Package leaflet: Information for the user

Avoclod, 5 mg, coated tablets
apixaban
Please read all of this leaflet carefully before taking this medicine, because 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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Avoclod is and what it is used for
What you need to know before taking Avoclod
How to take Avoclod
Possible side effects
How to store Avoclod
Contents of the pack and other information

1. What Avoclod is and what it is used for

Avoclod 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.
Avoclod is used in adults:

to prevent blood clots forming in the heart in patients with irregular heart rhythm (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 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 deep veins of the legs and (or) lungs.

Avoclod is used in children from 28 days to below 18 years of age, for the treatment of blood clots and prevention of 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 using Avoclod

When not to use Avoclod

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 major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage),
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 involving a switch in anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through this line to maintain 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 Avoclod, discuss with the doctor, pharmacist or
nurse if the patient has any of the following conditions:

increased risk of bleeding, for example:
conditions associated with bleeding, including those resulting in reduced platelet activity,
very high blood pressure not controlled by medication,
if the patient is over 75 years of age,
if the patient weighs 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 showing signs of liver function abnormalities,
spinal catheter or epidural/spinal injection (anaesthetic or pain relief). In such cases, the doctor will recommend taking this medicine 5 or more hours after removal of the catheter,
if the patient has a heart valve prosthesis,
if the doctor determines that the patient's blood pressure is unstable,
if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Avoclod

if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed. If surgery or a procedure associated with bleeding risk is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a procedure may involve bleeding, consult the doctor.

Children and adolescents
Avoclod is not recommended for use in children and adolescents under 18 years of age with body weight
below 35 kg.
Avoclod and other medicines
Inform the 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 use.
Some medicines may enhance the effect of Avoclod, while others may reduce its effectiveness.
The doctor will decide whether the patient should receive Avoclod while taking other medicines and how closely monitoring should be performed.
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 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); particularly if the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased,
medicines used for high blood pressure or heart problems (e.g. diltiazem),
antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce Avoclod's ability to prevent blood clots:

medicines used to prevent epilepsy or seizures (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 is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The effect of apixaban during pregnancy and on 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 apixaban passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.
Driving and operating machinery
Apixaban has no or negligible influence on the ability to drive and operate machinery.
Avoclod contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Avoclod

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any
doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Avoclod can be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time each day.
If you have difficulty swallowing the tablets whole, talk to your doctor about alternative ways of taking Avoclod. The tablet may be crushed immediately before administration 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 powder to a suitable container and mix it with a small amount, e.g., 30 mL (2 tablespoons) of water or another liquid listed above, to prepare a mixture.
Swallow the mixture.
Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), and swallow the rinsing liquid.

If necessary, your doctor may administer crushed Avoclod tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Avoclod should be taken as directed for the following indications:
Prevention of blood clots 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 mg tablet twice daily.
The recommended dose is one Avoclod 2.5 mg tablet twice daily if:

the patient has severe renal impairment, or
two or more of the following conditions are met:
blood test results suggest reduced kidney function (serum creatinine level 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two Avoclod 5 mg tablets twice daily for the first 7 days, for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one Avoclod 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one Avoclod 2.5 mg 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 recurrent 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, consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, try to take or administer the dose at the same time each day.
The dose of Avoclod depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two Avoclod 5 mg tablets, taken 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 Avoclod 5 mg tablet, taken twice daily, for example, one in the morning and one in the evening.
Parents and caregivers: observe your child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary with changes in body weight.
Your doctor may change the anticoagulant treatment as follows:

Switching from Avoclod to anticoagulant medicines Discontinue taking Avoclod. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Avoclod Discontinue taking anticoagulant medicines. Begin Avoclod treatment at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Avoclod Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will inform you when to start taking Avoclod.
Switching from Avoclod to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Avoclod for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor must perform blood tests and inform you when to stop taking Avoclod. Patients undergoing cardioversion Patients who require a cardioversion procedure 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 Avoclod than recommended If you have taken more than the recommended dose of this medicine, contact your doctor immediately. Bring the medicine packaging with you, even if it is empty. If you have taken more than the recommended dose of Avoclod, your risk of bleeding may be increased. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the factor Xa effect may be required. Missed dose of Avoclod
If you miss a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A missed evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue taking the medicine the next day as directed, twice daily.

If you have any doubts about taking the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.
Stopping Avoclod
Do not stop taking this medicine without consulting your doctor, as stopping Avoclod prematurely may increase the risk of blood clots.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common general adverse effect of this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse effects may occur when taking Avoclod to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

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

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

Bleeding:
into the brain or spinal canal;
in the mouth or coughing up blood;
in the abdomen or from the vagina;
bright red blood in stool;
bleeding after surgery, including 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;
Decreased platelet count in blood (which may affect blood clotting);
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product 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, seek medical advice immediately.

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

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

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

Skin rash, with blister formation, resembling 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 under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse effects may occur when taking Avoclod to treat or prevent recurrence of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs.

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

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

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

Low blood pressure, which may lead to fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the mouth or coughing up blood;
bright red blood in stool;
test results indicating blood in stool or urine;
bleeding after surgery, including 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, seek medical advice immediately;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

Bleeding:
in the brain or spinal canal;
in the lungs.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdomen or retroperitoneal space.
Skin rash, with blister formation, resembling 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 under the skin surface, or bruising;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse effects in children and adolescents
If any of the following symptoms occur, seek medical advice immediately:

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

Generally, adverse effects observed in children and adolescents treated with Avoclod were similar to those seen in adults and were mostly mild or moderate in severity. Adverse effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

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

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

Bleeding, including:
from the gums;
blood in urine;
subcutaneous haemorrhages (bruising) and swelling;
from the intestine or rectum;
bright red blood in stool;
bleeding after surgery, 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;
Decreased blood platelet count (which may affect clotting);
Nausea;
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may indicate:
abnormal liver function;
increased activity of certain liver enzymes;
increased alanine aminotransferase (ALT) activity.

Frequency not known (cannot be estimated from available data)

Bleeding:
into the abdomen or retroperitoneal space;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in sputum when coughing;
in the brain or spine;
in the lungs;
in muscle;
Skin rash, with blister formation, resembling 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 under the skin surface or bruising;
Blood test results may indicate:
increased gamma-glutamyltransferase (GGT) activity;
presence of blood in stool or urine.
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
After a medicinal product has been authorised, it is important to report suspected adverse effects. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse effects via 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to gather more information on the safety of the 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 stated on the outer carton and blister, following the abbreviation EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Crushed tablets
Crushed Avoclod tablets are stable in water, 5% glucose solution in water, 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 in use. This will help protect the environment.

6. Contents of the package and other information What does Avoclod contain

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
Other ingredients are:
Tablet core: microcrystalline cellulose type 101, anhydrous lactose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate.
Tablet coating: hypromellose type 2910, monohydrate lactose, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Avoclod looks like and contents of the pack
Pink, oblong coated tablets measuring 10.2 x 5.2 mm ± 0.2 mm.
Blister packs made of PVC/PVDC/Aluminum, in cardboard cartons.
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 Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Bulgaria: Авоклод
Croatia, Greece, Poland, Czech Republic, Romania, Slovakia, Hungary: Avoclod

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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: November 2025