APIXABAN ROVI 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Rovi 5mgfilm-coated tabletsEFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Apixaban Rovi and what is it used for

Apixaban Rovi contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent the formation of blood clots by blocking Factor Xa, an important component of blood clotting.

Apixaban Rovi is used in adults:

• to prevent the formation of a blood clot in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose, travel to the brain, and cause a stroke, or to other organs, preventing proper irrigation (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to 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 recurring in the blood vessels of the legs and/or lungs.

Apixaban Rovi is used in children from 28 days to less than 18 years of age to treat blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.

For the recommended dose suitable for body weight, see section 3.

2. What you need to know before you take Apixaban Rovi

Do not take Apixaban Rovi if:

• you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• you have excessive bleeding;
• you have a disease in an organof the body that increases the risk of severe bleeding (such as an active or recent stomach or intestinal ulcer, or recent brain hemorrhage);
• you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin) except when switching treatment, while having an arterial or venous line and being treated with heparin to keep that line open, or when having a tube inserted into a blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of these conditions:

• a increased risk of bleeding, such as:
• • bleeding disorders, including situations that result in a decrease in platelet activity;
  • very high blood pressure, not controlled by medical treatment;
  • you are over 75 years old;
  • you weigh 60 kg or less;
• a severe kidney disease or if you are on dialysis;
• a liver problem or history of liver problems;
• • This medicine will be used with caution in patients with signs of altered liver function
• if you have a heart valve replacement;
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive other treatment or undergo surgery to remove the blood clot from your lungs.

Be careful with Apixaban Rovi

• 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 it may be necessary to modify the treatment.

If you need to have surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medicine for a period of time. If you are not sure if a procedure may cause bleeding, talk to your doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents with a body weight below 35 kg.

Other medicines and Apixaban Rovi

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

Some medicines may increase the effects of Apixaban Rovi and some medicines may decrease its effects. Your doctor will decide if you should be treated with Apixaban Rovi when taking these medicines and if you should be kept under closer observation.

The following medicines may increase the effects of Apixaban Rovi and increase the possibility of an unwanted hemorrhage:

• some medicines for fungal infections(e.g., ketoconazole, etc.);
• some antiviral medicines for HIV/AIDS(e.g., ritonavir);
• other medicines to reduce blood clotting(e.g., enoxaparin, etc.);
• anti-inflammatoryor pain-relieving medicines(e.g., acetylsalicylic acid or naproxen). Especially if you are over 75 years old and taking acetylsalicylic acid, there is a higher likelihood of bleeding;
• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressants called selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Rovi to prevent blood clot formation:

• medicines for the treatment of epilepsy or convulsions(e.g., phenytoin, etc.);
• St. John's Wort(a plant-based supplement for the treatment of depression);
• medicines for the treatment of tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

The effects of Apixaban Rovi on pregnancy and the fetus are unknown. You should not take this medicine if you are pregnant. Tell your doctor immediatelyif you become pregnant while taking this medicine.

It is unknown whether Apixaban Rovi is excreted in human milk. Ask your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will tell you whether to interrupt breastfeeding or whether to stop or not start taking this medicine.

Driving and using machines

Apixaban Rovi has no influence on the ability to drive or use machines.

Apixaban Rovi contains lactose (a type of sugar) and sodium

If your doctor has told you that you have an intolerance to certain sugars, talk to 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 Apixaban Rovi

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

Dosage

Take the tablet with water. Apixaban Rovi can be taken with or without food. Try to take the tablets at the same time each day to achieve a better treatment effect.

If you have difficulty swallowing the tablet whole, talk to your doctor about other possible ways to take Apixaban Rovi. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.

Instructions for crushing:

• Crush the tablets with a mortar.
• Transfer all the powder carefully into a suitable container, mixing the powder with a small amount, e.g., 30 ml (2 tablespoons), of water or any of the liquids mentioned for making the mixture.
• Take the mixture.
• Rinse the mortar and the mortar's hand that have been used to crush the tablet and the container with a small amount of water or one of the other liquids (e.g., 30 ml), and take that liquid.

If necessary, your doctor may also administer the crushed Apixaban Rovi tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Rovi according to the following recommendations:

To prevent the formation of a blood clot in the heart in patients with an irregular heartbeat and at least one additional risk factor.

The recommended dose is one Apixaban Rovi tablet of 5mgtwice a day.

The recommended dose is one Apixaban Rovi tablet of 2.5mgtwice a day if:

• you have severely decreased kidney function;
• two or more of the following factors apply to you:

• your blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dl (133 micromoles/l) or higher);
• you are 80 years old or older;
• your weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, take one tablet in the morning and one in the evening. Your doctor will tell you how long you should continue the treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs

The recommended dose is two tabletsof Apixaban Rovi 5 mgtwice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is one tabletof Apixaban Rovi 5 mgtwice a day, for example, one tablet in the morning and one tablet in the evening.

