Apixaban olpha

Poland
Brand name Apixaban olpha
Form tablets, film-coated
Active substance / Dosage
apixaban · 2.5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100485886
Manufacturer Olpha

Table of Contents

Package leaflet: Information for the user

Apixaban Olpha, 2.5 mg, coated tablets
Apixabanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you personally. Do not pass it on to others. This medicine 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, please tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

  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 inhibiting factor Xa, an important component in the blood clotting process.

Apixaban Olpha is used in adults:

  • to prevent blood clots (deep vein thrombosis) after hip or knee replacement surgery. After hip or knee surgery, patients have an increased risk of developing blood clots in the veins of the legs. This may lead to leg swelling, with or without pain. If a blood clot travels from the leg to the lungs, it may block blood flow through the lungs, causing breathlessness with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
  • to prevent blood clots in the heart in patients with an irregular heartbeat (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, impairing blood supply to these organs (also known as systemic embolism). Stroke may 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.

Apixaban Olpha is used in children aged 28 days to below 18 years for the treatment of blood clots and to prevent recurrence of blood clots in veins or in the blood vessels of the lungs.
Information on 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 a disease of an organ 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 the case of switching anticoagulant therapy, when the patient has had an intravenous or arterial line 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.
  • a spinal (epidural) catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after removal of the catheter,
  • if the patient has a heart valve prosthesis,
  • if the doctor determines that the patient's blood pressure is unstable or if 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 reduce its effect.
The doctor will decide whether the patient should receive Apixaban 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 disease (e.g. diltiazem);
  • antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs).

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 baby, 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. The patient should consult her doctor, pharmacist or nurse before using this medicine during breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting this medicine.

Driving and operating machinery
Apixaban Olpha has not been shown to affect the ability to drive or operate machinery.

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 consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Apixaban Olpha

This medicine should always be taken as instructed by the doctor or pharmacist. If in doubt,
consult the doctor, pharmacist or nurse.
Dosage
Swallow the tablet with water. Apixaban Olpha can be taken independently
of meals. To achieve the best treatment results, it is recommended to take the tablets
at the same time each day.
If the patient has difficulty swallowing the tablets whole, discuss alternative methods of taking Apixaban Olpha with the doctor. The tablet may be crushed immediately before administration and mixed with water or 5% aqueous glucose solution, juice, or apple puree.
Instructions for crushing tablets:
Crush the tablet with a mortar and pestle.
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, mortar, and container used for crushing the tablets with a small amount of water or another liquid (e.g., 30 mL) and swallow (drink) the rinse liquid.
If necessary, the doctor may administer crushed Apixaban Olpha tablets mixed with 60 mL of water or 5% aqueous glucose solution through a nasogastric tube.
Apixaban Olpha should be taken as recommended for the following indications:
Prevention of blood clots after hip or knee replacement surgery
The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily. For example, one tablet in the morning and one in the evening. The first tablet should be taken 12 to 24 hours after surgery.
If the patient has undergone major hip surgery, the tablets are usually taken for 32 to 38 days.
If the patient has undergone major knee surgery, the tablets are usually taken for 10 to 14 days.
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 Apixaban Olpha 5 mg tablet twice daily.
The recommended dose is one Apixaban Olpha 2.5 mg tablet twice daily if:

  • the patient has severe kidney function impairment, or
  • two or more of the following conditions are met:
  • blood test results suggest reduced kidney function (serum creatinine concentration 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. The 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 Apixaban Olpha 5 mg tablets 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 Apixaban Olpha 5 mg tablet 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 Apixaban Olpha 2.5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
The 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 instructed by the doctor or pharmacist.
If in doubt, consult the 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 the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four Apixaban Olpha 2.5 mg tablets, administered 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 Apixaban Olpha 2.5 mg tablets, administered twice daily, for example, two in the morning and two 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 dose adjustment.
The doctor may change anticoagulant treatment as follows:
Switching from Apixaban Olpha to 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 anticoagulant medicines. Start treatment with Apixaban Olpha at the time the next dose of anticoagulant medicine was scheduled, then continue regular dosing.
Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apixaban Olpha
Discontinue the vitamin K antagonist-containing medicine. The doctor must perform blood tests and will inform the patient when to start taking Apixaban Olpha.
Switching from Apixaban Olpha to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin)
If the doctor informs the patient to start taking a vitamin K antagonist-containing medicine, continue taking Apixaban Olpha for at least 2 days after the first dose of the vitamin K antagonist-containing medicine.
The doctor must perform blood tests and inform the patient 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 times specified by the doctor to prevent blood clots in the brain's blood vessels and other blood vessels in the body.
Taking more Apixaban Olpha than recommended
If the patient has taken more than the recommended dose of this medicine, contact the doctor immediately. Bring the medicine packaging, even if it is empty.
If the patient has taken more than the recommended dose of Apixaban Olpha, the risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the factor Xa inhibitor effect may be necessary.
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 recommended, twice daily.
If in doubt about use of the medicine or if more than one dose is missed, consult the doctor, pharmacist or nurse.
Stopping Apixaban Olpha
Do not stop taking this medicine without consulting the doctor, as stopping Apixaban Olpha prematurely may increase the risk of blood clots.
If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Apixaban Olpha can be used in three different medical conditions. Known adverse effects and their frequency of occurrence may vary in each of these conditions and are listed separately below. In these conditions, the most common general adverse effect of this medicine is bleeding, which may potentially be life-threatening and may require immediate medical attention.

The following adverse effects may occur when taking Apixaban Olpha to prevent blood clots after hip or knee replacement surgery.

Common adverse effects (may occur in not more than 1 in 10 people)

  • Anaemia, which may cause fatigue or paleness;
  • Bleeding including:
    • Bruising (subcutaneous haemorrhages) and swelling;
  • Nausea.

Uncommon adverse effects (may occur in not more than 1 in 100 people)

  • Decreased platelet count (which may affect blood clotting);
  • Bleeding:
    • After surgery, including bruising (subcutaneous haemorrhages) and swelling, leakage of blood or other fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From the stomach, intestines, or bright red blood in stool;
    • Blood in urine;
    • Nosebleeds;
    • From the genital tract;
  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Blood test results may indicate:
    • Liver function disorders;
    • Increased activity of certain liver enzymes;
    • Increased bilirubin levels, a product formed from destroyed red blood cells, which may cause yellowing of the skin and eyes;
  • Itching.

Rare adverse effects (may occur in not more than 1 in 1,000 people)

  • 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, seek immediate medical attention;
  • Bleeding:
    • Into muscle;
    • Into the eye;
    • From gums and presence of blood in sputum when coughing;
    • From the rectum;
  • Hair loss.

Frequency not known (cannot be estimated from available data)

  • Bleeding:
    • Into the brain or spinal canal;
    • In the lungs or throat;
    • In the mouth;
    • Into the abdominal cavity or retroperitoneal space;
    • From haemorrhoids;
    • Test results indicating presence of blood in stool or urine;
  • Skin rash, which may develop blisters and resemble small target-like lesions (dark spots in the centre surrounded by a lighter ring, with a dark ring around the edge) (erythema multiforme);
  • Vasculitis (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots beneath the skin surface, or bruising (subcutaneous haemorrhages);
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following adverse 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 adverse effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • Into the eye;
    • Into the stomach or intestine;
    • From the rectum;
    • Blood in urine;
    • Nosebleeds;
    • From gums;
    • Bruising (subcutaneous haemorrhage) 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 indicate:
    • Increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse effects (may occur in not more than 1 in 100 people)

  • Bleeding:
    • Into the brain or spinal canal;
    • In the mouth or presence of blood in sputum when coughing;
    • Into the abdominal cavity or from the genital tract;
    • Bright red blood in stool;
    • Occurring after surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Presence of blood in stool or urine detected in laboratory tests;
  • Decreased platelet count (which may affect blood clotting);
  • Blood test results may indicate:
    • 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, seek immediate medical attention.

