Apixaban Grindex

Package leaflet: Information for the user

Apixaban Grindeks 2.5 mg film-coated tablets

apixaban
Generic medicine
Read this entire 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Apixaban Grindeks is and what it is used for
2. What you need to know before taking Apixaban Grindeks
3. How to take Apixaban Grindeks
4. Possible side effects
5. How to store Apixaban Grindeks
6. Contents of the pack and other information

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

Apixaban Grindeks 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. Apixaban Grindeks 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 your 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 with at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs, blocking normal blood supply 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 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.

Apixaban Grindeks is used in children aged 28 days to 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 Apixaban Grindeks

Do not take Apixaban Grindeks 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 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 a higher 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 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 an injection in your spine (for anaesthesia 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 Apixaban Grindeks

• 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 period. 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 weighing less than 35 kg.

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

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

• certain medicines for fungal infections (e.g., ketoconazole, etc.);
• certain 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);
• antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effect of Apixaban Grindeks 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 to treat tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
The effect of Apixaban Grindeks 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 Grindeks 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/avoid starting treatment with this medicine.

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

Apixaban Grindeks contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Grindeks

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban Grindeks can be taken with or without food.
Try to take the tablets at the same time each day to get the best effect from
treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take
Apixaban Grindeks. The tablet may be crushed and mixed with water, or with 50 mg/L (5%)
glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

• Crush the tablets using 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 Grindeks tablet mixed with 60 mL of water or 50 mg/mL (5%) glucose in water through a nasogastric tube.
Take Apixaban Grindeks as recommended:
Adults
To prevent the formation of blood clots after hip or knee replacement surgery.
The recommended dose is one Apixaban Grindeks 2.5 mg 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 had major surgery on the hip, you will usually take the tablets for 32 to 38 days. If you have had major surgery on the knee, you will usually take the tablets for 10 to 14 days.
To prevent the formation of blood clots in the heart in patients with irregular heartbeat and
at least one additional risk factor.
The recommended dose is one Apixaban Grindeks 5 mg tablet twice daily.
The recommended dose is one Apixaban Grindeks 2.5 mg 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 and in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Grindeks 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 Grindeks 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 tablet of Apixaban Grindeks 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 recurrence of blood clots in the veins or blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor or the child’s doctor or pharmacist. If you have any doubts, consult your doctor or the child’s doctor,
the pharmacist, or the nurse.
Try to take or administer the dose at the same time each day to achieve the best effect
from treatment.
The dose of Apixaban Grindeks 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
tablets of Apixaban Grindeks 2.5 mg 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 tablets of Apixaban
Grindeks 2.5 mg 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 Apixaban Grindeks to another anticoagulant medicine Stop taking Apixaban Grindeks. Start treatment with the anticoagulant medicine (e.g., heparin) at the time when you would have taken the next tablet.
• Switching from another anticoagulant medicine to Apixaban Grindeks Stop taking the anticoagulant medicine. Start treatment with Apixaban Grindeks at the time when you would have taken the next dose of the anticoagulant medicine, then continue taking it as usual.
• Switching from treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) to Apixaban Grindeks 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 Grindeks.
• Switching from Apixaban Grindeks to treatment with a vitamin K antagonist anticoagulant (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Grindeks 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 Grindeks.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure
called cardioversion, take this medicine at the times your doctor instructs you to take it,
to prevent blood clots in the blood vessels of the brain and in other blood vessels of your body.
If you take more Apixaban Grindeks than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine carton with you, even if no tablets remain.
If you take more Apixaban Grindeks than recommended, you may have an increased risk of
bleeding. If bleeding occurs, surgery, a blood transfusion, or other treatments that can reverse the anticoagulant effect on factor Xa may be required.
If you forget to take Apixaban Grindeks

• If you forget to take a morning dose, take it as soon as you remember; you may take it together with the evening dose.
• A forgotten evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue with the recommended 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. Do not take a double dose to make up for a missed dose.

If you stop taking Apixaban Grindeks
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 questions 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. Apixaban Grindeks may be given for three different medical conditions. The known side effects and their frequency may differ for each of these 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 Grindeks 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)

• 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, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
  • From the stomach, intestine, or clear/red blood in the faeces;
  • Blood in the urine;
  • From the nose;
  • From the vagina;
• Low blood pressure, which may cause weakness or a rapid heartbeat;
• Blood tests may show:
  • Abnormal 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;
• 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:
  • Into 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 the faeces 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 as 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 Grindeks 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 intestine;
  • 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:
  • An increase in gamma-glutamyl transferase (GGT).

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

• Bleeding:
  • Into 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 faeces;
  • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
  • From haemorrhoids;
• Tests showing blood in the faeces or urine;
• Reduction in the number of platelets in the blood (which may affect clotting);
• Blood tests may show:
  • Abnormal 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;
• 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 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 as 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 Grindeks 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, 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 clotting);
• Nausea (feeling unwell);
• 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 may cause weakness or a rapid heartbeat;
• Bleeding:
  • Into the eyes;
  • In the mouth or blood in sputum when coughing;
  • Clear/red blood in the faeces;
  • Tests showing blood in the faeces or urine;
  • Occurring after surgery, including bruising and swelling, bleeding or fluid leakage 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:
  • Abnormal 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:
  • Into 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 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 as 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
Inform 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 breathing difficulties. 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 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;
  • 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;
  • Clear/red blood in the faeces;
  • Occurring after any surgery, including bruising and swelling, bleeding or fluid leakage 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 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;
  • Increase in certain liver enzymes;
  • Increase in alanine aminotransferase (ALT).

Not known (frequency cannot be defined based on available data)

• Bleeding: in the abdomen or in 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; into 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 as skin 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 faeces 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Grindeks

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. Package contents and other information

What Apixaban Grindeks contains

• The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
• The other components are:
• Tablet core: microcrystalline cellulose (E460), lactose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b);
• Coating: grafted copolymer of poly(vinyl alcohol) macrogol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, poly(vinyl alcohol), yellow iron oxide (E172), black iron oxide (E172)

Description of the appearance of Apixaban Grindeks and contents of the pack
Apixaban Grindeks 2.5 mg is a yellow, biconvex, round (6 mm in diameter), film-coated tablet.

It is printed with "2.5" on one side and " " on the other.
Apixaban Grindeks 2.5 mg is available in blisters in cartons containing 10, 20, 60, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.

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

1. Take the card.
2. Tear out 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:
   • Weight:
   • Dose............. mg twice daily
   • Doctor's name:
   • Doctor's telephone number:
4. Fold the card and always keep it with you.

Marketing Authorization Holder
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Famar Health Care Services Madrid S.A.U.
Avenida Leganes 62,
Alcorcon, Madrid, 28923
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Apixaban Grindeks 2.5 mg, 5 mg Filmtabletten
Belgium Apixaban Grindeks 2.5 mg comprimés pelliculés/filmomhulde tabletten/Filmtabletten
Apixaban Grindeks 5 mg comprimés pelliculés/filmomhulde tabletten/Filmtabletten
Bulgaria Apixaban Grindeks 2.5 mg, 5 mg филмирани таблетки
Apixaban Grindeks 2.5 mg, 5 mg film-coated tablets
Croatia Apixaban Grindeks 2.5 mg, 5 mg filmom obložene tablete
Czech Republic Apixaban Grindeks
Denmark Apixaban Grindeks 2.5 mg, 5 mg filmovertrukne tabletter
Estonia Apixaban Grindeks
Finland Apixaban Grindeks 2.5 mg, 5 mg kalvopäällysteiset tabletit
France Apixaban Grindeks 2.5 mg, comprimé pelliculé
Apixaban Grindeks 5 mg, comprimé pelliculé
Germany Apixaban Grindeks 2.5 mg, 5 mg Filmtabletten
Greece APIXABAN/GRINDEKS
Hungary Apixaban Grindeks 2.5 mg, 5 mg filmtabletta
Ireland Apixaban Grindeks 2.5 mg, 5 mg film-coated tablets
Italy Apixaban Grindeks
Latvia Apixaban Grindeks 2.5 mg, 5 mg apvalkotās tabletes
Lithuania Apixaban Grindeks 2.5 mg plėvele dengtos tabletės
Apixaban Grindeks 5 mg plėvele dengtos tabletės
Netherlands Apixaban Grindeks 2.5 mg, 5 mg filmomhulde tabletten
Norway Apixaban Grindeks
Poland Apixaban Grindeks
Portugal Apixaban Grindeks 2.5 mg, 5 mg comprimidos revestidos por película
Romania Apixaban Grindeks 2.5 mg, 5 mg comprimate filmate
Slovakia Apixaban Grindeks 2.5 mg, 5 mg filmom obalené tablety
Slovenia Apiksaban Grindeks 2.5 mg, 5 mg filmsko obložene tablete
Spain Apixaban Grindeks 2.5 mg, 5 mg comprimidos recubiertos con película
Sweden Apixaban Grindeks

Package leaflet: information for the user

Apixaban Grindeks 5 mg film-coated tablets

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 other people, even if they have the same symptoms as yours, because it could 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

1. What Apixaban Grindeks is and what it is used for
2. What you need to know before taking Apixaban Grindeks
3. How to take Apixaban Grindeks
4. Possible side effects
5. How to store Apixaban Grindeks
6. Contents of the pack and other information

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

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

• 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 (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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Apixaban Grindeks is used in children aged 28 days to less than 18 years to treat blood clots and to prevent the 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 Apixaban Grindeks

Do not take Apixaban Grindeks 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 of the stomach or intestine, 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 it to keep it open, or if a catheter is inserted into a blood vessel (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 causing reduced platelet activity; 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 an injection in the spine (for anaesthesia or pain relief). Your doctor will tell you to take this medicine at least 5 hours or more after the catheter has been 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.

Take special care with Apixaban Grindeks

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

The following medicines may increase the effect of Apixaban Grindeks 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 or pain-relieving medicines (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 Grindeks 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, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

The effect of Apixaban Grindeks 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 Grindeks 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/avoid starting treatment with this medicine.

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

Apixaban Grindeks contains lactose 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 dose, i.e., essentially 'sodium-free'.

3. How to take Apixaban Grindeks

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with some water. Apixaban Grindeks 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 alternative ways of taking
Apixaban Grindeks. The tablet may be crushed and mixed with water, or with 50 mg/mL (5%)
glucose in water, or apple juice or apple puree, immediately before administration.
Instructions for crushing the tablet:

• Crush the tablets using a mortar and pestle.
• Carefully transfer all of 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 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 Apixaban Grindeks tablet mixed with 60 mL of water or 50 mg/mL (5%) glucose in water through a nasogastric tube.
Take Apixaban Grindeks as recommended:
Adults
To prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one Apixaban Grindeks 5 mg tablet twice daily.
The recommended dose is one Apixaban Grindeks 2.5 mg tablet 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 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 Grindeks 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 Grindeks 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 Grindeks 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.
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 Apixaban Grindeks 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 tablets of Apixaban Grindeks 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 Grindeks 5 mg twice daily, for example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken.
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 Apixaban Grindeks to another anticoagulant medicine Stop taking Apixaban Grindeks. 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 Grindeks Stop taking the anticoagulant medicine. Start treatment with Apixaban Grindeks at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.
• Switching from a vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Apixaban Grindeks 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 Grindeks.
• Switching from Apixaban Grindeks to a vitamin K antagonist anticoagulant treatment (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Grindeks 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 Apixaban Grindeks treatment.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take this medicine at the times your doctor tells you to, to prevent blood clots in blood vessels of the brain and other parts of the body.
If you take more Apixaban Grindeks 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 remain.
If you take more Apixaban Grindeks than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments to reverse the anticoagulant activity against factor Xa may be required.
If you forget to take Apixaban Grindeks

• 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 be taken only 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. Do not take a double dose to make up for a missed dose.
If you stop taking Apixaban Grindeks
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. The most common general side effect of 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 Grindeks 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 unwell);
• 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 mucus (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;
• Decrease in the number of platelets in the blood (which may affect blood clotting);
• Blood tests may show: liver function abnormalities; increase in certain liver enzymes; increase in 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; behind the abdominal cavity (retroperitoneal haemorrhage); 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 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 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 Grindeks 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, 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: 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 mucus (sputum) when coughing; clear/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 breathing difficulties. Contact your doctor immediately if you experience any of these symptoms;
• Blood tests may show: liver function abnormalities; 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 (retroperitoneal haemorrhage).
• Skin 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 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 breathing difficulties. 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 of a similar 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;
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; 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;
• Decrease 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:
• liver function abnormalities;
• increase in certain liver enzymes;
• increase in alanine aminotransferase (ALT).

