Package leaflet: Information for the user

Fydoco, 2.5 mg, coated tablets
apixaban
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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Fydoco is and what it is used for

Fydoco contains the active substance apixaban 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.
Fydoco is used in adults:

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

Fydoco 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.
The recommended dose adjusted for body weight is given in section 3.

2. Important information before using Fydoco

When not to use Fydoco

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 severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently experienced bleeding into the brain),
if the patient has liver disease leading to an increased risk of bleeding (liver coagulopathy),
if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in the case of switching anticoagulant therapy, when a venous or arterial access 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 the 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 activity,
- very high blood pressure not controlled with medication,
- if the patient is over 75 years of age,
- if the patient's body weight is 60 kg or less,
severe kidney disease or if the patient is on dialysis,
liver disease or history of liver disease. This medicine should be used with caution in patients with signs of impaired liver function.
a spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after removal of the catheter,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Fydoco

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

If surgery or a procedure that may involve bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may cause bleeding, ask the doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.
Fydoco and other medicines
Tell the 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 use.
Some medicines may enhance the effect of Fydoco, while others may reduce its effect. The doctor will decide whether the patient should receive Fydoco while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Fydoco and increase the risk of unwanted bleeding:

certain medicines used to treat fungal infections (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), 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 disease (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 Fydoco 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 a doctor, pharmacist or nurse before using this medicine.
The effect of Fydoco 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 the doctor immediately.
It is not known whether Fydoco passes into human milk. Consult a doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.
Driving and using machines
Fydoco has not been shown to affect the ability to drive or operate machinery.
Fydoco contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Fydoco

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any
doubts, consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Fydoco can be taken independently of meals. For optimal
treatment results, it is recommended to take the tablets at the same time each day.
If a patient has difficulty swallowing the tablets whole, they should discuss alternative methods of
taking Fydoco with their doctor. The tablet may be crushed immediately before administration and
mixed with water or a 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:

Crush the tablet with a pestle in a mortar.
Carefully transfer the entire 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 prepare a mixture.
Swallow (drink) the resulting mixture.
Rinse the pestle and mortar used to crush the tablet, 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, the doctor may administer crushed Fydoco tablets mixed with 60 mL of water or 5%
aqueous glucose solution via a nasogastric tube.
Fydoco should be taken as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Fydoco 2.5 mg tablet twice daily. For example, one tablet in the
morning and one in the evening.
The first tablet should be taken 12 to 24 hours after surgery.
If the patient underwent major hip surgery, they will usually take the tablets for 32 to 38 days. If the
patient underwent major knee surgery, they will usually take the tablets for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional
risk factor
The recommended dose is one Fydoco 5 mg tablet twice daily.
The recommended dose is one Fydoco 2.5 mg tablet twice daily if:

the patient has severe renal impairment,
two or more of the following conditions are met:
- blood test results indicate 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. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the legs and blood clots in the blood vessels of the lungs
The recommended dose is two Fydoco 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 Fydoco 5 mg tablet twice daily, for example, one tablet
in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one Fydoco 2.5 mg tablet twice daily, for example, one tablet in the
morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels of
the lungs.
This medicine should always be taken or administered as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcome, the dose should be taken or administered at the same time
each day.
The dose of Fydoco depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four
Fydoco 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 Fydoco 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 with
changes in the patient's body weight.
Your doctor may change anticoagulant therapy as follows:

Switching from Fydoco to other anticoagulant medicines Discontinue Fydoco. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next dose of Fydoco was scheduled.
Switching from other anticoagulant medicines to Fydoco Discontinue anticoagulant medicines. Start Fydoco at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
Switching from anticoagulant therapy with a vitamin K antagonist (e.g., warfarin) to Fydoco Discontinue the vitamin K antagonist medicine. Your doctor will order blood tests and inform you when to start taking Fydoco.
Switching from Fydoco to anticoagulant therapy with a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Fydoco for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will order blood tests and inform you when to stop taking Fydoco.

Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should
take this medicine at times specified by their doctor to prevent blood clots in the brain's blood
vessels and other blood vessels in the body.
Taking more Fydoco than recommended
If a patient has taken more than the recommended dose of this medicine, contact your doctor
immediately. Bring the medicine packaging with you, even if no tablets remain.
If a patient has taken more than the recommended dose of Fydoco, the risk of bleeding may increase.
In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse the effect
targeted against factor Xa may be required.
Missing a dose of Fydoco

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 recommended, twice daily.

If you have any doubts about taking the medicine or if more than one dose is missed, consult your
doctor, pharmacist, or nurse.
Stopping Fydoco
Do not stop taking this medicine without consulting your doctor, as stopping Fydoco prematurely may
increase the risk of blood clots.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible adverse effects

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

The following adverse effects may occur when taking Fydoco 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)

Reduced platelet count (which may affect blood clotting);
Bleeding:
- occurring 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 or intestines, or presence of bright red blood in stool;
- blood in urine;
- nosebleeds;
- vaginal bleeding;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Blood test results may indicate:
- liver function abnormalities;
- increased activity of certain liver enzymes;
- increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes (jaundice);
Itching.

Rare adverse 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 presence of blood in coughed-up sputum;
- from the rectum;
Hair loss.

Frequency not known (cannot be estimated from available data)

Bleeding:
- into the brain or spinal cord;
- into 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 centre 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 (haematomas).
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant drug administration).

The following adverse effects may occur when taking Fydoco 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 eyes;
- into the stomach or intestines;
- from the rectum;
- blood in urine;
- nosebleeds;
- from gums;
- bruising (haematoma) 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 cord;
- in the mouth or presence of blood in coughed-up sputum;
- into the abdominal cavity or from the vagina;
- bright red blood in stool;
- occurring after surgery, including bruising (haematoma) 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 clotting);
- Blood test results may indicate:
liver function abnormalities;
increased activity of certain liver enzymes;
increased bilirubin levels – a product formed from breakdown of red blood cells, which may cause yellowing of the skin and eyes (jaundice);
- 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 adverse effects (may occur in up to 1 in 1,000 people)

Bleeding:
- into 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, which may develop blisters and resembles small target-like lesions (dark spots in the centre 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 (haematomas).
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant drug administration).

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

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

Bleeding, including:
- nosebleeds;
- from gums;
- blood in urine;
- bruising and swelling;
- from stomach, intestines, rectum;
- in the mouth;
- vaginal bleeding;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect 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 presence of blood in coughed-up sputum;
- bright red blood in stool;
- test results indicating blood in stool or urine;
- occurring after surgery, including bruising (haematoma) 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 breathing difficulties. If any of these symptoms occur, seek immediate medical advice;
- Blood test results may indicate:
liver function abnormalities;
increased activity of certain liver enzymes;
increased bilirubin levels – a product formed from breakdown of red blood cells, which may cause yellowing of the skin and eyes (jaundice).

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

Bleeding:
- into the brain or spinal cord;
- 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 centre 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 (haematomas).
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (nephropathy associated with anticoagulant drug administration).

Additional adverse effects in children and adolescents
If any of the following symptoms occur, immediate medical advice must be sought:

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

In general, adverse effects observed in children and adolescents treated with Fydoco were similar
to those seen in adults and were mostly mild to moderate in severity. Adverse effects occurring
more frequently in children and adolescents include nosebleeds and unusual vaginal bleeding.

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

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

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

Bleeding, including:
- from gums;
- blood in urine;
- bruising (haematomas) and swelling;
- from intestines or rectum;
- bright red blood in stool;
- after surgery, including bruising (haematomas) 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 clotting);
- Nausea;
- Skin rash;
- Itching;
- Low blood pressure, which may cause fainting or rapid heartbeat in the child;
- Blood test results may indicate:
Liver function abnormalities;
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 coughed-up sputum;
- into the brain or spinal cord;
- into the lungs;
- into muscles;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the centre 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 (haematomas);
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 (nephropathy associated with anticoagulant drug administration).

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 of 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Fydoco medicine

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

6. Contents of the packaging and other information

What Fydoco contains

The active substance is apixaban. Each coated tablet contains 2.5 mg of apixaban.
The other ingredients are:
- Tablet core: lactose (see section 2), microcrystalline cellulose, sodium lauryl sulphate, sodium croscarmellose, magnesium stearate.
- Coating: hypromellose, polyethylene glycol, sodium lauryl sulphate, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

What Fydoco looks like and contents of the pack
The coated tablets are brown, round (approximately 6.4 mm in diameter), biconvex (curved outward on both sides), with bevelled edges, and marked with "X2" on one side and "M" on the other.
Fydoco is available in:

blisters in cardboard boxes containing 10, 20, 56, 60, 100, 168 or 200 coated tablets, or
unit-dose blister packs in cardboard boxes containing 10 x 1, 20 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 200 x 1 coated tablets, or
bottles containing 60, 180 or 200 coated tablets.

Not all pack sizes may be marketed.
Patient Alert Card: information for use
This package contains a Patient Alert Card or your physician may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and serves as a warning to other physicians that the patient is taking Fydoco. You should always carry this card with you.
Please cut the card from the packaging and complete the following sections or ask your doctor to complete them:

Name:
Date of birth:
Indication:
Child's body weight:
Dose: ........ mg twice daily
Physician's name:
Physician's telephone number:

You should always carry this card with you.
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer/Importer
Mylan Hungary Kft.
Mylan utca 1
2900 Komárom
Hungary
Mylan Germany GmbH
Benzstrasse 1
61352 Bad Homburg
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Croatia Fydoco 2.5 mg film-coated tablets
Finland Fydoco
Poland Fydoco
Romania Fydoco 2.5 mg film-coated tablets
Slovenia Fydoco 2.5 mg filmsko obložene tablete
Spain Fydoco 2.5 mg comprimidos recubiertos con película EFG
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00