Apixaban olpha

Poland
Brand name Apixaban olpha
Form tablets, film-coated
Active substance / Dosage
apixaban · 5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100485893
Manufacturer Olpha

Table of Contents

Package leaflet: Information for the user

Apixaban Olpha, 5 mg, film-coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

  1. What Apixaban Olpha is 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. Contents of the pack and other information

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

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

Apixaban Olpha is used in adults:

  • to prevent blood clots forming in the heart in patients with irregular heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or to other organs, blocking blood flow to these organs (also known as systemic embolism). 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 such clots in the veins of the legs and/or lungs.

Apixaban Olpha is also used in children aged from 28 days up to but not including 18 years of age, for the treatment of blood clots and prevention of recurrence of blood clots in the veins or in the blood vessels of the lungs.
Information regarding body weight and recommended dosage can be found in section 3.

2. Important information before using Apixaban Olpha

When not to use Apixaban Olpha

  • if the patient is allergic to apixaban or any of the other ingredients of this medicine (listed in section 6),
  • if the patient has excessive bleeding,
  • if the patient has an organ disease that increases the risk of severe bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial bleeding),
  • if the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy),
  • if the patient is taking anticoagulant medicines (e.g. warfarin, rivaroxaban, dabigatran or heparin), except in situations of switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through this line to maintain its patency, or when the patient is undergoing catheter ablation (a catheter is inserted into the vein) due to irregular heartbeat (arrhythmia).

Warnings and precautions
Before starting treatment, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

  • increased risk of bleeding, for example:
  • conditions involving bleeding, including cases resulting in reduced platelet activity,
  • very high blood pressure not controlled by medication,
  • if the patient is over 75 years of age,
  • if the patient's body weight is 60 kg or less,
  • severe kidney disease or if the patient is on dialysis,
  • liver disease or history of liver disease.
  • This medicine should be used with caution in patients showing signs of liver function abnormalities.
  • if the patient has a heart valve prosthesis,
  • if the doctor determines that the patient's blood pressure is unstable or other treatment or a surgical procedure to remove a blood clot from the lungs is planned.

When to exercise particular caution when using Apixaban Olpha

  • if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary.

If surgery or a procedure that may cause bleeding is required,
the doctor may ask the patient to temporarily stop taking this medicine for a short period.
If in doubt whether a particular procedure may be associated with bleeding, consult the doctor.

Children and adolescents
This medicine is not recommended for use in children and adolescents with body weight below 35 kg.

Apixaban Olpha and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may enhance the effect of Apixaban Olpha, while others may weaken its effect.
The doctor will decide whether the patient should receive Apixiban Olpha while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Olpha and increase the risk of unwanted bleeding:

  • certain medicines used to treat fungal infections (e.g. ketoconazole and others);
  • certain antiviral medicines used to treat HIV/AIDS infection (e.g. ritonavir);
  • other medicines used to reduce blood clotting (e.g. enoxaparin and others);
  • anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen); particularly if the patient is over 75 years of age and taking acetylsalicylic acid, the risk of unwanted bleeding may be increased;
  • medicines used for high blood pressure or heart conditions (e.g. diltiazem);
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Olpha to prevent blood clots:

  • medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
  • St John’s wort (an herbal supplement used for depression);
  • medicines used to treat tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of Apixaban Olpha on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Apixaban Olpha passes into human milk. Before using this medicine during breastfeeding, consult your doctor, pharmacist or nurse. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.

Driving and operating machinery
No effects of Apixaban Olpha on the ability to drive and operate machinery have been observed.

Apixaban Olpha contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Apixaban Olpha

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
please consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban Olpha may be taken with or without food. For optimal
treatment results, it is recommended to take the tablets at the same times each day.
If a patient has difficulty swallowing the tablets whole, please speak with your doctor about
alternative ways of taking Apixaban Olpha. The tablet may be crushed immediately before
administration and mixed with water or 5% glucose solution, fruit juice, or apple puree.
Instructions for crushing tablets:
Crush the tablet with a pestle in a mortar.
Carefully transfer the entire powder into a suitable container and mix it with a small amount,
e.g., 30 mL (2 tablespoons), of water or one of the liquids listed above to prepare a mixture.
Swallow (drink) the mixture.
Rinse the pestle and mortar used for crushing the tablets, as well as the container, with a small
amount of water or another liquid (e.g., 30 mL), and swallow (drink) the rinse liquid.
If necessary, your doctor may administer crushed Apixaban Olpha tablets mixed with 60 mL of
water or 5% glucose solution via a nasogastric tube.
Apixaban Olpha should be taken as recommended for the following indications:
Prevention of blood clots in the heart in patients with irregular heartbeat (arrhythmia) and at
least one additional risk factor
The recommended dose is one tablet of Apixaban Olpha 5 mg twice daily.
The recommended dose is one tablet of Apixaban Olpha 2.5 mg twice daily if:

  • the patient has severe renal impairment, or
  • two or more of the following conditions are met:
  • blood test results indicate reduced kidney function (serum creatinine level of 1.5 mg/dL (133 micromoles/L) or higher),
  • the patient is 80 years of age or older,
  • the patient’s body weight is 60 kg or less.