To prevent blood clots from recurring after 6 months of treatment

The recommended dose is one Apixaban Rovi tablet of 2.5mgtwice a day, for example, one tablet in the morning and one tablet in the evening.

Your doctor will tell you how long you should continue the treatment.

Use in children and adolescents

For the treatment of blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.

Try to take or administer the dose at the same time each day to achieve a better treatment effect.

The dose of Apixaban Rovi depends on body weight and will be calculated by your doctor.

The recommended dose for children and adolescents with a weight of at least 35 kg is two tabletsof Apixaban Rovi 5 mgtwice a day for the first 7 days, for example, two tablets in the morning and two tablets in the evening.

After 7 days, the recommended dose is one tabletof Apixaban Rovi 5 mgtwice a day, for example, one tablet in the morning and one tablet in the evening.

For parents and caregivers: observe the child to ensure they take the complete dose.

It is important to respect scheduled visits to the doctor, as it may be necessary to adjust the dose based on changes in weight.

Your doctor may change your anticoagulant treatment as follows:

• Changing from Apixaban Rovi to anticoagulant medicines

Stop taking Apixaban Rovi. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would take the next tablet.

• Changing from anticoagulant medicines to Apixaban Rovi

Stop taking anticoagulant medicines. Start treatment with Apixaban Rovi at the time you would take the next dose of an anticoagulant medicine, and then continue as usual.

• Changing from a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin) to Apixaban Rovi

Stop taking the medicine that contains a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking Apixaban Rovi.

• Changing from treatment with Apixaban Rovi to a treatment with anticoagulants that contain vitamin K antagonists (e.g., warfarin).

If your doctor tells you to start taking a medicine that contains a vitamin K antagonist, continue taking Apixaban Rovi for at least 2 days after your first dose of the medicine that contains a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to stop taking Apixaban Rovi.

Patients undergoing cardioversion

If your heartbeat needs to be restored through a process called cardioversion, take this medicine at the times your doctor indicates to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

If you take more Apixaban Rovi than you should

Tell your doctor immediatelyif you have taken a dose greater than the prescribed dose of this medicine. Take the medicine package to your doctor, even if there are no tablets left.

If you take more Apixaban Rovi than the recommended dose, you may increase the risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments that can reverse anti-factor Xa activity may be necessary.

If you forget to take Apixaban Rovi

• If you miss a morning dose, take it as soon as you remember and can take it with the evening dose.
• If you miss an evening dose, you can only take it during that same night. Do not take two doses the next morning, but continue taking the medicine the next day as usual, twice a day as recommended.

If you have doubts about what to do or if you miss more than one dose,ask your doctor, pharmacist, or nurse.

If you stop taking Apixaban Rovi

Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot may be greater if you stop treatment too soon.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. The most frequent adverse effect of this medicine is bleeding, which can put the patient's life at risk and require immediate medical attention.

The following adverse effects have been reported when taking Apixabán Rovi to prevent the formation of blood clots in the heart in patients with irregular heartbeats and at least one additional risk factor.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • in the eyes;
  • in the stomach or intestine;
  • from the rectum;
  • blood in the urine;
  • from the nose;
  • from the gums;
  • bruising and swelling;
• Anemia, which can cause fatigue or paleness;
• Low blood pressure that can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Bleeding:
• • in the brain or spinal cord;
  • in the mouth or coughing up blood in saliva;
  • in the abdomen, or from the vagina;
  • bright red blood in the stool;
  • bleeding after surgery, including bruising and swelling, bleeding or fluid discharge from the surgical wound/incision (suppuration) or injection site;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;
• Decreased platelet count in the blood (which can affect coagulation);
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Inform your doctor immediatelyif you experience any of these symptoms.

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

• Bleeding:
• • in the lungs or throat;
  • in the space behind the abdominal cavity;
  • in a muscle.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme).

Unknown Frequency (cannot be estimated from available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface, or bruising.

The following adverse effects have been reported when taking Apixabán Rovi to treat or prevent blood clots from recurring in the veins of the legs and in the blood vessels of the lungs.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • from the nose;
  • from the gums;
  • blood in the urine;
  • bruising and swelling;
  • from the stomach, intestine, or rectum;
  • in the mouth;
  • vaginal;
• Anemia, which can cause fatigue or paleness;
• Decreased platelet count in the blood (which can affect coagulation);
• Nausea (feeling of discomfort);
• Skin rash;
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT) or alanine aminotransferase (ALT)

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Low blood pressure that can cause fainting or a faster heartbeat;
• Bleeding:
• • in the eyes;
  • in the mouth or coughing up blood in saliva;
  • bright red blood in the stool;
  • tests showing blood in the stool or urine;
  • bleeding after surgery, including bruising and swelling, bleeding or fluid discharge from the surgical wound/incision (suppuration) or injection site;
  • hemorrhoidal;
  • in a muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Contact your doctor immediatelyif you experience any of these symptoms;
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.

