Package leaflet: Information for the user

Apixaban Olpha 2.5 mg film-coated tablets

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 seem identical to yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban Olpha contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps prevent the formation of blood clots by blocking Factor Xa, an important component in blood clotting.
Apixaban Olpha is used in adults:

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. Following surgery on the hip or knee, you may be at increased risk of developing blood clots in the veins of the legs. This can cause swelling of the legs, with or without pain. If a blood clot travels from the leg to the lungs, it can block 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 can break loose and travel to the brain, causing a stroke, or reach other organs and block normal blood supply to these organs (also known as systemic embolism). A 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 blood clots in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban Olpha

Do not take Apixaban Olpha 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 leads to an increased risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, recent bleeding in the brain);
you have a liver disease that leads to an increased 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 old;
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 injection in the spinal column (for anaesthesia or pain relief). Your doctor will tell you when to start taking 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.

Use particular care with Apixaban Olpha

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 needed. 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 may cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Apixaban Olpha
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 Apixaban Olpha, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Olpha when taking these medicines and how closely you should be monitored.

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

some medicines for fungal infections (e.g., ketoconazole, etc.);
some antiviral medicines for HIV/AIDS (e.g., ritonavir);
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 old 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 Apixaban Olpha 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 to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Apixaban Olpha during pregnancy and on the unborn child is 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 Apixaban Olpha passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines
Apixaban Olpha has not shown effects on the ability to drive or use machines.

Apixaban Olpha contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Olpha

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 tablet with some water. Apixaban Olpha may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways of taking Apixaban Olpha. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for crushing the tablet:

Crush the tablets with a mortar and pestle.
Carefully transfer all the powder 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 mentioned above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used for crushing the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

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

Take Apixaban Olpha as recommended:

To prevent blood clots after hip or knee replacement surgery:
The recommended dose is one 2.5 mg Apixaban Olpha tablet twice daily, for example, one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after surgery.
If you have undergone major surgery on the hip, you will usually take the tablets for a period of 32 to 38 days.
If you have undergone major surgery on the knee, you will usually take the tablets for a period of 10 to 14 days.

To prevent blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor:
The recommended dose is one 5 mg Apixaban Olpha tablet twice daily.
The recommended dose is one 2.5 mg Apixaban Olpha tablet 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 tablet 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 (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism):
The recommended dose is two 5 mg Apixaban Olpha tablets twice daily for the first 7 days, for example, two in the morning and two in the evening. After 7 days, the recommended dose is one 5 mg Apixaban Olpha tablet 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 Apixaban Olpha tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Your doctor may modify your anticoagulant treatment as follows:

Switching from Apixaban Olpha to another anticoagulant medicine
Stop taking Apixaban Olpha. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
Switching from another anticoagulant medicine to Apixaban Olpha
Stop taking the anticoagulant medicine. Start treatment with Apixaban Olpha at the time you would have taken your next dose of the anticoagulant, then continue taking it as usual.
Switching from a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Olpha
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Olpha.
Switching from Apixaban Olpha to a vitamin K antagonist anticoagulant (e.g., warfarin)
If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Olpha 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 on when to stop taking Apixaban Olpha.

Patients undergoing cardioversion
If your abnormal heart rhythm requires correction 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 elsewhere in the body.

If you take more Apixaban Olpha 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 tablets are left.

If you take more Apixaban Olpha than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments that can reverse the anticoagulant effect on factor Xa may be required.

If you forget to take Apixaban Olpha
Take the missed dose as soon as you remember, and:
take your next dose of Apixaban Olpha at the usual time,
then continue as directed.

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 Apixaban Olpha
Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped 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 Olpha may be given for three different medical conditions. The known side effects and how frequently 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 could potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Olpha 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)

Decrease 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 faeces;
- Blood in urine;
- Nosebleeds;
- Vaginal bleeding;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Blood tests may show:
- Liver function abnormalities;
- 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 breathing difficulties. 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 in the space behind the abdominal cavity;
- From haemorrhoids;
- Tests showing blood in faeces or urine;
Skin rash that may form blisters and appears 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 skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Olpha is taken to prevent blood clots 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 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) levels.

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 faeces;
- 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 faeces or urine;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
- Liver function abnormalities;
- 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 breathing difficulties. 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;
- In the space behind the abdominal cavity;
- Into the muscle.

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

Skin rash that may form blisters and appears 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 skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Olpha 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 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;
Decrease in the number of platelets in the blood (which may affect blood clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- Increased levels of 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 faeces;
- Tests showing blood in faeces or urine;
- 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;
- Into the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
Blood tests may show:
- Liver function abnormalities;
- 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 in the space behind the abdominal cavity;
Skin rash that may form blisters and appears 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 skin rashes or sharp, flat, red, round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Apixaban Olpha

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. or 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. Pack contents and other information

What Apixaban Olpha contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
The other components are:
- Tablet core: lactose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate.
- Coating: Yellow Opadry II (contains: hypromellose, monohydrate lactose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, yellow iron oxide (E172).
  Description of the appearance of Apixaban Olpha and pack contents
  The film-coated tablets are yellow, round, biconvex, with "I1" engraved on one side and smooth on the other.
- They are contained in transparent PVC/PVDC/aluminum blisters of 10 or 14 film-coated tablets, packaged in cartons containing 20, 60, or 168 film-coated tablets.
- 200 film-coated tablets are contained in an HDPE bottle with a tamper-evident PP cap.

