APIXABAN ROVI 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Rovi2.5 mg film-coated tablets EFG

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 element in the blood clotting process

Apixaban Rovi is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee replacement surgery, you may have a higher risk of blood clots forming in the veins of your legs. This can cause swelling in your legs, with or without pain. If a blood clot travels from your leg to your lungs, it can block the flow of blood, causing difficulty breathing, with or without chest pain. This medical condition (pulmonary embolism) can be life-threatening and requires immediate medical attention

• 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, move 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 happening again 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 happening again 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 takeApixaban Roviif:

• you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6)
• you have excessive bleeding
• you have an organ diseasethat 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

Tell 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
• you had a tube (catheter) or received an injection in your spine(for anesthesia or pain relief), your doctor will tell you to wait at least 5 hours after removing the catheter before taking this medicine
• if you have a heart valve replacement
• if your doctor determines that your blood pressure is unstable or you are scheduled to receive another 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 so that they can 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 while. If you are not sure if a procedure may cause bleeding, ask 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 while 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 risk of unwanted bleeding:

• 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 clots:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine

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

It is not known if Apixaban Rovi is excreted in human milk. Ask your doctor, pharmacist, or nurse for advice before taking this medicine during breastfeeding. They will tell you whether to stop 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 some 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, ask 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 effect of the treatment

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 other liquids mentioned to make the mixture
• Take the mixture
• Rinse the mortar and the mortar's hand that were 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 blood clots in hip or knee replacement surgery

The recommended dose is one Apixaban Rovi 2.5 mg tablet twice a day. For example, take one tablet in the morning and one in the evening

You should take the first tablet between 12 to 24 hours after surgery

If you have had major hip surgery, you will usually take the tablets for a period of 32 to 38 days

If you have had major knee surgery, you will usually take the tablets for a period of 10 to 14 days

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

The recommended dose is one Apixaban Rovi 5 mg tablet twice a day

The recommended dose is one Apixaban Rovi 2.5 mg tablet twice a day if:

• you have severely reduced 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 Apixaban Rovi 5 mg tablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening

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

To prevent blood clots from happening again after 6 months of treatment

The recommended dose is one Apixaban Rovi 2.5 mg tablet twice a day, for example, one tablet in the morning and one 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 happening again 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, ask your doctor, pharmacist, or nurse

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

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 four Apixaban Rovi 2.5 mg tabletstwice a day for the first 7 days, for example, four tablets in the morning and four in the evening

After 7 days, the recommended dose is two Apixaban Rovi 2.5 mg tabletstwice a day, for example, two tablets in the morning and two 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:

• Change fromApixaban Rovito anticoagulant medicines

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

• Change 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

• Change 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

• Change from treatment with Apixaban Rovi to a treatment with anticoagulants that contain a vitamin K antagonist (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. Bring the medicine pack 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 the anti-factor Xa activity may be necessary

If you forget to take Apixaban Rovi

• If you forget a morning dose, take it as soon as you remember and you can take it with the evening dose
• If you forget 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 forget to take 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 the 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. Apixaban Rovi can be administered in three different diseases. The known adverse effects and the frequency with which they occur may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine is bleeding, which can endanger the patient's life and require immediate medical attention.

The following adverse effects have been reported when taking Apixaban Rovi to prevent the formation of blood clots in hip or knee replacement surgery.

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

• Anemia, which can cause fatigue or pallor;
• Bleeding including:
• • hematoma and swelling;
• Nausea (general discomfort).

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

• Decrease in the number of platelets in the blood (which can affect coagulation);
• Bleeding:
• • after surgery, including hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration), or at the injection site;
  • from the stomach, intestine, or bright red blood in the stool;
  • blood in the urine;
  • from the nose;
  • vaginal;

• Low blood pressure that can cause fainting or a faster heart rate;
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes;

• Itching.

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

• 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.
• Bleeding:
• • in a muscle;
  • in the eyes;
  • from the gums and coughing up blood in saliva;
  • from the rectum;

• Hair loss.

Unknown Frequency (cannot be estimated from available data)

• Bleeding:
• • in the brain or spinal cord;
  • in the lungs or throat;
  • in the mouth;
  • in the abdomen or the space behind the abdominal cavity;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;

• 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 bruises.

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

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

• Bleeding that includes:
• • in the eyes;
  • in the stomach or intestine;
  • from the rectum;
  • blood in the urine;
  • from the nose;
  • from the gums;
  • hematoma and swelling;

• Anemia, which can cause fatigue or pallor;
• Low blood pressure that can cause fainting or a faster heart rate;
• 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 hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration) or at the injection site;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;

• Decrease in the number of platelets in the blood (which can affect coagulation);
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in 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 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 bruises.

The following adverse effects have been reported when taking Apixaban 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 that includes:
• • from the nose;
  • from the gums;
  • blood in the urine;
  • hematoma and swelling;
  • from the stomach, intestine, or rectum;
  • in the mouth;
  • vaginal;

• Anemia, which can cause fatigue or pallor;
• Decrease in the number of platelets in the blood (which can affect coagulation);
• Nausea (general discomfort);
• Skin rash;
• Blood tests may show:
• • an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (GPT).

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

• Low blood pressure that can cause fainting or a faster heart rate
• 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 hematoma and swelling, bleeding or fluid secretion from the wound/surgical incision (suppuration); or at the 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;
  • increase in some liver enzymes;
  • increase in 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 bruises.

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 Apixaban 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 that includes:
• • vaginal;
  • nasal.

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

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

• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decrease in the number of platelets 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 heart rate in the child;
• Blood tests may show:
• • abnormal liver function;
  • increase in some liver enzymes;
  • increase in 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 bruises;
• Blood tests may show:
• • an increase in gamma-glutamyl transferase (GGT);
  • tests showing blood in the stool or urine.

Reporting of 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 Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Apixaban Rovi

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 '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 through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, 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 Apixaban Rovi

• The active ingredient is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
• The other ingredients are: microcrystalline cellulose, anhydrous lactose(see section 2 "Apixaban 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 "Apixaban Rovi contains lactose (a type of sugar) and sodium"), titanium dioxide (E-171), triacetin, and yellow iron oxide (E-172).

Appearance of Apixaban Rovi and Package Contents

Flat, round, film-coated tablets, yellow in color, with approximate dimensions of 6 mm.

Packaged in PVC/PVDC/Aluminum blisters.

Package size: 60 film-coated tablets

Only some package sizes may be marketed.

Patient Information Card: Information Management

Inside the Apixaban 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 Apixaban 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 2.5 mg Filmtabletten

Spain: Apixabán Rovi 2.5 mg film-coated tablets EFG

France: Apixaban Liconsa 2.5 mg film-coated tablet

Ireland: Apixaban Rowa 2.5 mg Film-coated tablets

Italy: Apixaban Liconsa

Greece: APIXABAN/LICONSA

Croatia: Apiksaban Abela 2.5 mg film-coated tablets

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

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