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

• Bleeding:
• • in the brain or spinal cord;
  • in the lungs.

Unknown Frequency (cannot be estimated from available data)

• Bleeding:
• • in the abdomen or the space behind the abdominal cavity;
• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme);
• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface, or bruising.

Additional Adverse Effects in Children and Adolescents

Inform the child's doctor immediatelyif you observe any of these symptoms;

• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. These adverse effects are frequent (may affect up to 1 in 10 people).

In general, the adverse effects observed in children and adolescents treated with Apixabán Rovi were similar to those observed in adults and mainly of mild to moderate intensity. The most frequent adverse effects observed in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very Frequent Adverse Effects (may affect more than 1 in 10 people)

• Bleeding, including:
• • vaginal;
  • nasal.

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Bleeding, including:
• • from the gums;
  • blood in the urine;
  • bruising and swelling;
  • from the intestine or rectum;
  • bright red blood in the stool;
  • bleeding after surgery, including bruising and swelling, bleeding or fluid discharge from the surgical wound/incision (suppuration) or injection site;

• Hair loss;
• Anemia, which can cause fatigue or paleness;
• Decreased platelet count in the child's blood (which can affect coagulation);
• Nausea (general discomfort);
• Skin rash;
• Itching;
• Low blood pressure that can cause fainting or a faster heartbeat in the child
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased alanine aminotransferase (ALT).

Unknown Frequency (cannot be estimated from available data)

• Bleeding:
• • in the abdomen or the space behind the abdominal cavity;
  • in the stomach;
  • in the eyes;
  • in the mouth;
  • hemorrhoidal;
  • in the mouth or coughing up blood;
  • in the brain or spinal cord;
  • in the lungs;
  • in a muscle;
• Skin rash that can form blisters and resemble small targets (dark spots in the center surrounded by a paler area, with a dark ring around) (erythema multiforme);
• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of red, round, and smooth spots under the skin surface, or bruising;
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT);
  • tests showing blood in the stool or urine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is 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 Apixabán Rovi

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

Do not use this medicine after the expiration date stated on the carton and on each blister, after '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. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apixabán Rovi

• The active ingredient is apixaban. Each film-coated tablet contains 5 mg of apixaban.
• The other ingredients are: microcrystalline cellulose, anhydrous lactose(see section 2 "Apixabán Rovi contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, sodium croscarmellose, and magnesium stearate in the tablet core. The film coating contains: hypromellose (E-464), lactose monohydrate(see section 2 "Apixabán Rovi contains lactose (a type of sugar) and sodium"), titanium dioxide (E-171), triacetin, and red iron oxide (E-172).

Appearance of Apixabán Rovi and Package Contents

Film-coated tablets, oblong, pink, and approximately 10 x 5 mm in size.

Packaged in PVC/PVDC/Aluminum blisters.

Package size: 56 and 60 film-coated tablets

Only some package sizes may be marketed.

Patient Information Card: Information Management

Inside the Apixabán Rovi package, along with the leaflet, you will find a Patient Information Card or your doctor may give you a similar card.

This Patient Information Card includes useful information for you and will alert other doctors that you are being treated with Apixabán Rovi. You must keep this card with you at all times.

1. Take the card
2. Separate the language you need (this is facilitated through the perforated ends)
3. Complete the following sections or ask your doctor to complete them:
   1. Name
   2. Date of birth
   3. Indication
   4. Dose: ………… mg twice a day
   5. Doctor's name:
   6. Doctor's phone number:
4. Fold the card and carry it with you at all times.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo 35, 28037 Madrid

Spain

Manufacturer

Laboratorios LICONSA S.A.

Av. De Miralcampo 7

19200 Azuqueca de Henares

Guadalajara, Spain

or

ZENTIVA, S.A.

Theodor Pallady Bvd, no 50, 3 district,

032266, Bucharest, Romania

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

Denmark: Apixaban Liconsa

Germany: Apixaban Liconsa 5 mg Filmtabletten

Spain: Apixabán Rovi 5 mg film-coated tablets EFG

France: Apixaban Liconsa 5 mg film-coated tablets

Ireland: Apixaban Rowa 5 mg Film-coated tablets

Italy: Apixaban Liconsa

Greece: APIXABAN/LICONSA

Croatia: Apiksaban Abela 5 mg film-coated tablets

Date of the last revision of this leaflet:10/2024

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