APIXABAN NORMOGEN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Apixaban Normogen 5mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Apixaban Normogen is and what it is used for
2. What you need to know before taking Apixaban Normogen
3. How to take Apixaban Normogen
4. Possible side effects
5. Storage of Apixaban Normogen
6. Package contents and additional information

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

Apixaban Normogen 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.

Apixaban Normogen 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 Normogen

Do not take Apixaban Normogen if:

• you are allergicto apixaban or any of the other components of this medication (listed in section 6);
• you have excessive bleeding;
• 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 to 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 these conditions:

• an increased risk of bleeding, such as:
• • bleeding disorders, including situations that result in a decrease in 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 Normogen

If you need to undergo surgery or a procedure that may cause bleeding, your doctor will instruct 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.

Using Apixaban Normogen with other medications

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

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

The following medications may increase the effects of Apixaban Normogen and increase the possibility of unwanted bleeding:

• some antifungal 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). In particular, if you are over 75 years old and taking acetylsalicylic acid, there is a higher probability of bleeding;
• medications for high blood pressure or heart problems(e.g., diltiazem);
• antidepressantscalled selective serotonin reuptake inhibitorsor serotonin-norepinephrine reuptake inhibitors.

The following medications may reduce the ability of Apixaban Normogen 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, pharmacist, or nurse before using this medication.

The effects of Apixaban Normogen 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.

It is unknown whether Apixaban Normogen is excreted in human milk. Ask your doctor, pharmacist, or nurse 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 Normogen has no influence on the ability to drive or use machines.

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

If your doctor has told you that you have an intolerance to certain sugars, talk to them before taking this medication.

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

3. How to take Apixaban Normogen

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor, pharmacist, or nurse.

Dosage

Take the tablet with water. Apixaban Normogen 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 Normogen. 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 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 Normogen tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Normogen 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 Normogen is one Apixaban Normogen 5mgtablet twice a day.

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

• you have severely impaired kidney function;
• two or more of the following factors apply to you:
• • your blood test results suggest poor kidney function (creatinine serum 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, take one tablet in the morning and one in the evening.

Your doctor will tell you how long you should 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 Normogen 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 one Apixaban Normogen 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 Normogen 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 treatment.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Apixaban Normogen to anticoagulant medications

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

• Switching from anticoagulant medications to Apixaban Normogen

Stop taking anticoagulant medications. Start treatment with Apixaban Normogen 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 Normogen

Stop taking the medication that contains a vitamin K antagonist. Your doctor will need to perform blood tests and tell you when to start taking Apixaban Normogen.

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

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

Patients undergoing cardioversion

If your heartbeat needs to be restored through a process called cardioversion, take this medication 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 Normogen than you should

Tell your doctor immediatelyif you have taken a dose greater than the prescribed dose of Apixaban Normogen. Bring the medication package to your doctor, even if there are no tablets left.

If you take more Apixaban Normogen 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 medication and the amount ingested.

If you forget to take Apixaban Normogen

• Take the dose as soon as you remember and
• • take the next Apixaban Normogen dose 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 Normogen

Do not interrupt treatment with this medication without talking to your doctor first, as the risk of developing a blood clot may be greater 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. 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 Apixabán Normogen to prevent the formation of blood clots in the heart in patients with irregular heartbeats 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, which 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, including bruising and swelling, discharge of blood or fluid from the wound/surgical 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;
• 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 immediately if you experienceany 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).

Frequency Not Known (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 bruising.

The following adverse effects have been reported when taking Apixabán Normogen to treat or prevent blood clots from recurring in the veins of the legs and 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 coagulation);
• Nausea (general 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, which 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 showing blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, discharge of blood or fluid from the wound/surgical 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 experienceany 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.

Frequency Not Known (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 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 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 Apixabán Normogen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown 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 through wastewater or household waste. 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

Composition of Apixabán Normogen

• The active ingredient is apixaban. Each film-coated tablet contains 5 mg of apixaban.
• The other ingredients (excipients) are:

Tablet core: anhydrous lactose; microcrystalline cellulose (type 14); microcrystalline cellulose (type 101); sodium croscarmellose; sodium lauryl sulfate; magnesium stearate. See section 2 "Apixabán Normogen contains lactose (a type of sugar) and sodium".

Tablet film coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin; red iron oxide (E172).

Appearance and Package Contents

The film-coated tablets are pink and oval, measuring 11.0 mm ± 0.2 mm in length and 6.2 mm ± 0.2 mm in width.

They are presented in blisters within cartons containing 28 and 60 film-coated tablets.

Only some package sizes may be marketed.

Patient Information Card: Information Management

Inside the packaging of Apixabán Normogen, 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 Apixabán Normogen. 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

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

This medicine is authorized in EEA member states under the following names:

Spain, Apixabán Normogen 5 mg film-coated tablets EFG

Portugal, Apixabano Normogen

Date of the last revision of this prospectus:

December 2022

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.es/