Apixaban teva

Package leaflet: Information for the user

Apixabanum Teva, 2.5 mg, coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Apixabanum Teva is and what it is used for
2. What you need to know before taking Apixabanum Teva
3. How to take Apixabanum Teva
4. Possible side effects
5. How to store Apixabanum Teva
6. Contents of the pack and other information

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

Apixabanum Teva contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by blocking Factor Xa, an important component of the blood clotting process.

Apixabanum Teva is used in adults:

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

Apixabanum Teva is used in children from 28 days of life up to below 18 years of age, for the treatment of blood clots and prevention of recurrent blood clots in the veins or in the blood vessels of the lungs.
Information regarding body weight and the recommended dose can be found in section 3.

2. Important information before using Apixabanum Teva

Do not use Apixabanum Teva if:

• the patient is allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
• the patient has excessive bleeding;
• the patient has a disease of an organ which increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage);
• the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
• the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into a vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting treatment, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

• increased risk of bleeding, for example:
• conditions associated with bleeding, including those resulting in reduced platelet activity;
• very high blood pressure not controlled with medication;
• if the patient is over 75 years of age;
• if the patient weighs 60 kg or less;
• severe kidney disease or if the patient is on dialysis;
• liver problems or history of liver problems;
• Apixabanum Teva should be used with caution in patients showing signs of liver function abnormalities.
• spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking Apixabanum Teva at least 5 hours or more after removal of the catheter;
• if the patient has a heart valve prosthesis;
• if the doctor determines that the patient’s blood pressure is unstable, or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixabanum Teva:

• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If the patient needs to undergo surgery or a procedure that may involve bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding, consult the doctor.

Children and adolescents
Apixaban is not recommended for use in children and adolescents with body weight below 35 kg.

Apixabanum Teva and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of apixaban, while others may reduce it. The doctor will decide whether the patient should receive apixaban while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of apixaban and increase the risk of unwanted bleeding:

• some medicines used to treat fungal infections (e.g. ketoconazole and others);
• some antiviral medicines used to treat HIV/AIDS infection (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). Particularly when the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased.
• medicines used for high blood pressure or heart problems (e.g. diltiazem);
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce apixaban’s ability to prevent blood clots:

• medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
• St John’s wort (an herbal supplement used for depression);
• medicines used to treat tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of apixaban on pregnancy and unborn child is unknown. Apixaban should not be taken during pregnancy. If the patient becomes pregnant while taking apixaban, she should contact her doctor immediately.
It is not known whether apixaban passes into human milk. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting apixaban.

Driving and operating machinery
Apixaban has no or negligible influence on the ability to drive and operate machinery.

Apixabanum Teva contains lactose (a sugar) and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Apixabanum Teva

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Apixabanum Teva can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time each day.
If you have difficulty swallowing the tablets whole, talk to your doctor about other ways of taking Apixabanum Teva. The tablet may be crushed immediately before administration and mixed with water or 5% glucose solution, juice, or apple puree.
Instructions for crushing tablets:

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

If necessary, your doctor may administer crushed Apixabanum Teva tablets mixed with 60 mL of water or 5% glucose solution via a nasogastric tube.
Apixabanum Teva should be taken as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Apixabanum Teva 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 surgery, you will usually take the tablets for 32 to 38 days.
If you have undergone major knee surgery, you will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Apixabanum Teva 5 mg tablet twice daily.
The recommended dose is one Apixabanum Teva 2.5 mg tablet twice daily if:

• you have severe kidney function impairment;
• two or more of the following conditions are met:
• blood test results suggest reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher);
• you are 80 years of age 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 treatment should continue.
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 Apixabanum Teva 5 mg tablets 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 one Apixabanum Teva 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completing 6 months of treatment
The recommended dose is one Apixabanum Teva 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in the veins or pulmonary blood vessels.
This medicine should always be taken or administered exactly as directed by your pediatrician or pharmacist. If you are unsure, consult your pediatrician, pharmacist, or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same time each day.
The dose of Apixabanum Teva depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four Apixabanum Teva 2.5 mg tablets, taken 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 two Apixabanum Teva 2.5 mg tablets, taken twice daily, for example, two in the morning and two in the evening.
For parents and caregivers: you should observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary with changes in body weight.
Your doctor may change anticoagulant treatment as follows:

• Switching from Apixabanum Teva to other anticoagulant medicines: Discontinue Apixabanum Teva. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was due.
• Switching from anticoagulant medicines to Apixabanum Teva: Discontinue the anticoagulant medicine. Start Apixabanum Teva at the time the next anticoagulant dose was due, and continue regular dosing thereafter.
• Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Apixabanum Teva: Discontinue the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to start taking Apixabanum Teva.
• Switching from Apixabanum Teva to vitamin K antagonist anticoagulant therapy (e.g., warfarin): If your doctor tells you to start taking a vitamin K antagonist medicine, continue taking Apixabanum Teva for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to stop taking Apixabanum Teva.

