Zelinared

Leaflet accompanying the packaging: information for the user

Zelinared, 2.5 mg, film-coated tablets

Apixaban

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Zelinared and what is it used for
• 2. Important information before taking Zelinared
• 3. How to take Zelinared
• 4. Possible side effects
• 5. How to store Zelinared
• 6. Contents of the pack and other information

1. What is Zelinared and what is it used for

Zelinared contains the active substance apixaban and belongs to a group of so-called anticoagulant medicines. This medicine helps prevent the formation of blood clots by blocking factor Xa, which is an important element in the blood clotting process.

Zelinared is used in adults:

• to prevent the formation of blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, the patient may be at increased risk of developing blood clots in the legs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the leg to the lungs, it can block blood flow through the lungs, causing shortness of breath with chest pain or without. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
• to prevent the formation of blood clots in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and move to the brain, leading to a stroke, or to other organs, hindering blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), as well as to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Zelinared is used in children from 28 days to less than 18 years of age to treat and prevent the recurrence of blood clots in the veins or in the blood vessels of the lungs. The recommended dose, adjusted for body weight, is found in section 3.

2. Important information before taking Zelinared

When not to take 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 excessive bleeding,
• if the patient has an organ disease that increases the risk of severe bleeding (such as an active or recently diagnosed stomach or intestinal ulcer, recent bleeding into the brain),
• if the patient has liver disease that leads to an increased risk of bleeding (hepatic coagulopathy),
• if the patient is taking medicines that prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in situations where the anticoagulant treatment is changed, when a venous or arterial access line is inserted in the patient and heparin is administered through this line to maintain its patency or when the patient is undergoing catheter ablation (a catheter is inserted into their vein) due to irregular heart rhythm (arrhythmia).

Warnings and precautions

Before starting treatment, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• increased risk of bleeding, such as:
• bleeding disorders, including those that result in decreased platelet activity,
• very high blood pressure, uncontrolled with medication,
• if the patient is over 75 years old,
• if the patient's body weight is 60 kg or less,
• severe kidney disease or if the patient is on dialysis,
• liver disease or a history of liver disease.
• This medicine should be used with caution in patients with signs of liver dysfunction.
• a tube (catheter) or injection into the spine (anesthetic or pain-relieving), in which case the doctor will recommend taking this medicine after 5 or more hours after the catheter is removed,
• 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 surgery is planned to remove a blood clot from the lungs.

When to exercise special caution when taking Zelinared

• if the patient has a disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform the doctor, who will decide on possible changes to the treatment.

In case of surgery or a procedure that may be associated with bleeding, the doctor may ask the patient to temporarily stop taking this medicine for a short time. If there is any uncertainty about whether a given procedure may cause bleeding, the patient should ask their doctor.

Children and adolescents

This medicine is not recommended for use in children and adolescents with a body weight below 35 kg.

Zelinared and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may enhance the effect of Zelinared, and some may weaken its effect. The doctor will decide whether the patient should receive Zelinared while taking other medicines and how closely they should be monitored.

The following medicines may enhance the effect of Zelinared 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 (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 old and taking acetylsalicylic acid, may be at increased risk of unwanted bleeding
• medicines used to treat high blood pressure or heart disease (e.g., diltiazem)
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

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

• medicines used to prevent seizures or convulsions (e.g., phenytoin and others)
• St. John's wort (a herbal supplement used in depression)
• medicines used to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking 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, they should contact their doctor immediately. It is not known whether Zelinared passes into human milk. Before taking this medicine while breastfeeding, the patient should consult their doctor, pharmacist, or nurse. The patient may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

It has not been found that Zelinared affects the ability to drive and use machines.