The recommended dose is one tablet twice daily, for example, one tablet in the morning and one
in the evening. Your doctor will decide how long treatment should continue.
Treatment of blood clots in the deep veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixaban Olpha 5 mg twice daily for the first 7 days,
for example, two tablets in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Olpha 5 mg twice daily, for
example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completion of 6-month treatment
The recommended dose is one tablet of Apixaban Olpha 2.5 mg twice daily, for example, one
tablet in the morning and one in the evening.
Your doctor will decide how long treatment should continue.
Use in children and adolescents
Treatment of blood clots and prevention of recurrent blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered as directed by your doctor or pharmacist.
If in doubt, please consult your doctor, pharmacist, or nurse.
To achieve the best treatment effect, the dose should be taken or administered at the same time
each day.
The dose of Apixaban Olpha depends on body weight and will be calculated by your doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two tablets of
Apixaban Olpha 5 mg, administered twice daily for the first 7 days, for example, two in the
morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban Olpha 5 mg, administered twice
daily, for example, one in the morning and one in the evening.
For parents and caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled doctor’s appointments, as changes in body weight may require
adjustment of the dose.
Your doctor may change anticoagulant treatment as follows:
Switching from Apixaban Olpha to other anticoagulant medicines
Stop taking Apixaban Olpha. Start treatment with anticoagulant medicines (e.g., heparin) at the
time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Apixaban Olpha
Stop taking the anticoagulant medicines. Start treatment with Apixaban Olpha at the time the
next dose of anticoagulant medicine was scheduled, and then continue taking it as usual.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to
Apixaban Olpha
Discontinue the vitamin K antagonist medicine. Your doctor must perform blood tests and will
inform you when to start taking Apixaban Olpha.
Switching from Apixaban Olpha to anticoagulant treatment including a vitamin K antagonist
(e.g., warfarin)
If your doctor informs you that you should start taking a medicine containing a vitamin K antagonist,
continue taking Apixaban Olpha for at least 2 days after taking the first dose of the vitamin K
antagonist medicine.
Your doctor must perform blood tests and inform you when to stop taking Apixaban Olpha.
Patients undergoing cardioversion
Patients with irregular heartbeat who require cardioversion to restore normal heart rhythm should
take this medicine at the times specified by the doctor to prevent formation of blood clots in the
blood vessels of the brain and other blood vessels in the body.
Taking more Apixaban Olpha than recommended
If a patient takes more than the recommended dose of this medicine, contact your doctor
immediately. Bring the medicine packaging with you, even if it is empty.
If a patient takes more than the recommended dose of Apixaban Olpha, the risk of bleeding may
increase. In case of bleeding, surgical treatment, blood transfusion, or other treatments to reverse
the effect of factor Xa inhibition may be required.
Missing a dose of Apixaban Olpha
If a morning dose is missed, take it as soon as remembered, and it may be taken together with the
evening dose.
A missed evening dose may only be taken that same evening. Do not take two doses the next
morning instead; continue taking the medicine the next day as directed, twice daily.
If you have any doubts about how to use the medicine or if you miss more than one dose,
please consult your doctor, pharmacist, or nurse.
Stopping Apixaban Olpha
Do not stop taking this medicine without consulting your doctor, as stopping Apixaban Olpha
prematurely may increase the risk of blood clots.
If you have any further questions about using this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common general side effect with this medicine is bleeding, which may potentially
be life-threatening and may require immediate medical attention.
The following side effects may occur when taking Apixaban Olpha
to prevent blood clots in the heart in patients with irregular heartbeat and
at least one additional risk factor.
Common side effects (may affect up to 1 in 10 people)

  • Bleeding, including:
  • into the eyes;
  • into the stomach or intestines;
  • from the rectum;
  • blood in the urine;
  • from the nose;
  • from the gums;
  • subcutaneous haemorrhage (bruising) and swelling;
  • Anaemia, which may cause fatigue or paleness;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Nausea;
  • Blood test results may show:
  • increased activity of gamma-glutamyl transferase (GGT).

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

  • Bleeding:
  • into the brain or spinal canal;
  • in the mouth or presence of blood in sputum when coughing;
  • in the abdominal cavity or from the genital tract;
  • bright red blood in the stool;
  • bleeding after surgery, including subcutaneous haemorrhage (bruising) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • from haemorrhoids;
  • presence of blood in the stool or urine detected in laboratory tests;
  • Decreased platelet count in the blood (which may affect blood clotting);
  • Blood test results may show:
  • abnormal liver function;
  • increased activity of certain liver enzymes;
  • increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
  • Skin rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.

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

  • Bleeding:
  • into the lungs or throat;
  • into the retroperitoneal space (located at the back of the abdominal cavity);
  • into muscles.

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

  • Skin rash, during which blisters may form and which resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme).

Frequency not known (cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or subcutaneous haemorrhages (bruising);
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Apixaban Olpha
to treat or prevent recurrence of blood clots in the veins of the lower limbs and blood clots 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;
  • subcutaneous haemorrhage (bruising) and swelling;
  • in the stomach, intestines, or from the rectum;
  • in the mouth;
  • from the genital tract;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count in the blood (which may affect clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may show:
  • increased activity of gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
  • into the eyes;
  • in the mouth or presence of blood in sputum when coughing;
  • bright red blood in the stool;
  • test results indicating blood in the stool or urine;
  • bleeding after surgery, including subcutaneous haemorrhage (bruising) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
  • from haemorrhoids;
  • into muscles;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, contact your doctor immediately;
  • Blood test results may show:
  • abnormal liver function;
  • increased activity of certain liver enzymes;
  • increased bilirubin levels – a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

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

Frequency not known (cannot be estimated from available data)

  • Bleeding:
  • into the abdominal cavity or into the retroperitoneal space.
  • Skin rash, during which blisters may form and which resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, round spots beneath the skin surface, or subcutaneous haemorrhages (bruising);
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents
If any of the following symptoms occur, immediately inform your doctor:

  • 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 classified as “common” (may affect up to 1 in 10 people).

In general, side effects observed in children and adolescents treated with Apixaban Olpha
were similar to those seen in adults and were mostly mild or moderate in severity.
Side effects occurring more frequently in children and adolescents include 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;
  • subcutaneous haemorrhages (bruises) and swelling;
  • from the intestine or rectum;
  • bright red blood in the stool;
  • postoperative bleeding, including subcutaneous haemorrhages (bruises) and swelling, leakage of blood or fluid (discharge) from the surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count in the blood (which may affect clotting);
  • Nausea;
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Blood test results may show:
  • abnormal liver function;
  • increased activity of certain liver enzymes;
  • increased activity of alanine aminotransferase (ALT).

Frequency not known (cannot be estimated from available data)

  • Bleeding
  • into the abdominal cavity or retroperitoneal space;
  • in the stomach;
  • in the eyes;
  • in the mouth;
  • from haemorrhoids;
  • in the mouth or blood in sputum when coughing;
  • in the brain or spine;
  • in the lungs;
  • in muscle;
  • Skin rash, during which blisters may form and which resembles small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis, which may cause skin rash or raised, flat, red, round spots beneath the skin surface or bruising;
  • Blood test results may show:
  • increased activity of gamma-glutamyl transferase (GGT);
  • presence of blood in stool 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 any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apixaban Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Apixaban Olpha contains
The active substance 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 sulphate (see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”), magnesium stearate;
  • Coating: Opadry II Pink (hypromellose (E 464), monohydrate lactose [see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”], titanium dioxide (E 171), triacetin, iron oxide red (E 172)).

What Apixaban Olpha looks like and contents of the pack
Pink, oval, biconvex coated tablets with the imprint “I2” on one side and smooth on the other side.

  • PVC/PVDC/Aluminium blisters containing 10 or 14 coated tablets. Packs contain 28, 56, 60 or 168 coated tablets in a cardboard box.
  • HDPE bottle with PP screw cap and tamper-evident ring containing 200 coated tablets in a cardboard box.

Not all pack sizes may be marketed.
Patient Alert Card: information on use
Inside the packaging of Apixaban Olpha, alongside the patient leaflet, there is a Patient Alert Card, or your doctor may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other doctors that the patient is taking Apixaban Olpha. You should always carry this card with you.

  1. Take the card.
  2. If necessary, separate the appropriate language section (this is facilitated by perforated edges).
  3. Fill in the following details or ask your doctor to complete them:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: … mg twice daily
    • Doctor’s name:
    • Doctor’s telephone number:
  4. Fold the card and always carry it with you.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]
Importer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Czech Republic, Estonia, Germany: Apixaban Olpha
Poland, Spain, Italy: Apixaban Olpha
Slovakia: Apixaban Olpha 5 mg
France: APIXABAN OLPHA 5 mg, comprimé pelliculé
Lithuania: Apixaban Olpha 5 mg plėvele dengtos tabletės
Latvia: Apixaban Olpha 5 mg apvalkotās tabletes