Package leaflet: Information for the user

Erimpox 2.5 mg hard capsules

Apixaban
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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. This medicine helps prevent the formation of blood clots by inhibiting Factor Xa, an important component in the blood clotting process.
Erimpox is used in adults:

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After surgery on the hip or knee, you may be at increased risk of developing blood clots in the veins of the legs. This may cause swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it may block the blood flow, causing shortness of breath, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
to prevent the formation of 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 reach other organs and block normal 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 in the 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 aged from 28 days up to but less than 18 years to treat blood clots and to prevent recurrence of blood clots in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you should know before taking Erimpox

Do not take Erimpox if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you have excessive bleeding;
you have a disease in an organ of the body that increases the risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through that catheter to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
- bleeding disorders, including conditions leading to reduced platelet function;
- very high blood pressure not controlled by medical treatment;
- if you are over 75 years of age;
- if you weigh 60 kg or less;
severe kidney disease or if you are on dialysis;
liver problems or a history of liver problems; This medicine should be used with caution in patients showing signs of impaired liver function.
you have had a tube (catheter) or an injection in your spine (for anesthesia or pain relief). Your doctor will advise you to take this medicine at least 5 hours or more after removal of the catheter;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Erimpox

if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether a change in therapy is necessary.

If you are scheduled for surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure might cause bleeding, consult your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.
Other medicines and Erimpox
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effect of Erimpox, while others can reduce it. Your doctor will decide whether you should be treated with Erimpox when taking these medicines and how closely you should be monitored.
The following medicines may increase the effect of Erimpox and increase the risk of unwanted bleeding:

certain antifungal medicines (e.g., itraconazole, voriconazole, posaconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
certain medicines used to treat Cushing's syndrome (e.g., ketoconazole), when the body produces excess cortisol;
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). Particularly if you are over 75 years of age and taking acetylsalicylic acid, your risk of bleeding may be higher;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of Erimpox in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines for treating tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effects of Erimpox during pregnancy and on the unborn child are unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.
It is not known whether Erimpox passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise whether you should stop breastfeeding or stop/discontinue treatment with this medicine.
Driving and use of machines
Erimpox has not been shown to affect the ability to drive or operate machinery.
Erimpox contains lactose (a type of sugar)
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
Erimpox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Erimpox

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dose

Swallow the capsule with a glass of water. Erimpox may be taken with or without food. Try to take the capsules at the same time each day to achieve the best effect from treatment.

If you have difficulty swallowing the capsule whole, ask your doctor about other ways of taking Erimpox. The capsule may be opened and the contents mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for opening the capsule:

Hold the capsule firmly between the thumbs and index fingers of both hands over a tablespoon or small bowl.
Carefully twist the capsule and pull it apart to open.
Pour or tap the contents into a suitable container and 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 prepare a mixture.
Swallow the mixture.

If necessary, your doctor may also administer the capsule contents mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take Erimpox as recommended for the following:

To prevent 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.

Take the first capsule 12 to 24 hours after surgery.

If you have had major surgery on the hip, you will usually take the capsules for a period of 32 to 38 days.

If you have had major surgery on the knee, you will usually take the capsules for a period of 10 to 14 days.

To prevent 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:

you have severely reduced kidney function;
you meet two or more of the following criteria:
blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher);
you are 80 years of age or older;
your 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 should continue treatment.

To treat blood clots in the veins of the legs and 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.

To prevent recurrence of blood clots after completing 6 months of treatment.

The recommended dose is one 2.5 mg Erimpox capsule twice daily, for example, one in the morning and one in the evening.

Your doctor will decide how long you should continue treatment.

Use in children and adolescents

To treat blood clots and to prevent recurrence of blood clots in veins or in blood vessels of the lungs.

Take or administer this medicine exactly as instructed by your doctor, the child's doctor, or pharmacist. If you have any doubts, consult your doctor, the child's doctor, pharmacist, or nurse.

Try to take or administer the dose at the same time each day to achieve the best effect from treatment.

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 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 or caregivers: Observe the child to ensure they have taken the full dose.

It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.

Your doctor may modify your anticoagulant treatment as follows:

Switching from Erimpox to another anticoagulant medicine
Stop taking Erimpox. Start treatment with the other anticoagulant medicine (e.g., heparin) at the time you would have taken your next capsule.
Switching from another anticoagulant medicine to Erimpox
Stop taking the other anticoagulant medicine. Start taking Erimpox at the time you would have taken your next dose of the other anticoagulant, then continue taking it normally.
Switching from a vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Erimpox
Stop taking the medicine containing the vitamin K antagonist. Your doctor will need to perform blood tests and advise you when to start treatment with Erimpox.
Switching from Erimpox to a vitamin K antagonist anticoagulant treatment (e.g., warfarin)
If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking Erimpox for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop taking Erimpox.

