APIXABAN OLPHA 5 mg FILM-COATED TABLETS

Introduction

A.

Package Leaflet: Information for the User

Apixaban Olpha 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 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 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.

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

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 medications to prevent blood coagulation(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when changing anticoagulant treatment, while having an arterial or venous line and being treated with heparin to keep that 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 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 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 might 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-noradrenaline reuptake inhibitors.

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

• 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 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 whether to interrupt breastfeeding or whether to 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.

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 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 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 apixaban 5mgtablet twice a day.

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

-

• two or more of the following factors apply to you:
• • your blood test results suggest poor kidney function (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 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 you should continue the treatment.

Your doctor may change your anticoagulant treatment as follows:

• Switching 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.

• Switching 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 an anticoagulant medication, and then continue as usual.

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

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

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

If your doctor tells you to start taking a medication that contains a vitamin K antagonist, continue taking apixaban for at least 2 days after your first dose of the vitamin K antagonist 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 ingested.

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, as the risk of developing a blood clot may be higher 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 everybody gets them. 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 the heart in patients with an irregular heartbeat and at least one additional risk factor.

Common side 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, which can cause fainting or a faster heartbeat;
• Nausea (general discomfort);
• Blood tests may show:
• • an increase in gamma glutamyl transferase (GGT).

Uncommon side 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 wound/surgical incision (purulent discharge) or at the injection site;
  • hemorrhoidal;
  • tests showing blood in the stool or urine;
• Decreased platelet count in the blood (which can affect coagulation);
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) that can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Tell your doctor immediatelyif you experience any of these symptoms.

Rare side 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 side 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 small, 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 side 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;
  • hematoma and swelling;
  • from the stomach, intestine, or rectum;
  • in the mouth;
  • vaginal;
• Anemia, which can cause fatigue or paleness;
• Decreased platelet count in the blood (which can affect coagulation);
• Nausea (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 hematoma and swelling, discharge 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 cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. Contact your doctor immediatelyif you experience any of these symptoms.
• Blood tests may show:
• • abnormal liver function;
  • increased liver enzymes;
  • increased bilirubin, a byproduct of red blood cells, which can cause yellowing of the skin and eyes.

Rare adverse effects (may affect up to 1 in 1,000 people)

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

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 red, round, and smooth spots under the skin surface, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, which can cause the kidneys to malfunction (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 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 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 disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

• The active ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
• • Tablet core:} (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 Pink (contains: hypromellose, }, (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, iron oxide red (E172)).

Appearance and package contents

The film-coated tablets are oval, biconvex, pink, with engraving “I2” on one side, and smooth on the other.

• 10 or 14 film-coated tablets in aluminum-PVC/PVDC blisters. In packs containing 28, 56, 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 Apixaban packaging, 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 mustcarrythis card withyouat 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 5 mg

France: APIXABAN OLPHA 5 mg, film-coated tablet

Latvia: Apixaban Olpha 5 mg apvalkotas tabletes

Lithuania: Apixaban Olpha 5 mg plevele dengtos tabletes

Date of the last revision of this leafletJune 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/