APIXABAN 2.5 mg Film-coated tablets

Зміст інструкції

1. Apixaban Olpha 2,5 mg film-coated tablets
   1. What is Apixaban Olpha and what it is used for
   2. What you need to know before taking Apixaban Olpha
   3. How to take Apixaban Olpha
   4. Possible side effects
   5. How to store Apixaban Olpha
   6. Package Contents and Other Information
2. Apixaban Olpha 5 mg film-coated tablets
   1. What is Apixaban Olpha and what is it used for
   2. What you need to know before taking Apixaban Olpha
   3. How to take Apixaban Olpha
   4. Possible side effects
   5. How to store Apixaban Olpha
   6. Package Contents and Other Information

Apixaban Olpha 2,5 mg film-coated tablets

apixaban

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
• 1. What Apixaban Olpha is and what it is used for
• 2. What you need to know before you take Apixaban Olpha
• 3. How to take Apixaban Olpha
• 4. Possible side effects
• 5. How to store Apixaban Olpha
• 6. Contents of the pack and other information

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

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

• to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After a hip or knee operation, 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 moves 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 with at least one additional risk factor. Blood clots can break off and reach the brain, leading to stroke, or reach other organs preventing 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 blood clots from reforming 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 allergicto 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 organthat leads to a higher risk of serious bleeding (such as a recentor ongoing stomach or intestinal ulcer, recent bleeding in the brain);
• you have a liver diseasethat leads to a higher risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clots from forming(e.g., warfarin, rivaroxaban, dabigatran or heparin), except when you are changing anticoagulant treatment, 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 your blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia). Warnings and precautionsTalk 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 that lead to reduced platelet activity;
• very high blood pressure,not controlled by medical treatment;
• if you are over 75 years of age;
• if you weigh 60 kg or less;
• a serious 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 with signs of altered liver function.
• you have a tube (catheter) or have had an injection into your spine(for anesthesia or pain relief). Your doctor will tell you to take this medicine 5 hours or more after the catheter is removed;
• 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.

Pay particular attention with Apixaban Olpha

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy. If you need to undergo surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily interrupt taking this medicine for a short time. If you are not sure if a procedure may cause bleeding, ask your doctor. Children and adolescentsThis medicine is not recommended in children and adolescents under 18 years of age. Other medicines and Apixaban OlphaTell 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 and others can decrease it. Your doctor will decide if you should be treated with Apixaban Olpha when taking these medicines and how carefully you should be monitored.
The following medicines can increase the effect of Apixaban Olpha and increase the possibility 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-inflammatoryor painkillers(e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a greater

risk of bleeding;

• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.The following medicines can reduce the effect of Apixaban Olpha in helping to prevent the formation of blood clots:
• medicines for epilepsy or seizures(e.g., phenytoin, etc.);
• St. John's wort(a herbal product used for depression);
• medicines to treat tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor, pharmacist or nurse for advice before taking this medicine.
The effect of Apixaban Olpha on pregnancy and the unborn child are unknown. You should not take this medicine if you are pregnant. Contact your doctor immediatelyif 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 stop/not start therapy with this medicine.

Driving and using machines
Apixaban Olpha has not shown effects on the ability to drive vehicles 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 some 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a little water. Apixaban Olpha can be taken with or without food.
Try to take the tablets at the same time each day, to obtain the best effect from the
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take
Apixaban Olpha. The tablet can be crushed and mixed with water, or 5% glucose solution in
water, or apple juice or applesauce, immediately before taking it.

Instructions for crushing the tablet:

• Crush the tablets with a pestle and mortar.
• 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 pestle and mortar used to crush 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 Apixaban Olpha tablet crushed and
mixed with 60 mL of water or 5% glucose solution in water, through a nasogastric tube.

