


Ask a doctor about a prescription for APIXABAN TEVA 2.5 mg FILM-COATED TABLETS
Package Leaflet: Information for the Patient
Apixaban Teva 2.5 mg film-coated tablets EFG
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Contents of the Package Leaflet
This medication contains the active substance apixaban and belongs to a group of medications called anticoagulants. Apixaban helps prevent the formation of blood clots by blocking Factor Xa, an important element in blood coagulation.
Apixaban is used in adults:
Apixaban Teva is used in children from 28 days to less than 18 years of age to treat blood clots and to prevent these blood clots from recurring in the veins and blood vessels of the lungs.
For the recommended dose appropriate for body weight, see section 3.
Do not take Apixaban Teva
Warnings and precautions
Tell your doctor, pharmacist, or nurse before taking this medication if you have any of these conditions:
Be careful with Apixaban Teva
If you need to have surgery or a procedure that may cause bleeding, your doctor will tell you to temporarily stop taking this medication for a while. If you are not sure if a procedure may cause bleeding, consult your doctor.
Children and adolescents
The use of this medication is not recommended in children and adolescents with a body weight below 35 kg.
Other medications and Apixaban Teva
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take other medications.
Some medications may increase the effects of apixaban, and other medications may decrease its effects. Your doctor will decide if you should be treated with apixaban if you are taking these medications and if you should be monitored more closely.
The following medications may increase the effects of apixaban and increase the risk of unwanted bleeding:
The following medications may reduce the ability of apixaban to prevent blood clots.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
The effects of apixaban on pregnancy and the fetus are unknown. You should not take this medication if you are pregnant. Tell your doctor immediately if you become pregnant while taking this medication.
It is unknown if apixaban is excreted in human milk. Ask your doctor or pharmacist 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 has no influence on the ability to drive or use machines.
Apixaban Teva contains lactose (a type of sugar) and sodium.
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse again.
Dosage
Take the tablet with water. This medication can be taken with or without food.
Try to take the tablets at the same time every day to achieve a better treatment effect.
If you have difficulty swallowing the whole tablet, talk to your doctor about other possible ways to take this medication. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before taking it.
Crushing instructions:
If necessary, your doctor may also administer the crushed apixaban tablet mixed in 60 ml of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Teva according to the following recommendations:
To prevent the formation of blood clots in hip or knee replacement surgery.
The recommended dose is one 2.5 mg tablet twice a day.
For example, take one tablet in the morning and another in the evening.
You should take the first tablet between 12 to 24 hours after surgery.
If you have undergone major hipsurgery, you will generally take the tablets for a period of 32 to 38 days.
If you have undergone major kneesurgery, you will generally take the tablets for a period of 10 to 14 days.
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 is one 5 mgtablet twice a day.
The recommended dose is one 2.5 mgtablet twice a day if:
The recommended dose is one tablet twice a day, for example, take one tablet in the morning and another in the evening. Your doctor will indicate how long you should continue the treatment.
To treat blood clots in the veins of the legs and in the blood vessels of the lungs
The recommended dose is two 5 mg tabletstwice 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 5 mg tablettwice a day, for example, one tablet in the morning and another in the evening.
To prevent blood clots from happening again after 6 months of treatment
The recommended dose is one 2.5 mgtablet twice a day, for example, one tablet in the morning and another in the evening.
Your doctor will indicate how long you should continue the treatment.
Use in children and adolescents
For the treatment of blood clots and to prevent these blood clots from happening again in the veins and blood vessels of the lungs.
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time every day to achieve a better treatment effect.
The dose of apixaban depends on body weight and will be calculated by your doctor. The recommended dose for children and adolescents with a weight of at least 35 kg is four 2.5 mg apixaban tabletstwice a day for the first 7 days, for example, four tablets in the morning and four in the evening.
After 7 days, the recommended dose is two 2.5 mg apixaban tabletstwice a day, for example, two tablets in the morning and two in the evening.
For parents and caregivers: observe the child to ensure they take the complete dose.
It is essential to respect scheduled visits to the doctor, as it may be necessary to adjust the dose based on weight changes.
Your doctor may change your anticoagulant treatment as follows:
Stop taking this medication. Start treatment with anticoagulant medications (for example, heparin) at the time you would take the next tablet.
Stop taking anticoagulant medications. Start treatment with apixaban at the time you would take the next dose of an anticoagulant medication, and then continue normally.
Stop taking the medication that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and indicate when to start taking apixaban.
If your doctor indicates that you should start taking a medication that contains a Vitamin K antagonist, continue taking apixaban for at least 2 days after the first dose of the medication that contains a Vitamin K antagonist. Your doctor will need to perform blood tests and indicate when to stop taking apixaban.
Patients undergoing cardioversion
If your heart rhythm needs to be restored through a process called cardioversion, take this medication at the times indicated by your doctor to prevent blood clots in the blood vessels of the brain and other blood vessels in the body.
If you take more Apixaban Teva than you should
Inform your doctor immediatelyif you have taken a dose greater than the prescribed dose of this medication.
Take the medication packaging to your doctor, even if there are no tablets left.
