Patient Information Leaflet

Erimpox, 5 mg hard capsules
Apixaban
Please read all of this leaflet carefully before you start taking this medicine, because it contains information that is important 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 share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

1. What Erimpox is and what it is used for

Erimpox contains the active substance apixaban and belongs to a group of medicines called anticoagulants. It works by inhibiting Factor Xa, an important component in the blood clotting process, thereby helping to prevent the formation of harmful blood clots. Erimpox is used in adults:

To prevent blood clots forming in the heart in patients with an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing stroke, or to other organs, impairing blood flow to these organs (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 the lungs.

Erimpox is also used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
Dosage recommendations based on body weight are provided in section 3.

2. Important information before using Erimpox

When not to use Erimpox:

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 a disease of an organ that increases the risk of serious bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestines, recently diagnosed 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 patency, or when a catheter (catheter ablation) is introduced into the patient's blood vessel for the treatment of irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting to take this medicine, 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 states resulting in reduced platelet activity; very high blood pressure not controlled with medication; if the patient is over 75 years of age; if the patient's body weight is 60 kg or less;
severe kidney disease or if the patient is on dialysis;
liver problems or history of liver problems; This medicine should be used with caution in patients showing signs of impaired liver function.
if the patient has had a tube (catheter) or spinal injection (anaesthetic or pain-relieving), in which case the doctor will recommend 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 another treatment or surgical procedure to remove a blood clot from the lungs is planned.

When to exercise special caution when using Erimpox:

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 a change in treatment is necessary.

If surgery or a procedure that may cause bleeding is required, the doctor may ask the patient to temporarily stop taking this medicine for a short period. If in doubt whether a particular procedure may be associated with bleeding, consult the doctor.

Children and adolescents
Use of this medicine is not recommended in children and adolescents with body weight less than 35 kg.

Erimpox and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Erimpox, while others may reduce its effect. The doctor will decide whether the patient should receive Erimpox while taking these medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of Erimpox and increase the risk of unwanted bleeding:

certain medicines used to treat fungal infections (e.g. itraconazole, voriconazole, posaconazole, etc.);
certain antiviral medicines used to treat HIV/AIDS (e.g. ritonavir);
certain medicines used to treat Cushing's syndrome (e.g. ketoconazole), a condition in which the body produces excess cortisol;
other medicines used to reduce blood clotting (e.g. enoxaparin, etc.);
anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen). Particularly when the patient is over 75 years of age and taking acetylsalicylic acid, the risk of 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 the ability of Erimpox to prevent blood clots:

medicines used to prevent epilepsy or seizures (e.g. phenytoin, etc.);
St John's wort (an 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 baby, she should consult her doctor, pharmacist, or nurse before using this medicine.
The effect of Erimpox on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Erimpox passes into human milk. Before using this medicine during breastfeeding, consult a doctor, pharmacist, or nurse. They will advise whether breastfeeding should be discontinued, or whether use of this medicine should be stopped or not initiated.

Driving and operating machinery
No effects of Erimpox on the ability to drive or operate machinery have been observed.

Erimpox contains lactose (a type of sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Erimpox contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".

3. How to take Erimpox

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
Dosage
The capsule should be swallowed with water. Erimpox may be taken regardless of meals.
To achieve the best treatment outcomes, it is recommended to take the capsules at the same times every day.
If a patient has difficulty swallowing the capsule whole, they should discuss alternative methods of taking Erimpox with their doctor. The capsule may be opened and its contents mixed immediately before administration with water or a 5% aqueous glucose solution, apple juice, or apple puree.

Instructions for opening capsules:

Firmly hold the capsule between the thumbs and index fingers of both hands over a tablespoon or small bowl.
Carefully twist and open the capsule.
Pour out the contents of the capsule, gently tapping if necessary, into a suitable container, then mix the powder with a small amount (e.g. 30 mL (2 tablespoons)) of water or one of the other liquids listed above to form a mixture.
Swallow the mixture.

If necessary, a doctor may also administer the capsule contents mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Erimpox should be taken as directed 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 Erimpox 5 mg capsule twice daily.
The recommended dose is one Erimpox 2.5 mg capsule twice daily if:

the patient has severe renal impairment;
at least two of the following conditions are met:
blood test results indicate reduced kidney function (serum creatinine concentration of 1.5 mg/dL (133 micromoles/L) or higher);
the patient is 80 years of age or older;
the patient’s body weight is 60 kg or less.

The recommended dose is one capsule twice daily, for example, one in the morning and one in the evening.
The doctor will decide how long the patient should 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 two Erimpox 5 mg capsules 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 Erimpox 5 mg capsule twice daily, for example, one in the morning and one in the evening.

Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one Erimpox 2.5 mg capsule twice daily, for example, one capsule in the morning and one in the evening.
The doctor will decide how long the patient should continue treatment.

Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in the veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
To achieve the best treatment outcome, it is recommended to take or administer the dose at the same times every day.
The dose of Erimpox depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with body weight of at least 35 kg is two Erimpox 5 mg capsules 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 Erimpox 5 mg capsule twice daily, for example, one capsule in the morning and one in the evening.

For parents and caregivers: Observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor visits, as dose adjustments may be necessary as the patient’s body weight changes.

The doctor may change anticoagulant treatment as follows:

Switching from Erimpox to other anticoagulant medicines Discontinue taking Erimpox. Start treatment with another anticoagulant (e.g., heparin) at the time the next capsule was scheduled to be taken.
Switching from other anticoagulant medicines to Erimpox Discontinue use of other anticoagulants. Begin Erimpox treatment at the time the next dose of the other anticoagulant was scheduled, then continue treatment according to the normal schedule.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Erimpox Discontinue use of the vitamin K antagonist-containing medicine. The doctor will order blood tests and inform the patient when to start taking Erimpox.
Switching from Erimpox to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If the doctor prescribes starting a vitamin K antagonist-containing medicine, continue taking Erimpox for at least 2 more days after taking the first dose of the vitamin K antagonist-containing medicine. The doctor will order blood tests and inform the patient when to stop taking Erimpox.

Patients undergoing cardioversion
If restoration of normal heart rhythm is required using a procedure called cardioversion, this medicine should be taken at the time recommended by the doctor to prevent formation of blood clots in the blood vessels of the brain and other blood vessels in the patient’s body.

Taking more Erimpox than recommended
If a patient has taken more Erimpox than recommended, they should immediately inform their doctor. The medicine packaging should be brought along, even if no capsules remain.
Taking more Erimpox than recommended may increase the risk of bleeding. In case of bleeding, surgical treatment, blood transfusion, or other treatments capable of reversing the anti-factor Xa effect may be required.

Missed dose of Erimpox

If a morning dose is missed, take it as soon as possible and may be taken together with the evening dose.
A missed evening dose may only be taken the same evening. Do not take two doses the next morning; instead, continue taking the medicine the next day as directed, twice daily.

If in doubt about use of the medicine or if more than one dose is missed, consult a doctor, pharmacist, or nurse.

Stopping Erimpox
Do not stop taking this medicine without first consulting a doctor, as the risk of blood clots may be higher if treatment is stopped prematurely.
If there are any further doubts about using this medicine, consult a 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 be life-threatening
and 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 no more than 1 in 10 people)

Bleeding, including:
into the eyes;
into the stomach or intestines;
from the rectum;
blood in the urine;
from the nose;
from the gums;
subcutaneous haemorrhage and swelling;
Anaemia, which may cause fatigue or paleness;
Low blood pressure, which may cause fainting or rapid heartbeat;
Nausea (feeling sick);
Blood tests may show:
increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse effects (may occur in no more than 1 in 100 people)

Bleeding:
into the brain or spinal column;
in the mouth or blood in coughed-up phlegm;
into the abdominal cavity or from the vagina;
presence of bright red blood in stool;
bleeding after surgery, including subcutaneous haemorrhage and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
tests indicating presence of blood in stool or urine;
Decreased platelet count (which may affect blood clotting);
Blood tests may show:
liver function abnormalities;
increased activity of certain liver enzymes;
increased bilirubin levels, a breakdown product of red blood cells, which may cause yellowing of the skin and whites of the 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. You should inform your doctor immediately if any of these symptoms occur.

Rare adverse effects (may occur in no more than 1 in 1000 people)

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

Very rare adverse effects (may occur in no more than 1 in 10,000 people)

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

Frequency unknown (cannot be estimated from available data)

Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising.
Bleeding in the kidneys, sometimes with blood in the 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 deep veins of the legs and blood clots in blood vessels of the lungs.
Common adverse effects (may occur in no more than 1 in 10 people)

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

Uncommon adverse effects (may occur in no more than 1 in 100 people)

Low blood pressure, which may cause fainting or rapid heartbeat;
Bleeding:
into the eyes;
in the mouth or blood in coughed-up phlegm;
presence of bright red blood in stool;
test results indicating blood in stool or urine;
bleeding after surgery, including subcutaneous haemorrhage and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
within muscles;
Itching;
Hair loss;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. You should contact your doctor immediately if any of these symptoms occur;
Blood tests may show:
liver function abnormalities;
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 no more than 1 in 1000 people)
Bleeding:

into the brain or spinal column;
into the lungs. Frequency unknown (cannot be estimated from available data)

Bleeding:

into the abdominal cavity or retroperitoneal space.
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or subcutaneous haemorrhages.
Bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse effects in children and adolescents
You should inform the child's doctor immediately if any of these symptoms are observed:

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 no more than 1 in 10 people). In general, adverse effects observed in children and adolescents treated with apixaban were similar in type to those seen in adults and were mostly mild to moderate in severity. Adverse effects observed 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 effect (may occur in no more than 1 in 10 people)
Bleeding, including:
from the gums;
blood in the urine;
subcutaneous haemorrhage and swelling;
from the intestine or rectum;
presence of bright red blood in stool;
bleeding after surgery, including subcutaneous haemorrhage and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect blood clotting);
Nausea (feeling sick);
Skin rash;
Itching;
Low blood pressure, which may cause fainting or rapid heartbeat;
Blood test results may show:
liver function abnormalities;
increased activity of certain liver enzymes;
increased alanine aminotransferase (AlAT) activity.

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 blood in coughed-up phlegm;
into the brain or spinal column;
into the lungs;
within muscles;
Skin rash, which may develop blisters and resembles small target-like lesions (dark spots in the center surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface or bruising;
Blood test results may show:
increased gamma-glutamyl transferase (GGT) activity;
tests indicating presence of blood in stool or urine.
Bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Erimpox

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 after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 Erimpox contains

The active substance is apixaban. Each capsule contains 5 mg of apixaban.
The other ingredients are:
Capsule contents: monohydrate lactose, microcrystalline cellulose (type 102), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
- Capsule shell: red iron oxide (E172), gelatin.

What Erimpox looks like and contents of the pack
Hard gelatin capsule size "2", red in colour (body and cap), with black imprint "5 mg" on the body, filled with white or almost white powder.
Blister made of Aluminium/OPA/PVC/Aluminium foil or blister made of foil in a carton box.
Pack contains 20, 28, 56, or 60 capsules.
Not all pack sizes may be marketed.

Patient card: information on management
Inside the Erimpox packaging, together with the patient leaflet, there is a patient card, or a similar card may be provided by the treating physician.
The patient card contains helpful information for the patient and warns other physicians that the patient is taking Erimpox. The card should always be carried on the person.

Take the card.
Detach the appropriate language version (perforated edges facilitate this).
Complete the following sections or ask your doctor to complete them:
- Name and surname:
- Date of birth:
- Indication:
- Body weight:
- Dose: ........ mg twice daily

Physician's name:
Physician's telephone number:

Fold the card and always carry it on the person.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorised in the European Economic Area countries under the following names:

Poland	Erimpox
Spain	Erimpox
Portugal	Erimpox
Italy	Erimpox