Apixaban adamed

Package leaflet: Information for the patient

Apixaban Adamed, 5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Apixaban Adamed is and what it is used for

Apixaban Adamed 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.

Apixaban Adamed is used in adults:

• 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 loose 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 such blood clots in the veins of the legs and/or lungs.

Apixaban is used in children aged 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the pulmonary blood vessels.
The recommended dose adjusted to body weight is given in section 3.

2. Important information before using Apixaban Adamed

When not to use Apixaban Adamed

• if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive bleeding;
• if the patient has an organ disease that increases the risk of severe bleeding (such as active or recently diagnosed gastric or intestinal ulcer, recently experienced 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 when switching anticoagulant therapy, when a venous or arterial line has been inserted and heparin is administered through this 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 involving bleeding, including those leading to reduced platelet activity,
  • very high blood pressure not controlled by 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 showing signs of impaired liver function.
• a catheter or injection in the spine (anaesthetic or pain-relieving). In such a case, the doctor will advise taking this medicine at least 5 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, or if other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Adamed:

• if the patient has a condition called antiphospholipid syndrome (an autoimmune disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

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 particular procedure may cause bleeding, consult the doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.
Apixaban Adamed and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may enhance the effect of Apixaban Adamed, while others may reduce its effect.
The doctor will decide whether the patient should receive Apixaban Adamed while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Adamed and increase the risk of unwanted bleeding:

• certain medicines used to treat fungal infections (e.g. ketoconazole and others);
• certain antiviral medicines used to treat HIV/AIDS 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 conditions (e.g. diltiazem);
• antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).

The following medicines may reduce the ability of Apixaban Adamed 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 her doctor, pharmacist, or nurse before using this medicine.
The effect of Apixaban Adamed 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 Apixaban Adamed 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 Adamed has not been shown to affect the ability to drive or operate machinery.
Apixaban Adamed contains lactose (a type of sugar)
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Apixaban Adamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Apixaban Adamed

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Adamed may 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 you have difficulty swallowing the tablets whole, you should talk to your doctor about alternative
ways of taking Apixaban Adamed. 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 entire powder into a suitable container and then mix it with a small amount, e.g., 30 mL (2 tablespoons), of water or another liquid listed above to prepare a mixture.
• Swallow (drink) the resulting mixture.
• Rinse the pestle and mortar used to crush the tablet, as well as the container, with a small amount of water or another liquid (e.g., 30 mL), and then swallow (drink) the rinsing liquid.

If necessary, your doctor may administer crushed Apixaban Adamed tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Adamed should be taken as recommended for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one Apixaban Adamed tablet 5 mg twice daily.
The recommended dose is one Apixaban Adamed tablet 2.5 mg 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 level 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 tablets of Apixaban Adamed 5 mg 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 tablet of Apixaban Adamed 5 mg 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 Apixaban Adamed tablet 2.5 mg 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 veins or in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as prescribed by your doctor or pharmacist.
If you are unsure, you should 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 apixaban dose 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 tablets of apixaban 5 mg ,
administered 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 tablet of apixaban 5 mg , administered twice daily, for example one in the morning and one in the evening.
For parents and caregivers: you should observe the child to ensure the full dose has been taken.
It is important to keep scheduled appointments with your doctor, as dose adjustments may be necessary as the patient's body weight changes.
Your doctor may change anticoagulant treatment as follows:

• Switching from Apixaban Adamed to other anticoagulant medicines Discontinue taking Apixaban Adamed. Start treatment with anticoagulant medicines (e.g., heparin) at the time the next tablet was scheduled to be taken.
• Switching from other anticoagulant medicines to Apixaban Adamed Discontinue taking the anticoagulant medicines. Begin treatment with Apixaban Adamed at the time the next dose of the anticoagulant medicine was scheduled, and then continue regular dosing.
• Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apixaban Adamed Discontinue the vitamin K antagonist medicine. Your doctor will order blood tests and inform you when to start taking Apixaban Adamed.
• Switching from Apixaban Adamed 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 Apixaban Adamed 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 Apixaban Adamed.