If you take more apixaban than the recommended dose, you may increase the risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatments that can reverse anti-factor Xa activity may be necessary.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Apixaban Teva
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 Teva
DO NOT interrupt treatment with this medication without first talking to your doctor, because the risk of developing a blood clot may be greater if you interrupt treatment too soon.
If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.
Like all medicines, apixaban can cause adverse effects, although not all people suffer from them. This medicine can be administered for three different diseases. The known adverse effects and their frequency may be different and are therefore indicated separately below. For these conditions, the most frequent adverse effect of this medicine is bleeding, which can endanger the patient's life and requires immediate medical attention.
The following adverse effects have been reported when taking apixaban for the preventionof the formationof blood clots after hip or knee replacement surgery.
Frequent Adverse Effects (may affect up to 1 in 10 people)
Uncommon Adverse Effects (may affect up to 1 in 100 people)
Rare Adverse Effects (may affect up to 1 in 1,000 people)
Unknown Frequency (cannot be estimated from available data)
The following adverse effects have been reported when taking apixaban to prevent the formationof blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.
Frequent Adverse Effects (may affect up to 1 in 10 people)
Uncommon Adverse Effects (may affect up to 1 in 100 people)
Rare Adverse Effects (may affect up to 1 in 1,000 people)
Very Rare Adverse Effects (may affect up to 1 in 10,000 people)
Unknown Frequency (cannot be estimated from available data)
The following adverse effects have been reported when taking apixaban to treat or prevent the recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.
Frequent Adverse Effects (may affect up to 1 in 10 people)
Uncommon Adverse Effects (may affect up to 1 in 100 people)
Rare Adverse Effects (may affect up to 1 in 1,000 people)
Unknown Frequency (cannot be estimated from available data)
Additional Adverse Effects in Children and Adolescents
Inform your child's doctor immediatelyif you observe any of these symptoms:
In general, the adverse effects observed in children and adolescents treated with apixaban were similar to those observed in adults and were mainly mild to moderate in intensity. The most frequent adverse effects observed in children and adolescents were nosebleeds and abnormal vaginal bleeding.
Very Frequent Adverse Effects (may affect more than 1 in 10 people)
Frequent Adverse Effects (may affect up to 1 in 10 people)
Unknown Frequency (cannot be estimated from available data)
Reporting of Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the carton, blister, and bottle after "EXP". The expiration date is the last day of the month indicated.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
Composition of Apixaban Teva
The active ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
The other ingredients are:
Appearance of the Product and Package Contents
The tablets are light yellow, film-coated, round, with "TV" engraved on one side and "G1" on the other side. Dimensions: 5.9 - 6.5 mm in diameter, 3.0 - 3.6 mm in thickness.
They are available in:
Not all pack sizes may be marketed.
Patient Information Card: Managing Information
Inside the package of this medicine, along with the leaflet, you will find a Patient Information Card or your doctor may give you a similar card.
This Patient Information Card includes useful information for you and will alert other doctors that you are being treated with apixaban. You must keep this card with you at all times.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U
C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,
Alcobendas 28108
Madrid (Spain)
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600.
This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria:
Apixaban ratiopharm 2.5 mg Filmtabletten
Belgium:
Apixaban Teva 2.5 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
Bulgaria:
????????? ???? 2,5 mg ????????? ????????
Czech Republic:
Apixaban Teva
Germany:
Apixaban-ratiopharm 2.5 mg Filmtabletten
Denmark:
Apixaban Teva
Estonia:
Apixaban Teva
Spain:
Apixaban Teva 2.5 mg comprimidos recubiertos con película EFG
Finland:
Apixaban ratiopharm 2.5 mg tabletti, kalvopäällysteinen
France:
Apixaban TEVA 2.5 mg, comprimé pelliculé
Croatia:
Apiksaban Teva 2.5 mg filmom obložene tablete
Hungary:
Apixaban-Teva 2.5 mg filmtabletta
Ireland:
Apixaban Teva 2.5 mg Filmcoated Tablets
Iceland:
Apixaban Teva
Italy:
APIXABAN TEVA
Lithuania:
Apixaban Teva 2,5 mg plevele dengtos tabletes
Latvia:
Apixaban Teva 2,5 mg apvalkotas tablets
Luxembourg:
Apixaban-ratiopharm 2.5 mg Filmtabletten
Netherlands:
Apixaban Teva 2,5 mg, filmomhulde tabletten Teva B.V.
Norway:
Apixaban Teva
Poland:
Apixaban Teva
Romania:
Apixaban Teva BV 2,5 mg comprimate filmate
Sweden:
Apixaban Teva 2,5mg filmdragerade tabletter
Slovenia:
Apiksaban Teva 2,5 mg filmsko obložene tablete
Slovakia:
Apixaban Teva 2,5 mg
United Kingdom:
Apixaban Teva 2.5 mg Filmcoated Tablets
Date of the last revision of this leaflet:July 2025
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85787/P_85787.html
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for APIXABAN TEVA 2.5 mg FILM-COATED TABLETS – subject to medical assessment and local rules.