COAGUBAN 2.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Coaguban 2.5 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 Coaguban and what is it used for
2. What you need to know before you take Coaguban
3. How to take Coaguban
4. Possible side effects
5. Storing Coaguban
6. Contents of the pack and other information

1. What is Coaguban and what is it used for

You have been prescribed Coaguban because you have been diagnosed with acute coronary syndrome (a group of disorders that include myocardial infarction and unstable angina, a type of severe chest pain) and your blood tests have shown high results in certain heart tests.

Rivaroxaban reduces the risk of having another myocardial infarction in adults, or reduces the risk of death due to heart or blood vessel disease.

You will be prescribed rivaroxaban along with another medicine. Your doctor will also tell you to take:

• aspirin or
• aspirin plus clopidogrel or ticlopidine

or

• you have been diagnosed with a high risk of blood clot formation due to coronary artery disease or peripheral artery disease that causes symptoms. Rivaroxaban reduces the risk of blood clot formation (atherothrombotic events) in adults. You will be prescribed this medicine along with another medicine. Your doctor will also tell you to take aspirin.

Coaguban contains the active substance rivaroxaban, which belongs to a group of medicines called antithrombotic agents. It works by blocking a clotting factor (factor Xa) and thus reducing the tendency of blood to form clots.

2. What you need to know before you take Coaguban

Do not take Coaguban

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• if you bleed excessively
• if you have a disease or problem in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent brain or eye surgery)
• if you are taking medicines to prevent blood clot formation (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to another anticoagulant treatment or while being administered heparin through a venous or arterial catheter, so that it does not become blocked
• if you have acute coronary syndrome and have previously had a bleeding or blood clot in the brain (stroke)
• if you have coronary artery disease or peripheral artery disease and have previously had a bleeding in the brain (stroke) or an obstruction of the small arteries that supply blood to the deep tissues of the brain (lacunar stroke) or if you have had a blood clot in the brain (non-lacunar ischemic stroke) in the previous month
• if you have a liver disease that may increase the risk of bleeding
• if you are pregnant or breastfeeding.

Do not take Coaguban and inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rivaroxaban.

Coaguban should not be used in combination with other medicines that reduce blood clotting, other than aspirin or clopidogrel/ticlopidine, such as prasugrel or ticagrelor.

Be careful with Coaguban

• If you have an increased risk of bleeding, as may occur in the following situations:
  • severe kidney failure, as kidney function may affect the amount of medicine that works in your body
  • if you are taking other medicines to prevent blood clot formation (e.g. warfarin, dabigatran, apixaban or heparin), when switching to another anticoagulant treatment or while receiving heparin through a venous or arterial catheter, so that it does not become blocked (see section "Other medicines and Coaguban")
  • bleeding disorder
  • uncontrolled high blood pressure
  • stomach or intestine diseases that may cause bleeding, such as stomach or intestine inflammation, esophagus inflammation (e.g. due to gastroesophageal reflux disease)
  • 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 if you have had a previous bleeding in the lungs
  • you are over 75 years old
  • your weight is 60 kg or less.

• If you have a heart valve prosthesis

Tell your doctor if you have any of these situationsbefore 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 the operation, exactly at the times indicated by your doctor.
• If your operation requires the placement of a catheter or injection in the spinal column (e.g. for epidural or spinal anesthesia, or pain relief):

It is very important to take rivaroxaban before and after the injection or catheter removal, exactly at the times indicated by your doctor.

Inform your doctor immediately if you experience numbness or weakness in your legs or problems in your intestine or bladder at the end of anesthesia, as urgent attention is necessary.

Children and adolescents

Rivaroxaban is not recommended in children and adolescents under 18 years of age.There is not enough information on its use in children and adolescents.

Other medicines and Coaguban

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
  • 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), prasugrel and ticagrelor (see section "Warnings and precautions")
  • anti-inflammatory medicines and pain relievers (e.g. naproxen or aspirin)
  • 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 circumstances apply to you, tell your doctorbefore taking rivaroxaban, because the effect of this medicine 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 intestine ulcer, they may recommend that you also use a preventive treatment.

• If you are taking:
  • any medicine for the treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
  • St. John's Wort (Hipericum perforatum) a herbal medicine for the treatment of depression
  • rifampicin, an antibiotic

If any of the above circumstances apply to you, tell your doctorbefore taking Coaguban, 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 breastfeeding

Do not take Rivaroxaban if you are pregnant or breastfeeding. 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, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Coaguban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, "Possible side effects"). Do not drive or use machines if you are affected by these symptoms.