Patients undergoing cardioversion
Patients who require a cardioversion procedure to restore normal heart rhythm should take Apixabanum Teva at the times specified by their doctor to prevent blood clots in the brain’s blood vessels and other blood vessels in the body.
Taking more Apixabanum Teva than recommended
If you take more Apixabanum Teva than recommended, you should contact your doctor immediately. Bring the medicine packaging with you, even if it is empty.
If you take more than the recommended dose of Apixabanum Teva, your risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse the effect of factor Xa inhibitors may be required.
Missed dose of Apixabanum Teva

• If you miss a morning dose, take it as soon as you remember, and you may take it at the same time as your evening dose.
• A missed evening dose may only be taken that same evening. Do not take two doses the next morning. Instead, continue taking the medicine the next day as directed, twice daily.

If you have any doubts about how to take the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping Apixabanum Teva
Do not stop taking this medicine without consulting your doctor, as stopping treatment prematurely may increase the risk of developing blood clots.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Apixaban may be used for three different medical conditions. Known adverse reactions and their frequency of occurrence in each of these medical conditions may differ and are listed separately below. In these conditions, the most common general adverse reaction associated with this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse reactions may occur when taking apixaban to prevent blood clots after hip or knee replacement surgery.

Common adverse reactions (may occur in up to 1 in 10 people)

• Anaemia, which may cause fatigue or pallor;
• Bleeding including:
  • Bruising and swelling;
• Nausea.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Reduced platelet count (which may affect blood clotting);
• Bleeding:
  • After surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From the stomach, intestines, or bright red blood in stool;
  • Blood in urine;
  • Nosebleeds;
  • Vaginal bleeding;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Blood test results may indicate:
  • Liver function abnormalities;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels, a product of destroyed red blood cells, which may cause yellowing of the skin and eyes;
• Itching.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Allergic reactions (hypersensitivity) which may cause: facial, lip, mouth, tongue and (or) throat swelling, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.
• Bleeding:
  • Into muscle tissue;
  • Into the eye;
  • From gums and coughing up blood;
  • From the rectum;
• Hair loss.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the brain or spinal cord;
  • In the lungs or throat;
  • In the mouth;
  • Into the abdominal cavity or retroperitoneal space;
  • From haemorrhoids;
  • Test results indicating presence of blood in stool or urine.
• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking apixaban to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common adverse reactions (may occur in up to 1 in 10 people)

• Bleeding, including:
  • Into the eye;
  • Into the stomach or intestine;
  • From the rectum;
  • Blood in urine;
  • Nosebleeds;
  • Gum bleeding;
  • Bruising and swelling;
• Anaemia, which may cause fatigue or pallor;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Bleeding:
  • Into the brain or spinal cord;
  • In the mouth or coughing up blood;
  • In the abdominal cavity or from the vagina;
  • Bright red blood in stool;
  • Postoperative bleeding, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From haemorrhoids;
  • Presence of blood in stool or urine detected in laboratory tests;
• Decreased platelet count (which may 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, which may cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which may cause: facial, lip, oral cavity, tongue and (or) throat swelling, and breathing difficulties. If any of these symptoms are observed, contact your doctor immediately.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Bleeding:
  • In the lungs or throat;
  • Into the retroperitoneal space;
  • Into muscle tissue.

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising.
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse reactions may occur when taking apixaban for the treatment or prevention of recurrent venous blood clots in the legs and pulmonary embolism (blood clots in the lungs).

Common adverse reactions (may occur in up to 1 in 10 people)

• Bleeding, including:
  • Nosebleeds;
  • Gum bleeding;
  • Blood in urine;
  • Bruising and swelling;
  • In the stomach, intestine, or from the rectum;
  • In the mouth;
  • Vaginal bleeding;
• Anaemia, which may cause fatigue or pallor;
• Decreased platelet count (which may affect blood clotting);
• Nausea;
• Skin rash;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Bleeding:
  • Into the eye;
  • In the mouth or coughing up blood;
  • Bright red blood in stool;
  • Test results indicating blood in stool or urine;
  • Postoperative bleeding, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • From haemorrhoids;
  • Into muscle tissue;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which may cause: facial, lip, oral cavity, tongue and (or) throat swelling, and breathing difficulties. If any of these symptoms are observed, contact your doctor immediately.
• Blood test results may indicate:
  • Abnormal liver function;
  • Increased activity of certain liver enzymes;
  • Increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Bleeding:
  • Into the brain or spinal cord;
  • In the lungs.

