Apixaban Adamed

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Apixaban Adamed, 5 mg, film-coated tablets

Apixabanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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 important element in the blood clotting process.
Apixaban Adamed is used in adults:

• 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 move to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (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), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

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 blood vessels of the lungs.
The recommended dose, adjusted for body weight, can be found in section 3.

2. Important information before taking Apixaban Adamed

When not to take Apixaban Adamed

• If the patient is allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive bleeding;
• if the patient has organ diseasethat increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recent bleeding into the brain);
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy);
• if the patient is taking medicines that prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where the anticoagulant treatment is changed, when the 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, the patient should discuss the following conditions with their doctor, pharmacist, or nurse:

• Increased risk of bleeding, for example:
• Bleeding disorders, including cases that result in decreased platelet activity;
• Very high blood pressure, uncontrolled with medication;
• if the patient is over 75 years old;
• if the patient's body weight is 60 kg or less;
• Severe kidney disease or if the patient is on dialysis;
• Liver disease or a history of liver disease. This medicine should be used with caution in patients with signs of liver dysfunction.
• if the patient has a prosthetic heart valve;
• if the doctor determines that the patient's blood pressure is unstable or if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Apixaban Adamed:

• if the patient has a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide on possible treatment changes.

In case of surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If there is any uncertainty about whether a given procedure may cause bleeding, the patient should ask their doctor.

Children and adolescents

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

Apixaban Adamed and other medicines

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

• some antifungal medicines(e.g., ketoconazole and others);
• some antiviral medicines used to treat HIV/AIDS(e.g., ritonavir);
• other medicines used to reduce blood clotting(e.g., enoxaparin and others);
• anti-inflammatory or pain-relieving medicines(e.g., acetylsalicylic acid or naproxen), especially if the patient is over 75 years old and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding;
• medicines used to treat high blood pressure or heart disease(e.g., diltiazem);
• antidepressant medicinesknown as 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 tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.
The effect of Apixaban Adamed on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, they should contact their doctor immediately.
It is not known whether Apixaban Adamed passes into breast milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

It has not been found that Apixaban Adamed affects the ability to drive or use machines.

Apixaban Adamed contains lactose (a type of sugar)

If the patient has previously been found to have intolerance to some sugars, they should contact their doctor before taking the medicine.

Apixaban Adamed contains sodium

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

3. How to take Apixaban Adamed

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed 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 the patient has difficulty swallowing the tablets whole, they should discuss alternative ways of taking Apixaban Adamed with their doctor. The tablet can be crushed immediately before administration and mixed with water or a 5% aqueous glucose solution, juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the entire powder to a suitable container and then mix it with a small amount (e.g., 30 mL or 2 tablespoons) of water or another liquid listed 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) and then swallow (drink) the rinse liquid.

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

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

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 mg tablet twice a day.
The recommended dose is one Apixaban Adamed 2.5 mg tablet twice a day if:

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

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. The doctor will decide how long the treatment should be continued.
Treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two Apixaban Adamed 5 mg tablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one Apixaban Adamed 5 mg tablet twice a day, 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 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
The doctor will decide how long the treatment should be continued.
Use in children and adolescents
Treatment and prevention of recurrent blood clots in the veins or blood vessels of the lungs.
This medicine should always be taken or administered as directed by the doctor or pharmacist. In case of doubts, the patient should consult their 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 depends on body weight and will be calculated by the doctor. The recommended dose for children and adolescents weighing 35 kg or more is two apixaban 5 mg tablets, administered twice a day for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one apixaban 5 mg tablet, administered twice a day, for example, one in the morning and one in the evening.
For parents and caregivers: the child should be observed to ensure they have taken the full dose.
It is essential to follow the scheduled doctor's appointments, as the dose may need to be adjusted if the patient's body weight changes.

The doctor may change the anticoagulant treatment as follows:

• Switching from Apixaban Adamed to other anticoagulant medicinesThe patient should stop taking Apixaban Adamed. Treatment with other anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Apixaban Adamed tablet.
• Switching from other anticoagulant medicines to Apixaban AdamedThe patient should stop taking other anticoagulant medicines. Treatment with Apixaban Adamed should be started at the time of the scheduled intake of the next dose of the other anticoagulant medicine and then continued as usual.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban AdamedThe patient should stop taking the vitamin K antagonist. The doctor will order blood tests and inform the patient when to start taking Apixaban Adamed.
• Switching from Apixaban Adamed to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor recommends that the patient start taking a vitamin K antagonist, they should continue taking Apixaban Adamed for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order blood tests and inform the patient 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 the times specified by their doctor to prevent the formation of blood clots in the brain and other blood vessels.

