Package leaflet: Information for the user

Zelinared, 5 mg, film-coated tablets
Apixabanum
Please read the entire leaflet carefully 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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

What Zelinared is and what it is used for
Important information before taking Zelinared
How to take Zelinared
Possible side effects
How to store Zelinared
Contents of the pack and other information

1. What Zelinared is and what it is used for

Zelinared contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent blood clots by inhibiting factor Xa, an important component in the blood clotting process.
Zelinared 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 loose 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 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.

Zelinared 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 pulmonary blood vessels.
The recommended dose adjusted to body weight is provided in section 3.

2. Important information before using Zelinared

When not to use Zelinared

if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
if the patient has active bleeding,
if the patient has a disease of an organ that increases the risk of severe bleeding (such as active or recently diagnosed stomach or intestinal ulcer, recent intracranial haemorrhage),
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 a venous or arterial access 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 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 showing symptoms of liver dysfunction.
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 special caution when using Zelinared

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

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

certain antifungal medicines (e.g. ketoconazole and others)
certain antiviral medicines used to treat HIV/AIDS (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)
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Zelinared to prevent blood clots:

antiepileptic medicines (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 Zelinared 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 Zelinared passes into human breast milk. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine.
Driving and operating machinery
No effects of Zelinared on the ability to drive and operate machinery have been observed.
Zelinared contains lactose (a type of sugar) and sodium
If the patient has been previously 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; therefore, this medicine is considered “sodium-free”.

3. How to take Zelinared

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any doubts,
please consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Zelinared may be taken regardless 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 the tablets whole, they should discuss alternative methods of taking
Zelinared 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 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 and the container with a small amount of water or another liquid (e.g., 30 mL), then swallow (drink) the rinsing liquid.

If necessary, your doctor may administer crushed Zelinared tablets mixed with 60 mL of water or
5% aqueous glucose solution via a nasogastric tube.
Zelinared should be taken as recommended in 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 tablet of Zelinared 5 mg twice daily.
The recommended dose is one tablet of Zelinared 2.5 mg 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 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. 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 tablets of Zelinared 5 mg 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 tablet of Zelinared 5 mg 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 tablet of Zelinared 2.5 mg 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 recurrence of 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, please 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 Zelinared 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 two tablets
of Zelinared 5 mg , 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 tablet of Zelinared 5 mg ,
administered twice daily, for example, one in the morning and one in the evening.
For parents and caregivers: please observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor visits, as changes in body weight may require dose adjustment.
Your doctor may change anticoagulant treatment as follows:

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

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 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 Zelinared
If a patient has taken more than the recommended dose of this medicine, you should 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 Zelinared, 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 may be necessary.
Missing a dose of Zelinared

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 Zelinared 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;
blood in the 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 show:
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;
bright red blood in the stool;
bleeding 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;
Decrease in blood platelet count (which may affect blood clotting);
Blood test results may show:
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 breathing difficulties. If any of these symptoms occur, contact your doctor 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 behind 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 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 subcutaneous haemorrhages (bruising).

The following adverse reactions may occur when taking Zelinared for the
treatment or prevention of recurrent blood clots in the leg veins 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;
blood in the urine;
subcutaneous haemorrhage (bruising) and swelling;
from the stomach, intestines, or rectum;
in the mouth;
from the vagina;
Anaemia, which may cause fatigue or paleness;
Decrease in blood platelet count (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Blood test results may show:
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;
bright red blood in the stool;
test results indicating blood in stool or urine;
bleeding 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 breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
Blood test results may show:
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 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 subcutaneous haemorrhages (bruising).

Additional adverse reactions 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 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 Zelinared
were similar to those seen in adults and were mostly mild to moderate in severity.
Adverse reactions occurring more frequently 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;
blood in the urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in the 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;
Decrease in platelet count (which may affect clotting);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat in children;
Blood test results may show:
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 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 subcutaneous haemorrhages (bruising);
Blood test results may show:
increased gamma-glutamyl transferase (GGT) activity;
presence of blood in faeces or urine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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 .
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 Zelinared

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 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. This will help protect the environment.

6. Contents of the pack and other information

What Zelinared contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other ingredients are:
Tablet core: lactose, microcrystalline cellulose with silica (microcrystalline cellulose and colloidal anhydrous silica), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b)
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).

See section 2 "Zelinared contains lactose (a type of sugar) and sodium".

What Zelinared looks like and contents of the pack
Pink to dark pink, round, biconvex film-coated tablets. Tablet dimensions:
diameter approx. 8.0 mm, height approx. 3.6 mm.
Zelinared is available in cardboard boxes. Each cardboard box contains 6 blisters made of PVC/PVDC/Aluminium, each blister containing 10 tablets.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the following European Economic Area countries under the following names:
Czech Republic, Estonia, Poland, Slovakia: Zelinared