APIXABAN TAD 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban TAD 5mg 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 TAD and what is it used for
2. What you need to know before you take Apixaban TAD
3. How to take Apixaban TAD
4. Possible side effects
5. Storage of Apixaban TAD
6. Pack contents and further information

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

This medicine contains the active substance apixaban, which 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 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 travel to other organs and prevent proper irrigation of the organ (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 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 appropriate for body weight, see section 3.

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

Do not take Apixaban TAD

• to apixaban or any of the other ingredients of this medicine (listed in section 6);
• that increases the risk of severe bleeding (such as an active or recent stomach or intestinal ulcer, recent brain hemorrhage);
• that increases the risk of bleeding (hepatic coagulopathy);
• (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 the 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 Apixaban TAD if you have any of the following conditions:

• an 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

• 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 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

• (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 while. If you are unsure 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 TAD

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

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

The following medicines may increase the effects of apixaban 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). In particular, 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)
• antidepressantscalled selective serotonin reuptake inhibitorsor serotonin-noradrenaline reuptake inhibitors

The following medicines may reduce the ability of apixaban to prevent blood clots.

• medicines for the treatment of epilepsy or convulsions(e.g., phenytoin, etc.)
• St. John's Wort(a herbal medicine for the treatment of depression)
• medicines for the treatment of tuberculosisor 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 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 is excreted in human milk. Ask your doctor or pharmacist for advice before taking this medicine during breastfeeding. They will tell you whether to stop breastfeeding or to stop or not start taking this medicine.

Driving and using machines

Apixaban has not been shown to affect your ability to drive or use machines.

Apixaban TAD contains lactose 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 TAD

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, talk to your doctor, pharmacist, or nurse.

Dosage

Take the tablet with water.

This medicine 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. 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 one of the other liquids mentioned for making the mixture.
• Take the mixture.
• Rinse the mortar and pestle 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 tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take this medicine 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 5mgtablet twice a day.

The recommended dose is one apixaban 2.5 mgtablet twice 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 (serum creatinine value of 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, one tablet in the morning and one in the evening.

Your doctor will tell you how long to continue treatment.

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

The recommended dose is twoapixaban 5mgtablets twice 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 oneapixaban 5mgtablet twice a day, for example, one tablet in the morning and one in the evening.

To prevent blood clots from recurring after 6 months of treatment

The recommended dose is one apixaban 2.5mgtablet twice a day, for example, one tablet in the morning and one in the evening.

Your doctor will tell you how long to continue 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.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, talk to 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 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 twoapixaban 5 mgtablets 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 oneapixaban 5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.

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

It is essential to keep scheduled appointments with your doctor, as it may be necessary to adjust the dose based on changes in weight.

Your doctor may change your anticoagulant treatment as follows:

• Switching from apixaban to other anticoagulant medicines

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

• Switching from other anticoagulant medicines to apixaban

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

• Switching from treatment with anticoagulants that contain Vitamin K antagonists (e.g., warfarin) to apixaban

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.

• Switching from apixaban to 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 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.

Patients undergoing cardioversion

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

If you take more Apixaban TAD than you should

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

If you take more apixaban 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.

In case of overdose or accidental ingestion, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Apixaban TAD

• 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 that same evening. Do not take two doses the next morning, but continue taking the medicine as usual, twice a day as recommended.

If you are unsure what to do or if you miss more than one dose,ask your doctor, pharmacist, or nurse.

If you stop taking Apixaban TAD

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

If you have any further questions on 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 requires immediate medical attention.

The following adverse effects have been reported when taking apixaban to prevent the formation of blood clots in the heart in patients with irregular heartbeat 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).

Infrequent 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 the abdomen, or vagina;
• bright red blood in the stool;
• bleeding after surgery that includes bruising and swelling, bleeding or fluid discharge from the surgical wound/incision or injection site;
• hemorrhoidal;
• tests that show blood in the stool or urine;

• Decrease in the number of platelets in the blood (which can affect clotting);

• Blood tests may show:

• abnormal liver function;
• an increase in some liver enzymes;

• an 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 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 round, smooth red spots under the skin surface, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

The following adverse effects have been reported when taking apixaban 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;
• Decrease in the number of platelets in the blood (which can affect clotting);
• Nausea (feeling of discomfort);
• Skin rash;

• Blood tests may show:

• an increase in gamma glutamyl transferase (GGT) or alanine aminotransferase (GPT).

Infrequent 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;
• bright red blood in the stool;
• tests that show blood in the stool or urine;
• bleeding after surgery that includes bruising and swelling, bleeding or fluid discharge from the surgical wound/incision 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. Inform your doctor immediatelyif you experience any of these symptoms.

• Blood tests may show:

• abnormal liver function;
• an increase in some liver enzymes;
• an 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 round, smooth red spots under the skin surface, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

Additional Adverse Effects in Children and Adolescents

Inform your 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 were similar to those observed in adults and were mainly mild to moderate in 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 that includes bruising and swelling, bleeding or fluid discharge from the surgical wound/incision or injection site;
• Hair loss;
• Anemia, which can cause fatigue or paleness;
• Decrease in the number of platelets in the child's blood (which can affect clotting);
• 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;
  • an increase in some liver enzymes;
  • an increase in alanine aminotransferase (GPT).

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 round, smooth red spots under the skin surface, or bruising;
• Blood tests may show:
  • • an increase in gamma glutamyl transferase (GGT);
    • tests that show blood in the stool or urine;
  • Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to fail to function properly (anticoagulant-related nephropathy).

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 Apixaban TAD

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, 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 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 Apixaban TAD

• The active ingredient is apixaban. Each film-coated tablet contains 5 mg of apixaban.

• The other ingredients (excipients) are:
• Core of the tablet; microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose (E468), sodium lauryl sulfate, hydroxyethylcellulose, magnesium stearate (E470b)
• Coating of the tablet; hypromellose (E464), propylene glycol (E1520), titanium dioxide (E171), talc (E553b), and yellow iron oxide (E172).
• See section 2 "Apixaban TAD contains lactose and sodium"

Appearance of the Product and Package Contents

Yellow-brown, oval, biconvex film-coated tablets, marked with the number 5 on one face of the tablet.

Tablet dimensions: length x width approximately 10.5 x 5.5 mm.

It is available in packages that contain:

• 10, 14, 20, 28, 56, 60, 100, 168, or 200 film-coated tablets in non-perforated blisters.
• 10 x 1, 14 x 1, 20 x 1, 28 x 1, 56 x 1, 60 x 1, 100 x 1, or 168 x 1 film-coated tablets in perforated unit blisters.
• 100 or 168 film-coated tablets in a child-resistant PP closure bottle.

Not all package sizes may be marketed.

Patient Information Card: Information Management

Inside the apixaban 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. 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:
   • Name:
   • Date of birth:
   • Indication:
   • Body weight (for the pediatric population):
   • Dose: ........mg twice a day
   • Doctor's name:
   • Doctor's phone number:

1. Fold the card and carry it with you at all times

Marketing Authorization Holder

TAD Pharma GmbH, Heinz Lohmann strasse, 5, Cuxhaven, D-27472, Germany

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this leaflet:June 2025

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/)