Avoclod

Leaflet accompanying the packaging: information for

the user

Avoclod, 2.5 mg, film-coated tablets

apixaban

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Avoclod and what is it used for

Avoclod 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.
Avoclod 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 blood clots in the veins of the lower limbs. This can lead to swelling of the legs, with or without pain. If a blood clot moves from the lower limb 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, making it difficult for these organs to receive blood (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
• to treat blood clots in the veins of the lower limbs (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 lower limbs and/or lungs.

Avoclod 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 blood vessels of the lungs.
Information on body weight and recommended dose can be found in section 3.

2. Important information before taking Avoclod

When not to take Avoclod

• If you are allergicto apixaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have an organ diseasethat increases the risk of significant bleeding (such as active or recently diagnosed stomach or intestinal ulcers, recently diagnosed bleeding into the brain),
• if you have liver diseasethat leads to an increased risk of bleeding (liver coagulopathy),
• if you are taking medicines to prevent blood clotting(e.g., warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the anticoagulant treatment is changed, when the patient has a venous or arterial access line 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 with Avoclod, you should discuss with your doctor, pharmacist, or nurse if you 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 pressurethat is not controlled with medication,
• if you are over 75 years old,
• if you weigh 60 kg or less,
• severe kidney disease or if you are on dialysis,
• liver disease or a history of liver disease. This medicine should be used with caution in patients with signs of liver function changes.
• Tube (catheter) or injection into the spine(anesthetic or pain reliever), in which case the doctor will recommend taking this medicine after 5 or more hours after catheter removal,
• if you have a heart valve prosthesis,
• if your doctor determines that your blood pressure is unstable,
• if other treatment or surgery is planned to remove a blood clot from the lungs.

When to be particularly careful when taking Avoclod

In case of need for surgery or a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are unsure whether a given procedure may be associated with bleeding, you should ask your doctor.

Children and adolescents

Avoclod is not recommended for children and adolescents under 18 years of age with a body weight below 35 kg.

Avoclod and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may enhance the effect of Avoclod, and some may weaken its effect. Your doctor will decide whether you should receive Avoclod while taking other medicines and how closely you should be monitored.
The following medicines may enhance the effect of Avoclod 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-inflammatoryor analgesic 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 for high blood pressure or heart problems(e.g., diltiazem)
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medicines may reduce the ability of Avoclod 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 tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
The effect of apixaban on pregnancy and the unborn child is not known. You should not take this medicine during pregnancy. If you become pregnant while taking this medicine, you should contact your doctor immediately.
It is not known whether apixaban passes into breast milk. Before taking this medicine while breastfeeding, ask your doctor, pharmacist, or nurse. You may be advised to stop breastfeeding or stop/avoid taking this medicine.

Driving and using machines

Apixaban has no or negligible influence on the ability to drive and use machines.

Avoclod contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Avoclod

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

Swallow the tablet with water. Avoclod can be taken with or without food.
To get the best effect, it is recommended to take the tablets at the same time every day.
If you have problems swallowing the tablets whole, you should talk to your doctor about other ways of taking Avoclod. The tablet can be crushed just before taking and mixed with water or 5% glucose solution, juice, or apple puree.

Instructions for crushing tablets:

• Crush the tablet with a pestle in a mortar.
• Carefully transfer the powder to a suitable container, then mix it with a small amount, e.g., 30 mL (2 tablespoons) of water or another liquid mentioned above to make a mixture.
• Swallow the 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 swallow the rinse liquid.

If necessary, your doctor may give you a crushed Avoclod tablet mixed with 60 mL of water or 5% glucose solution through a nasogastric tube.

Avoclod 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 Avoclod 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 hip replacement surgery, they will usually take the tablets for 32 to 38 days.
If the patient has undergone major knee replacement surgery, 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 (atrial fibrillation) and at least one additional risk factor
The recommended dose is one Avoclod 5 mgtablet twice a day.
The recommended dose is one Avoclod 2.5 mgtablet twice a day if:

• the patient has severe kidney problems,
• 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 weighs 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. Your doctor will decide how long to continue treatment.
Treatment of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs
The recommended dose is twoAvoclod 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 oneAvoclod 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 Avoclod 2.5 mgtablet twice a day, for example, one tablet in the morning and one in the evening.
Your 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 blood vessels of the lungs.
This medicine should always be taken or administered as recommended by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

The doctor may change the anticoagulant treatment as follows:

• Changing from Avoclod to anticoagulant medicinesStop taking Avoclod. Treatment with anticoagulant medicines (e.g., heparin) should be started at the time of the scheduled intake of the next tablet.
• Changing from anticoagulant medicines to AvoclodStop taking anticoagulant medicines. Treatment with Avoclod should be started at the time of the scheduled intake of the next dose of anticoagulant medicine, and then continue with the usual intake.
• Changing from treatment with a vitamin K antagonist (e.g., warfarin) to AvoclodStop taking the vitamin K antagonist. The doctor must perform blood tests and will inform the patient when to start taking Avoclod.
• Changing from Avoclod to treatment with a vitamin K antagonist (e.g., warfarin)If the doctor informs the patient that they should start taking a vitamin K antagonist, they should continue taking Avoclod for at least 2 days after taking the first dose of the vitamin K antagonist.

The doctor must perform blood tests and inform the patient when to stop taking Avoclod.

Patients undergoing cardioversion

Patients who need to undergo a cardioversion procedure to restore a normal heart rhythm should take this medicine at the times specified by their doctor to prevent the formation of blood clots in the blood vessels of the brain and other blood vessels in the body.

