Apixaban aurovitas

Poland
Brand name Apixaban aurovitas
Form tablets, film-coated
Active substance / Dosage
apixaban · 5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100421709
Manufacturer APL Swift Services (Malta) Ltd. Arrow Generiques Generis Farmacêutica, S.A.

Table of Contents

Package leaflet: Information for the user

Apixaban Aurovitas, 5 mg, coated tablets
Apixabanum
Please read the entire leaflet before taking this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, please consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
  • If you experience any adverse 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 inhibiting factor Xa, an important component of the blood clotting process.
Apixaban Aurovitas is used in adults:

  • To prevent blood clots in the heart in patients with irregular heart rhythm (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 (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), and to prevent recurrence of blood clots in the veins of the legs and/or lungs.

Apixaban Aurovitas is used in children from 28 days to below 18 years of age 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 can be found in section 3.

2. Important information before using Apixaban Aurovitas

When not to use Apixaban Aurovitas:

  • if the patient is allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • if the patient has active bleeding;
  • if the patient has a disease of an organ that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, or recent intracranial haemorrhage);
  • 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 a venous or 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 involving bleeding, including those resulting in reduced platelet function;
    • very high blood pressure that is 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;
    • Apixaban Aurovitas should be used with caution in patients showing signs of liver function abnormalities.
  • 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 particular caution when using Apixaban Aurovitas
If the patient has a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether any change in treatment is needed.
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 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 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);
  • antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the ability of Apixaban Aurovitas 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 Aurovitas on pregnancy and the unborn child is unknown. This medicine should not be used 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 milk. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding, stop or not start taking this medicine.

Driving and operating machinery
Apixaban Aurovitas has no effect or has a 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 consult their 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 exactly as prescribed by your doctor or pharmacist. If you are unsure,
please consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban Aurovitas can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If you have difficulty swallowing tablets whole, speak to your 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, fruit juice, or apple puree.
Instructions for crushing tablets:

  • Crush the tablet using a mortar and pestle.
  • 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 mortar, pestle, and container used to crush the tablet 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 Apixaban Aurovitas tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Aurovitas should be taken as directed for the following indications:
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 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; or
  • two or more of the following conditions are met :
    • blood test results suggest reduced kidney function (serum creatinine concentration ≥1.5 mg/dL [133 micromoles/L]);
    • 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 tablet in the morning and one in the evening. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Aurovitas 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 5 mg tablet of Apixaban Aurovitas 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 2.5 mg tablet of Apixaban Aurovitas 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 and prevention of blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as prescribed by your doctor or pharmacist. If you are unsure, please consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, try to take or administer the dose at the same time each day.
The dose of Apixaban Aurovitas depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two 5 mg tablets of Apixaban Aurovitas, taken 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 5 mg tablet of Apixaban Aurovitas, taken twice daily, for example, one in the morning and one 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 dose adjustments may be necessary as the patient’s body weight changes.
Your doctor may change anticoagulant therapy as follows:

  • Switching from Apixaban Aurovitas to other anticoagulant medicines Stop taking Apixaban Aurovitas. Start anticoagulant treatment (e.g., heparin) at the time the next dose of Apixaban Aurovitas was due.
  • Switching from other anticoagulant medicines to Apixaban Aurovitas Stop taking the other anticoagulant medicines. Start Apixaban Aurovitas at the time the next dose of the previous anticoagulant was due, and continue taking it as usual.
  • Switching from anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) to Apixaban Aurovitas Discontinue the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Apixaban Aurovitas.
  • Switching from Apixaban Aurovitas to anticoagulant therapy including a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist, continue taking Apixaban Aurovitas for at least 2 days after taking the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Apixaban Aurovitas.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take Apixaban Aurovitas at the times specified by their doctor to prevent blood clots in the brain and other blood vessels.
Taking more Apixaban Aurovitas than prescribed
If you have taken more Apixaban Aurovitas than prescribed, you must contact your doctor immediately. Bring the medicine packaging with you, even if it is empty.
If you have taken more than the prescribed dose of Apixaban Aurovitas, your risk of bleeding may increase. Surgical treatment, blood transfusion, or other treatments to reverse the anticoagulant effect (anti-factor Xa) may be necessary in case of bleeding.
Missing a dose of Apixaban Aurovitas

  • 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 on the 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 taking this medicine or if you miss more than one dose, please consult your doctor, pharmacist, or nurse.
Stopping Apixaban Aurovitas
Do not stop taking Apixaban Aurovitas 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, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most common general adverse reaction with Apixaban Aurovitas is bleeding, which
may potentially be life-threatening and may require immediate medical attention.

The following adverse reactions may occur when taking Apixaban Aurovitas to prevent blood clots in the heart in patients with irregular heartbeat 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;
    • from the nose;
    • from the gums;
    • subcutaneous haemorrhage and swelling;
  • Anaemia, which may cause fatigue or paleness;
  • 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 canal;
    • in the mouth or coughing up blood;
    • in the abdominal cavity or from the vagina;
    • bright red blood in stool;
    • bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue incision site (wound discharge) or injection site;
    • from haemorrhoids;
    • presence of blood in stool or urine detected in laboratory tests;
  • Decreased platelet count in blood (which may affect blood clotting);
  • Blood test results may indicate:
    • abnormal liver function;
    • increased activity of certain liver enzymes;
    • elevated bilirubin levels – a breakdown product of red blood cells that may cause yellowing of the skin and eyes;
  • Skin rash;
  • Itching;
  • Hair loss;
  • Allergic (hypersensitivity) reactions, 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 adverse reactions (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • in the lungs or throat;
    • into the retroperitoneal space (behind the abdominal cavity);
    • into muscles.

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

  • Skin rash with blister formation, resembling 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)

  • Inflammation of blood vessels (vasculitis), 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 Aurovitas for the treatment or prevention of recurrent venous blood clots in the legs and pulmonary embolism (blood clots in the blood vessels of the lungs).

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

  • Bleeding, including:
    • from the nose;
    • from the gums;
    • blood in urine;
    • subcutaneous haemorrhage 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 in blood (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 eyes;
    • in the mouth or coughing up blood;
    • bright red blood in stool;
    • test results indicating blood in stool or urine;
    • bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/tissue incision site (wound discharge) or injection site;
    • from haemorrhoids;
    • into muscles;
  • Itching;
  • Hair loss;
  • Allergic (hypersensitivity) reactions, 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;
    • elevated bilirubin levels – a breakdown product of red blood cells that may cause yellowing of the skin and eyes.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • in 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 with blister formation, resembling small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), 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 occur, immediately inform the doctor:

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

In general, adverse reactions observed in children and adolescents treated with apixaban were similar to those seen 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:
    • from the vagina;
    • from the nose.

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

  • Bleeding, including:
    • from the gums;
    • blood in urine;
    • subcutaneous haemorrhages (bruising) and swelling;
    • from the intestine or rectum;
    • bright red blood in stool;
    • bleeding after surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count in blood (which may affect clotting);
  • 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;
  • Skin rash with blister formation, resembling 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 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 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Apixaban Aurovitas

Keep this medicine out of 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 instructions 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 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 pink to pink, oval, biconvex film-coated tablets, embossed with "N" on one side and "5" on the other side.
Apixaban Aurovitas film-coated tablets are available in blisters and HDPE bottles, packed in a cardboard box.
Pack sizes:
Blisters: 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 exclusively for hospital use and for pharmacies dispensing doses) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
email: [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 medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Apixaban AB 5 mg filmomhulde tabletten
Apixaban AB 5 mg comprimés pelliculés
Apixaban AB 5 mg Filmtabletten
Germany: Apixaban PUREN 5 mg Filmtabletten
France: Apixaban Arrow 5 mg, comprimé pelliculé
Netherlands: Apixaban Aurobindo 5 mg, filmomhulde tabletten
Poland: Apixaban Aurovitas
Portugal: Apixabano Generis
Spain: Apixabán Aurovitas 5 mg comprimidos recubiertos con película EFG