Apixaban sandoz

Poland
Brand name Apixaban sandoz
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100480158
Manufacturer Adalvo Limited Pharmadox Healthcare Limited
Apixaban sandoz tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

Apixaban Sandoz, 2.5 mg, coated tablets
Apixabanum
Please read the entire leaflet before using this medicine, as it contains important information
for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.
Table of contents

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

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

Apixaban Sandoz contains the active substance apixaban and belongs to a group of medicines known as anticoagulants.
This medicine helps prevent blood clots by inhibiting Factor Xa, an important component in the blood clotting process.
This medicine is used in adults:

  • to prevent the formation of 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 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) can be life-threatening and requires immediate medical attention.
  • to prevent the formation of blood clots in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break off and travel to the brain, causing a 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 intervention.
  • 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.

2. Important Information Before Using Apixaban Sandoz

When not to use Apixaban Sandoz

  • 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 serious bleeding (such as active or recently diagnosed gastric or intestinal ulcer, recently diagnosed intracranial haemorrhage);
  • if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
  • if the patient is taking anticoagulant medicines (such as warfarin, rivaroxaban, dabigatran or heparin), except during a switch of 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 undergoes 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 an increased risk of bleeding, for example:
    • disorders associated with bleeding, including conditions resulting in reduced platelet activity;
    • very high blood pressure, uncontrolled with medication;
    • if the patient is over 75 years of age;
    • if the patient weighs 60 kg or less;
  • the patient has severe kidney disease or is on dialysis;
  • the patient has liver disease or a history of liver disease. This medicine should be used with caution in patients showing signs of liver function abnormalities.
  • a tube (catheter) has been inserted or an injection has been given into the spine (anaesthetic or painkiller), in which case the doctor will advise taking this medicine 5 or more hours after catheter removal;
  • the patient has a heart valve prosthesis;
  • 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 Apixaban Sandoz

  • if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clots), the patient should inform the doctor, who will decide whether treatment adjustment is needed.
  • if surgery or a procedure associated with bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If in doubt whether a procedure may involve bleeding, consult the doctor.

Children and adolescents
Apixaban Sandoz is not recommended for patients under 18 years of age.
Apixaban Sandoz and other medicines
Tell your doctor, pharmacist or nurse about all medicines currently taken, recently taken, or planned to be taken.
Some medicines may enhance the effect of Apixaban Sandoz, while others may weaken its effect.
The doctor will decide whether the patient should receive Apixaban Sandoz while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Sandoz and increase the risk of
unwanted bleeding:

  • certain antifungal medicines (such as ketoconazole and others);
  • certain antiviral medicines used to treat HIV/AIDS infection (such as ritonavir);
  • other medicines used to reduce blood clotting (such as enoxaparin and others);
  • anti-inflammatory or pain medicines (such as acetylsalicylic acid or naproxen), especially if the patient is over 75 years of age and taking acetylsalicylic acid, which may increase the risk of unwanted bleeding;
  • medicines used for high blood pressure or heart problems (such as diltiazem);
  • antidepressants known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

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

  • antiepileptic medicines or medicines used to prevent seizures (such as phenytoin and others);
  • St John’s wort (an herbal supplement used for depression);
  • medicines used to treat tuberculosis or other infections (such as 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 this medicine 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 this medicine passes into human milk. Before using this medicine during breastfeeding, consult your doctor, pharmacist or nurse. The patient may be advised to stop breastfeeding or to discontinue/avoid starting this medicine.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery.
Apixaban Sandoz contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their 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 use Apixaban Sandoz
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor, pharmacist or nurse.
Dosage
Swallow the tablet with water. This medicine can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same times every day.
If the patient has difficulty swallowing tablets whole, discuss alternative ways of taking Apixaban Sandoz with the doctor. 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 in a mortar with a 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 one of the other liquids mentioned above to prepare 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, the doctor may administer crushed Apixaban Sandoz tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Sandoz should be taken as directed for the following indications:

  • Prevention of blood clots after hip or knee replacement surgery
    The recommended dose is one 2.5 mg tablet of Apixaban Sandoz twice daily. For example, one tablet in the morning and one in the evening. The first dose should be taken 12 to 24 hours after surgery.

    • If the patient has undergone major hip surgery, tablets are usually taken for 32 to 38 days.
    • If the patient has undergone major knee surgery, tablets are usually taken 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 5 mg tablet of Apixaban Sandoz twice daily.
    The recommended dose is one 2.5 mg tablet of Apixaban Sandoz twice daily if:

  • the patient has severe renal impairment;

  • two or more of the following conditions are present:

    • blood test results suggest reduced kidney function (serum creatinine concentration 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 tablet in the morning and one in the evening. The 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 Sandoz 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 Sandoz 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 Sandoz twice daily, for example, one tablet in the morning and one in the evening.
    The doctor will decide how long treatment should continue.
    The doctor may change anticoagulant treatment as follows:

  • Switching from Apixaban Sandoz to anticoagulant medicines
    Stop taking Apixaban Sandoz. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.

  • Switching from anticoagulant medicines to Apixaban Sandoz
    Stop taking anticoagulant medicines. Start Apixaban Sandoz at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.

  • Switching from vitamin K antagonist anticoagulant therapy (e.g., warfarin) to Apixaban Sandoz
    Discontinue the vitamin K antagonist medicine. The doctor must perform blood tests and will inform the patient when to start taking Apixaban Sandoz.

  • Switching from Apixaban Sandoz to vitamin K antagonist anticoagulant therapy (e.g., warfarin)
    If the doctor informs the patient to start taking a vitamin K antagonist medicine, continue taking Apixaban Sandoz 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 stop taking Apixaban Sandoz.

Use in patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Sandoz
If the patient has taken more than the recommended dose of this medicine, contact the doctor immediately. Bring the medicine packaging, even if empty.
If the patient has taken more than the recommended dose of Apixaban Sandoz, there may be an increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse the effect of factor Xa inhibitor may be required.
Missing a dose of Apixaban Sandoz
Take the missed dose as soon as the patient remembers and:

  • take the next dose at the usual time;
  • then continue taking the medicine as before. If in doubt about use of the medicine or if more than one dose has been missed, consult the doctor, pharmacist or nurse.

Stopping Apixaban Sandoz
Do not stop taking this medicine without consulting your doctor, as stopping Apixaban Sandoz prematurely may increase the risk of blood clots.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
The medicine Apixaban Sandoz can be used for three different medical conditions. Known adverse effects and their frequency of occurrence may differ for each of these conditions and are listed separately below. In these conditions, the most common general adverse effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.

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

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

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including bruising and swelling;
  • Nausea.

Uncommon adverse 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 or injection site (wound discharge);
    • 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 breakdown product of destroyed red blood cells that may cause yellowing of the skin and eyes;
  • Itching.

Rare adverse effects (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 eyes;
    • from the gums and coughing up blood;
    • from the rectum;
  • Hair loss.

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

  • Bleeding:
    • into the brain or spinal column;
    • in the lungs or throat;
    • in the mouth;
    • into the abdominal cavity or the retroperitoneal space;
    • from haemorrhoids;
    • test results indicating blood in stool or urine;
  • Skin rash, sometimes with blister formation, resembling 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, round spots beneath the skin surface, or bruising.
  • Kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse effects may occur when taking Apixaban Sandoz to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

  • Bleeding, including:
    • into the eye;
    • in the stomach or intestine;
    • from the rectum;
    • blood in urine;
    • nosebleeds;
    • from the gums;
    • bruising 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 effects (may occur in up to 1 in 100 people)

  • Bleeding:
    • into the brain or spinal column;
    • 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 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 (which may affect blood clotting);
  • Blood test results may indicate:
    • abnormal liver function;
    • increased activity of certain liver enzymes;
    • increased bilirubin levels—breakdown product of red blood cells that 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 are observed, contact your doctor immediately.

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

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

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

  • Skin rash, sometimes with blister formation, resembling 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 (frequency cannot be estimated from available data)

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

The following adverse effects may occur when taking Apixaban Sandoz for the treatment or prevention of recurrent blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

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

  • Bleeding, including:
    • nosebleeds;
    • from the gums;
    • blood in urine;
    • bruising and swelling;
    • in the stomach, intestines, or from the rectum;
    • in the mouth;
    • from the vagina;
  • Anaemia, which may cause fatigue or paleness;
  • 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 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;
    • postoperative bleeding, including bruising and swelling, leakage of blood or fluid from the surgical wound or tissue 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 are observed, contact your doctor immediately.
  • Blood test results may indicate:
    • abnormal liver function;
    • increased activity of certain liver enzymes;
    • increased bilirubin levels—breakdown product of red blood cells that may cause yellowing of the skin and eyes.

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

  • Bleeding:
    • into the brain or spinal column;
    • in the lungs.

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

  • Bleeding into the abdominal cavity or retroperitoneal space.
  • Skin rash, sometimes with blister formation, resembling 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, round spots beneath the skin surface, or bruising.
  • Kidney bleeding, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Apixaban Sandoz

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

6. Contents of the packaging and other information

What Apixaban Sandoz contains
The active substance is apixaban. Each coated tablet contains 2.5 mg of apixaban.
Other ingredients are:

  • Tablet core: monohydrate lactose (see section "Apixaban Sandoz contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, povidone K30, crospovidone (Type A), sodium lauryl sulfate, sodium stearyl fumarate
  • Coating: monohydrate lactose (see section "Apixaban Sandoz contains lactose (a type of sugar) and sodium"), hypromellose, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172)

What Apixaban Sandoz looks like and contents of the pack
The coated tablets are yellow, round, with a diameter of 6.1 mm.
They are packed in blisters or in single-dose perforated blisters made of Aluminium/PVC/PVdC foil,
contained in a cardboard carton.
Pack sizes:

  • 10, 20, 28, 56, 60 or 168 coated tablets in blisters
  • 10 x 1, 20 x 1, 28 x 1, 56 x 1, 60 x 1 or 168 x 1 coated tablets in single-dose perforated blisters

Not all pack sizes may be marketed.
Patient Alert Card: information for the user
Inside the packaging, together with the Patient Leaflet, a Patient Alert Card is included.
A similar card can also be obtained from your doctor.
This Patient Alert Card contains information that may be helpful for the patient and
may serve as a warning to other physicians that the patient is taking Apixaban Sandoz.
The card should always be carried on your person.

  1. Remove the card.
  2. Fill in the following details or ask your doctor for help:
    • Name and surname
    • Date of birth
    • Indication
  • Dosage: …. mg twice daily
  • Name of the doctor
  • Doctor's telephone number
  1. Fold the card and always keep it with you

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola
PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate, San Gwann
SGN 3000, Malta
This medicine is authorised for sale in the European Economic Area under the following names:
Finland Apixaban Hexal
Bulgaria Apixaban Sandoz
Cyprus Apixaban/Ebewe 2.5 mg
film-coated tablets
Greece Apixaban/Ebewe
Lithuania Apixaban Sandoz 2.5 mg plėvele dengtos tabletės
Latvia Apixaban Sandoz 2.5 mg apvalkotās tabletes
Poland Apixaban Sandoz
Romania Apixaban Sandoz 2.5 mg comprimate filmate
Slovakia Apixaban Sandoz 2.5 mg filmom obalené tablety