Fydoco

Poland
Brand name Fydoco
Form tablets, film-coated
Active substance / Dosage
apixaban · 5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100487521
Manufacturer Mylan Germany GmbH, Mylan Hungary Ltd.

Table of Contents

Package leaflet: Information for the user

Fydoco, 5 mg, coated tablets
apixaban
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

  • Keep this leaflet, as you may need to read it again.
  • If you have any 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 other people, 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.

Leaflet contents

  1. What Fydoco is and what it is used for
  2. What you need to know before taking Fydoco
  3. How to take Fydoco
  4. Possible side effects
  5. How to store Fydoco
  6. 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 known as anticoagulants.
This medicine helps prevent blood clots by inhibiting Factor Xa, which is an important component in the blood clotting process.
Fydoco 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 may break off and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (known as systemic embolism). Stroke can 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), as well as 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 to prevent recurrence of blood clots in veins or in the blood vessels of the lungs.
The recommended dose adjusted to 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 stomach or intestinal ulcer, 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 situations of 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 starting treatment, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

  • increased risk of bleeding, for example:
    • conditions associated with bleeding, including those resulting in reduced platelet activity,
    • very high blood pressure not controlled by medication,
    • if the patient is over 75 years of age,
    • if the patient'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 showing signs of impaired liver function,
  • 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 treatment needs to be changed. 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 time. If in doubt whether a given procedure may cause bleeding, ask the doctor.

Children and adolescents
This medicine is not recommended for use in children and adolescents weighing less than 35 kg.
Fydoco 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 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 conditions (e.g. diltiazem)
  • antidepressants known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce Fydoco's ability 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 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 her doctor immediately.
It is not known whether Fydoco passes into human milk. Consult your 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 operating machinery
No effects of Fydoco on the ability to drive or operate machinery have been observed.
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 the 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 directed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Fydoco can be taken independently of meals.
To achieve the best 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 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 Fydoco tablets mixed with 60 mL of water or
5% aqueous glucose solution via a nasogastric tube.
Fydoco 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 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 suggest reduced kidney function (serum creatinine concentration is 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 legs and blood clots in 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.
The doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in 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 outcome, try to take or administer the dose 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 body weight of at least 35 kg is two
Fydoco 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 Fydoco 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
due to changes in the patient’s body weight.
The doctor may change anticoagulant treatment as follows:

  • Switching from Fydoco to other anticoagulant medicines Discontinue taking Fydoco. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
  • Switching from other anticoagulant medicines to Fydoco Discontinue taking other anticoagulant medicines. Begin treatment with Fydoco at the time the next dose of the anticoagulant medicine was scheduled, then continue taking it as usual.
  • Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Fydoco Discontinue the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient when to start taking Fydoco.
  • Switching from Fydoco 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 Fydoco for at least 2 days after the first dose of the vitamin K antagonist medicine. The doctor will order blood tests and inform the patient 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 the times specified by the doctor to prevent formation of blood clots in brain vessels and other blood vessels in the body.
Taking more than the recommended dose of Fydoco
If a patient has taken more than the recommended dose of Fydoco, they should immediately inform
their doctor. Bring the medicine packaging, even if no tablets remain.
If a patient has taken more than the recommended dose of this medicine, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect directed against factor Xa may be necessary.
Missing a dose of Fydoco

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The most common general side effect with this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.

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

  • Bleeding, including:
    • into the eyes;
    • into the stomach or intestine;
    • from the rectum;
    • blood in the urine;
    • from the nose;
    • from the gums;
    • bruising (subcutaneous haemorrhage) 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-glutamyltransferase (GGT) activity.

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

  • Bleeding:
    • into the brain or spinal canal;
    • in the mouth or presence of blood in coughed-up phlegm;
    • in the abdominal cavity or from the vagina;
    • bright red blood in the stool;
    • bleeding following surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from the surgical incision/wound site (wound discharge) or injection site;
    • from haemorrhoids;
    • blood in stool or urine detected in laboratory tests;
  • Decreased platelet count in the blood (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 (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 side effects (may occur in up to 1 in 1,000 people)

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

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

  • Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

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

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

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

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

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

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
    • into the eyes;
    • in the mouth or presence of blood in coughed-up phlegm;
    • bright red blood in the stool;
    • test results indicating blood in stool or urine;
    • bleeding following surgery, including bruising (subcutaneous haemorrhage) 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 (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;
    • increased bilirubin levels – a substance formed from the breakdown of red blood cells, which may cause yellowing of the skin and eyes.

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

  • Bleeding:
    • into the brain or spinal canal;
    • into the lungs.

Frequency not known (cannot be estimated from available data)

  • Bleeding:
    • into the abdominal cavity or retroperitoneal space (area behind the abdominal cavity);
  • Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or bruising (subcutaneous haemorrhages).
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant drug-related nephropathy).

Additional side effects in children and adolescents
If any of the following symptoms occur, immediately
inform your doctor:

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

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

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

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

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

  • Bleeding, including:
    • from the gums;
    • blood in the urine;
    • bruising (subcutaneous haemorrhages) and swelling;
    • from the intestine or rectum;
    • bright red blood in the stool;
    • postoperative bleeding, including bruising (subcutaneous haemorrhages) 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 the blood (which may affect 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 coughed-up phlegm;
    • 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 bruising (subcutaneous haemorrhages);
  • Blood test results may indicate:
    • increased gamma-glutamyltransferase (GGT) activity;
    • presence of blood in stool or urine;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant drug-related nephropathy).

Reporting of side effects
If any side effects occur, including any not listed
in this leaflet, tell your doctor, pharmacist or nurse. Side effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Fydoco

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

6. Contents of the pack and other information

What Fydoco contains

  • The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
  • The other components are:
    • Tablet core: lactose (see section 2), microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.
    • Coating: hypromellose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

What Fydoco looks like and contents of the pack
The film-coated tablets are brown, oval (approximately 6.2 x 10.2 mm), biconvex (curved outward on both sides), with bevelled edges, and marked with "X5" on one side and "M" on the other side.
Fydoco is available in:

  • Blister packs contained in cardboard boxes of 10, 20, 56, 60, 100, 168 or 200 film-coated tablets, or
  • Unit dose divisible blisters in cardboard boxes of 10 x 1, 20 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 200 x 1 film-coated tablets, or
  • Bottles containing 60, 180 or 200 film-coated tablets.

Not all pack sizes may be marketed.
Patient Warning Card: information for users
The packaging contains a Patient Warning Card, or your physician may provide you with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Fydoco. You should always carry this card with you.
You should 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 for marketing in the European Economic Area under the following names:
Croatia Fydoco 5 mg filmom obložene tablete
Finland Fydoco
Poland Fydoco
Romania Fydoco 5 mg comprimate filmate
Slovenia Fydoco 5 mg filmsko obložene tablete
Spain Fydoco 5 mg comprimidos recubiertos con película EFG
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00