APIXABAN OLPHA 2.5 mg FILM-COATED TABLETS

Introduction

A.

Package Leaflet: Information for the User

Apixaban Olpha 2.5mg film-coated tablets EFG

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

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

Contents of the Package Leaflet:

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

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

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

Apixaban 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 forming blood clots in the veins of your legs. This can cause swelling in the legs, with or without pain. If a blood clot travels from your leg to your lungs, it can block blood flow, 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 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 Olpha

Do not take Apixaban Olpha if:

• you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);

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• you have a disease in an organof the body that increases the risk of severe bleeding (such as

a recent or active stomach or intestinal ulcer, or recent cerebral hemorrhage);

• you have a liver diseasethat increases the risk of bleeding (hepatic coagulopathy);
• you are taking medications to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching 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 starting to take this medicine if you have any of these 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;

-;

• 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 had a catheter or received an injection in the 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;
• you have a heart valve prosthesis;
• 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

• if you know you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of forming blood clots), inform your doctor to decide if it may be necessary to modify the treatment.

If you need to undergo 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, consult your doctor.

Children and Adolescents

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

Other Medicines and Apixaban Olpha

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use 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 possibility 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 coagulation(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);

-

serotonin-norepinephrine reuptake inhibitors.

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

• medicines for the treatment of epilepsy or seizures(e.g., phenytoin, etc.);
• St. John's Wort(a herbal medicine for the treatment of depression);
• medicines to treat 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, pharmacist, or nurse before using this medicine.

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

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

Driving and Using Machines

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

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

If your doctor has told you that you have an intolerance to certain sugars, consult with 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 Olpha

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

Dosage

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 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.

Crushing Instructions:

• Crush the tablets with a mortar.
• Carefully transfer all the powder 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 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 tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Olpha according to the following recommendations:

To prevent the formation of blood clots in hip or knee replacement surgeries.

The recommended dose of apixaban is one 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 and 24 hours after surgery.

If you have undergone hipsurgery, you will generally take the tablets for a period of 32 to 38 days.

If you have undergone kneesurgery, you will generally take the tablets for a period of 10 to 14 days.

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 of apixaban is one 5mgtablet twice a day.

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

-

• you apply two or more of the following factors:
• • 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 two5mgtablets 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 one5mgtablet 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 2.5mgtablet 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.

Your doctor may change your anticoagulant treatment as follows:

• Changing from apixaban to anticoagulant medications

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

• Changing from anticoagulant medications to apixaban

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

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

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

• Changing from apixaban treatment to an anticoagulant treatment that contains a vitamin K antagonist (e.g., warfarin).

If your doctor tells you to start taking a vitamin K antagonist-containing medication, continue taking apixaban for at least 2 days after your first dose of the vitamin K antagonist-containing medication. Your doctor will need to perform blood tests and tell you when to stop taking apixaban.

Patients Undergoing Cardioversion

If your irregular 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 Olpha than you should

Tell your doctor immediatelyif you have taken a dose greater than the prescribed dose of this medicine. Bring the medicine 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 that can reverse anti-factor Xa activity may be necessary.

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

If you forget to take Apixaban Olpha

Take the dose as soon as you remember and:

• take the next dose of apixaban at the usual time
• then, continue taking the medicine 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 stop taking Apixaban Olpha

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 Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Apixaban can be administered in three different diseases. The known side effects and their frequency may be different and are therefore indicated separately below. For these conditions, the most common side effect of this medicine is bleeding, which can be life-threatening and requires immediate medical attention.

The following side effects have been reported when taking apixaban to prevent blood clot formation in hip or knee replacement surgeries.

Common Side Effects (may affect up to 1 in 10 people)

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

Uncommon Side 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, discharge of blood or fluid from the wound/surgical incision (suppuration), or at the injection site;
  • from the stomach, intestine, or red/bright blood in the stool;
  • blood in the urine;
  • from the nose;
  • vaginal;
• Low blood pressure, which can cause fainting or a faster heartbeat;
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a product derived from red blood cells, which can cause yellowing of the skin and eyes;
• Itching.

Rare Side 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. Tell your doctor immediatelyif you experience any of these symptoms.
• Bleeding:
• • in a muscle;
  • in the eyes;
  • from the gums and coughing up blood;
  • from the rectum;
• Hair loss.

Frequency not known (cannot be estimated from the 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 round and smooth red spots under the skin surface or hematomas;
• Bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy).

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

Common 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 paleness;
• Low blood pressure that can produce fainting or 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 that includes hematoma and swelling, secretion of blood or fluid 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 produce: 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;
  • within 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).

Frequency not known (cannot be estimated from the available data)

• Inflammation of the blood vessels (vasculitis) that can cause skin rash, appearance of round and smooth red spots under the skin surface or hematomas.
• Bleeding in the kidney, sometimes with blood in the urine, which causes 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.

Common 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 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 produce fainting or 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, which includes hematoma and swelling, secretion of blood or fluid from the wound/surgical incision (suppuration); or at the injection site;
  • hemorrhoidal;
  • in a muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can produce: 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.

Frequency not known (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 round and smooth red spots under the skin surface or hematomas;
• Bleeding in the kidney, sometimes with blood in the urine, which causes the kidneys to fail to function properly (anticoagulant-related nephropathy).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. 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 Olpha

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 CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging of medicines you no longer need. This will help protect the environment.

6. Package contents and additional information Composition of Apixaban Olpha

• The active ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• • Core of the tablet: lactose(see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), magnesium stearate;
  • Coating:Opadry II Yellow (contains: hypromellose, lactose monohydrate, (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, yellow iron oxide (E172)).

Appearance of the product and package contents

The film-coated tablets are round, biconvex, yellow in color, and engraved with I1 on one side, and smooth on the other.

• 10 or 14 film-coated tablets in aluminum-PVC/PVDC blisters. In boxes containing 20, 60 or 168 (clinical packaging) film-coated tablets.
• 200 film-coated tablets in HDPE bottles with a PP child-resistant cap (clinical packaging).

Not all pack sizes may be marketed.

Patient Information Card: information management

Inside the packaging of apixaban, along with the prospectus, 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 carry 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

Olpha AS, Rupnicu iela 5, Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

Olpha AS, Rupnicu iela 5, Olaine, Olaines novads, LV-2114,

Latvia

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

Germany, Estonia, Italy, Poland, Czech Republic: Apixaban Olpha

Slovakia: Apixaban Olpha 2.5 mg

France: APIXABAN OLPHA 2.5 mg, film-coated tablet

Latvia: Apixaban Olpha 2.5 mg film-coated tablets

Lithuania: Apixaban Olpha 2.5 mg film-coated tablets

Date of last revision of this prospectus June 2025

Other sources of information

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/