Frequency not known (cannot be estimated from available data)

• Bleeding:
  • Into the abdominal cavity or retroperitoneal space;
• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising.
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents

If any of the following symptoms are observed, contact your paediatrician immediately:

• Allergic reactions (hypersensitivity), which may cause: facial, lip, oral cavity, tongue and (or) throat swelling, and breathing difficulties. The frequency of these adverse reactions has been classified as "common" (may occur in up to 1 in 10 people). Generally, adverse reactions observed in children and adolescents treated with Apixabanum Teva were similar to those observed in adults and were mostly mild or moderate in severity. Adverse reactions reported more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse reactions (may occur in more than 1 in 10 people)

• Bleeding, including:
  • Vaginal bleeding;
  • Nosebleeds.

Common adverse reactions (may occur in up to 1 in 10 people)

• Bleeding, including:
  • Gum bleeding;
  • Blood in urine;
  • Bruising (ecchymoses) and swelling;
  • From intestine or rectum;
  • Bright red blood in stool;
  • Postoperative bleeding, including bruising (ecchymoses) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
• Hair loss;
• Anaemia, which may cause fatigue or pallor;
• Decreased platelet count (which may affect coagulability);
• Nausea;
• Skin rash;
• Itching;
• Low blood pressure, which may 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 (cannot be estimated from available data)

• Bleeding:
  • Into the abdominal cavity or retroperitoneal space;
  • In the stomach;
  • In the eyes;
  • In the mouth;
  • From haemorrhoids;
  • In the mouth or blood in sputum when coughing;
  • In the brain or spine;
  • In the lungs;
  • In muscle tissue;
• Skin rash, which may develop blisters and resembles target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis, which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
• Blood test results may indicate:
  • Increased gamma-glutamyl transferase (GGT) activity;
  • Presence of blood in faeces or urine.
• Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl ;
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Apixabanum Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack after EXP. The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Apixabanum Teva contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• Other ingredients are:
• Tablet core: lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (of plant origin).
• Coating: monohydrate lactose, hypromellose 2910 (15 mPa), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172). See section 2, "Apixabanum Teva contains lactose (a type of sugar) and sodium".

What Apixabanum Teva looks like and contents of the pack
Apixabanum Teva is a yellow, round, biconvex film-coated tablet with a diameter of approximately 6 mm and a thickness of 3 mm.
Apixabanum Teva is available in the following pack sizes:
PVC/PVDC/Aluminium blisters in cardboard boxes containing 20, 60, or 60x1 film-coated tablets.

Patient Alert Card: information on use
Inside the Apixabanum Teva packaging, alongside the patient leaflet, there is a Patient Alert Card, or the treating physician may provide the patient with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians that the patient is taking Apixabanum Teva. You should always carry this card with you.

1. Take the card
2. Fill in the following details, or ask your doctor to complete them:
   • Name and surname:
   • Date of birth:
   • Indication:
   • Dose: ........ mg twice daily
   • Doctor's name:
   • Doctor's telephone number:
3. Fold the card and always keep it with you

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

Manufacturer
Combino Pharm (Malta) Limited
60 Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:

| Country | Product Name | |---------|--------------| | Malta | Apixaban Combino Pharm 2.5 mg film-coated tablets | | Germany | Apixaban-ratiopharm 2,5 mg Filmtabletten | | Austria | Apixaban ratiopharm GmbH 2,5 mg Filmtabletten | | Belgium | Apixaban Teva Generics 2,5 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten | | Bulgaria | Апиксабан Тева Фарма 2,5 mg филмирани таблетки / Apixaban Teva Pharma 2.5 mg film-coated tablets | | Czech Republic | Apixaban Teva CR | | Denmark | Apixaban Teva GmbH | | Estonia | Apixaban Teva Pharma | | Spain | APIXABAN TEVAGEN 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | | Finland | Apixaban ratiopharm GmbH 2,5 mg tabletti, kalvopäällysteinen | | France | APIXABAN TEVA SANTE 2,5 mg, comprimé pelliculé | | Croatia | Apiksaban Teva 2,5 mg filmom obložene tablete | | Hungary | Apixaban Teva GmbH 2,5 mg filmtabletta | | Ireland | Apixaban 2.5 mg and 5 mg Film-coated Tablet | | Iceland | Apixaban Teva GmbH | | Italy | APIXABAN TEVA ITALIA | | Lithuania | Apixaban TevaPharm 2,5 mg plėvele dengtos tabletės | | Germany | Apixaban Teva GmbH 2,5 mg plėvele dengtos tabletės | | Luxembourg | Apixaban-ratiopharm 2,5 mg Filmtabletten | | Latvia | Apixaban TevaPharm 2,5 mg apvalkotās tablets | | Netherlands | Apixaban Teva 2,5 mg, filmomhulde tabletten | | Norway | Apixaban Teva GmbH | | Poland | Apixabanum Teva | | Portugal | Apixabano Teva | | Romania | Apixaban Teva 2,5 mg comprimate filmate | | Sweden | Apixaban Teva GmbH | | Slovenia | Apiksaban Teva GmbH 2,5 mg filmsko obložene tablete | | Slovakia | Apixaban Teva Slovakia 2.5 mg |