Zelinared contains lactose (a type of sugar) and sodium

If the patient has previously been found to have intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Zelinared

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Dose

The tablet should be swallowed with water. Zelinared can be taken with or without food. To achieve the best treatment results, it is recommended to take the tablets at the same time every day. If the patient has problems swallowing the tablets whole, they should talk to their doctor about other ways to take Zelinared. The tablet can be crushed just before taking and mixed with water or 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 then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid mentioned above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablets and the container with a small amount of water or another liquid (e.g., 30 mL) and then swallow (drink) the rinse liquid.

If necessary, the doctor may administer a crushed Zelinared tablet mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube.

Zelinared should be taken as recommended in the following indications:

Prevention of blood clot formation after hip or knee replacement surgery The recommended dose is one Zelinared 2.5 mg tablet twice a day. 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 has undergone major hipsurgery, they will usually take the tablets for 32 to 38 days. If the patient has undergone major kneesurgery, they will usually take the tablets for 10 to 14 days. Prevention of blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor The recommended dose is one Zelinared 5 mgtablet twice a day. The recommended dose is one Zelinared 2.5 mgtablet twice a day if:

• the patient has severe kidney dysfunction,
• two or more of the following conditions are met:
• the patient's blood test results suggest decreased kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L) or higher),
• the patient is 80 years old or older,
• the patient's body weight is 60 kg or less.

The recommended dose is one tablet twice a day, for example, one tablet in the morning and one in the evening. The doctor will decide how long to continue treatment. Treatment of blood clots in the legs and blood clots in the blood vessels of the lungs The recommended dose is twoZelinared 5 mgtablets twice a day for the first 7 days, for example, two tablets in the morning and two in the evening. After 7 days, the recommended dose is oneZelinared 5 mgtablet twice a day, for example, one tablet in the morning and one in the evening. Prevention of recurrence of blood clots after completing 6 months of treatment The recommended dose is one Zelinared 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening. The doctor will decide how long to continue treatment. Use in children and adolescents Treatment and prevention of recurrence of blood clots in the veins or in the blood vessels of the lungs. This medicine should always be taken or administered as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor, pharmacist, or nurse. To achieve the best treatment results, the dose should be taken or administered at the same time every day. The dose of Zelinared is dependent 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 fourZelinared 2.5 mgtablets, administered twice a day for the first 7 days, for example, four in the morning and four in the evening. After 7 days, the recommended dose is twoZelinared 2.5 mgtablets, administered twice a day, for example, two in the morning and two in the evening. For parents and caregivers: it is essential to observe the child to ensure they have taken the full dose. It is crucial to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

The doctor may change the anticoagulant treatment as follows:

• Switching from Zelinared to other anticoagulant medicinesThe patient should stop taking Zelinared. Treatment with other anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next Zelinared tablet.
• Switching from other anticoagulant medicines to ZelinaredThe patient should stop taking other anticoagulant medicines. Treatment with Zelinared should be started at the time of the scheduled intake of the next dose of the other anticoagulant medicine and then continue with the usual intake of Zelinared.
• Switching from treatment with a vitamin K antagonist (e.g., warfarin) to ZelinaredThe patient should stop taking the vitamin K antagonist. The doctor will order blood tests and inform the patient when to start taking Zelinared.
• Switching from Zelinared to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor recommends that the patient start taking a vitamin K antagonist, they should continue taking Zelinared for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor will order blood tests and inform the patient when to stop taking Zelinared.

Patients undergoing cardioversion

Patients with irregular heart rhythm who require cardioversion to restore a 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.

Taking a higher dose of Zelinared than recommended

If the patient has taken a higher dose of this medicine than recommended, they should contact their doctor immediately. The patient should take the packaging of the medicine with them, even if there are no more tablets left. If the patient has taken a higher dose of Zelinared than recommended, they may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of factor Xa inhibition may be necessary.

Missing a dose of Zelinared

• If the patient misses a morning dose, they should take it as soon as they remember and can take it together with the evening dose.
• A missed evening dose can only be taken on the same evening. The patient should not take two doses the next morning, but instead continue taking the medicine the next day as recommended, twice a day.

