BlomenSY 15 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Blomensy 15 mg film-coated tablets EFG

Blomensy 20 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because 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 Blomensy is and what it is used for
2. What you need to know before taking Blomensy
3. How to take Blomensy
4. Possible adverse effects
5. Storage of Blomensy
6. Contents of the pack and other information

1. What Blomensy is and what it is 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 type 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 reoccurring in the blood vessels of the legs 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 blood clots and prevent the recurrence of these blood clots in the veins or in the blood vessels of the lungs, following an initial treatment of at least 5 days with injectable medicines used to treat blood clots.

Blomensy 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 form clots.

2. What you need to know before starting to take Blomensy

Do not take Blomensy

• 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 severe bleeding (for example, 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 from one anticoagulant treatment to another or while heparin is being administered 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 Blomensy and inform your doctor if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Blomensy.

Take special care with Blomensy

• if you have an increased risk of bleeding, as may occur in the following situations:
  • severe renal impairment in adults and moderate or severe renal impairment in children and adolescents, since kidney function may affect the amount of drug active 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”);
  • hemorrhagic disorders;
  • very high blood pressure not controlled by medical treatment;
  • stomach or intestinal diseases that may cause bleeding, such as intestinal or gastric inflammation, esophageal inflammation (e.g., due to gastroesophageal reflux disease— a condition in which stomach acid rises up into the esophagus), or tumors located in the stomach, intestines, genital tract, or urinary tract;
  • a problem with blood vessels at the back of your eyes (retinopathy);
  • a lung disease in which bronchi are dilated and filled with pus (bronchiectasis), or previous lung bleeding.
• 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 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 you are in any of these situations before taking Blomensy. Your doctor will decide whether you should be treated with this medicine and whether you require closer monitoring.

If you need a surgical procedure

• It is very important to take Blomensy before and after surgery, exactly at the times your doctor has instructed you to do so.
• If your operation requires the placement of a catheter or an injection into the spine (for example, 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 your doctor has indicated;
  • inform your doctor immediately if you experience numbness or weakness in the legs, or problems with the bowel or bladder after the anesthesia, as urgent medical attention is required.

Children and adolescents

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

Other medicines and Blomensy

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking
  • any medicine for a fungal infection (e.g., fluconazole, itraconazol, voriconazole, posaconazole), except if applied only to the skin;
  • ketoconazole tablets (used to treat Cushing's syndrome, a condition 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 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 apply to you, inform your doctor before taking Blomensy, as the effect of Blomensy could be increased. Your doctor will decide whether you should be treated with this medicine and whether you need to be more closely monitored.

If your doctor considers you to be at higher risk of developing a stomach or intestinal ulcer, they may recommend you also use a preventive 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 apply to you, inform your doctor before taking Blomensy, as the effect of Blomensy could be reduced. Your doctor will decide whether you should be treated with Blomensy and whether you need to be more closely monitored.

Pregnancy and breastfeeding

Do not take Blomensy if you are pregnant or breastfeeding. If there is any possibility that you could become pregnant, use a reliable contraceptive method while taking Blomensy. If you become pregnant while taking this medicine, inform your doctor immediately; your doctor will decide how you should be treated.

Driving and operating machinery

Blomensy may cause dizziness (a common adverse effect) or fainting (an uncommon adverse effect) (see section 4 “Possible adverse 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; hence, it is essentially "sodium-free".

3. How to take Blomensy

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Swallow the tablets whole, preferably with water.

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 taking. 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 in the body.

The recommended dose is one Blomensy 20 mg tablet once daily.

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

If you require a procedure to treat blocked blood vessels in your heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to support reducing the dose to one Blomensy 15 mg tablet once daily (or 10 mg once daily if your kidneys are not functioning properly), 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 recurring.

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

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

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

Children and adolescents

The dose of Blomensy depends on body weight and will be calculated by the physician:

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one tablet of Blomensy 15 mg once daily.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one tablet of Blomensy 20 mg once daily.

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

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

Since the dose of Blomensy is based on body weight, it is important to attend scheduled visits with the physician, as the dose may need to be adjusted 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 in an attempt to obtain a fraction of the tablet dose.

If a lower dose is required, your doctor may recommend using rivaroxaban granules for oral suspension.