Rare adverse effects (may occur in not more than 1 in 1,000 people)

  • Bleeding:
    • In the lungs or throat;
    • Into the retroperitoneal space;
    • Into muscle.

Very rare adverse effects (may occur in not more than 1 in 10,000 people)

  • Skin rash, which may develop blisters and resemble 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)

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

The following adverse effects may occur when taking Apixaban Olpha for the treatment or prevention of recurrent blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

Common adverse effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • Nosebleeds;
    • From gums;
    • Blood in urine;
    • Bruising (subcutaneous haemorrhage) and swelling;
    • In the stomach, intestine, or from the rectum;
    • In the mouth;
    • From the genital tract;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect blood clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may indicate:
    • Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon adverse effects (may occur in not more than 1 in 100 people)

  • Low blood pressure, which may lead to fainting or rapid heartbeat;
  • Bleeding:
    • Into the eye;
    • In the mouth or presence of blood in sputum when coughing;
    • Bright red blood in stool;
    • Test results indicating blood in stool or urine;
    • Occurring after surgery, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site;
    • From haemorrhoids;
    • Into muscle;
  • 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, seek immediate medical attention;
  • Blood test results may indicate:
    • 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 adverse effects (may occur in not more than 1 in 1,000 people)

  • Bleeding:
    • Into the brain or spinal canal;
    • In the lungs.

Frequency not known (cannot be estimated from available data)

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

Additional adverse 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 adverse effects is classified as "common" (may occur in not more than 1 in 10 people).

Overall, adverse effects observed in children and adolescents treated with Apixaban Olpha were generally similar to those seen in adults and were mostly mild or moderate in severity. Adverse effects occurring more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

Very common adverse effects (may occur in more than 1 in 10 people)

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

Common adverse effects (may occur in not more than 1 in 10 people)

  • Bleeding, including:
    • From gums;
    • Blood in urine;
    • Bruising (subcutaneous haemorrhages) and swelling;
    • From the intestine or rectum;
    • Bright red blood in stool;
    • After surgery, including bruising (subcutaneous haemorrhages) 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 (which may affect clotting);
  • Nausea;
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause fainting or rapid heartbeat;
  • Blood test results may indicate:
    • Abnormal liver function;
    • Increased activity of certain liver enzymes;
    • Increased alanine aminotransferase (ALT) activity.

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 during coughing;
    • Into the brain or spine;
    • In the lungs;
    • Into muscle;
  • Skin rash, which may develop blisters and resemble 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, circular spots beneath the skin surface or bruising;
  • Blood test results may indicate:
    • Increased gamma-glutamyl transferase (GGT) activity;
    • Presence of blood in stool or urine;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of 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 adverse effects helps provide more information on the safety of this medicine.

5. How to store Apixaban Olpha

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

6. Contents of the pack and other information

What Apixaban Olpha contains

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • The other components are:
  • Tablet core: lactose (see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”), microcrystalline cellulose, sodium croscarmellose (see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”), sodium lauryl sulfate (see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”), magnesium stearate;
  • Coating: Opadry II Yellow (hypromellose (E 464), monohydrate lactose (see section 2 “Apixaban Olpha contains lactose (a type of sugar) and sodium”), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172)).

What Apixaban Olpha looks like and contents of the pack
Yellow, round, biconvex coated tablets with the inscription “I1” debossed on one side and smooth on the other side.
Blister packs made of PVC/PVDC/Aluminium containing 10 or 14 coated tablets.
Pack sizes of 20, 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 physician may provide you with a similar card.
The Patient Alert Card contains helpful information for the patient and warns other physicians 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 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 2.5 mg
France: APIXABAN OLPHA 2.5 mg, comprimé pelliculé
Lithuania: Apixaban Olpha 2.5 mg plėvele dengtos tabletės
Latvia: Apixaban Olpha 2.5 mg apvalkotās tabletes