Not known (frequency cannot be defined based on available data)

• Bleeding:
• in the abdomen or behind the abdominal cavity (retroperitoneal haemorrhage);
• in the stomach;
• in the eyes;
• in the mouth;
• from haemorrhoids;
• in the mouth or blood in coughed-up mucus (sputum) when coughing;
• in the brain or spinal cord;
• in the lungs;
• in the muscle;
• Skin 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 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 Apixaban Grindeks

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 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 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 Apixaban Grindeks contains

• The active substance is apixaban. Each tablet contains 5 mg of apixaban.
• The other components are:
  Tablet core: microcrystalline cellulose (E460), lactose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b);
  Coating: grafted poly(vinyl alcohol) copolymer, polyethylene glycol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, poly(vinyl alcohol), iron oxide red (E172)

Description of the appearance of Apixaban Grindeks and package contents
Apixaban Grindeks 5 mg is a pink, biconvex, oblong tablet (approximately 10 mm x 5 mm), film-coated, marked with "5" on one side and " " on the other.

Apixaban Grindeks 5 mg is available in blisters packed in cartons containing 28, 30, 56, 60, 100, 168 or 200 film-coated tablets.
Not all pack sizes may be marketed.

Patient Alert Card: managing the information
Inside the Apixaban Grindeks package, together with the package leaflet, you will find a Patient Alert Card, or your doctor may have given you a similar one.
This Patient Card contains important information that may be helpful to you and alerts other doctors that you are taking Apixaban Grindeks. You must always carry this card with you.

1. Take the card.
2. Tear off 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:
   • Weight:
   • Dose ............ mg twice daily
   • Doctor’s name:
   • Doctor’s telephone number:
4. Fold the card and always keep it with you.

Marketing Authorization Holder
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Famar Health Care Services Madrid S.A.U.
Avenida Leganes 62,
Alcorcón, Madrid, 28923
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Apixaban Grindeks 2.5 mg, 5 mg Filmtabletten
Belgium Apixaban Grindeks 2.5 mg comprimés pelliculés/filmomhulde tabletten/Filmtabletten
Apixaban Grindeks 5 mg comprimés pelliculés/filmomhulde tabletten/Filmtabletten
Bulgaria Apixaban Grindeks 2.5 mg, 5 mg филмирани таблетки / Apixaban Grindeks 2.5 mg, 5 mg film-coated tablets
Croatia Apixaban Grindeks 2.5 mg, 5 mg filmom obložene tablete
Czech Republic Apixaban Grindeks
Denmark Apixaban Grindeks 2.5 mg, 5 mg filmovertrukne tabletter
Estonia Apixaban Grindeks
Finland Apixaban Grindeks 2.5 mg, 5 mg kalvopäällysteiset tabletit
France Apixaban Grindeks 2.5 mg, comprimé pelliculé / Apixaban Grindeks 5 mg, comprimé pelliculé
Germany Apixaban Grindeks 2.5 mg, 5 mg Filmtabletten
Greece APIXABAN/GRINDEKS
Hungary Apixaban Grindeks 2.5 mg, 5 mg filmtabletta
Ireland Apixaban Grindeks 2.5 mg, 5 mg film-coated tablets
Italy Apixaban Grindeks
Latvia Apixaban Grindeks 2.5 mg, 5 mg apvalkotās tabletes
Lithuania Apixaban Grindeks 2.5 mg plėvele dengtos tabletės / Apixaban Grindeks 5 mg plėvele dengtos tabletės
Netherlands Apixaban Grindeks 2.5 mg, 5 mg filmomhulde tabletten
Norway Apixaban Grindeks
Poland Apixaban Grindeks
Portugal Apixaban Grindeks 2.5 mg, 5 mg comprimidos revestidos por película
Romania Apixaban Grindeks 2.5 mg, 5 mg comprimate filmate
Slovakia Apixaban Grindeks 2.5 mg, 5 mg filmom obalené tablety
Slovenia Apiksaban Grindeks 2.5 mg, 5 mg filmsko obložene tablete
Spain Apixaban Grindeks 2.5 mg, 5 mg comprimidos recubiertos con película
Sweden Apixaban Grindeks