20 mg tablet once a day.

If you have kidney problems and are taking one Blomensy 20 mg tablet once a day, your doctor may decide to reduce the treatment dose to one Blomensy 15 mg tablet once a day after 3 weeks if the risk of bleeding is higher than the risk of having another blood clot.

Children and adolescents

The dose of Blomensy depends on body weight and will be calculated by your doctor:

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Blomensy 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or moreis one Blomensy 20 mgtablet once a day.

Take each dose of Blomensy with a drink (e.g. water or juice) during a meal. Take the tablets every day at about the same time. Consider setting an alarm to remind you.

For parents or caregivers: observe the child to ensure they take the entire dose.

Since the dose of Blomensy is based on body weight, it is important to attend scheduled visits with your doctor, as it may be necessary to adjust the dose as weight changes.

Never adjust the dose of Blomensy on your own. Your doctor will adjust the dose if necessary.

Do not split the tablet to try to get a fraction of the tablet dose.

If a smaller dose is required, your doctor may recommend the use of rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow the tablets whole, you can crush the Blomensy film-coated tablet and mix it with water or apple sauce immediately before taking it. Take some food after taking this mixture. If necessary, your doctor may also administer the crushed Blomensy tablet through a gastric tube.

If you spit out the dose or vomit

• less than 30 minutes after taking Blomensy, take a new dose.
• more than 30 minutes after taking Blomensy, do not takea new dose. In this case, take the next dose of Blomensy at the usual time.

Call your doctor if you spit out the dose or vomit repeatedly after taking Blomensy.

When to take Blomensy

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

Try to take the tablets at the same time every day to remember when you should take them.

Your doctor will decide how long you should continue taking the treatment.

To prevent the formation of blood clots in the brain (stroke) or in other blood vessels of the body:

If it is necessary to normalize your heart rhythm through a procedure called cardioversion, take Blomensy film-coated tablets at the times indicated by your doctor.

If you take more Blomensy than you should

Call your doctor immediately if you have taken too many Blomensy tablets. Taking too much Blomensy 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 Blomensy

Adults, children and adolescents:

• If you are taking one 20 mg or one 15 mg tablet once a day, and you miss a dose, take it as soon as you remember. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the next day and, after that, take one tablet every day.

Adults:

• If you are taking one 15 mg tablet twice a day, and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time, for a total of two tablets (30 mg) in one day. The next day, you should continue taking one 15 mg tablet twice a day.

If you stop taking Blomensy

Do not stop taking Blomensy without first talking to your doctor, as Blomensy treats and prevents serious conditions.

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 medicines that reduce blood clotting, Blomensy may cause bleeding that 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 immediatelyif you experience any of the following symptoms:

• Signs of bleeding
• • bleeding in the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiff 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, which may be signs of bleeding.

Your doctor may decide to keep you under closer observation or change your treatment.

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• severe skin reactions 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).

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• 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 found in adults, children, and adolescents:

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

• decrease in red blood cells that can cause paleness and weakness or difficulty breathing
• bleeding from the stomach or intestine, urogenital hemorrhage (including blood in the urine and heavy menstrual bleeding), nasal bleeding, gum bleeding
• bleeding in the eye (including bleeding in the white part 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
• alteration of kidney function (may be seen in tests performed by the doctor)
• fever
• stomach pain, indigestion, nausea or feeling of nausea, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)
• general decrease in strength and energy (weakness, fatigue), 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 in a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells that help blood clotting)
• allergic reaction, including skin allergic reaction
• alteration of liver function (may be seen in tests performed by the doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes, or platelet count
• fainting
• feeling of discomfort
• increased heart rate
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 people):

• bleeding in a muscle
• cholestasis (decrease in 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 after a complication in cardiac 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 granulocytic white blood cells that cause inflammation in the lung (eosinophilic pneumonia)

Unknown(frequency cannot be estimated from available data):

• kidney failure after severe bleeding.
• bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to malfunction (anticoagulant-related nephropathy).
• increase in pressure in the muscles of the legs or arms after bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome after bleeding)

Adverse effects in children and adolescents:

In general, the adverse effects observed in children and adolescents treated with Blomensy were similar to those observed in adults and their severity was mainly mild to moderate.

Adverse effects that were more frequently observed in children and adolescents:

Very frequent(may affect more than 1 in 10 people):

• headache
• fever
• nasal bleeding
• vomiting

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

• accelerated heart rate
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low platelet count, cells that help blood clotting)
• heavy menstrual bleeding

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

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Blomensy

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box after CAD.

The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Crushed tablets

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Blomensy

• The active ingredient is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are:

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

Film coating of the tablet: hypromellose 3 cps (E464), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E 171), red iron oxide (E 172).

Appearance of the product and package contents

Blomensy 15 mg film-coated tablets EFG: film-coated tablets, round, biconvex, reddish-brown in color, engraved with E843 on one side and smooth on the other side, with a diameter of approximately 8.1 mm.

Blomensy 20 mg film-coated tablets EFG: film-coated tablets, round, biconvex, brown in color, engraved with E844 on one side and smooth on the other side, with a diameter of approximately 9.1 mm.

Blomensy 15 mg film-coated tablets EFG

OPA/Al/PVC//Al blister pack in a cardboard box of 28, 42, 98, or 100 film-coated tablets.

Blomensy 20 mg film-coated tablets EFG

OPA/Al/PVC//Al blister pack in a cardboard box of 28, 98, or 100 film-coated tablets.

A blister pack contains 10 or 14 film-coated tablets, depending on the package size.

Only some package sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary.

Manufacturer

Egis Pharmaceuticals PLC, Site 2.

1165 Budapest, Bökényföldi út 118-120.

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

Spain

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

Netherlands Blomensy 15 mg, 20 mg film-coated tablets

France Rivaroxaban Biogaran 15 mg, 20 mg, film-coated tablet

Spain Blomensy 15 mg, 20 mg film-coated tablets EFG

Greece Blomensy 15 mg, 20 mg επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?α

Ireland Blomensy 15 mg, 20 mg film-coated tablets

Finland Blomensy 15 mg, 20 mg tablet, film-coated

Sweden Blomensy 15 mg, 20 mg film-coated tablets

Denmark Blomensy 15 mg, 20 mg film-coated tablets

Norway Blomensy

Date of the last revision of this prospectus:

08/2023

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