Patients undergoing cardioversion
Patients with irregular heartbeat who require a cardioversion procedure to restore 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 parts of the body.
Taking more Apixaban Adamed than recommended
If you take more of this medicine than recommended, you should contact your doctor immediately.
Take the medicine packaging with you, even if no tablets remain.
If you take more than the recommended dose of Apixaban Adamed, your risk of bleeding may increase. If bleeding occurs, surgical treatment, blood transfusion, or other treatment to reverse the effect of the factor Xa inhibitor may be necessary.
Missing a dose of Apixaban Adamed

• 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 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 you miss more than one dose, you should consult your doctor, pharmacist or nurse.
Stopping Apixaban Adamed
Do not stop taking this medicine without consulting your doctor, as stopping Apixaban Adamed prematurely may increase the risk of blood clots.
If you have any further questions about the use of 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 apixaban 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 not more than 1 in 10 people)

• Bleeding, including:
• into the eyes;
• into the stomach or intestine;
• from the rectum;
• blood in urine;
• from the nose;
• from the gums;
• subcutaneous haemorrhage (bruising) and swelling;
• Anaemia, which may cause fatigue or pallor;
• Low blood pressure, which may lead to fainting or rapid heartbeat;
• Nausea (feeling sick);
• Blood test results may indicate:
• increased activity of gamma-glutamyl transferase (GGT).

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

• Bleeding:
• into the brain or spinal canal;
• in the mouth or presence of blood in sputum when coughing;
• in the abdominal cavity or from the vagina;
• bright red blood in stool;
• bleeding occurring after surgery, including subcutaneous haemorrhage (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 product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, you must contact your doctor immediately.

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

• Bleeding:
• into the lungs or throat;
• into the retroperitoneal space (located at the back of the abdominal cavity);
• into muscles.

Very rare adverse effects (may occur in not more than 1 in 10,000 people)

• Skin rash, which may develop blisters and resemble small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency unknown (cannot be estimated from available data)

• Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or subcutaneous haemorrhages (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 apixaban to
treat or prevent recurrence of blood clots in the legs and pulmonary embolism (blood clots in the lungs).

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

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

Uncommon adverse 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 subcutaneous haemorrhage (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 (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, you must contact your doctor immediately;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased bilirubin levels – a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

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

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

Frequency unknown (cannot be estimated from available data)

• Bleeding:
• into the abdominal cavity or into the retroperitoneal space.
• Skin rash, which may develop blisters and resemble 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, round spots beneath the skin surface, or subcutaneous haemorrhages (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 are observed, you must immediately
inform your doctor:

• Allergic (hypersensitivity) reactions, 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 not more than 1 in 10 people).

In general, adverse effects observed in children and adolescents treated with apixaban
were similar to those seen in adults and were mostly mild to moderate in severity.
Adverse effects occurring more frequently in children and adolescents include nosebleeds and unusual 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 not more than 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 or fluid (discharge) from the surgical wound or injection site;
• Hair loss;
• Anaemia, which may cause fatigue or pallor;
• Decreased platelet count in blood (which may affect clotting);
• Nausea (feeling sick);
• Skin rash;
• Itching;
• Low blood pressure, which may cause fainting or rapid heartbeat in the child;
• Blood test results may indicate:
• abnormal liver function;
• increased activity of certain liver enzymes;
• increased activity of alanine aminotransferase (AlAT).

Frequency unknown (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 canal;
• into the lungs;
• into muscles;
• Skin rash, which may develop blisters and resemble 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, round spots beneath the skin surface or subcutaneous haemorrhages (bruising);
• Blood test results may indicate:
• increased activity of gamma-glutamyl transferase (GGT);
• 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
If you experience any adverse effects, including any not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Apixaban Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after: "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Apixaban Adamed contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients are:
  • Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate.
  • Coating: monohydrate lactose, hypromellose 2910, titanium dioxide (E171), triacetin, iron oxide red (E172).

See section 2 "Apixaban Adamed contains lactose (a type of sugar) / sodium".
What Apixaban Adamed looks like and contents of the pack
The coated tablets are pink, oval-shaped, biconvex, with the imprint "AX" on one side and "5" on the other.
The tablets are packed in blisters within cardboard boxes containing 14, 20, 28, 56, 60, 100, 168, and 200 coated tablets.
Single-dose divisible blisters are also available in cardboard boxes containing 100x1 coated tablet, intended for hospitals.
Not all pack sizes may be marketed.
Patient Warning Card: information for users
Inside the Apixaban Adamed packaging, alongside the patient leaflet, there is a Patient Warning Card, or the treating physician may provide the patient with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other physicians that the patient is taking Apixaban Adamed. You should always carry this card with you.

1. Take the card.
2. If necessary, separate the appropriate language section (facilitated by perforated edges).
3. Fill in the following details, or ask your doctor to complete them:
   • Name and surname:
   • Date of birth:
   • Indication:
   • Dose: ........ mg twice daily
   • Doctor's name:
   • Doctor's telephone number:
4. Fold the card and always keep it with you.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00
Manufacturer / Importer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Delorbis Pharmaceuticals Ltd
17 Athinon Str.
Ergates Industrial Area
2643 Ergates, Nicosia
Cyprus

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names: