Apixaban Adamed

PATIENT INFORMATION LEAFLET

Enclosed patient information leaflet

Apixaban Adamed, 2.5 mg, film-coated tablets

Apixaban

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Apixaban Adamed and what is it used for
• 2. Important information before taking Apixaban Adamed
• 3. How to take Apixaban Adamed
• 4. Possible side effects
• 5. How to store Apixaban Adamed
• 6. Contents of the pack and other information

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

Apixaban Adamed contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an essential element in the blood clotting process.
Apixaban Adamed is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of developing blood clots in the leg veins. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the leg to the lungs, it can block blood flow through the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, leading to a stroke, or to other organs, hindering blood flow to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the leg veins (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the leg and/or lung blood vessels.

Apixaban is used in children from 28 days to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or lung blood vessels.
The recommended dose is adjusted according to body weight and is specified in section 3.

2. Important information before taking Apixaban Adamed

When not to take Apixaban Adamed

• If you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• If you have excessive bleeding;
• If you have an organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent bleeding in the brain);
• If you have liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy);
• If you are taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where anticoagulant therapy is changed, when a patient has a venous or arterial access line and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions

Before starting treatment, you should discuss with your doctor, pharmacist, or nurse if you have any of the following conditions:

• Increased risk of bleeding, such as:
• Bleeding disorders, including cases resulting in decreased platelet activity;
• Very high blood pressure, uncontrolled with medication;
• If you are over 75 years old;
• If your body weight is 60 kg or less;
• Severe kidney disease or if you are on dialysis;
• Liver disease or a history of liver disease. This medicine should be used with caution in patients with signs of liver dysfunction.
• Tube (catheter) or injection into the spine(anesthetic or pain-relieving), in which case the doctor will advise taking this medicine after 5 or more hours after catheter removal;
• Heart valve prosthesis;
• If your doctor determines that your blood pressure is unstable or other treatment or surgery is planned to remove a blood clot from the lungs.

When to exercise special caution when taking Apixaban Adamed:

• If you have a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment.

In case of surgery or procedures that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a procedure may cause bleeding, you should ask your doctor.

Children and adolescents

This medicine is not recommended for children and adolescents with a body weight below 35 kg.

Apixaban Adamed and other medicines

You should tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may enhance the effect of Apixaban Adamed, and some may weaken its effect.
Your doctor will decide whether you should receive Apixaban Adamed while taking other medicines and how closely you should be monitored.
The following medicines may enhance the effect of Apixaban Adamed and increase the risk of unwanted bleeding:

• Certain antifungal medicines(e.g., ketoconazole and others);
• Certain antiviral medicines used to treat HIV/AIDS(e.g., ritonavir);
• Other medicines used to reduce blood clotting(e.g., enoxaparin and others);
• Anti-inflammatoryor analgesic medicines(e.g., acetylsalicylic acid or naproxen), especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding;
• Medicines used for high blood pressure or heart disease(e.g., diltiazem);
• Antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

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

• Medicines used to prevent seizures or fits(e.g., phenytoin and others);
• St. John's Wort(a herbal supplement used for depression);
• Medicines used to treat tuberculosis or other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effect of Apixaban Adamed on pregnancy and the unborn child is unknown. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether Apixaban Adamed passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse for advice. You may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

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

Apixaban Adamed contains lactose (a type of sugar)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Apixaban Adamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

Apixaban Adamed contains dyes

These dyes are tartrazine (E102) and orange yellow FCF (E110), which may cause allergic reactions.

3. How to take Apixaban Adamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Apixaban Adamed can be taken with or without food. To achieve the best treatment results, it is recommended to take the tablets at the same time every day.
If you have difficulty swallowing the tablets whole, you should talk to your doctor about other ways of taking Apixaban Adamed. The tablet can be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer all the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinse liquid.

If necessary, your doctor may administer a crushed Apixaban Adamed tablet mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube.

Apixaban Adamed should be taken as recommended in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery
The recommended dose is one Apixaban Adamed 2.5 mg tablet twice daily.
For example, one tablet in the morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If you have undergone major hip replacement surgery, you will usually take the tablets for 32 to 38 days.
If you have undergone major knee replacement surgery, you will usually take the tablets for 10 to 14 days.
Prevention of blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one Apixaban Adamed 5 mgtablet twice daily.
The recommended dose is one Apixaban Adamed 2.5 mgtablet twice daily if:

• you have severe kidney problems;
• two or more of the following conditions are met:
• your blood test results suggest impaired kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher);
• you are 80 years old or older;
• your body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one in the evening. Your doctor will decide how long to continue treatment.
Treatment of blood clots in the leg veins and blood clots in the lung blood vessels
The recommended dose is twoApixaban Adamed 5 mgtablets twice daily 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 Adamed 5 mgtablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clot formation after completing 6 months of treatment
The recommended dose is one Apixaban Adamed 2.5 mgtablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long to continue treatment.
Use in children and adolescents
Treatment and prevention of recurrent blood clots in the veins or lung blood vessels.
This medicine should always be taken or administered as recommended by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.
To achieve the best treatment results, the dose should be taken or administered at the same time every day.
The dose of apixaban is based on body weight and will be calculated by your doctor. The recommended dose for children and adolescents weighing at least 35 kg is fourapixaban 2.5 mgtablets, administered twice daily for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is twoapixaban 2.5 mgtablets, administered twice daily, for example, two in the morning and two in the evening.
For parents and caregivers: you should observe the child to ensure that the full dose is taken.
It is essential to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

Your doctor may change your anticoagulant treatment as follows:

• Switching from Apixaban Adamed to other anticoagulant medicinesStop taking Apixaban Adamed. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled next dose of Apixaban Adamed.
• Switching from other anticoagulant medicines to Apixaban AdamedStop taking anticoagulant medicines. Apixaban Adamed treatment should be started at the time of the scheduled next dose of anticoagulant medicine, and then continue with its usual administration.
• Switching from anticoagulant treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban AdamedStop taking the vitamin K antagonist. Your doctor will order blood tests and inform you when to start taking Apixaban Adamed.
• Switching from Apixaban Adamed to anticoagulant treatment with a vitamin K antagonist (e.g., warfarin)If your doctor advises you to start taking a vitamin K antagonist, you should continue taking Apixaban Adamed for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will order blood tests and inform you when to stop taking Apixaban Adamed.

