Avoclod

Package Leaflet: Information for the User

Avoclod, 5 mg, Film-Coated Tablets

Apixaban

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only. 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 package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 Package 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 medicines called anticoagulants. This medication helps prevent blood clots by blocking factor Xa, which is an important part of the blood clotting process. Avoclod is used in adults:

• to prevent 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 travel to the brain, causing a stroke, or to other organs, reducing blood flow to those organs (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 legs (deep vein thrombosis) and blood clots in the blood vessels of the lungs (pulmonary embolism), as well as to prevent new blood clots in the blood vessels of the legs and/or lungs.

Avoclod is used in children from 28 days to less than 18 years of age to treat and prevent 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 medication (listed in section 6),
• If you have excessive bleeding,
• If you have a condition that increases the risk of major bleeding(such as an active or recently diagnosed stomach or intestinal ulcer, recent bleeding in the brain),
• If you have liver diseasethat increases the risk of bleeding (liver coagulopathy),
• If you are taking medications that prevent blood clotting(such as warfarin, rivaroxaban, dabigatran, or heparin), except in cases where the treatment is being switched, and the patient has a venous or arterial access line and heparin is being administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into a vein) due to irregular heart rhythm (arrhythmia).

Warnings and Precautions

Before starting Avoclod, 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 reduced platelet activity,
• Very high blood pressure, uncontrolled by 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 medication should be used with caution in patients with signs of liver function changes,
• If you have a heart valve replacement,
• If your doctor determines that your blood pressure is unstable
• If you are scheduled for another treatment or surgery to remove a blood clot from the lungs.

When to be Extra Careful When Taking Avoclod

• If you have a condition called antiphospholipid syndrome(an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change your treatment. If you need to undergo surgery or a procedure that may be associated with bleeding, your doctor may ask you to temporarily stop taking this medication for a short time. If you are unsure whether a procedure may be associated with bleeding, you should ask your doctor.

Children and Adolescents

Avoclod should not be used in children and adolescents under 18 years of age with a body weight below 35 kg.

Avoclod and Other Medications

Tell your doctor, pharmacist, or nurse about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Some medications may enhance the effect of Avoclod, and some may reduce its effect. Your doctor will decide whether you should receive Avoclod while taking other medications and how closely you should be monitored. The following medications may enhance the effect of Avoclod and increase the risk of unwanted bleeding:

• Certain antifungal medications(such as ketoconazole and others)
• Certain antiviral medications used to treat HIV/AIDS(such as ritonavir)
• Other medications used to reduce blood clotting(such as enoxaparin and others)
• Anti-inflammatory or pain-relieving medications(such as acetylsalicylic acid or naproxen), especially if you are over 75 years old and taking acetylsalicylic acid, you may be at increased risk of unwanted bleeding
• Medications used to treat high blood pressure or heart problems(such as diltiazem)
• Antidepressant medications called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

The following medications may reduce the ability of Avoclod to prevent blood clot formation:

• Medications used to prevent seizures or convulsions(such as phenytoin and others)
• St. John's Wort(a herbal supplement used for depression)
• Medications used to treat tuberculosis or other infections(such as rifampicin)

Pregnancy and Breastfeeding

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

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 medication. This medication 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 medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Dose

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

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 or 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.

Take Avoclod as Directed in 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:

• you have severe kidney problems,
• two or more of the following conditions are met:
• your blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromole/L) or higher),
• you are 80 years old or older,
• your 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 you should continue treatment. 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 new blood clots after completing 6 months of 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 you should continue treatment. Use in Children and Adolescents. Treatment and prevention of blood clots in the veins or blood vessels of the lungs. This medication should always be taken or administered as directed by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse. To get the best effect, try to take or administer the dose at the same time every day. The dose of Avoclod is based on body weight and will be calculated by your doctor. The recommended dose for children and adolescents weighing 35 kg or more is two Avoclod 5 mg tablets 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 twice daily, for example, one in the morning and one in the evening. For parents and caregivers: observe the child to ensure they take the full dose. It is important to follow the scheduled doctor's visits, as the dose may need to be adjusted with changes in the patient's body weight.

Your Doctor May Switch Your Anticoagulant Treatment as Follows:

• Switching from Avoclod to other anticoagulantsStop taking Avoclod. Start treatment with other anticoagulants (such as heparin) at the time of the next scheduled dose.
• Switching from other anticoagulants to AvoclodStop taking other anticoagulants. Start Avoclod at the time of the next scheduled dose of the other anticoagulant, and then continue with the usual dosing schedule.
• Switching from treatment with a vitamin K antagonist (such as warfarin) to AvoclodStop taking the vitamin K antagonist. Your doctor will perform blood tests and inform you when to start taking Avoclod.
• Switching from Avoclod to treatment with a vitamin K antagonist (such as warfarin)If your doctor tells you to start taking a vitamin K antagonist, you should continue taking Avoclod for at least 2 days after the first dose of the vitamin K antagonist. Your doctor will perform blood tests and inform you when to stop taking Avoclod.