Take Apixaban Olpha as recommended:
To prevent the formation of blood clots after hip or
knee replacement surgeries.
The recommended dose is one Apixaban Olpha 2.5 mg tablet twice a day. For example,
one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after the surgery.
If you have had a major hipsurgery, you will generally take the tablets for a period of 32 to
38 days.
If you have had a major kneesurgery, you will generally take the tablets for a period of
10 to 14 days.
To prevent the formation of blood clots in the heart in patients with irregular heartbeat and
with at least one additional risk factor.
The recommended dose is one Apixaban Olpha 5 mgtablet twice a day.
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day if:

• you have severely reduced kidney function;
• you fall into two or more of the following conditions:
• blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dL (133 micromol/L) or higher);
• you are 80 years of age or older;
• your weight is 60 kg or less. The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue the treatment. To treat blood clots in the veins of the legs and in the blood vessels of the lungs The recommended dose is two tabletsof Apixaban Olpha 5 mgtwice a day for the first 7 days, for example two in the morning and two in the evening. After 7 days the recommended dose is one tabletof Apixaban Olpha 5 mgtwice a day, for example, one in the morning and one in the evening.

To prevent blood clots from reforming after completing 6 months of treatment
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day, for example,
one in the morning and one in the evening.
Your doctor will decide how long you should continue the treatment.

Your doctor may modify your anticoagulant treatment as follows:

• Switching from Apixaban Olpha to an anticoagulant medicineStop taking Apixaban Olpha. Start treatment with the anticoagulant medicine (for example heparin) at the time you would have taken the next Apixaban Olpha tablet.
• Switching from an anticoagulant medicine to Apixaban OlphaStop taking the anticoagulant medicine. Start treatment with Apixaban Olpha at the time you would have taken the next dose of the anticoagulant medicine, then continue taking it normally.
• Switching from treatment with an anticoagulant containing a vitamin K antagonist (e.g.warfarin) to Apixaban OlphaStop taking the medicine containing the vitamin K antagonist. Your doctor will need to perform blood tests and instruct you on when to start treatment with Apixaban Olpha.
• Switching from Apixaban Olpha to treatment with an anticoagulant 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 medicine containing a vitamin K antagonist. Your doctor will need to perform blood tests and instruct you on when to stop treatment with Apixaban Olpha. Patients undergoing cardioversionIf your irregular heartbeat needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to take it, to prevent blood clots in the blood vessels in the brain and in other blood vessels in your body. If you take more Apixaban Olpha than you shouldInform your doctor immediatelyif you have taken more than the prescribed dose of this medicine. Bring the medicine packaging with you, even if there are no tablets left.

If you take more Apixaban Olpha than recommended, you may have a greater risk of
bleeding. If bleeding occurs, surgery, a
transfusion or other treatments that can inactivate the activity against factor Xa may be necessary.

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

If you have doubts about what to do or if you have forgotten 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, because the risk of
developing a blood clot may be greater if you stop treatment too soon.
If you have any doubts about using 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 can be given for three different medical conditions. The known side effects and the
frequency with which they occur may be different for each of these medical conditions and are listed
separately below. For these conditions, the most common general side effect of 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 Olpha is taken to prevent the
formation of blood clots after hip or knee replacement surgery.

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

• Anemia which can cause fatigue or paleness;
• Bleeding, including:
• bruising and swelling;
• Nausea (feeling sick).

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:
• that occurs after surgery, including bruising and swelling, leakage of blood or fluids from the
  wound/surgical incision (wound secretion) or from the injection site;
• from the stomach, intestines, or bright/red blood in the stool;
• blood in the urine;
• from the nose;
• from the vagina;
• Low blood pressure which can cause weakness or a fast heartbeat;
• Blood tests may show:
• abnormal liver function;
• increased levels of certain liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin
  and eyes;
• Itching.

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

• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue
  and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms
  occur.
• Bleeding:
• in the muscle;
• in the eyes;
• in the gums and blood when coughing;
• from the rectum;
• Hair loss.

Not known (frequency cannot be estimated from the available data)

• Bleeding:
• in the brain or spinal cord;
• in the lungs or throat;
• in the mouth;
• in the abdomen or the space behind the abdominal cavity;
• from hemorrhoids;
• tests showing blood in the stool or urine;
• Skin rash that may blister and appears as small targets (dark central spots surrounded by a clearer
  area, with a dark ring around the edge) (erythema multiforme);
• Inflammation of blood vessels (vasculitis) which may manifest with skin rashes or pinpoint, 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 the
formation of blood clots in the heart in patients with irregular heartbeat and with 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;
• Anemia which can cause fatigue or paleness;
• Low blood pressure which can cause weakness or a fast 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 when coughing;
• in the abdomen or from the vagina;
• bright/red blood in the stool;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluids from the
  wound/surgical incision (wound secretion) or from the injection site;
• from hemorrhoids;
• tests showing blood in the stool 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 breakdown product of red blood cells, which can cause yellowing of the skin
  and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue
  and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms
  occur. 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)

• Skin rash that may blister and appears as small targets (dark central spots surrounded by a clearer
  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 manifest with skin rashes or pinpoint, 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 blood clots from reforming in the veins of the legs and
  blood vessels in 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, from the rectum;
• in the mouth;
• from the vagina;
• Anemia which can cause fatigue or paleness;
• Reduction in the number of platelets in the blood (which may affect blood clotting);
• Nausea (feeling sick);
• Skin 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 can cause weakness or a fast heartbeat
• Bleeding:
• in the eyes;
• in the mouth or blood when coughing;
• bright/red blood in the stool;
• tests showing blood in the stool or urine;
• bleeding that occurs after any surgery, including bruising and swelling, leakage of blood or fluids from the
  wound/surgical incision (wound secretion) or from the injection site;
• from hemorrhoids;
• in the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue
  and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms
  occur.
• Blood tests may show:
• abnormal liver function;
• increased levels of certain liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can 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 the space behind the abdominal cavity.
• Skin rash that may blister and appears as small targets (dark central spots surrounded by a clearer
  area, with a dark ring around the edge) (erythema multiforme);
• Inflammation of blood vessels (vasculitis) which may manifest with skin rashes or pinpoint, flat, red,
  round spots under the skin surface or bruising.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system located 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 box and on the blister after
Scad. 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 in waste water 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 ingredient is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other ingredients 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, lactose monohydrate(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 package contentsThe film-coated tablets are yellow, round, biconvex, with “I1” imprinted 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 of 20, 60, 168 film-coated tablets.
• 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
Your Patient Alert Card or your doctor may give you a similar one.
This Patient Alert Card includes information that may be useful to you and that
alerts other doctors that you are taking Apixaban Olpha. You should always carry this
card with you.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Rep., 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

Apixaban Olpha 5 mg film-coated tablets

apixaban

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
• 1. What is Apixaban Olpha and what it is used for
• 2. What you need to know before you take Apixaban Olpha
• 3. How to take Apixaban Olpha
• 4. Possible side effects
• 5. How to store Apixaban Olpha
• 6. Contents of the pack and other information

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

Apixaban Olpha contains the active ingredient apixaban and belongs to a group of medicines called
anticoagulants. This medicine helps to prevent the formation of blood clots by blocking
Factor Xa, which is an important component of 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) and with at least one additional risk factor. Blood clots can detach and reach the brain, leading to stroke, or reach other organs preventing the 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 blood clots from reforming 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 allergicto 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 organthat leads to a higher risk of serious bleeding (such as a recentor ongoing stomach or intestinal ulcer,recent bleedingin the brain);
• you have a liver diseasethat leads to a higher risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clots from forming(e.g., warfarin, rivaroxaban, dabigatran or heparin), except when you are changing anticoagulant treatment, 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 your blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia). Warnings and precautionsTalk 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 activity;
• very high blood pressure,not controlled by medical treatment;
• if you are over 75 years of age;
• if you weigh 60 kg or less;
• a serious 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 with signs of altered 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.

Pay particular attention with Apixaban Olpha

• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that increases the risk of blood clots), tell your doctor, who will decide if it is necessary to change therapy.

If you are to undergo surgery or a procedure that may cause bleeding,
your doctor may ask you to temporarily interrupt taking this
medicine for a short time. If you are not sure if a procedure may cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended in 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 may
take any other medicines.
Some medicines can increase the effect of Apixaban Olpha and others can decrease it. Your doctor will decide
if you should be treated with Apixaban Olpha when taking these medicines and how
carefully you should be monitored.
The following medicines can increase the effect of Apixaban Olpha and increase the possibility of
undesirable 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-inflammatoryor painkillers(e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a higher chance of bleeding;
• medicines for high blood pressure or heart problems(e.g., diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitors orserotonin-norepinephrine reuptake inhibitors.The following medicines can reduce the effect of Apixaban Olpha in helping to prevent blood clots from forming:
• medicines for epilepsy or seizures(e.g., phenytoin, etc.);
• St. John's wort(a herbal product used for depression);
• medicines to treat tuberculosisor other infections(e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor, pharmacist or nurse for advice before taking this
medicine.
The effect of Apixaban Olpha on pregnancy and the unborn child are unknown. You should not take
this medicine if you are pregnant. Contact your doctor immediatelyif 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 stop/not start therapy with this medicine.

Driving and using machines
Apixaban Olpha has not shown effects on the ability to drive vehicles 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 some sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially
‘sodium-free’.

3. How to take Apixaban Olpha

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a little water. Apixaban Olpha can be taken with or without food.
Try to take the tablets at the same time each day, to obtain the best effect from the
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take
Apixaban Olpha. The tablet can be crushed and mixed with water, or 5% glucose in
water, or apple juice or applesauce, immediately before taking it.

Instructions for crushing the tablet:

• Crush the tablets with a pestle and mortar.
• 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 pestle and mortar used to crush 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 and mixed Apixaban Olpha tablet with 60 mL of water or 5% glucose in water, through a nasogastric tube. Take Apixaban Olpha as recommended:To prevent the formation of blood clots in the heart in patients with irregular heartbeat and with at least one additional risk factor.

The recommended dose is one Apixaban Olpha 5 mgtablet twice a day.
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day if:

• you have a severely reduced kidney function;
• you fall into two or more of the following conditions:
• blood test results suggest poor kidney function (the serum creatinine value is 1.5 mg/dL (133 micromoles/L) or higher);
• you are 80 years of age or older;
• your weight is 60 kg or less. The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening. Your doctor will decide how long you should continue the treatment. To treat blood clots in the veins of the legs and in the blood vessels of the lungs The recommended dose is two tabletsof Apixaban Olpha 5 mgtwice a day for the first 7 days, for example two in the morning and two in the evening. After 7 days the recommended dose is one tabletof Apixaban Olpha 5 mgtwice a day, for example, one in the morning and one in the evening.

To prevent blood clots from reforming after completion of 6 months of treatment
The recommended dose is one Apixaban Olpha 2.5 mgtablet twice a day, for example,
one in the morning and one in the evening.
Your doctor will decide how long you should continue the treatment.

Your doctor may modify your anticoagulant treatment as follows:

• Switching from Apixaban Olpha to an anticoagulant medicineStop taking Apixaban Olpha. Start treatment with the anticoagulant medicine (for example heparin) at the time you would have taken the next Apixaban Olpha tablet.
• Switching from an anticoagulant medicine to Apixaban OlphaStop taking the anticoagulant medicine. Start treatment with Apixaban Olpha at the time you would have taken the next dose of the anticoagulant medicine, then continue taking it normally.
• Switching from treatment with an anticoagulant containing a vitamin K antagonist(e.g. warfarin) to Apixaban OlphaStop taking the medicine containing the vitamin K antagonist. The doctor will need to perform blood tests and instruct you on when to start treatment with Apixaban Olpha.
• Switching from Apixaban Olpha to treatment with an anticoagulant 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 medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and instruct you on when to stop treatment with Apixaban Olpha. Patients undergoing cardioversionIf your irregular heartbeat needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to take it, to prevent blood clots in the blood vessels in the brain and in other blood vessels in your body. If you take more Apixaban Olpha than you shouldImmediately inform your doctorif you have taken more than the prescribed dose of this medicine. Bring the medicine packaging with you, even if there are no tablets left.

If you take more Apixaban Olpha than recommended, you may have a greater risk of
bleeding. If bleeding occurs, surgery, a transfusion or other treatments that can inactivate the activity against factor Xa may be necessary.

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

• take the next dose of Apixaban Olpha at the usual time
• then continue as established. If you have doubts about what to do or if you have forgotten more than one dose,consult your doctor, pharmacist or nurse. If you stop taking Apixaban OlphaDo not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot may be greater if you stop treatment too soon.

If you have any further questions on the use of 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.
The most common general side effect of 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 Olpha is taken to prevent the
formation of blood clots in the heart in patients with irregular heartbeat and with 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;
• Anemia which can cause fatigue or paleness;
• Low blood pressure which can cause weakness or a fast 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 sputum when coughing;
• in the abdomen or from the vagina;
• light/red blood in the stool;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluids from the wound/surgical incision (wound secretion) or from the injection site;
• from hemorrhoids;
• tests showing blood in the stool or urine;
• Reduced number of platelets in the blood (which can affect blood clotting);
• Blood tests may show:
• liver function abnormalities;
• increased levels of certain liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes;
• Skin rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur. 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)

• Skin rash that may blister and appears as small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme). Not known (frequency cannot be estimated from the available data)
• Inflammation of the blood vessels (vasculitis) which can manifest with skin rashes or pointed, 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 blood clots from reforming in the leg veins and blood vessels in 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, from the rectum;
• in the mouth;
• from the vagina;
• Anemia which can cause fatigue or paleness;
• Reduced number of platelets in the blood (which can affect blood clotting);
• Nausea (feeling sick);
• Skin 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 can cause weakness or a fast heartbeat
• Bleeding:
• in the eyes;
• in the mouth or blood in sputum when coughing;
• light/red blood in the stool;
• tests showing blood in the stool or urine;
• bleeding that occurs after surgery, including bruising and swelling, leakage of blood or fluids from the wound/surgical incision (wound secretion) or from the injection site;
• from hemorrhoids;
• in the muscle;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediatelyif any of these symptoms occur.
• Blood tests may show:
• liver function abnormalities;
• increased levels of certain liver enzymes;
• increased bilirubin, a breakdown product of red blood cells, which can 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.
• Skin rash that may blister and appears as small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme);
• Inflammation of the blood vessels (vasculitis) which can manifest with skin rashes or pointed, flat, red, round spots under the skin surface or bruising.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 package and on the 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 in 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 ingredient is apixaban. Each tablet contains 5 mg of apixaban.
• The other ingredients 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:Rosa Opadry II (contains: hypromellose, lactose monohydrate(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 package contents
The film-coated tablets are pink, oval, biconvex, with “I2” imprinted on one side and smooth
on the other.

• They are contained in transparent PVC/PVDC/ aluminum blisters packaged in 10, 14 tablets, film-coated tablets packaged in cartons of 28, 56, 60, 168 film-coated tablets.
• 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
Alert for the Patient or their doctor may give you a similar one.
This Patient Alert Card includes information that may be useful to you and that
warns other doctors that you are taking Apixaban Olpha. You should always carry this
card with you.

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

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Rep., Estonia, Germany, Italy, Spain, Poland: Apixaban Olpha
France: APIXABAN OLPHA 5 mg, coated tablet
Latvia: Apixaban Olpha 5 mg apvalkotās tabletes
Lithuania: Apixaban Olpha 5 mg plėvele dengtos tabletės
Slovakia: Apixaban Olpha 5 mg