Patients undergoing cardioversion

Patients with irregular heartbeat who require cardioversion to restore a normal heart rhythm should take this medicine at times specified by their doctor to prevent blood clot formation in the brain and other blood vessels.

Taking a higher dose of Apixaban Adamed than recommended

If you have taken a higher dose of this medicine than recommended, you should immediately inform your doctor.
You should take the packaging of this medicine with you, even if there are no tablets left in it.
If you have taken a higher dose of Apixaban Adamed than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment that can reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Adamed

• If you miss a morning dose, take it as soon as you remember and take the evening dose as scheduled.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as scheduled, twice daily.

If you have any doubts about taking this medicine or if you miss more than

one dose, ask your doctor, pharmacist, or nurse.

Stopping Apixaban Adamed treatment

Do not stop taking this medicine without consulting your doctor, as stopping Apixaban Adamed treatment prematurely may increase the risk of blood clot formation.
If you have any further doubts about taking 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.
Apixaban can be used in three different medical conditions. The known side effects and their frequency in each of these medical conditions may be different and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.
The following side effects may occur when taking apixaban to prevent blood clot formation after hip or knee replacement surgery.

Common side effects (may affect up to 1 in 10 people)

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• subcutaneous hemorrhages (bruises) and swelling;
• Nausea (vomiting).

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including subcutaneous hemorrhages (bruises) and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

Rare side effects (may affect up to 1 in 1000 people)

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you experience any of these symptoms, you should immediately contact your doctor.
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and presence of blood in sputum when coughing;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or subcutaneous hemorrhages (bruises).

The following side effects may occur when taking apixaban to prevent blood clot formation in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• into the eyes;
• from the stomach or intestines;
• from the rectum
• blood in the urine;
• from the nose;
• from the gums;
• subcutaneous hemorrhage (bruise) and swelling;
• Anemia, which can cause fatigue or pallor;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including subcutaneous hemorrhage (bruise) and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you experience any of these symptoms, you should immediately contact your doctor;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1000 people)

• Bleeding:
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs;
• into the muscles.

Blood clots in the leg veins and lung blood vessels

The following side effects may occur when taking apixaban to treat or prevent recurrent blood clots in the leg veins and lung blood vessels.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• subcutaneous hemorrhage (bruise) and swelling;
• from the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

Uncommon side effects (may affect up to 1 in 100 people)

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• in the mouth or presence of blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including subcutaneous hemorrhage (bruise) and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• from hemorrhoids;
• into the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you experience any of these symptoms, you should immediately contact your doctor;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels, a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1000 people)

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

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

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity;
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or subcutaneous hemorrhages (bruises).

Additional side effects in children and adolescents
If you experience any of the following symptoms, you should immediately inform your doctor:

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. The frequency of these side effects is "common" (may affect up to 1 in 10 people).

Generally, the side effects observed in children and adolescents treated with apixaban were similar to those observed in adults and were mostly mild to moderate in severity.
The side effects that occurred more frequently in children and adolescents were nosebleeds and unusual vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

• Bleeding, including:
• from the vagina;
• from the nose.

Common side effects (may affect up to 1 in 10 people)

• Bleeding, including:
• from the gums;
• blood in the urine;
• subcutaneous hemorrhage (bruise) and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including subcutaneous hemorrhage (bruise) and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat in the child;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• into the abdominal cavity or the space behind the abdominal cavity;
• into the stomach;
• into the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or presence of blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscles;
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or subcutaneous hemorrhages (bruises);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Apixaban Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Adamed contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate.
• Coating: lactose monohydrate, hypromellose 2910, tartrazine aluminum lake (E102), titanium dioxide (E171), triacetin, orange yellow FCF aluminum lake (E110), iron oxide yellow (E172).

See section 2 "Apixaban Adamed contains lactose (a type of sugar) / sodium / dyes".

What Apixaban Adamed looks like and contents of the pack

The film-coated tablets are yellow, round, biconvex, with "AX" embossed on one side and "2.5" on the other side.
They are packaged in blisters in cardboard boxes containing 10, 20, 60, 100, 168, and 200 film-coated tablets.
Single-dose blisters are also available in cardboard boxes containing 60x1 and 100x1 film-coated tablets intended for hospitals.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the Apixaban Adamed packaging, along with the patient information leaflet, you will find a Patient Alert Card or your doctor may give you a similar card.
The Patient Alert Card contains information that will help you and alert other doctors that you are taking Apixaban Adamed. You should always carry this card with you.

• 1. Take the card.
• 2. If necessary, separate the relevant language (this is facilitated by perforated edges).
• 3. Fill in the following points or ask your doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: ........ mg twice daily
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and always carry it with you.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: +48 22 732 77 00

Manufacturer / Importer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Delorbis Pharmaceuticals Ltd
17 Athinon Str.
Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus

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

Date of last revision of the leaflet: