Package leaflet: Information for the user

AVASSAN 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Avassan is and what it is used for
What you need to know before taking Avassan
How to take Avassan
Possible side effects
How to store Avassan
Contents of the pack and other information

1. What Avassan is and what it is used for

Avassan contains apixaban as the active substance and belongs to a group of medicines called
anticoagulants. This medicine helps prevent blood clots by blocking factor Xa, which is an important
component in the blood clotting process.
Avassan is used in adults:

to prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break off and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (also known as systemic embolism). Stroke can be life-threatening and requires immediate medical attention.
to treat blood clots in the 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.

Avassan 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 the veins or in the blood vessels of the lungs.
The recommended dose adjusted to body weight is given in section 3.
2. What you need to know before taking Avassan
Do not take Avassan if

you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
you have active bleeding,
you have a disease of an organ that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer in the stomach or intestine, recently diagnosed bleeding into the brain),
you have liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
you are 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 this 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 taking Avassan, talk to your doctor, pharmacist or nurse if you have any of the following conditions:

increased risk of bleeding, for example:
bleeding disorders, including conditions resulting in reduced platelet activity,
very high blood pressure not controlled by medication,
if you are over 75 years of age,
if your body weight is 60 kg or less,
severe kidney disease or if you are on dialysis,
if you currently have or have had liver disease in the past,
This medicine should be used with caution in patients showing signs of impaired liver function,
if you have a heart valve prosthesis,
if your doctor determines that your blood pressure is unstable or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to be especially careful when taking Avassan

if you have a condition called antiphospholipid syndrome (an immune system disorder causing increased risk of clots), you should inform your doctor, who will decide whether your treatment needs to be changed.

If you need to undergo surgery or a procedure that may involve bleeding, your doctor may ask you to
temporarily stop taking this medicine for a short time. If you are not sure whether a procedure may cause
bleeding, ask your doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.
Avassan and other medicines
Tell your doctor, pharmacist or nurse about all medicines you are currently taking, have recently taken or
plan to take.
Some medicines may enhance the effect of Avassan, while others may reduce its effect. Your doctor will
decide whether you should take Avassan while taking other medicines and how you should be monitored.
The following medicines may enhance the effect of Avassan and increase the risk of unwanted bleeding:

some medicines used to treat fungal infections (e.g. itraconazole, voriconazole, posaconazole and others)
some medicines used to treat Cushing's syndrome (e.g. ketoconazole) when the body produces excess cortisol
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 medicines (e.g. acetylsalicylic acid or naproxen), especially if you are over 75 years of age and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding
medicines used for high blood pressure or heart conditions (e.g. diltiazem)
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce Avassan's ability to prevent 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
you should consult your doctor, pharmacist or nurse before taking this medicine.
The effect of Avassan during pregnancy and on the unborn child is unknown. You must not take this
medicine during pregnancy. If you become pregnant while taking this medicine, you should
contact your doctor immediately.
It is not known whether Avassan passes into human milk. Before taking this medicine during
breastfeeding, consult your doctor, pharmacist or nurse. You may be advised to stop breastfeeding or to stop/avoid starting this medicine.
Driving and using machines
Avassan has not been shown to affect the ability to drive or operate machinery.
Avassan contains lactose (a type of sugar) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered to be “sodium-free”.

3. How to take Avassan

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. Avassan may be taken independently 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 with their doctor about alternative ways of taking Avassan. The tablet may be crushed immediately before administration and mixed with water or a 5% aqueous glucose solution, fruit juice, or apple puree.
Instructions for crushing tablets:

Crush the tablet with a pestle in a mortar.
Carefully transfer the entire 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 prepare a mixture.
Swallow (drink) the resulting mixture.
Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinsing liquid.

If necessary, a doctor may administer crushed Avassan tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Avassan should be taken as directed for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one Avassan 5 mg tablet twice daily.
The recommended dose is one Avassan 2.5 mg tablet twice daily if:

the patient has severe renal impairment
two or more of the following conditions are met:
laboratory test results suggest reduced kidney function (serum creatinine level ≥1.5 mg/dL [133 micromoles/L])
the patient is aged 80 years 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 legs and blood clots in blood vessels of the lungs
The recommended dose is two Avassan 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 Avassan 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Avassan 2.5 mg tablet twice daily, for example, one tablet 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 recurrence of blood clots in veins or in 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 Avassan depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two Avassan 5 mg tablets, administered 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 Avassan 5 mg tablet, administered 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 with changes in the patient's body weight.
The doctor may change anticoagulant treatment as follows:

Switching from Avassan to other anticoagulant medicines Discontinue taking Avassan. Start anticoagulant treatment (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from other anticoagulant medicines to Avassan Discontinue taking anticoagulant medicines. Begin Avassan treatment at the time the next dose of anticoagulant medicine was scheduled, then continue taking it as usual.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Avassan Discontinue the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient when to start taking Avassan.
Switching from Avassan to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If the doctor advises the patient to start taking a vitamin K antagonist medicine, continue taking Avassan for at least 2 days after taking the first dose of the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient when to stop taking Avassan.

Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by the doctor to prevent formation of blood clots in blood vessels of the brain and other parts of the body.
Taking more Avassan than recommended
If a patient takes more Avassan than recommended, they should immediately inform their doctor. Bring the medicine packaging, even if no tablets remain.
If a patient takes more than the recommended dose of Avassan, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effects of factor Xa inhibition may be necessary.
Missing a dose of Avassan

If a morning dose is missed, take it as soon as remembered, and it may be taken together with 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 Avassan
Do not stop taking this medicine without consulting a doctor, as stopping treatment prematurely may increase the risk of blood clots.
If there are any further questions about use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The most common general adverse reaction 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 Avassan 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 eyes;
into the stomach or intestine;
from the rectum;
presence of blood in urine;
from the nose;
from the gums;
subcutaneous haemorrhage (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 adverse reactions (may occur in up to 1 in 100 people)

Bleeding:
into the brain or spinal canal;
in the mouth or presence of blood in sputum when coughing;
in the abdominal cavity or from the vagina;
presence of bright red blood in stool;
bleeding occurring after surgery, including subcutaneous haemorrhage (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 substance formed from the breakdown 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 difficulty breathing. If any of these symptoms occur, seek medical advice immediately.

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

Bleeding:
into the lungs or
throat;
into the retroperitoneal space (area at the back of the abdominal cavity);
into muscles.

Very rare adverse reactions (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)

Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or subcutaneous haemorrhages (bruising).

The following adverse reactions may occur when taking Avassan for the
treatment or prevention of recurrent blood clots in the legs and blood clots
in 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;
presence of blood in urine;
subcutaneous haemorrhage (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 blood clotting);
Nausea (feeling sick);
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 presence of blood in sputum when coughing;
presence of bright red blood in stool;
test results indicating blood in stool or urine;
bleeding occurring after surgery, including subcutaneous haemorrhage (bruising) and swelling, leakage of blood or fluid from the 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 difficulty breathing. If any of these symptoms occur, seek medical advice immediately;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a substance formed from the breakdown of red blood cells, which may cause yellowing of the skin and eyes.

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

Bleeding:
into the brain or spinal canal;
into 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 );
Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or subcutaneous haemorrhages (bruising).

Additional adverse reactions in children and adolescents
If any of the following symptoms occur, seek medical advice immediately:

Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and difficulty breathing. 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 Avassan
were similar to those seen in adults and were mostly mild to moderate in severity. Adverse reactions more commonly reported in children and adolescents include nosebleeds and unusual 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;
presence of blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
postoperative bleeding, 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 (which may affect blood clotting);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat in the child;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased alanine aminotransferase (AlAT) activity.

Frequency not known (cannot be estimated from available data)

Bleeding
into the abdominal cavity or retroperitoneal space;
into the stomach;
into the eyes;
in the mouth;
from haemorrhoids;
in the mouth or presence of blood in sputum when coughing;
into the brain or spinal canal;
into the lungs;
into muscles;
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, round spots beneath the skin surface or subcutaneous haemorrhages (bruising);
Blood test results may indicate:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in stool or urine.

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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store AVASSAN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Avassan contains
The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other components are:

Tablet core: lactose monohydrate [see section 2 "Avassan contains lactose (a type of sugar) and sodium"], microcrystalline cellulose, sodium croscarmellose [see section 2 "Avassan contains lactose (a type of sugar) and sodium"], sodium lauryl sulfate, povidone, magnesium stearate (E 470b),
Coating: lactose monohydrate [see section 2 "Avassan contains lactose (a type of sugar) and sodium"], hypromellose (E 464), titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Avassan looks like and contents of the pack
Oval, film-coated tablets, pale pink to pink in colour, approximately 10 mm in length and 5 mm in width, with the imprint "A3" on one side and plain on the other.

Avassan, film-coated tablets in blisters made of Aluminium/PVC/PVDC foil, packed in cardboard boxes containing 10, 20, 60, 100 and 200 tablets.
Avassan, film-coated tablets in perforated blisters made of Aluminium/PVC/PVDC foil, packed in cardboard boxes containing 10x1, 20x1, 60x1, 100x1 and 200x1 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75
Manufacturer/Importer
Terapia SA
124 Fabricii Street
400632, Cluj-Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH, Hoofddorp
The Netherlands
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Patient Warning Card: information on use
Inside the Avassan packaging, alongside the patient leaflet, there is a Patient Warning Card, or the treating physician may provide the patient with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Avassan.
You should always carry this card with you.

Take the card.
If necessary, separate the appropriate language section (facilitated by perforated edges).
Complete the following sections or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ........ mg twice daily
- Doctor's name:
- Doctor's telephone number:
Fold the card and always keep it with you.