It is possible that not all pack sizes are marketed.
Patient Alert Card: managing information
Inside the Apixaban Olpha packaging, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with a similar one.
This Patient Alert Card contains important information that may be useful to you and alerts other healthcare professionals that you are taking Apixaban Olpha. 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 complete them:
- Name:
- Date of birth:
- Indication:
- Dose ........... mg twice daily
- Doctor's name:
- Doctor's telephone number:
Fold the card and always keep it with you.

Marketing Authorization Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic, Estonia, Germany, Italy, Spain, Poland: Apixaban Olpha
France: APIXABAN OLPHA 2.5 mg, comprimé pelliculé
Latvia: Apixaban Olpha 2.5 mg apvalkotās tabletes
Lithuania: Apixaban Olpha 2.5 mg plėvele dengtos tabletės
Slovakia: Apixaban Olpha 2.5 mg

Package leaflet: information for the user

Apixaban Olpha 5 mg film-coated tablets

apixaban
Generic medicine
Please read this leaflet carefully before taking this medicine as 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 they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban Olpha 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 blood coagulation.
Apixaban Olpha is used in adults:

to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) who have 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.

2. What you should know before taking Apixaban Olpha

Do not take Apixaban Olpha 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 leads to a higher risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, recent bleeding in the brain);
you have a liver disease that leads to an increased 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 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 not controlled by medical treatment;
- if you are over 75 years old;
- 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 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 Apixaban Olpha

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.

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 time. If you are unsure whether a procedure might cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Apixaban Olpha
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 Apixaban Olpha, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Olpha when taking these medicines and how closely you should be monitored.

The following medicines can increase the effect of Apixaban Olpha and increase the risk of unwanted bleeding:

some medicines for fungal infections (e.g., ketoconazole, etc.);
some antiviral medicines for HIV/AIDS (e.g., ritonavir);
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 old 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 Apixaban Olpha in helping to prevent blood clots:

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effects of Apixaban Olpha on pregnancy and 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 Apixaban Olpha passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine during breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

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

3. How to take Apixaban Olpha

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

Dosage

Swallow the tablet with some water. Apixaban Olpha can be taken with or without food.
Try to take the tablets at the same time each day to achieve the best effect from treatment.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Olpha. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for crushing the tablet:

Crush the tablets with a mortar and pestle.
Carefully transfer all the powder 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 mentioned above to prepare a mixture.
Swallow the mixture.
Rinse the mortar and pestle used for crushing the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse. If necessary, your doctor may also administer crushed Apixaban Olpha tablets mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.

Take Apixaban Olpha as recommended:

To prevent blood clots in the heart in patients with irregular heart rhythm and at least one additional risk factor:

The recommended dose is one Apixaban Olpha 5 mg tablet twice daily.

The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily if:

you have severely reduced kidney function; or
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 tablet 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 tablets of Apixaban Olpha 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 tablet of Apixaban Olpha 5 mg twice daily, for example, one in the morning and one in the evening.

To prevent recurrence of blood clots after completion of 6 months of treatment:

The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Your doctor may adjust your anticoagulant treatment as follows:

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

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 Apixaban Olpha than you should
Inform your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine pack with you, even if no tablets are left.

If you forget to take Apixaban Olpha
Take the missed dose as soon as you remember and:

take your next dose of Apixaban Olpha at the usual time;
then continue as directed.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common general side effect of 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 Olpha is taken to prevent the formation of blood clots 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 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 coughed-up phlegm;
- 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;
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 breathing difficulties. 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;
- in the space 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 appears 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 the available data)

Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots or bruises under the skin surface.

The following side effects are known to occur when Apixaban Olpha is taken to treat or prevent recurrence of blood clots in the veins of the legs and in the 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 unwell);
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 coughed-up phlegm;
- 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;
- in the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. 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 the available data)

Bleeding:
- in the abdomen or in the space behind the abdominal cavity;
Rash that may blister and appears 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 skin rashes or small, flat, red, round spots or bruises under the skin surface.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Apixaban Olpha

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. or 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 any medicine 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 Apixaban Olpha contains

The active substance is apixaban. Each tablet contains 5 mg of apixaban.
The other components are:
- Tablet core: lactose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate.
- Coating: Pink Opadry II (contains: hypromellose, monohydrate lactose (see section 2 "Apixaban Olpha contains lactose (a type of sugar) and sodium"), titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Olpha and contents of the pack
The film-coated tablets are pink, oval-shaped, biconvex, with "I2" engraved on one side and smooth on the other.

They are contained in transparent PVC/PVDC/aluminum blisters, packed in quantities of 10, 14, 28, 56, 60, 168 film-coated tablets, in cartons.
200 film-coated tablets are contained in an HDPE bottle with a tamper-evident PP cap.

Not all pack sizes may be marketed.

Patient Alert Card: managing information
Inside the Apixaban Olpha packaging, together with the package leaflet, you will find a Patient Alert Card, or your doctor may provide you with a similar one.
This Patient Alert Card includes information that may be useful to you and alerts other physicians that you are taking Apixaban Olpha. 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:
- Dose mg twice daily
- Doctor's name:
- Doctor's telephone number:
Fold the card and always keep it with you.

Marketing Authorization Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic, Estonia, Germany, Italy, Spain, Poland: Apixaban Olpha
France: APIXABAN OLPHA 5 mg, comprimé pelliculé
Latvia: Apixaban Olpha 5 mg apvalkotās tabletes
Lithuania: Apixaban Olpha 5 mg plėvele dengtos tabletės
Slovakia: Apixaban Olpha 5 mg