Taking a higher dose of Avoclod than recommended

If you have taken a higher dose of this medicine than recommended, you should contact your doctor immediately.
You should take the packaging with you, even if it is empty.
If you have taken a higher dose of Avoclod than recommended, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect against factor Xa may be necessary.

Missing a dose of Avoclod

• If you miss a morning dose, take it as soon as you remember and take the evening dose at the usual time.
• If you miss an evening dose, you can take it only on the same evening. Do not take two doses the next morning, 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

contact your doctor, pharmacist, or nurse.

Stopping Avoclod

Do not stop taking this medicine without consulting your doctor, as the risk of blood clot formation may be higher if you stop taking Avoclod too early.
If you have any further doubts about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Avoclod can cause side effects, although not everybody gets them.
Avoclod can be used in three different medical conditions. The known side effects and their frequency in each of these medical conditions may be different 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.
The following side effects may occur when taking Avoclod to prevent blood clot formation after hip or knee replacement surgery.

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

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

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

• Decreased platelet count (which can affect blood clotting);
• Bleeding:
• after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision site (wound discharge) or injection site;
• from the stomach, intestines, or bright red blood in the stool;
• 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 function disorders;
• 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 affect up to 1 in 1000 people)

• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you notice any of these symptoms, you should contact your doctor immediately;
• Bleeding:
• into the muscle;
• into the eyes;
• from the gums and coughing up blood;
• from the rectum;
• Hair loss.

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

• Bleeding:
• into the brain or spinal cord;
• into the lungs or throat;
• into the abdominal cavity or retroperitoneal space;
• 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 elevated, flat, red, round patches under the skin surface, or bruises.

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

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

• Bleeding, including:
• into the eye;
• into the stomach or intestines;
• from the rectum
• blood in the urine;
• from the nose;
• from the gums;
• bruises 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 affect up to 1 in 100 people)

• Bleeding:
• into the brain or spinal cord;
• into the mouth or throat;
• into the abdominal cavity or vagina;
• bright red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision site (wound discharge) or injection site
• from hemorrhoids;
• Blood test results may indicate:
• liver function disorders;
• 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: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you notice any of these symptoms, you should contact your doctor immediately;

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

• Bleeding:
• into the lungs or throat;
• into the retroperitoneal space;
• into the muscle.

Very rare side effects (may affect 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 (frequency cannot be estimated from the available data)

• Vasculitis (inflammation of blood vessels), which can cause skin rash or elevated, flat, red, round patches under the skin surface, or bruises.

The following side effects may occur when taking Avoclod to treat or prevent the recurrence of blood clots in the veins of the lower limbs and blood clots in the blood vessels of the lungs.

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

• Bleeding, including:
• from the nose;
• from the gums;
• blood in the urine;
• bruises and swelling;
• from the stomach, intestines, or rectum;
• in the mouth;
• from the vagina;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (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 affect 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 throat;
• 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/incision site (wound discharge) or injection site
• from hemorrhoids;
• into the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: facial swelling, lip swelling, mouth swelling, tongue swelling, and (or) throat swelling, as well as difficulty breathing. If you notice any of these symptoms, you should contact your doctor immediately;
• Blood test results may indicate:
• liver function disorders;
• 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 affect up to 1 in 1000 people)

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

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

• Bleeding:
• into the abdominal cavity or retroperitoneal space;
• 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 elevated, flat, red, round patches under the skin surface, or bruises.

Additional side effects in children and adolescents
If you notice any of the following symptoms, you should contact your doctor immediately:

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

Generally, the side effects reported in children and adolescents taking Avoclod were similar to those observed in adults and were mostly mild or moderate. Side effects reported more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

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

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

• Bleeding, including:
• from the gums;
• blood in the urine;
• bruises (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/incision site (wound discharge) or injection site;
• Hair loss;
• Anemia, which can cause fatigue or pallor;
• Decreased platelet count (which can affect blood clotting);
• Nausea (vomiting);
• Skin rash;
• Itching;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Blood test results may indicate:
• liver function disorders;
• increased activity of certain liver enzymes;
• increased alanine aminotransferase (ALT) activity.

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

• Bleeding
• into the abdominal cavity or retroperitoneal space;
• into the stomach;
• into the eyes;
• into the mouth;
• from hemorrhoids;
• into the mouth or throat;
• 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 elevated, flat, red, round patches under the skin surface, or bruises;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• blood in the stool or urine.

Reporting side effects

After the authorization of the medicinal product, it is important to report any suspected adverse reaction. This allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avoclod

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed Avoclod tablets are stable in water, 5% glucose solution, apple juice, and apple puree for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information What Avoclod contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients are: Tablet core: microcrystalline cellulose type 101, anhydrous lactose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate. Tablet coating: hypromellose type 2910, lactose monohydrate, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Avoclod looks like and contents of the pack

Yellow, oval, film-coated tablets with a diameter of 6.2 mm ± 0.2 mm
Blisters of PVC/PVDC/Aluminum, in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 90, 100, 120, 168, and 200 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta
This medicine is authorized in the Member States of the European Economic Area under the following names:
Czech Republic, Greece, Poland: Avoclod
Bulgaria: Авоклод 2,5 mg филмирани таблетки
Hungary: Avoclod 2,5 mg filmtabletta
Croatia: Avoclod 2,5 mg filmom obložene tablete
Romania: Avoclod 2,5 mg comprimate filmate
Slovakia: Avoclod 2,5 mg
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2025