Apixaban aurovitas

Poland
Brand name Apixaban aurovitas
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100421690
Manufacturer APL Swift Services (Malta) Ltd. Arrow Generiques Generis Farmacêutica, S.A.

Table of Contents

Package leaflet: Information for the user

Apixaban Aurovitas, 2.5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before you start 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.

Table of contents

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

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

Apixaban Aurovitas 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.

Apixaban Aurovitas is used in adults:

  • to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the deep veins of the legs. This may lead to leg swelling, 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 stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical treatment.
  • to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of such clots in the veins of the legs and/or lungs.

Apixaban Aurovitas is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Information on body weight and recommended dosage is provided in section 3.

2. Important information before using Apixaban Aurovitas

When not to use Apixaban Aurovitas:

  • if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
  • if the patient has excessive bleeding;
  • if the patient has an organ disease that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding);
  • if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
  • if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except when switching anticoagulant therapy, when an intravenous or intra-arterial line has been inserted and heparin is administered through the line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the 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 by 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;
    • Apixaban Aurovitas should be used with caution in patients showing signs of liver function abnormalities;
  • if the patient has had a tube (catheter) or spinal injection (anaesthetic or pain-relieving), in which case the doctor will advise taking Apixaban Aurovitas 5 or more hours after catheter removal;
  • 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 a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise special caution when using Apixaban Aurovitas
If the patient has a disorder called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.
If surgery or a procedure involving bleeding risk is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If unsure whether a procedure may involve bleeding, consult the doctor.
Children and adolescents
Apixaban Aurovitas is not recommended for use in children and adolescents with body weight below 35 kg.
Apixaban Aurovitas 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 Aurovitas, while others may reduce its effect. The doctor will decide whether the patient should receive Apixaban Aurovitas while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Aurovitas and increase the risk of unwanted bleeding:

  • certain antifungal medicines (e.g. ketoconazole and others);
  • certain 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 if 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 and noradrenaline reuptake inhibitors.

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

  • medicines used to prevent seizures or convulsions (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 Aurovitas 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, she should contact her doctor immediately.
It is not known whether Apixaban Aurovitas passes into human breast milk. Consult your doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to stop breastfeeding, stop or not start taking this medicine.
Driving and operating machinery
Apixaban Aurovitas has no effect or negligible effect on the ability to drive and operate machinery.
Apixaban Aurovitas contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Apixaban Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Apixaban Aurovitas

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Aurovitas may be taken regardless of
meals. To achieve the best treatment results, it is recommended to take the tablets at the
same times each day.
If a patient has difficulty swallowing tablets whole, they should speak to their doctor about
alternative ways of taking Apixaban Aurovitas. The tablet may be crushed immediately before
administration and mixed with water or 5% aqueous glucose solution, juice or apple puree.
Instructions for crushing tablets:

  • Crush the tablet with a pestle in a mortar.
  • Carefully transfer the powder to 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 tablet and the container with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinse liquid.

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

  • the patient has severe renal 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);
    • the patient is 80 years of age or older;
    • the patient’s body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one in the morning and one
in the evening. The doctor will decide how long treatment should continue.
Treatment of venous thromboembolism (blood clots in the deep veins of the legs) and pulmonary embolism (blood clots in the blood vessels of the lungs)
The recommended dose is two Apixaban Aurovitas 5 mg tablets twice daily 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 Aurovitas 5 mg tablet twice daily,
for example, one in the morning and one in the evening.
Prevention of recurrent blood clots after completing 6 months of treatment
The recommended dose is one Apixaban Aurovitas 2.5 mg tablet twice daily, for example,
one in the morning and one in the evening.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist. If
in doubt, consult a doctor, 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 Apixaban Aurovitas depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four Apixaban
Aurovitas 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 Apixaban Aurovitas 2.5 mg
tablets, taken twice daily, for example, two in the morning and two in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as the dose may need to be adjusted as the patient’s body weight changes.
The doctor may change anticoagulant treatment as follows:

  • Switching from Apixaban Aurovitas to other anticoagulant medicines Discontinue Apixaban Aurovitas. Start treatment with other anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
  • Switching from other anticoagulant medicines to Apixaban Aurovitas Discontinue other anticoagulant medicines. Start treatment with Apixaban Aurovitas at the time the next dose of the anticoagulant medicine was scheduled to be taken, then continue regular dosing.
  • Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apixaban Aurovitas Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and will inform the patient when to start taking Apixaban Aurovitas.
  • Switching from Apixaban Aurovitas to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If the doctor informs the patient that they should start taking a vitamin K antagonist medicine, continue taking Apixaban Aurovitas

for at least 2 days after taking the first dose of the vitamin K antagonist
medicine. The doctor must perform blood tests and inform the patient when to
discontinue Apixaban Aurovitas.
Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take Apixaban Aurovitas at the times specified by the doctor to prevent blood clots in the brain’s blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Aurovitas
If a patient has taken more than the recommended dose of this medicine, they should contact their doctor immediately. They should bring the medicine packaging, even if it is empty.
If a patient has taken more than the recommended dose of Apixaban Aurovitas, the risk of bleeding may be increased. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse the effect of factor Xa inhibitor may be necessary.
Missed dose of Apixaban Aurovitas

  • If a morning dose is missed, take it as soon as remembered, and it may be taken at the same time as the 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 in doubt about use of the medicine or if more than one dose is missed, consult a doctor, pharmacist or nurse.
Stopping Apixaban Aurovitas
Do not stop taking Apixaban Aurovitas without consulting a doctor, as the risk of developing a blood clot may be higher if treatment is stopped prematurely.
If there are any further doubts about using this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

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

The following side effects may occur when taking Apixaban Aurovitas to prevent blood clots after hip or knee replacement surgery.

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

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including: bruising and swelling;
  • Nausea (feeling sick).

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

  • Decreased 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;
    • from the vagina;
  • 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 from destroyed red blood cells, which may cause yellowing of the skin and eyes;
  • Itching.

Rare side effects (may occur in up to 1 in 1,000 people)

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.
  • Bleeding:
    • into muscle;
    • into the eyes;
    • 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 canal;
    • 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 small 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 side effects may occur when taking Apixaban Aurovitas to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common side effects (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;
  • from gums;
  • bruising and swelling;
    • Anaemia, which may cause fatigue or paleness;
    • Low blood pressure, which may lead to fainting or rapid heartbeat;
    • Nausea (feeling sick);
    • Blood test results may indicate:
  • increased gamma-glutamyl transferase (GGT) activity.

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

  • Bleeding:
    • into the brain or spinal canal;
    • in the mouth or coughing up blood;
    • into the abdominal cavity or from the vagina;
    • bright red blood in stool;
    • post-surgical bleeding, including bruising and swelling, leakage of blood or fluid from 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: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.

Rare side effects (may occur in up to 1 in 1,000 people)

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

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

  • Skin rash, which may develop blisters and resembles small 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 side effects may occur when taking Apixaban Aurovitas to treat or prevent recurrence of venous blood clots in the legs and pulmonary embolism.

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

  • Bleeding, including:
    • nosebleeds;
    • from gums;
    • blood in urine;
    • bruising and swelling;
    • in the stomach, intestine, or from the rectum;
    • in the mouth;
    • from the vagina;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect clotting);
  • Nausea (feeling sick);
  • Skin rash;
  • Blood test results may indicate:
    • increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT) activity.

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

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
    • into the eyes;
    • in the mouth or coughing up blood;
    • bright red blood in stool;
    • test results indicating blood in stool or urine;
    • post-surgical bleeding, including bruising and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
    • from haemorrhoids;
    • into muscles;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.
  • 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 side effects (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • into the brain or spinal canal;
    • 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 small 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 side effects in children and adolescents
If any of the following symptoms occur, immediately inform your doctor:

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these side effects is classified as “common” (may occur in up to 1 in 10 people).

Overall, side effects observed in children and adolescents treated with apixaban were generally similar to those seen in adults and were mostly mild or moderate in severity. Side effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

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

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

  • Bleeding, including:
    • from gums;
    • blood in urine;
    • bruising (haematomas) and swelling;
    • from the intestine or rectum;
    • bright red blood in stool;
    • post-surgical bleeding, including bruising (haematomas) and swelling, leakage of blood (discharge) from surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect clotting);
  • Nausea (feeling sick);
  • 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;
    • into the brain or spine;
    • in the lungs;
    • into muscle;
  • Skin rash, which may develop blisters and resembles small 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 stool or urine;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also 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 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apixaban Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle, and blister pack following: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Apixaban Aurovitas contains
The active substance is apixaban. Each coated tablet contains 2.5 mg of apixaban.
The other ingredients are:
Tablet core: lactose, microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose,
magnesium stearate.
Tablet coating: monohydrate lactose, hypromellose 2910 (6 cps), triacetin, titanium dioxide
(E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Apixaban Aurovitas looks like and contents of the pack
Film-coated tablet.
Light yellow to yellow, round, biconvex film-coated tablet, embossed with "N" on one side and "2.5" on the other.
Apixaban Aurovitas film-coated tablets are available in blisters and HDPE bottles, packed in a cardboard box.
Pack sizes:
Blisters: 10, 14, 20, 28, 56, 60, 100, 168 and 200 film-coated tablets.
HDPE bottles: 60, 100, 200, 250 and 500 (packs of 250 and 500 are intended for hospital use only and for pharmacies dispensing doses) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Belgium: Apixaban AB 2.5 mg filmomhulde tabletten
Apixaban AB 2.5 mg comprimés pelliculés
Apixaban AB 2.5 mg Filmtabletten
Germany: Apixaban PUREN 2.5 mg Filmtabletten
France: Apixaban Arrow 2.5 mg, comprimé pelliculé
Netherlands: Apixaban Aurobindo 2.5 mg, filmomhulde tabletten
Poland: Apixaban Aurovitas
Portugal: Apixabano Generis
Spain: Apixabán Aurovitas 2.5 mg comprimidos recubiertos con película EFG