Coaguban contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Coaguban contains sodium

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

3. How to take Coaguban

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one 2.5 mg tablet twice a day. Take Coaguban at the same time every day (e.g. one tablet in the morning and one in the evening).

You should take Rivaroxaban with food. Swallow the tablets, preferably with water.

If you have difficulty swallowing the whole tablet, 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.

You will be prescribed Coaguban along with another medicine.

Your doctor will tell you to take aspirin as well.

If you receive rivaroxaban after an acute coronary syndrome, your doctor may tell you to take clopidogrel or ticlopidine as well

Your doctor will tell you the dose to take (usually between 75 and 100 mg of aspirin per day, or a dose of 75 to 100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start treatment with Coaguban

Treatment with rivaroxaban after an acute coronary syndrome should be started as soon as possible, once the acute coronary syndrome has been stabilized, i.e. from 24 hours after hospital admission and at the time when parenteral anticoagulant treatment (by injection) would be finished.

Your doctor will tell you when to start treatment with rivaroxaban if you have been diagnosed with coronary artery disease or peripheral artery disease.

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

If you take more Coaguban than you should

Call your doctor immediately if you have taken too many Coaguban tablets. Taking too much rivaroxaban increases the risk of bleeding. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Coaguban

Do not take more than one tablet in one day to make up for a forgotten dose. If you forget to take a dose, take the next tablet at the usual time.

If you stop taking Coaguban

Take rivaroxaban regularly for the time indicated by your doctor.

Do not stop taking rivaroxaban without talking to your doctor first. If you stop taking this medicine, you may increase your risk of having another myocardial infarction, a stroke or dying from a heart or blood vessel disease.

If you have any other 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 all people suffer from them.

Like other similar medicines (antithrombotics), Coaguban may cause bleeding that can put the patient's life at risk. Excessive bleeding can cause a sudden drop in blood pressure (shock). In some cases, the bleeding may not be evident.

Possible Adverse Effects that May be Signs of Bleeding:

Inform your doctor immediatelyif you experience any of the following symptoms:

• prolonged or excessive bleeding
• exceptional weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain or angina, as they may be signs of bleeding.

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

Possible Adverse Effects that May be Signs of Severe Skin Reaction

Inform your doctor immediatelyif you experience skin reactions such as:

• intense skin rashes that spread, blisters, or lesions on the mucous membranes, e.g., in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis). The frequency of this adverse effect is very rare (up to 1 in 10,000).
• drug reaction that causes rash, fever, inflammation of internal organs, hematological abnormalities, and systemic disease (DRESS syndrome). The frequency of this adverse effect is very rare (up to 1 in 10,000).

Possible Adverse Effects that May be Signs of Severe Allergic Reaction

Inform your doctor immediatelyif you experience any of the following adverse effects:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing; hives, and difficulty breathing; sudden drop in blood pressure. The frequencies of these adverse effects 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

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

• decrease in red blood cells that may cause paleness and weakness or difficulty breathing
• stomach or intestinal bleeding, 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
• limb pain
• alteration of kidney function (may be seen in analyses performed by the doctor)
• fever
• stomach pain, indigestion, dizziness, or feeling of dizziness, constipation, diarrhea
• low blood pressure (symptoms may be dizziness or fainting when standing up)

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

• bleeding in the brain or inside the skull
• 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 analyses 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 patients):

• 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 as a complication after cardiac surgery in which a catheter is inserted into the leg artery (pseudoaneurysm)

Frequency Not Known(frequency cannot be estimated from available data):

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

Reporting of Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this leaflet. 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 medicine.

5. Storage of Coaguban

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

Do not use this medicine after the expiration date that appears on the packaging and on each blister after "CAD" or "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Coaguban

• The active ingredient is rivaroxaban. Each tablet contains 2.5 mg of rivaroxaban.
• The other components are:

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

Tablet film coating: macrogol 3350, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the Product and Package Contents

The film-coated tablets of Coaguban 2.5 mg are yellow, round, biconvex, engraved with "E21" on one side and smooth on the other.

They are packaged in PVC-PVdC/Aluminum blisters, in packs of 56 film-coated tablets, or in single-dose blisters, in packs of 100x1.

Marketing Authorization Holder

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles, Barcelona, Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/de Sant Martí, 75-97, 08107, Martorelles, Barcelona, Spain.

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, PLA3000, Paola, Malta

Date of the Last Revision of this Leaflet:October 2024

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