Zelinared

Poland
Brand name Zelinared
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100490546
Manufacturer Farmak International Sp. z o.o.

Table of Contents

Package leaflet: Information for the user

Zelinared, 2.5 mg, coated tablets
Apixabanum
Please read this leaflet carefully before taking this medicine, as 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 them, even if their symptoms are the same.
  • If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

  1. What Zelinared is and what it is used for
  2. What you need to know 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 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 blocking factor Xa, an important component in the blood clotting process.

Zelinared 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 leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) may 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 off and travel to the brain, causing stroke, or to other organs, impairing blood flow 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 blood vessels of the lungs (pulmonary embolism), as well as to prevent recurrence of such blood clots in the veins of the legs and/or lungs.

Zelinared is also 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 blood vessels of the lungs.
The recommended dose adjusted for 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 is experiencing excessive bleeding,
  • if the patient has an organ disease that increases the risk of severe bleeding (such as active or recently diagnosed gastric or intestinal ulcer, recent intracranial bleeding),
  • if the patient has liver disease leading to an increased risk of bleeding (hepatic 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 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 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 disorders.
  • This medicine should be used with caution in patients with symptoms of impaired liver function.
  • spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after catheter removal,
  • if the patient has a heart valve prosthesis,
  • if the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Zelinared

  • if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform their 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 particular procedure may cause bleeding, consult the doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents weighing less than 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 its effectiveness. 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:

  • some medicines used to treat fungal infections (e.g. ketoconazole and others)
  • some antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir)
  • other medicines used to reduce blood clotting (e.g. enoxaparin and others)
  • anti-inflammatory or pain-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 and noradrenaline reuptake inhibitors.

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

  • antiepileptic medicines used to prevent seizures or convulsions (e.g. phenytoin and others)
  • St John's wort (a 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 plans to become pregnant, 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 milk. Consult your doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to stop or not start taking this medicine.
Driving and using machines
No effects of Zelinared on the ability to drive and use machines have been observed.
Zelinared contains lactose (a type of sugar) 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 tablet, meaning the 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 can be taken independently of meals.
To achieve the best treatment results, it is recommended to take the tablets at the same times each day.
If a patient has difficulty swallowing the tablets whole, they should discuss alternative ways 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 mortar and pestle.
  • Carefully transfer the entire powder into a suitable container, then mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or any other liquid listed above to prepare a mixture.
  • Swallow (drink) the resulting mixture.
  • Rinse the pestle, mortar, and container used for crushing the tablet 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 for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg Zelinared 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 has undergone major hip surgery, they will usually take tablets for 32 to 38 days.
If the patient has undergone major knee surgery, they will usually take 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 5 mg Zelinared tablet twice daily.
The recommended dose is one 2.5 mg Zelinared 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 5 mg Zelinared 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 5 mg Zelinared tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one 2.5 mg Zelinared 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 recurrence of blood clots in the veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as instructed 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 your doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four 2.5 mg Zelinared tablets, administered 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 2.5 mg Zelinared tablets, administered 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 changes in body weight may require dose adjustments.
Your doctor may change anticoagulant treatment as follows:

  • Switching from Zelinared to other anticoagulant medicines Discontinue taking Zelinared. Start anticoagulant treatment (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. Start Zelinared 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 Zelinared Discontinue the vitamin K antagonist 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 medicine, continue taking Zelinared for at least 2 days after taking the first dose of the vitamin K antagonist 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 their doctor to prevent blood clots in the brain's blood vessels and in other blood vessels of the body.
Taking more Zelinared 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 Zelinared, there may be an increased risk of bleeding. 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 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, consult your doctor, pharmacist, or nurse.
Stopping Zelinared
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 doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Zelinared can be used for three different medical conditions. Known side 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
side effect of this medicine is bleeding, which may potentially be life-threatening
and may require immediate medical attention.

The following side effects may occur when taking Zelinared
to prevent blood clots after hip or knee replacement surgery.

Common side effects (may occur in not more than 1 in 10 people)

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including:
    • Bruising (haematomas) and swelling;
  • Nausea.

Uncommon side effects (may occur in not more than 1 in 100 people)

  • Decrease in platelet count (which may affect blood clotting);
  • Bleeding:
    • Occurring after surgery, including bruising (haematomas) 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 the breakdown of red blood cells, which may cause yellowing of the skin and eyes;
  • Itching.

Rare side effects (may occur in not more than 1 in 1000 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, contact your doctor immediately;
  • Bleeding:
    • Into muscle tissue;
    • Into the eyes;
    • From gums and presence of blood in sputum when coughing;
    • 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 into the 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);
  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (haematomas).

The following side effects 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 side effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • Into the eyes;
    • Into the stomach or intestine;
    • From the rectum;
    • Blood in urine;
    • Nosebleeds;
    • From gums;
    • Bruising (haematomas) 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 side effects (may occur in not more than 1 in 100 people)

  • Bleeding:
    • Into the brain or spinal cord;
    • In the mouth or presence of blood in sputum when coughing;
    • Into the abdominal cavity or from the vagina;
    • Bright red blood in stool;
    • Bleeding occurring after surgery, including bruising (haematomas) 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 platelet count (which may affect blood clotting);
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels – a product 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 are observed, contact your doctor immediately.

Rare side effects (may occur in not more than 1 in 1000 people)

  • Bleeding:
    • Into the lungs or throat;
    • Into the retroperitoneal space;
    • Into muscles.

Very rare side effects (may occur in not more than 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)

  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (haematomas).

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

Common side effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • Nosebleeds;
    • From gums;
    • Blood in urine;
    • Bruising (haematomas) and swelling;
    • From stomach, intestines, or rectum;
    • In the mouth;
    • Vaginal bleeding;
  • Anaemia, which may cause fatigue or paleness;
  • Decrease in 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 side effects (may occur in not more than 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 stool;
    • Test results indicating blood in stool or urine;
    • Bleeding occurring after surgery, including bruising (haematomas) 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 are observed, contact your doctor immediately;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels – a product formed from the breakdown of red blood cells, which may cause yellowing of the skin and eyes.

Rare side effects (may occur in not more than 1 in 1000 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);
  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (haematomas).

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 not more than 1 in 10 people).

Generally, side effects observed in children and adolescents treated with Zelinared
were similar to those seen in adults and were mostly mild to moderate in severity.
Side effects reported 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:
    • Vaginal bleeding;
    • Nosebleeds.

Common side effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • From gums;
    • Blood in urine;
    • Bruising (haematomas) and swelling;
    • From intestine or rectum;
    • Bright red blood in stool;
    • Postoperative bleeding, including bruising (haematomas) and swelling, leakage of blood (discharge) from surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decrease in platelet count (which may affect blood clotting);
  • Nausea;
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause fainting or rapid heartbeat in children;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased alanine aminotransferase (AlAT) activity.

Frequency not known (cannot be estimated from available data)

  • Bleeding:
    • Into the abdominal cavity or retroperitoneal space;
    • Into the stomach;
    • Into the eyes;
    • In the mouth;
    • From haemorrhoids;
    • In the mouth or presence of blood in sputum when coughing;
    • Into the brain or spinal 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.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet,
tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
at 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 this medicine.

5. How to store the medicine Zelinared

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging 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 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 packaging 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 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
Brown-yellow, round, biconvex film-coated tablets. Tablet dimensions: diameter approx.
6.0 mm, height approx. 3.0 mm.
Zelinared is available in cardboard boxes. Each cardboard box contains 6 blisters
made of PVC/PVDC/Aluminium, each 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 for supply in the European Economic Area countries under the following names:
Czech Republic, Estonia, Poland, Slovakia: Zelinared