APIXABAN STADA 5 mg FILM-COATED TABLETS

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

Apixaban Stada contains the active substance apixaban and belongs to a group of medications called anticoagulants. This medication helps prevent the formation of blood clots by blocking Factor Xa, an important element in blood coagulation.

This medication 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, move to the brain, and cause a stroke, or move 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.

2. What you need to know before taking Apixaban Stada

Do not take Apixaban Stada

• if you are allergicto apixaban or any of the other components of this medication (listed in section 6)

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• if you have an organ diseasethat increases the risk of severe bleeding (such as an active or recent stomach or intestinal ulcer, or recent cerebral hemorrhage)
• if you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy)
• if you are taking medications to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching to a different anticoagulant treatment, while having an arterial or venous line and being treated with heparin to keep the line open, or when a tube is 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 medication if you have any of the following conditions:

• an increased risk of bleeding, such as:
• • bleeding disorders, including situations that result in decreased platelet activity
  • very high blood pressurethat is 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 medication will be used with caution in patients with signs of altered liver function
• you have a heart valve prosthesis
• 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

• 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 surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medication for a period. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age.

Other medications and Apixaban Stada

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use any other medication.

Some medications may increase the effects of apixaban, and some medications may decrease its effects. Your doctor will decide if you should be treated with apixaban if you are taking these medications and if you should be monitored more closely.

The following medications may increase the effects of apixaban and increase the risk of unwanted bleeding:

• some fungal infection medications(e.g., ketoconazole, etc.);
• some antiviral medications for HIV/AIDS(e.g., ritonavir);
• other medications to reduce blood coagulation(e.g., enoxaparin, etc.);
• anti-inflammatoryor pain-relieving medications(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.
• medications for high blood pressure or heart problems(e.g., diltiazem);
• antidepressants calledselective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medications may reduce the ability of apixaban to prevent blood clot formation.

• medications for the treatment of epilepsy or seizures(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medication for the treatment of depression);
• medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

It is unknown if apixaban is excreted in human milk. Ask your doctor or pharmacist before taking this medication during breastfeeding. They will tell you whether to interrupt breastfeeding or whether to stop or not start taking this medication.

Driving and using machines

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

Apixaban Stada contains lactose and sodium.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Apixaban Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse.

Dosage

The tablet can be divided into equal doses.

Take the tablet with water. Apixaban can be taken with or without food.

Try to take the tablets at the same time every day to achieve a better treatment effect.

If you have difficulty swallowing the whole tablet, 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.

Crushing instructions:

• 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.
• rinsing 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 taking 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 apixaban 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 5 mgtablet twice a day.

The recommended dose is one apixaban 2.5 mgtablet twice a day if:

• you have severely impaired kidney function

• two or more of the following factors apply

• your blood test results suggest poor kidney function (creatinine serum 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 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 5 mgtablets 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 5 mgtablet 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 2.5 mgtablet 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.

Your doctor may change your anticoagulant treatment as follows:

• Changing from apixaban to other anticoagulant medications

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

• Changing from other anticoagulant medications to apixaban

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

• Changing from a treatment with anticoagulants containing Vitamin K antagonists (e.g., warfarin) to apixaban

Stop taking the medication containing a Vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking apixaban.

• Changing from apixaban to a treatment with anticoagulants containing Vitamin K antagonists (e.g., warfarin).

If your doctor tells you to start taking a medication containing a Vitamin K antagonist, continue taking apixaban for at least 2 days after your first dose of the medication containing 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 medication at the times indicated by your doctor to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.

If you take more Apixaban Stada than you should

Tell your doctor immediatelyif you have taken a dose larger than the prescribed dose of this medication. Bring the medication package 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 may be necessary to reverse the anti-factor Xa activity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91562 04 20, indicating the medication and the amount ingested.

If you forget to take Apixaban Stada

• Take the dose as soon as you remember and
• • take the next dose of apixaban at the usual time
  • then continue taking the medication as usual

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 interrupt treatment with Apixaban Stada

Do not interrupt treatment with this medication without talking to your doctor first, as the risk of developing a blood clot may be higher if treatment is interrupted too soon.

If you have any other questions about the use of this medication, 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.

For these conditions, 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 toprevent the formation of blood clotsinthe 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 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 the abdomen, or vagina
  • bright red blood in the stool
  • bleeding after surgery, including bruising and swelling, discharge of blood or fluid from the surgical wound/incision (suppuration) or 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. Tell 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 the 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 apixaban totreat or prevent blood clots from recurringin theveins of the legsand inthe 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 or intestine
  • from the rectum
  • in the mouth
  • vaginal
• anemia, which can cause fatigue or paleness
• 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
  • bright red blood in the stool
  • tests showing blood in the stool or urine
  • bleeding after surgery, including bruising and swelling, discharge of blood or fluid 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 immediately if 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 the 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.

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 Medicines and Health Products Agency's website (http://www.aemps.gob.es/). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Apixaban Stada

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 pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Apixaban Stada

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:

Core of the tablet: microcrystalline cellulose, sodium croscarmellose, sodium docusate, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, magnesium stearate.

Coating (Opadry II pink): hypromellose (2910, 15 mPas), lactose monohydrate, titanium dioxide (E171), macrogol (3350), red iron oxide (E172), yellow iron oxide (E172).

Appearance of the Product and Package Contents

The film-coated tablets are pink, oval, and have a score line on one side.

They are available in blisters within cartons containing 14, 20, 28, 30, 56, 60, 100 (clinical packaging), 168, and 200 film-coated tablets.

Single-dose blisters are also available within cartons containing 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 100 x 1 (clinical packaging), 168 x 1, and 200 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Patient Information Card: information management

Inside the packaging of Apixaban Stada, 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 should 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:
   • Dose: mg twice a day
   • Doctor's name:
   • Doctor's phone number:
4. Fold the card and carry it with you at all times

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

E91 D768 Clonmel, Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E

4814NE Breda

Netherlands

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

Date of the Last Revision of this Leaflet:May 2022

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/)