In case of doubts about taking the medicine or missing more than

one dose, the patient should consult their doctor, pharmacist, or nurse.

Stopping treatment with Zelinared

The patient should not stop taking this medicine without consulting their doctor, as the risk of blood clot formation may be higher if treatment with Zelinared is stopped prematurely. In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Zelinared can cause side effects, although not everybody gets them. Zelinared can be used in three different medical conditions. The known side effects and their frequency may vary in each of these medical conditions and are listed separately below. In these conditions, the most common overall side effect of this medicine is bleeding, which can potentially be life-threatening and may require immediate medical attention.

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

• Anemia, which can cause fatigue or pallor;
• Bleeding, including:
• bruises and swelling;
• Nausea (vomiting).

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

• Decreased platelet count in the blood (which can affect blood clotting);
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from the stomach, intestines, or rectum;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Itching.

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

• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. In case of any of these symptoms, the patient should contact their doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and presence of blood in sputum when coughing;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or the space behind the abdominal cavity;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round spots under the skin surface, or bruising.

The following side effects may occur when taking Zelinared to prevent blood clot formation in the heart in patients with irregular heart rhythm and at least one additional risk factor.

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

• Bleeding, including:
• into the eyes;
• from the stomach or intestines;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause fatigue or pallor;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (vomiting);
• 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 cord;
• into the mouth or presence of blood in sputum when coughing;
• into the abdominal cavity or from the vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• blood test results indicating blood in the stool or urine;
• Decreased platelet count in the blood (which can affect blood clotting);
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. In case of any of these symptoms, the patient should contact their doctor immediately.

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

• Bleeding:
• into the lungs or throat;
• into the space behind the abdominal cavity;
• into the muscle.

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

• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).

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

• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round spots under the skin surface, or bruising.

The following side effects may occur when taking Zelinared to treat or prevent the recurrence of blood clots in the legs and blood clots in the 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 and swelling;
• from the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) activity.

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

• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Bleeding:
• into the eyes;
• into the mouth or presence of blood in sputum when coughing;
• bright red blood in the stool;
• blood test results indicating blood in the stool or urine;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, as well as difficulty breathing. In case of any of these symptoms, the patient should contact their doctor immediately;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a product of red blood cell breakdown, which can cause yellowing of the skin and eyes.

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

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

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

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity.
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round spots under the skin surface, or bruising.

Additional side effects in children and adolescents If the patient experiences any of the following symptoms, they should immediatelyinform their doctor:

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

Generally, the side effects observed in children and adolescents treated with Zelinared were similar to those observed in adults and were mostly mild to moderate. Side effects that occurred more frequently in children and adolescents were 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 and swelling;
• from the intestines or rectum;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count in the blood (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can cause fainting or rapid heartbeat in the child;
• Blood test results may indicate:
• liver dysfunction;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding:
• into the abdominal cavity or the space behind the abdominal cavity;
• into the stomach;
• into the eyes;
• in the mouth;
• from hemorrhoids;
• in the mouth or presence of blood in sputum when coughing;
• into the brain or spinal cord;
• into the lungs;
• into the muscle;
• A skin rash, which can form blisters and resembles small targets (dark spots in the center surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of blood vessels), which can cause skin rash or raised, flat, red, round spots under the skin surface, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health: 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 authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Zelinared

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month stated. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 2.5 mg of apixaban.
• The other ingredients are:
• Tablet core: lactose, microcrystalline cellulose silanized (microcrystalline cellulose and silicon dioxide), croscarmellose sodium, 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

Brown-yellow, round, biconvex film-coated tablets. Tablet dimensions: diameter approximately 6.0 mm, height approximately 3.0 mm. Zelinared is available in cardboard boxes. Each cardboard box contains 6 blisters of PVC/PVDC/Aluminum foil, each containing 10 tablets.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Estonia, Poland, Slovakia: Zelinared Date of last revision of the leaflet:May 2025