Patients undergoing cardioversion

If your abnormal heart rhythm needs to be restored to normal by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in the blood vessels of the brain and other parts of your body.

If you take more Erimpox than you should

Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine pack with you, even if no capsules remain.

If you take more Erimpox than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, blood transfusions, or other treatments that can reverse the anticoagulant activity against factor Xa.

If you forget to take Erimpox

If you forget to take your morning dose, take it as soon as you remember. You may take it together with your evening dose.
A forgotten evening dose may only be taken the same evening. Do not take two doses the following morning; instead, continue with your regular twice-daily dosing schedule the next day.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.

If you stop taking Erimpox

Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher if you stop treatment too early.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Apixaban may be given for three different medical conditions. The known side effects and how often they occur may differ for each of these medical conditions and are listed separately below. For these conditions, the most common general side effect with this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when apixaban is taken to prevent blood clots after hip or knee replacement surgery.

Common side effects (may affect up to 1 in 10 people)

Anaemia, which may cause tiredness or pale skin;
Bleeding, including:
- Bruising and swelling;
Nausea (feeling unwell).

Uncommon side effects (may affect up to 1 in 100 people)

Reduction in the number of platelets in the blood (which may affect blood clotting);
Bleeding:
- Occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From the stomach, intestine, or clear/red blood in the stools;
- Blood in the urine;
- Nosebleeds;
- Vaginal bleeding;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Itching.

Rare side effects (may affect up to 1 in 1,000 people)

Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Bleeding:
- Into the muscle;
- Into the eyes;
- From the gums and blood in sputum when coughing;
- From the rectum;
Hair loss.

Not known (frequency cannot be estimated from available data)

Bleeding:
- In the brain or spinal cord;
- In the lungs or throat;
- In the mouth;
- In the abdomen or into the space behind the abdominal cavity;
- From haemorrhoids;
Tests showing blood in the stools or urine;
Skin rash which may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present with skin rashes or small, flat, red, round spots under the skin surface or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban is taken to prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
- In the eyes;
- In the stomach or intestine;
- From the rectum;
- Blood in the urine;
- Nosebleeds;
- From the gums;
- Bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT).

Uncommon side effects (may affect up to 1 in 100 people)

Bleeding:
- In the brain or spinal cord;
- In the mouth or blood in sputum when coughing;
- In the abdomen or from the vagina;
- Clear/red blood in the stools;
- Bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- Tests showing blood in the stools or urine;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
- In the lungs or throat;
- Into the space behind the abdominal cavity;
- Into the muscle.

Very rare side effects (may affect up to 1 in 10,000 people)

Skin rash which may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may present with skin rashes or small, flat, red, round spots under the skin surface or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban is taken to treat or prevent recurrence of 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:
- Nosebleeds;
- From the gums;
- Blood in the urine;
- Bruising and swelling;
- In the stomach, intestine, or from the rectum;
- In the mouth;
- From the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon side effects (may affect up to 1 in 100 people)

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
- In the eyes;
- In the mouth or blood in sputum when coughing;
- Clear/red blood in the stools;
- Tests showing blood in the stools or urine;
- Bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- Into the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
- In the brain or spinal cord;
- In the lungs.

Not known (frequency cannot be estimated from available data)

Bleeding:
- In the abdomen or into the space behind the abdominal cavity.
Skin rash which may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present with skin rashes or small, flat, red, round spots under the skin surface or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these symptoms:

Allergic reactions (hypersensitivity) which may 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).

In general, the side effects observed in children and adolescents treated with apixaban have been similar in type to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

Bleeding, including:
- From the vagina;
- Nosebleeds.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
- From the gums;
- Blood in the urine;
- Bruising and swelling;
- From the intestine or rectum;
- Clear/red blood in the stools;
- Bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
Hair loss;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the child’s blood (which may affect blood clotting);
Nausea (feeling unwell);
Skin rash;
Itching;
Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased alanine aminotransferase (ALT).

Not known (frequency cannot be determined from available data)

Bleeding:
- In the abdomen or into the space behind the abdominal cavity;
- In the stomach;
- In the eyes;
- In the mouth;
- From haemorrhoids;
- In the mouth or blood in sputum when coughing;
- In the brain or spinal cord;
- In the lungs;
- Into the muscle;
Skin rash which may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Inflammation of blood vessels (vasculitis), which may present with skin rashes or small, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT);
- Tests showing blood in the stools or urine.
Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this 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 which is stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Erimpox contains

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

Description of the appearance of Erimpox and package contents
Hard gelatin capsule of size "4"; yellow in colour (body and cap), printed with "2.5 mg" in black ink on the body, filled with white or almost white powder.
Blister made of oPA/AL/PVC laminate and aluminium foil or transparent PVC/PVDC film and aluminium foil. The blisters and a patient leaflet are packaged in a cardboard box.
Pack sizes: 20 and 60 capsules.
Not all pack sizes may be marketed.

Patient Card: managing information
Inside the Erimpox package, together with the package leaflet, you will find a Patient Card or your doctor may provide you with a similar one.
This Patient Card includes information that may be useful to you and alerts other physicians that you are taking Erimpox. You must always carry this card with you.

Take the card.
Tear off the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections or ask your doctor to do so:
- Name:
- Date of birth:
- Indication:
- Weight:
- Dose ....... mg twice daily
- Physician's name:
- Physician's telephone number:
Fold the card and always keep it with you.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed s.r.l., Via G. Mazzini 20, 20123 Milan, Italy
Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Erimpox
Italy: Erimpox
Portugal: Erimpox
Spain: Erimpox 2.5 mg hard capsules EFG

Package leaflet: information for the user

Erimpox 5 mg hard capsules

Apixaban
Generic medicine
Please read 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and with at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or travel to other organs and block normal blood flow to those organs (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 in the 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 aged 28 days up to but less than 18 years to treat blood clots and to prevent recurrence of blood clots in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you need to know before taking Erimpox

Do not take Erimpox if:

you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
you have excessive bleeding;
you have a disease in a body organ that increases the risk of serious bleeding (such as a recent or active ulcer in the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have an intravenous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure, uncontrolled by medical treatment;
if you are over 75 years of age;
if you weigh 60 kg or less;
severe kidney disease or if you are on dialysis;
liver problems or a history of liver problems;
This medicine will be used with caution in patients showing signs of impaired liver function.
you have had a tube (catheter) or an injection into your spine (for anaesthesia or pain relief). Your doctor will tell you to take this medicine at least 5 hours or more after removal of the catheter;
you have had a tube (catheter) or an injection into your spine (for anaesthesia or pain relief). Your doctor will tell you to take this medicine at least 5 hours or more after removal of the catheter;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Erimpox

if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether therapy needs to be changed.

Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.

Other medicines and Erimpox
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effect of Erimpox, while others can reduce it. Your doctor will decide whether you should be treated with Erimpox when taking these medicines and how closely you should be monitored.

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

certain antifungal medicines (e.g., itraconazole, voriconazole, posaconazole, etc.);
certain antiviral medicines for HIV/AIDS (e.g., ritonavir);
certain medicines used to treat Cushing's syndrome (e.g., ketoconazole), when the body produces excess cortisol;
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). Particularly if you are over 75 years of age and taking acetylsalicylic acid, your risk of bleeding may be higher;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effect of Erimpox in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines for treating tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effects of Erimpox during pregnancy and on the unborn child are unknown. You must not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while taking this medicine.
It is not known whether Erimpox passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will advise you whether to discontinue breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines
Erimpox has not shown any effects on the ability to drive or operate machinery.

Erimpox contains lactose (a type of sugar)
If your doctor has informed you of an intolerance to certain sugars, contact them before taking this medicine.

Erimpox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Erimpox

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.

Dose
Swallow the capsule with some water. Erimpox can be taken with or without food. Try to take the capsules at the same time each day to get the best effect from treatment.
If you have difficulty swallowing the capsule whole, ask your doctor about other ways to take Erimpox. The capsule may be opened and the contents mixed with water, or 5% glucose in water, or apple juice or apple puree, immediately before taking.

Instructions for opening the capsule:

Hold the capsule firmly between the thumbs and index fingers of both hands over a tablespoon or small bowl.
Carefully twist the capsule and pull it apart.
Pour or tap the contents 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 prepare a mixture.
Swallow the mixture.

If necessary, your doctor may also administer the capsule contents mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take Erimpox as recommended for the following:

To prevent blood clots from forming in the heart in patients with irregular heartbeat and at least one additional risk factor:
The recommended dose is one capsule of Erimpox 5 mg twice daily.

The recommended dose is one capsule of Erimpox 2.5 mg twice daily if:

you have severely reduced kidney function;
you meet two or more of the following conditions:
- blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL (133 micromoles/L) or higher);
- you are 80 years of age or older;
- your 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 should continue treatment.

To treat blood clots in the veins of the legs and in the blood vessels of the lungs:
The recommended dose is two capsules of Erimpox 5 mg 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 capsule of Erimpox 5 mg twice daily, for example, one in the morning and one in the evening.

To prevent blood clots from recurring after completing 6 months of treatment:
The recommended dose is one capsule of Erimpox 2.5 mg twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Use in children and adolescents
To treat blood clots and to prevent blood clots from recurring in veins or blood vessels of the lungs:
Take or administer this medicine exactly as instructed by your doctor, the child’s doctor, or pharmacist. If you have any doubts, consult your doctor, the child’s doctor, pharmacist, or nurse.
Try to take or administer the dose at the same time each day to achieve the best treatment effect.
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 capsules of Erimpox 5 mg 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 capsule of Erimpox 5 mg twice daily, for example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure they have taken the full dose.
It is important to keep scheduled medical appointments, as the dose may need to be adjusted as body weight changes.

Your doctor may change your anticoagulant treatment in the following ways:

Switching from Erimpox to another anticoagulant medicine
Stop taking Erimpox. Start treatment with the other anticoagulant medicine (e.g., heparin) at the time you would have taken your next capsule.
Switching from another anticoagulant medicine to Erimpox
Stop taking the other anticoagulant medicine. Start treatment with Erimpox at the time you would have taken your next dose of the other anticoagulant, then continue taking it as usual.
Switching from a vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Erimpox
Stop taking the medicine containing the vitamin K antagonist. Your doctor will need to perform blood tests and advise you when to start treatment with Erimpox.
Switching from Erimpox to a vitamin K antagonist anticoagulant treatment (e.g., warfarin)
If your doctor tells you to start taking a medicine containing a vitamin K antagonist, continue taking Erimpox for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop treatment with Erimpox.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in blood vessels of the brain and elsewhere in your body.

If you take more Erimpox than you should
Contact your doctor immediately if you have taken more than the prescribed dose of Erimpox. Bring the medicine pack with you, even if no capsules remain.
If you take more Erimpox than recommended, you may have an increased risk of bleeding. If bleeding occurs, you may require surgery, blood transfusions, or other treatments that can reverse the anticoagulant effect on factor Xa.

If you forget to take Erimpox

If you forget to take a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
A forgotten evening dose may only be taken on the same evening. Do not take two doses the next morning; instead, continue with the recommended twice-daily dosing schedule the following day.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.

If you stop taking Erimpox
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher if you stop treatment too early.
If you have any questions about using this medicine, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common general side effect with this medicine is bleeding, which may potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when apixaban is taken to prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.

Common side effects (may affect up to 1 in 10 people)

Bleeding, including:
in the eyes;
in the stomach or intestines;
from the rectum;
blood in the urine;
from the nose;
from the gums;
bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Nausea (feeling sick);
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT).

Uncommon side effects (may affect up to 1 in 100 people)

Bleeding:
in the brain or spinal cord;
in the mouth or blood in coughed-up phlegm when coughing;
in the abdomen or from the vagina;
bright red blood in the stools;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
tests showing blood in the stools or urine;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.

Rare side effects (may affect up to 1 in 1,000 people)

Bleeding:
in the lungs or throat;
behind the abdominal cavity;
in the muscle.

Very rare side effects (may affect up to 1 in 10,000 people)

Rash that may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme ).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may present as rashes or small, flat, red, round spots under the skin surface or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban is taken to treat or prevent recurrence of 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, intestines, or from the rectum;
in the mouth;
from the vagina;
Anaemia, which may cause tiredness or pale skin;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling sick);
Rash;
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

Uncommon side effects (may affect up to 1 in 100 people)

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
in the eyes;
in the mouth or blood in coughed-up phlegm when coughing;
bright red blood in the stools;
tests showing blood in the stools or urine;
bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
from haemorrhoids;
in the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately if you experience any of these symptoms;
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes.

Rare side effects (may affect up to 1 in 1,000 people)

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

Not known (frequency cannot be estimated from available data)

Bleeding:
in the abdomen or behind the abdominal cavity;
Rash that may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme );
Inflammation of blood vessels (vasculitis), which may present as rashes or small, flat, red, round spots under the skin surface or bruising;
Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these symptoms:

Allergic reactions (hypersensitivity) which may 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).

In general, side effects observed in children and adolescents treated with apixaban have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were 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;
from the intestine or rectum;
bright red blood in the stools;
bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision (wound discharge) or from the injection site;
Hair loss;
Anaemia, which may cause tiredness or pale skin;
Decrease in the number of platelets in the child’s blood (which may affect blood clotting);
Nausea (feeling sick);
Rash;
Itching;
Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
Blood tests may show:
abnormalities in liver function;
increase in certain liver enzymes;
increase in alanine aminotransferase (ALT).

Not known (frequency cannot be determined from available data)

Bleeding:
in the abdomen or behind the abdominal cavity;
in the stomach;
in the eyes;
in the mouth;
from haemorrhoids;
in the mouth or blood in coughed-up phlegm when coughing;
in the brain or spinal cord;
in the lungs;
in the muscle;
Rash that may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme );
Inflammation of blood vessels (vasculitis), which may present as rashes or small, flat, red, round spots under the skin surface or bruising;
Blood tests may show:
an increase in gamma-glutamyl transferase (GGT);
tests showing blood in the stools or urine;
Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this 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 carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Erimpox contains

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

Description of the appearance of Erimpox and contents of the pack
Hard gelatin capsule of size "2"; red in colour (body and cap), printed with "5 mg" in black ink on the body, filled with white or almost white powder.
Blister made of laminated oPA/Al/PVC and aluminium foil or blister made of transparent PVC/PVDC film and aluminium foil. The blisters and a patient leaflet are packaged in a cardboard box.
Pack sizes of 20, 28, 56 and 60 capsules.
Not all pack sizes may be marketed.

Patient Card: information management
Inside the Erimpox package, together with the package leaflet, you will find a Patient Card, or your doctor may provide you with a similar one.
This Patient Card contains information that may be useful to you and alerts other doctors that you are taking Erimpox. You must always carry this card with you.

Take the card.
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
Complete the following sections or ask your doctor to do so:
- Name:
- Date of birth:
- Indication:
- Weight:
- Dose ....... mg twice daily
- Doctor's name:
- Doctor's telephone number:
Fold the card and keep it with you at all times.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed s.r.l., Via G. Mazzini 20, 20123 Milano, Italy
Manufacturer
Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Erimpox
Italy: Erimpox
Portugal: Erimpox
Spain: Erimpox 5 mg cápsulas duras EFG

PATIENT CARD
Erimpox (apixaban)
Patient Card
You/the child/the caregiver must always carry this card with you.
Show this card to the pharmacist, dentist, and any other healthcare professional before treatment.
I am on anticoagulant therapy with Erimpox (apixaban) to prevent blood clots.
Please complete this section or ask your doctor to do so
Name:
Date of birth:
Indication:
Weight:
Dose: …mg twice daily
Doctor's name:
Doctor's telephone number:

Information for patients/caregivers

Take/Give Erimpox regularly as directed. If you forget to take/give a morning dose, take/give it as soon as you remember; you may take/give it together with the evening dose. A forgotten evening dose may only be taken/given on the same evening. Do not take/give two doses the following morning; instead, continue following your twice-daily dosing schedule as recommended the next day.
Do not stop taking/administering Erimpox without first talking to your doctor, as you/the patient is at risk of having a stroke, blood clot, or other complications.
Erimpox helps to thin the blood. However, this may increase the risk of bleeding.
Signs and symptoms of bleeding include bruises or bleeding under the skin, tar-coloured stools, blood in the urine, nosebleeds, dizziness, fatigue, paleness or weakness, sudden severe headache, coughing up blood or blood in vomit.
If bleeding does not stop on its own, seek immediate medical help.
If you/the patient need to undergo surgery or any invasive procedure, inform the doctor that you/the patient are taking Erimpox.

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Information for healthcare professionals

Erimpox (apixaban) is an oral anticoagulant that acts via direct selective inhibition of factor Xa.
Erimpox may increase the risk of bleeding. In case of major bleeding events, Erimpox must be discontinued immediately.
Treatment with Erimpox does not require routine monitoring of drug exposure levels. A calibrated quantitative anti-factor Xa assay may be useful in exceptional circumstances, such as overdose or emergency surgery (coagulation tests such as prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) are not recommended) – see SmPC. An antidote is available for adults that reverses the anti-factor Xa activity of apixaban; however, its safety and efficacy have not been established in paediatric patients (see the summary of product characteristics of andexanet alfa).