Patients Undergoing Cardioversion

Patients who require cardioversion to restore a normal heart rhythm should take this medication at the times specified by their doctor to prevent blood clots in the blood vessels of the brain and other blood vessels.

Taking More than the Recommended Dose of Avoclod

If you take more than the recommended dose of this medication, contact your doctor immediately. Take the package leaflet with you, even if it is empty. If you take more than the recommended dose of Avoclod, you may be at increased risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect on 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 as usual. You can take the morning dose at the same time as the evening dose.
• 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 with the next dose as directed, twice daily.

If You Have Any Questions About Taking Avoclod or Miss More Than One Dose

contact your doctor, pharmacist, or nurse.

Stopping Avoclod

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

4. Possible Side Effects

Like all medications, Avoclod can cause side effects, although not everybody gets them. The most common side effect of this medication is bleeding, which can be life-threatening and may require immediate medical attention. The following side effects may occur when taking Avoclod to prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor.

Common Side Effects (May Affect Up to 1 in 10 People)

• Bleeding, including:
• in the eye;
• in the stomach or intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling;
• Anemia, which can cause tiredness or pale skin;
• Low blood pressure, which can lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity.

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• Bleeding:
• in the brain or spinal cord;
• in the mouth or coughing up blood;
• in the abdomen or from the vagina;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from hemorrhoids;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels - a breakdown product of red blood cells that can cause yellowing of the skin and eyes;
• Rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.

Rare Side Effects (May Affect Up to 1 in 1000 People)

• Bleeding:
• in the lungs or throat;
• in the space behind the abdomen;
• in the muscles.

Very Rare Side Effects (May Affect Up to 1 in 10,000 People)

• A skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency Not Known (Cannot be Estimated from the Available Data)

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

The following side effects may occur when taking Avoclod to treat or prevent new blood clots in the veins of the legs and 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;
• bruising and swelling;
• in the stomach or intestine;
• from the mouth;
• from the vagina;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count, which can affect blood clotting;
• Nausea (feeling sick);
• 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:
• in the eyes;
• in the mouth or coughing up blood;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• from hemorrhoids;
• in the muscles;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity), which can cause: swelling of the face, lips, mouth, tongue, and/or throat, and difficulty breathing. If you notice any of these symptoms, contact your doctor 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 that can cause yellowing of the skin and eyes.

Rare Side Effects (May Affect Up to 1 in 1000 People)

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

Frequency Not Known (Cannot be Estimated from the Available Data)

• Bleeding:
• in the abdomen or in the space behind the abdomen;
• A skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of the blood vessels), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising.

Additional Side Effects in Children and Adolescents. If you notice any of the following symptoms, contact your doctor immediately:

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

Generally, side effects reported in children and adolescents taking Eliquis were similar to those 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;
• bruising and swelling;
• in the intestine or rectum;
• red blood in the stool;
• bleeding after surgery, including bruising and swelling, bleeding or fluid from the surgical wound or injection site;
• Hair loss;
• Anemia, which can cause tiredness or pale skin;
• Reduced platelet count, which can affect blood clotting;
• Nausea (feeling sick);
• Rash;
• Itching;
• Low blood pressure, which can lead to 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 the Available Data)

• Bleeding:
• in the abdomen or in the space behind the abdomen;
• in the stomach;
• in the eyes;
• in the mouth or coughing up blood;
• in the brain or spinal cord;
• in the lungs;
• in the muscles;
• A skin rash that may have blisters and looks like small targets (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
• Vasculitis (inflammation of the blood vessels), which can cause a skin rash or raised, flat, red, round patches under the skin, or bruising;
• Blood test results may indicate:
• increased gamma-glutamyltransferase (GGT) activity;
• presence of blood in the stool or urine.

Reporting Side Effects. After the authorization of the medication, it is important to report any suspected side effects. This allows for continuous monitoring of the benefit/risk balance of the medication. Healthcare professionals are asked to report any suspected side effects via the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych: Al. Jerozolimskie 181C, 02-222 Warszawa, 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 medication.

5. How to Store Avoclod

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

6. Contents of the Package and Other Information

What is in Avoclod? The active substance is apixaban. Each tablet contains 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, iron oxide red (E 172).

What Avoclod Looks Like and Contents of the Package

Pink, elongated film-coated tablets, 10.2 x 5.2 mm ± 0.2 mm. PVC/PVDC/Aluminum blisters 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 medication is authorized in the European Economic Area member states under the following names: Czech Republic, Greece, Poland: Avoclod, Bulgaria: Авоклод 5 mg филмирани таблетки, Hungary: Avoclod 5 mg filmtabletta, Croatia: Avoclod 5 mg filmom obložene tablete, Romania: Avoclod 5 mg comprimate filmate, Slovakia: Avoclod 5 mg. For more information on this medication, 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 the Last Revision of the Package Leaflet:March 2025