Erimpox

Poland
Brand name Erimpox
Form capsules, hard
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100507678
Manufacturer Adamed Pharma S.A.

Table of Contents

Package leaflet: Information for the user

Erimpox, 2.5 mg, hard capsules
Apixabanum
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, please ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

  1. What Erimpox is and what it is used for
  2. What you need to know before taking Erimpox
  3. How to take Erimpox
  4. Possible side effects
  5. How to store Erimpox
  6. 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. This medicine helps prevent blood clots by blocking factor Xa, an important component in the blood clotting process. Erimpox is used in adults:

  • to prevent blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee surgery, patients may have an increased risk of developing blood clots in the deep veins of the legs. This may cause leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow, causing breathlessness with or without chest pain. This condition (pulmonary embolism) may be life-threatening and requires immediate medical attention.
  • 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 normal blood flow to these organs (also known as systemic embolism). Stroke may be life-threatening and requires immediate medical attention.
  • to treat blood clots in the deep veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

Erimpox 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 veins or blood vessels of the lungs.
Information on the recommended dose according to body weight is 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 an organ disease 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 in situations when switching anticoagulant therapy, when an intravenous or intra-arterial line has been inserted and heparin is administered through this line to maintain its patency, or when a catheter (catheter ablation) is introduced into the patient's blood vessel to treat irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting to take this medicine, discuss with a 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 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 liver function disorders.
  • if the patient has had a tube (catheter) or injection into the spine (anaesthetic or pain-relieving), in which case the doctor will advise taking this medicine 5 or more hours after removal of the catheter;
  • if the patient has a heart valve prosthesis;
  • if the doctor finds 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 particular caution when using Erimpox:

  • if the patient has a condition 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 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 a doctor.
Children and adolescents
This medicine is not recommended for use in children and adolescents weighing less than 35 kg.
Erimpox 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 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). Especially 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-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 child, she should consult a 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 a doctor before taking this medicine.
Erimpox contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Erimpox

This medicine should always be taken as instructed by your doctor or pharmacist. If you are
unsure, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the capsule with water. Erimpox can be taken with or without food.
To achieve the best treatment results, it is recommended to take the capsules at the same time
every day.
If you have difficulty swallowing the capsule whole, speak to your doctor about other ways of
taking Erimpox. The capsule can be opened, and its contents mixed immediately before intake
with water or a 5% aqueous glucose solution, apple juice, or applesauce.
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 or gently tap to empty them into an appropriate container, then mix the powder with a small amount (e.g., 30 mL (2 tablespoons)) of water or another liquid listed above to prepare a mixture.
  • Swallow the mixture.

If necessary, your 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 instructed for the following indications:
Prevention of blood clots after hip or knee replacement surgery.
The recommended dose is one 2.5 mg Erimpox capsule twice daily,
for example, one in the morning and one in the evening.
The first capsule should be taken 12–24 hours after surgery.
Patients undergoing major hip surgery usually take the capsules for 32 to 38 days.
Patients undergoing major knee surgery usually take the capsules for 10 to 14 days.
Prevention of blood clots in the heart in patients with irregular heartbeat and at least one
additional risk factor.
The recommended dose is one 5 mg Erimpox capsule twice daily.
The recommended dose is one 2.5 mg Erimpox capsule twice daily if:

  • the patient has severe kidney function impairment; or
  • at least two 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 capsule twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you need to continue treatment.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two 5 mg Erimpox 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 5 mg Erimpox capsule twice daily, for example,
one 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 2.5 mg Erimpox capsule twice daily, for example, one
capsule in the morning and one in the evening.
Your doctor will decide how long you need to continue treatment.
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 as instructed by your doctor or pharmacist. If
you are unsure, consult your doctor, pharmacist, or nurse.
To achieve the best treatment outcome, it is recommended to take or administer the dose at the
same time every day.
The dose of Erimpox depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents with a body weight of at least 35 kg is four 2.5 mg Erimpox capsules twice daily for the first 7 days, for example, four in the morning and four in the evening.
After 7 days, the recommended dose is two 2.5 mg Erimpox capsules twice daily, for example,
two in the morning and two in the evening.
For 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 anticoagulant treatment as follows:

  • Switching from Erimpox to other anticoagulant medicines Discontinue Erimpox. Start treatment with another anticoagulant (e.g., heparin) at the time the next Erimpox capsule was due.
  • Switching from other anticoagulants to Erimpox Discontinue the other anticoagulant. Start Erimpox at the time the next dose of the other anticoagulant was due, then continue treatment according to the normal schedule.
  • Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Erimpox Discontinue the vitamin K antagonist medicine. Your doctor will order blood tests and inform you when to start taking Erimpox.
  • Switching from Erimpox 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 Erimpox for at least 2 more days after the first dose of the vitamin K antagonist medicine. Your doctor will order blood tests and inform you when to stop taking Erimpox.

