COAGUBAN 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Coaguban 15 mg film-coated tablets EFG

Coaguban 20 mg film-coated tablets EFG

Rivaroxaban

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Coaguban and what is it used for
2. What you need to know before taking Coaguban
3. How to take Coaguban
4. Possible side effects
5. Storage of Coaguban
6. Package contents and additional information

1. What is Coaguban and what is it used for

Coaguban contains the active substance rivaroxaban and is 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 heartbeat 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 occurring again in the blood vessels of the legs and/or lungs.

Rivaroxaban belongs to a group of medications 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 taking Coaguban

Do not take Coaguban

• if you are allergic to rivaroxaban or any of the other ingredients of this medication (listed in section 6)
• if you have excessive bleeding
• 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 surgery in the brain or eyes)
• if you are taking medications to prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching to another anticoagulant treatment or while receiving 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 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.

Be careful with Coaguban

• If you have an increased risk of bleeding, such as in the following situations:
  • severe kidney failure, as kidney function may affect the amount of medication that works in the body
  • if you are taking other medications to prevent blood clotting (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 medications and Coaguban")
  • bleeding disorder
  • uncontrolled high blood pressure
  • stomach or intestinal diseases that may cause bleeding, such as intestinal inflammation or stomach inflammation, esophageal 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 previous lung bleeding

• if you have a heart valve prosthesis
• 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.

Inform your doctor if you have any of these situationsbefore taking rivaroxaban. Your doctor will decide if you should be treated with this medication and if you should be kept under closer observation.

If you need surgery:

• It is very important to take rivaroxaban before and after surgery, 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 intestines or bladder after anesthesia, as urgent attention is necessary.

Children and adolescents

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

Other medications and Coaguban

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

• If you are taking:
  • any medication 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 excess cortisol)
  • any medication for bacterial infections (e.g., clarithromycin, erythromycin)
  • any antiviral medication for HIV/AIDS (e.g., ritonavir)
  • other medications to reduce blood clotting (e.g., enoxaparin, clopidogrel, or vitamin K antagonists, such as warfarin or acenocoumarol)
  • anti-inflammatory medications or pain relievers (e.g., naproxen or acetylsalicylic acid)
  • dronedarone, a medication for the treatment of irregular heartbeat
  • certain medications 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, inform your doctorbefore taking rivaroxaban, as the effect of this medication may be increased. Your doctor will decide if you should be treated with this medication 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 use a preventive treatment.

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

If any of the above circumstances apply to you, inform your doctorbefore taking rivaroxaban, as the effect of this medication may be reduced. Your doctor will decide if you should be treated with this medication 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 any possibility that you may become pregnant, use a reliable contraceptive while taking this medication. If you become pregnant while taking this medication, inform your doctor immediately, who will decide how you should be treated.

Driving and using machines

Rivaroxaban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 "Possible side effects"). You should 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 certain sugars, consult with them before taking this medication.

Coaguban contains sodium

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

3. How to take Coaguban

Follow the instructions for administration of this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

What dose to take

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

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

If you have kidney problems, the dose may be reduced to one 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 placement), there is limited evidence to reduce the dose to one 15 mg rivaroxaban tablet once a day (or to one 10 mg rivaroxaban tablet once a day if your kidneys do not function properly) in addition to an antiplatelet medication such as clopidogrel.

• 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 occurring again.

The recommended dose is one 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 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 10 mg tablet once a day or one 20 mg tablet once a day.

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

Swallow the tablets, preferably with water. Take Coaguban with food.

If you have difficulty swallowing the tablet whole, 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.

When to take Coaguban

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 to take them. The 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: If you need to undergo a procedure to normalize your heartbeat, called cardioversion, take rivaroxaban at the times indicated by your doctor.

If you take more Coaguban than you should

Call your doctor immediately if you have taken too many rivaroxaban tablets. Taking too much medication 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 medication and the amount ingested.

If you forget to take Coaguban

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

Do not stop taking rivaroxaban without consulting your doctor first, as this medication treats and prevents serious conditions.

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

4. Possible Adverse Effects

Like all medicines, Coaguban can cause adverse effects, although not all people suffer from them.

Like other similar medicines (antithrombotics), rivaroxaban can cause bleeding that can endanger the patient's life. 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, which may be signs of bleeding.

Your doctor may decide 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

Common Adverse Effects(may affect up to 1 in 10 patients)

• decrease in red blood cells that can 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)
• bloody cough
• 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, dizziness or feeling of dizziness, 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 Adverse Effects(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 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 Adverse Effects(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 after a complication in cardiac surgery where 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 not listed 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 sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and on each blister after "CAD" or "EXP".

The expiration date is the last day of the month indicated. It does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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 15 mg or 20 mg of rivaroxaban.
• The other components are:

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

Coating of the 15 mg tablet: macrogol 3350, hypromellose, titanium dioxide (E-171), red iron oxide (E-172).

Coating of the 20 mg tablet: macrogol 3350, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), red iron oxide (E-172), and talc.

Appearance of the Product and Package Contents

The film-coated tablets of Coaguban 15 mg are round, biconvex, brown-red in color, engraved with "E3" on one side, and smooth on the other side.

The film-coated tablets of Coaguban 20 mg are round, biconvex, dark red in color, engraved with "E4" on one side, and smooth on the other side.

Coaguban 15 mg

They are packaged in PVC-PVdC/Aluminum blisters, in boxes of 28 or 42 film-coated tablets or in unit-dose blisters, in packages of 100 x 1.

Coaguban 20 mg

They are packaged in PVC-PVdC/Aluminum blisters, in boxes of 28 film-coated tablets or in unit-dose blisters, in packages of 100 x 1.

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 Last Revision of this Leaflet:October 2024

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