Taking a higher dose of Apixaban Adamed than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately inform their doctor.
The patient should take the packaging of the medicine with them, even if there are no more tablets left.
If the patient has taken a higher dose of Apixaban Adamed than recommended, they 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 the patient misses a morning dose, they should take it as soon as they remember and can take it together with the evening dose.
• A missed evening dose can only be taken on the same evening. The patient should not take two doses the next morning instead; they should continue taking the medicine the next day as directed, twice a day.

In case of doubts about taking the medicine or missing more than one dose

The patient should consult their doctor, pharmacist, or nurse.

Stopping treatment with Apixaban Adamed

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if treatment with Apixaban Adamed is stopped prematurely.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Apixaban Adamed can cause side effects, although not everybody gets them.
The most common overall side effect of this medicine is bleeding, which can be life-threatening and may require immediate medical attention.
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:
• in the eyes;
• in the stomach or intestines;
• from the rectum
• blood in the urine;
• from the nose;
• from the gums;
• bruising (hematoma) and swelling;
• Anemia, which can cause fatigue or pallor;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• Abnormal blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

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

• Bleeding:
• in the brain or spinal cord;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or retroperitoneal space;
• in muscles.

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

• Bleeding:
• in the lungs or throat;
• in the abdominal cavity or retroperitoneal space;
• in muscles.

Very rare side effects (may affect up to 1 in 10,000 people)

• A skin rash that may 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).

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

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round patches under the skin surface, or bruising.

The following side effects may occur when taking apixaban to treat or prevent the recurrence of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruising (hematoma) and swelling;
• from the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Abnormal 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:
• in the eyes;
• in the mouth or presence of blood in sputum when coughing;
• red blood in the stool;
• abnormal blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising (hematoma) and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• in muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling and difficulty breathing. If the patient experiences any of these symptoms, they should immediately contact their doctor;
• Abnormal blood test results may indicate:
• impaired liver function;
• 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:
• in the brain or spinal cord;
• in the lungs.

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

• Bleeding:
• in the abdominal cavity or retroperitoneal space.
• A skin rash that may 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 bruising.

Additional side effects in children and adolescents
If the patient experiences any of the following symptoms, they should immediately inform their doctor:

• Allergic reactions (hypersensitivity), which can cause: facial, lip, mouth, tongue, and/or throat swelling and 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;
• bruising (hematoma) and swelling;
• from the intestines or rectum;
• red blood in the stool;
• bleeding after surgery, including bruising (hematoma) and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat in the child;
• Abnormal blood test results may indicate:
• impaired liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• in the abdominal cavity or retroperitoneal space;
• in the stomach;
• in the eyes;
• in the mouth or presence of blood in sputum when coughing;
• in the brain or spinal cord;
• in the lungs;
• in muscles;
• A skin rash that may 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 bruising;
• Abnormal blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +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 gather more information on the safety of this medicine.

5. How to store Apixaban Adamed

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Apixaban Adamed contains

• The active substance of the medicine is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients are:
• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate.
• Coating: lactose monohydrate, hypromellose 2910, titanium dioxide (E171), triacetin, iron oxide red (E172).

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

What Apixaban Adamed looks like and contents of the pack

The film-coated tablets are pink, oval, biconvex, with the inscription "AX" on one side and "5" on the other.
They are packaged in blisters in cartons of 14, 20, 28, 56, 60, 100, 168, and 200 film-coated tablets.
Divisible unit-dose blisters are also available in cartons of 100x1 film-coated tablets for hospitals.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

Inside the packaging of Apixaban Adamed, next to the patient information leaflet, there is a Patient Alert Card or the doctor may provide the patient with a similar card.
The Patient Alert Card contains information that helps the patient and warns other doctors that the patient is taking Apixaban Adamed. The patient should always carry this card with them.

• 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 the doctor to fill them in:
• Name:
• Date of birth:
• Indication:
• Dose: ........ mg twice a day
• 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
Tel: +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: