Apixaban Teva

Leaflet attached to the packaging: information for the user

Apixaban Teva, 5 mg, coated tablets

Apixabanum

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Apixaban Teva 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 factor in blood clotting.
Apixaban Teva is used in adults:

• to prevent the formation of blood clots in the heart in patients with an irregular heart rhythm (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 lower limbs (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 lower limbs and/or lungs.

Apixaban Teva is used in children from 28 days of age to less than 18 years of age, for the treatment of blood clots and to prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs.
Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Apixaban Teva

When not to take Apixaban Teva:

• 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, 1 DE/H/6351/001-002/IA/014/G
• if the patient has an organ diseasethat increases the risk of significant bleeding (such as active or recently diagnosed stomach or intestinal ulcersor recent brain bleeding),
• if the patient has liver diseasethat leads to an increased risk of bleeding (hepatic coagulopathy),
• if the patient is taking anticoagulant medicines(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases 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 with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, for example:
• bleeding disorders, including cases resulting in reduced platelet activity
• very high blood pressure, uncontrolled with medication
• if the patient is over 75 years old
• if the patient weighs 60 kg or less
• severe kidney disease or if the patient is on dialysis
• liver problems or a history of liver problems. This medicine should be used with caution in patients with signs of liver function changes.
• This medicine should be used with caution in patients with signs of liver function changes.
• if the patient has a heart valve prosthesis
• 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 Teva

• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

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 time. If there is any uncertainty about whether a procedure may be associated with bleeding, the patient should ask their doctor.

Children and adolescents

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

Apixaban Teva 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 Teva, and some may weaken its effect.
The doctor will decide whether the patient should receive Apixaban Teva while taking other medicines and how closely they should be monitored.
The following medicines may enhance the effect of Apixaban Teva 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)

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• 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, they may be at increased risk of unwanted bleeding.
• medicines used to treat high blood pressure or heart problems(e.g., diltiazem)
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Teva 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 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 immediately
contact their doctor.
It is not known whether apixaban 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

Apixaban has no or negligible influence on the ability to drive and use machines.

Apixaban Teva contains lactose (a sugar) and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Apixaban Teva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Apixaban Teva can be taken with or without food. To get the best effect, the patient should try to take the doses at the same time every day.
The recommended dose is one 5 mg tablet twice a day.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.

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• Carefully transfer the powder to a suitable container, then mix it with a small amount of water or another liquid (e.g., 30 mL or 2 tablespoons) to prepare a mixture.
• Swallow the 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 swallow the rinse liquid.

In case of need, the doctor may administer a crushed Apixaban Teva tablet mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube.

Apixaban Teva should be taken as follows in the following indications:

Prevention of blood clot formation in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor

The recommended dose is one 5 mg tablet twice a day.
The recommended dose is one 2.5 mg tablet twice a day if:

• the patient has severe kidney problems
• two or more of the following conditions are met:
• the patient's blood test results indicate reduced 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 lower limbs and blood clots in the blood vessels of the lungs

The recommended dose is two 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 5 mg tablet twice a day, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after 6 months of treatment
The recommended dose is one 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 recurrence of blood clots in the veins or in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as prescribed by the pediatrician or pharmacist. If the patient has any doubts, they should consult their pediatrician, pharmacist, or nurse.
To get the best effect, the dose should be taken or administered at the same time every day.
The dose of Apixaban Teva is based on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing 35 kg or more is two 5 mg tablets of Apixaban Teva, administered 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 5 mg tablet of Apixaban Teva, administered twice a day, for example, one tablet in the morning and one in the evening.
For parents and caregivers: the child should be observed to ensure they take the full dose.
It is essential to follow the scheduled doctor's visits, 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 Teva to anticoagulant medicinesThe patient should stop taking Apixaban Teva. Anticoagulant treatment (e.g., heparin) should be started at the time of the scheduled intake of the next Apixaban Teva tablet.
• Switching from anticoagulant medicines to Apixaban TevaThe patient should stop taking anticoagulant medicines. Apixaban Teva treatment should be started at the time of the scheduled intake of the next anticoagulant dose, and then continued as usual.
• Switching from anticoagulant treatment with a vitamin K antagonist (e.g., warfarin) to Apixaban TevaThe patient should stop taking the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to start taking Apixaban Teva.
• Switching from Apixaban Teva to anticoagulant treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs the patient that they should start taking a vitamin K antagonist, they should continue taking Apixaban Teva for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will perform blood tests and inform the patient when to stop taking Apixaban Teva.

Patients undergoing cardioversion

Patients who need to undergo a cardioversion procedure 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 Teva than recommended

If the patient has taken a higher dose of this medicine than recommended, they should immediately
inform their doctor. They should take the packaging with them, even if it is empty.
If the patient has taken a higher dose of Apixaban Teva than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Apixaban Teva

• 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.
• If the patient misses an evening dose, they can take it only on the same evening. They should not take two doses the next morning, but instead continue taking the medicine the next day as prescribed, 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.
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Stopping Apixaban Teva treatment

The patient should notstop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if the treatment is stopped too early.
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, this medicine can cause side effects, although not everybody gets them.
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 in the heart in patients with irregular heart rhythm and at least one additional risk factor.

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

• Bleeding, including:
• in the eye
• 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 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:
• in the brain or spinal cord
• in the mouth or coughing up blood
• in the abdominal cavity or in the space behind the abdominal cavity
• in the muscles
• Reduced platelet count in the blood (which can affect blood clotting)
• Blood test results may indicate:
• abnormal liver function
• increased activity of certain liver enzymes
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes
• Skin rash
• Itching
• Hair loss

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• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. In case of any of these symptoms, the patient should immediately contact their doctor.

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

• Bleeding:
• in the lungs or throat
• in the abdominal cavity or in the space behind the abdominal cavity
• in the muscles

Very rare side effects (may affect less than 1 in 10,000 people)

• Skin rash, which can cause 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 (frequency cannot be estimated from the available data)

• Vasculitis (inflammation of blood vessels), which can cause skin rash or elevated, flat, red, round patches under the skin surface, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

The following side effects may occur when taking apixaban for the treatment or prevention of recurrence of blood clots in the veins of the lower limbs 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 and swelling
• in the stomach or intestine
• in the mouth
• from the vagina
• Anemia, which can cause fatigue or pallor
• Reduced platelet count in the blood (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:
• in the eyes
• in the mouth or coughing up blood
• blood in the stool
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site
• from hemorrhoids
• in the muscles
• Itching

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• Hair loss
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. In case of any of these symptoms, the patient should immediately contact their doctor.
• Blood test results may indicate:
• abnormal liver function
• increased activity of certain liver enzymes
• increased bilirubin levels - a breakdown product of red blood cells that 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

Side effects with frequency not known (frequency cannot be estimated from the available data)

• Bleeding:
• in the abdominal cavity or in the space behind the abdominal cavity
• Skin rash, which can cause 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 elevated, flat, red, round patches under the skin surface, or bruising.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

Additional side effects in children and adolescents

In case of any of the following symptoms, the patient should immediately inform their pediatrician:

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, 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 taking Apixaban Teva were similar to those in adults and were mostly mild or moderate. The side effects that occurred more frequently in children and adolescents were nosebleeds and abnormal 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 and swelling;
• in the intestine or rectum;
• blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;

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• Anemia, which can cause fatigue or pallor;
• Reduced 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;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• in the abdominal cavity or in the space behind the abdominal cavity;
• in the stomach;
• in the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or coughing up blood;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• Skin rash, which can cause blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (rumień wielopostaciowy);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or elevated, flat, red, round patches under the skin surface, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.
• Bleeding in the kidney, sometimes with blood in the urine, leading to kidney function disorder (nephropathy associated with anticoagulant administration).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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.
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Apixaban Teva

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
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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 packaging and other information

What Apixaban Teva contains

• The active substance of Apixaban Teva is apixaban. Each tablet contains 5 mg of apixaban.
• Other ingredients are:
• Tablet core: lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
• Coating: lactose monohydrate (see section 2), hypromellose 2910 (6 MPA.S), titanium dioxide (E 171), macrogol MW3350, triacetin, iron oxide red (E 172).

What Apixaban Teva looks like and contents of the pack

Pale pink, oval, film-coated tablets with "TV" engraved on one side and "G2" on the other. Dimensions: length 9.9 - 10.5 mm, width 5.0 - 5.6 mm, thickness 4.2 - 4.8 mm.
Transparent single-dose blisters of PVC/PE/PVDC/Aluminum, in a cardboard box containing: 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 100 x 1, 120 x 1, 168 x 1, 200 x 1 film-coated tablets,
White HDPE bottle with a white PP cap with a child-resistant closure, containing 180, 200, and 500 film-coated tablets, in a cardboard box.
White HDPE bottle with a white PP cap with a child-resistant closure and a cotton pad, containing 180, 200, and 500 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Patient Alert Card: information for use

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

• 1. The patient should take the card
• 2. The patient should fill in the following points or ask their doctor to fill them in:
• Name and surname:
• Date of birth:
• Indication:
• Dose: ........ mg twice a day
• Doctor's name:
• Doctor's phone number:
• 3. The patient should fill in the card and always carry it with them

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warszawa
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Importer

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

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

Member State Name of the medicinal product

Austria

Apixaban ratiopharm 5 mg Filmtabletten
BelgiumApixaban Teva Generics 5 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Bulgaria

Апиксабан Тева 5 mg филмирани таблетки

Czech Republic

Apixaban Teva

Germany

Apixaban-ratiopharm 5 mg Filmtabletten

Denmark

Apixaban Teva

Estonia

Apixaban Teva

Spain

Apixaban Teva 5 mg comprimidos recubiertos con película EFG

Finland

Apixaban ratiopharm 5 mg tabletti, kalvopäällysteinen

France

Apixaban TEVA 5 mg, comprimé pelliculé

Croatia

Apiksaban Pliva 5 mg filmom obložene tablete

Hungary

Apixaban-Teva 5 mg filmtabletta

Ireland

Apixaban 2.5 mg and 5 mg Film-coated Tablets

Iceland

Apixaban Teva

Italy

APIXABAN TEVA
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Lithuania

Apixaban Teva 5 mg plėvele dengtos tabletės

Latvia

Apixaban Teva 5 mg apvalkotās tabletes

Luxembourg

Apixaban-ratiopharm 5 mg Filmtabletten

Netherlands

Apixaban Teva 5 mg, filmomhulde tabletten

Norway

Apixaban Teva

Romania

Apixaban Teva BV 5 mg Film-coated tablets

Poland

Apixaban Teva

Sweden

Apixaban Teva 2,5 mg, 5 mg filmdragerade tabletter

Slovenia

Apiksaban Teva 5 mg filmsko obložene tablete

Slovakia

Apixaban Teva 5 mg

United Kingdom

Apixaban Teva 2.5 mg and 5 mg Film-coated Tablets

Date of last revision of the leaflet: May 2025

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