In children and adolescents who cannot swallow the tablets whole, the Blomensy film-coated tablet may be crushed and mixed with water or apple puree immediately before administration. Give some food after taking this mixture. If necessary, your doctor may also administer the crushed Blomensy tablet through a tube inserted into the stomach.

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 take a new dose. In this case, take the next dose of Blomensy at your usual time.

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

When to take Blomensy

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

Try to take the tablets at the same time each day to help you remember when to 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 the heartbeat 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

Contact your doctor immediately if you have taken too many Blomensy film-coated 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Blomensy

Adults, children and adolescents:

• If you are taking one 20 mg tablet or one 15 mg tablet once daily and you forget to take a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a missed dose. Take the next tablet the following day, and then continue taking one tablet each day.

Adults:

• If you are taking one 15 mg tablet twice daily and you forget to take a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in a single day. If you forget to take a dose, you may take two 15 mg tablets at the same time to obtain a total of two tablets (30 mg) in one day. The following day, resume taking one 15 mg tablet twice daily.

If you interrupt treatment with Blomensy

Do not stop treatment with Blomensy without first consulting your doctor, as Blomensy treats and prevents serious conditions.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Like other similar medicines used to reduce blood clot formation, Blomensy may cause bleeding that could be life-threatening. Excessive bleeding may lead to 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 symptoms:

• Signs of bleeding
  • bleeding in the brain or within the skull (symptoms may include headache, one-sided weakness, 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, which may be signs of bleeding.

Your doctor may decide to monitor you more closely or change your treatment.

-Signs of severe skin reactions

• severe skin rashes that spread, blisters, or lesions on mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• drug reaction with eosinophilia and systemic symptoms causing rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome).

The frequency of these adverse reactions 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 observed in adults, children, and adolescents:

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

• Decrease in red blood cells that may cause paleness, weakness, or difficulty breathing
• Bleeding from the stomach or intestines, urogenital bleeding (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 body tissue or cavity (hematoma, bruising)
• Coughing up blood
• Bleeding of the skin or under the skin
• Bleeding after surgery
• Oozing 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 a physician)
• Fever
• Stomach pain, indigestion, dizziness or feeling faint, constipation, diarrhea
• Low blood pressure (symptoms may include dizziness or fainting upon standing)
• General decrease in strength and energy (weakness, fatigue), headache, dizziness
• Skin rash, itching of the skin
• 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 a physician)
• Blood tests may show increased levels of bilirubin, certain pancreatic or liver enzymes, or increased 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
• Blood collection (hematoma) in the groin following a complication from 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)

Not known (frequency 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 following bleeding, causing pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding)

Adverse effects in children and adolescents:

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

Adverse effects observed more frequently in children and adolescents:

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

• Headache
• Fever
• Nosebleeds
• Vomiting

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

• Increased heart rate
• Blood tests may show increased bilirubin (bile pigment)
• Thrombocytopenia (low platelet count, the cells that help blood clot)
• Heavy menstrual bleeding

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

• Blood tests may show increased levels in a subcategory of bilirubin (direct bilirubin, bile pigment)

Reporting of adverse reactions

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

5. Storage of Blomensy

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

Do not use this medicine after the expiry date stated on the carton after EXP.

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

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature conditions.

Crushed tablets

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blomensy

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other components 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), iron oxide red (E 172).

Nature of the product and contents of the pack

Blomensy 15 mg film-coated tablets EFG: round, biconvex, film-coated tablets of reddish-brown colour, 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: round, biconvex, film-coated tablets of brown colour, 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 containing 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 containing 28, 98 or 100 film-coated tablets.

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

Only certain pack 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

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

Laboratorios Servier S.L.
Avenida de los Madroños 33
28043 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Netherlands Blomensy 15 mg, 20 mg filmomhulde tabletten
France Rivaroxaban Biogaran 15 mg, 20 mg, comprimé pelliculé
Spain Blomensy 15 mg, 20 mg comprimidos recubiertos con película 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 Tabletti, kalvopäällysteinen
Sweden Blomensy 15 mg, 20 mg filmdragerade tabletter
Denmark Blomensy 15 mg, 20 mg filmovertrukne tabletter
Norway Blomensy

Date of the most recent review of this leaflet:
08/2023

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/