Patients undergoing cardioversion
If restoration of normal heart rhythm by a procedure called cardioversion is necessary, this medicine
should be taken at the time recommended by your doctor to prevent formation of blood clots in the
brain’s blood vessels and other blood vessels in the body.
Taking more Erimpox 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 no longer contains any capsules.
Taking more Erimpox than recommended may increase the risk of bleeding. In the event of bleeding,
surgical treatment, blood transfusion, or other treatments to reverse the anti-factor Xa effect may be
necessary.
Missing a dose of Erimpox

  • If you miss a morning dose, take it as soon as possible and you may take it together with your evening dose.
  • A missed evening dose may only be taken the same evening. Do not take two doses the next morning, but continue taking the medicine the next day as instructed, twice daily. If you have any doubts about use of the medicine or if you miss more than one dose, consult your doctor, pharmacist, or nurse.

Stopping Erimpox
Do not stop taking this medicine without first consulting your doctor, as stopping treatment early 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.
Apixaban can be used in three different medical conditions. The known adverse effects and their frequency of occurrence may differ for each of these conditions and are listed separately below. In these conditions, 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 after hip or knee replacement surgery.

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

  • Anaemia, which may cause fatigue or pallor;
  • Bleeding, including:
  • bruising and swelling;
  • Nausea.

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

  • Decrease in platelet count (which may affect blood clotting);
  • Bleeding:
  • occurring after surgery, including bruising and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
  • from the stomach, intestines, or bright red blood in stool;
  • presence of blood in urine;
  • from the nose;
  • from the vagina;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Blood test results may indicate:
  • 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;
  • Itching.

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

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, oral cavity, tongue and (or) throat, and breathing difficulties. Seek immediate medical attention if any of these symptoms occur.
  • Bleeding:
  • into muscle;
  • into the eyes;
  • from gums and blood in sputum when coughing;
  • from the rectum;
  • Hair loss.

Frequency not known (cannot be estimated from available data)

  • Bleeding:
  • in the brain or spinal canal;
  • into the lungs or throat;
  • in the mouth;
  • into the abdominal cavity or retroperitoneal space;
  • from haemorrhoids;
  • test results indicating presence of blood in stool or urine;
  • Skin rash, which may develop blisters and resemble 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.
  • Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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 up to 1 in 10 people)

  • Bleeding, including:
  • into the eyes;
  • in the stomach or intestines;
  • from the rectum;
  • presence of blood in urine;
  • from the nose;
  • from the gums;
  • Bruising and swelling;
  • Anaemia, which may cause fatigue or pallor;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Nausea;
  • Blood test results may indicate:
  • increased gamma-glutamyl transferase (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 blood in sputum when coughing;
  • into the abdominal cavity or from the vagina;
  • presence of bright red blood in stool;
  • bleeding occurring after surgery, including bruising 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;
  • Decrease in platelet count (which may affect blood clotting);
  • Blood tests may indicate:
  • 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, oral cavity, tongue and (or) throat, and breathing difficulties. Inform your doctor immediately if any of these symptoms occur.

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

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

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

  • Skin rash, which may develop blisters and resemble small target-like lesions (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 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 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 veins of the lower limbs and in 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;
  • presence of blood in urine;
  • bruising and swelling;
  • in the stomach, intestines, or from the rectum;
  • in the mouth;
  • from the vagina;
  • Anaemia, which may cause fatigue or pallor;
  • Decrease in platelet count (which may affect blood clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may indicate:
  • increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

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

  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Bleeding:
  • into the eyes;
  • in the mouth or blood in sputum when coughing;
  • presence of bright red blood in stool;
  • test results indicating presence of blood in stool or urine;
  • bleeding occurring 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, oral cavity, tongue and (or) throat, and breathing difficulties. Seek immediate medical attention if any of these symptoms occur.
  • Blood test results may indicate:
  • 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 up to 1 in 1000 people)
Bleeding:

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

Frequency not known (cannot be estimated from available data)

  • Bleeding:
  • into the abdominal cavity or retroperitoneal space.
  • Skin rash, which may develop blisters and resemble 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.
  • Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse effects in children and adolescents
Inform the child's doctor immediately if any of the following symptoms are observed:

  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, oral cavity, 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).

Overall, adverse effects observed in children and adolescents treated with apixaban were generally similar in type to those observed 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 effects (may occur in up to 1 in 10 people)

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

Frequency not known (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 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 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 indicate:
  • increased gamma-glutamyl transferase (GGT) activity;
  • tests indicating presence of blood in stool or urine.
  • Bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can 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 provide more information on the safety of this medicine.

5. How to store the medicine Erimpox

Keep this medicine out of 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Erimpox contains

  • The active substance is apixaban. Each capsule contains 2.5 mg of apixaban.
  • Other ingredients are:
    • Capsule contents: lactose monohydrate, microcrystalline cellulose (type 102), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
    • Capsule shell: yellow iron oxide (E172), gelatin.

What Erimpox looks like and contents of the pack
Hard gelatin capsule size "4", yellow in colour (body and cap), with black imprint "2.5 mg" on the body, filled with white or almost white powder.
Blister made of Aluminium/OPA/PVC/Aluminium foil or blister made of foil.
Pack contains 20 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.

  1. Take the card.
  2. Separate the appropriate language section (perforated edges make this easier).
  3. Fill in the following details or ask your doctor to complete them:
    • Name and surname:
    • Date of birth:
    • Indication:
    • Body weight:
    • Dose: ........ mg twice daily
    • Doctor's name:
    • Doctor's telephone number:
  4. Fold the card and always carry 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
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

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

PolandErimpox
SpainErimpox
PortugalErimpox
ItalyErimpox