Apixaban gedeon richter: detailed information

Package leaflet: Information for the user

APIXABAN GEDEON RICHTER, 2.5 mg, film-coated tablets
Apixabanum
Please read 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

What Apixaban Gedeon Richter is and what it is used for
Important information before taking Apixaban Gedeon Richter
How to take Apixaban Gedeon Richter
Possible side effects
How to store Apixaban Gedeon Richter
Contents of the pack and other information

1. What Apixaban Gedeon Richter is and what it is used for
Apixaban Gedeon Richter contains the active substance apixaban and belongs to a group of medicines known as anticoagulants. This medicine helps prevent blood clots by inhibiting Factor Xa, an important component in the blood clotting process.
Apixaban Gedeon Richter is used in adults:

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee surgery, patients may have an increased risk of developing blood clots in the veins of the lower limbs. This may lead to swelling of the legs, 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) may be life-threatening and requires immediate medical attention.
to prevent the formation of blood clots 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 a stroke, or may travel to other organs, impairing blood flow to those 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 blood clots in the blood vessels of the legs and/or lungs.

Apixaban Gedeon Richter is used in children aged from 28 days to below 18 years for the treatment of blood clots and prevention of 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 taking Apixaban Gedeon Richter

When not to use Apixaban Gedeon Richter:

if the patient is allergic to apixaban or to 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 situations of switching anticoagulant therapy, when a venous or arterial access line has been inserted and heparin is administered through the line to maintain patency, or when the patient is undergoing catheter ablation (a catheter is inserted into a 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 associated with bleeding, including those 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.
spinal catheter or spinal injection (anaesthetic or pain relief), in which case the doctor will advise taking this medicine 5 or more hours after catheter removal,
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 Gedeon Richter

if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of clots), the patient should inform the doctor, who will decide whether treatment adjustment 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 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 Gedeon Richter 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 Gedeon Richter, while others may reduce its effect. The doctor will decide whether the patient should receive Apixaban Gedeon Richter while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of Apixaban Gedeon Richter 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), especially 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 problems (e.g. diltiazem);
antidepressants known as selective serotonin reuptake inhibitors or serotonin-noradrenaline reuptake inhibitors.

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

medicines used to prevent epilepsy or seizures (e.g. phenytoin and others);
St John’s wort (a 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 Gedeon Richter on pregnancy and the unborn child is unknown. This medicine should not be used during pregnancy. If the patient becomes pregnant while taking this medicine, she should contact her doctor immediately.
It is not known whether Apixaban Gedeon Richter 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 treatment with this medicine.

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

Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered “sodium-free”.

3. How to take Apixaban Gedeon Richter

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor, pharmacist or nurse.
Dosage
The tablet should be swallowed with water. Apixaban Gedeon Richter may be taken
independently of meals.
To achieve the best treatment results, it is recommended to take the tablets at the same
times each day.
If a patient has difficulty swallowing tablets whole, they should speak to their doctor about
alternative ways of taking Apixaban Gedeon Richter. The tablet may be crushed immediately
before administration and mixed with water or a 5% aqueous glucose solution, juice or apple
purée.
Instructions for crushing tablets:

Crush the tablet with a pestle in a mortar.
Carefully transfer the entire powder into a suitable container, then 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 to crush 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, a doctor may administer crushed Apixaban Gedeon Richter tablets mixed with
60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Gedeon Richter should be taken as directed in the following
indications:
Prevention of blood clots after hip or knee replacement surgery.
The recommended dose is one Apixaban Gedeon Richter 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 joint surgery, they will usually take tablets for
32 to 38 days.
If the patient has undergone major knee joint surgery, they will usually take tablets 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 Gedeon Richter 5 mg tablet twice daily.
The recommended dose is one Apixaban Gedeon Richter 2.5 mg tablet twice daily if:

the patient has severe renal 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 in the morning and one
in the evening. The doctor will decide how long treatment should continue.
Treatment of blood clots in the veins of the legs and blood clots in the blood vessels of the
lungs
The recommended dose is two tablets of Apixaban Gedeon Richter 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 Gedeon Richter 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 Apixaban Gedeon Richter 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 directed by a doctor or pharmacist. If in doubt, consult a 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 Gedeon Richter 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 tablets of Apixaban Gedeon Richter 2.5 mg, 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 tablets of Apixaban Gedeon Richter 2.5 mg, 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 dose adjustments may be
necessary with changes in the patient's body weight.
The doctor may change anticoagulant therapy as follows:

Switching from Apixaban Gedeon Richter to anticoagulant medicines Discontinue Apixaban Gedeon Richter. Begin anticoagulant therapy (e.g. heparin) at the time the next tablet was scheduled to be taken.
Switching from anticoagulant medicines to Apixaban Gedeon Richter Discontinue anticoagulant therapy. Begin Apixaban Gedeon Richter at the time the next dose of anticoagulant was scheduled, then continue regular dosing.
Switching from anticoagulant therapy including a vitamin K antagonist (e.g. warfarin) to Apixaban Gedeon Richter Discontinue the vitamin K antagonist. The doctor must perform blood tests and will inform when to start taking Apixaban Gedeon Richter.
Switching from Apixaban Gedeon Richter to anticoagulant therapy including a vitamin K antagonist (e.g. warfarin) If the doctor informs the patient to start taking a vitamin K antagonist, continue taking Apixaban Gedeon Richter for at least 2 days after taking the first dose of the vitamin K antagonist. The doctor must perform blood tests and inform when to stop taking Apixaban Gedeon Richter.

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 brain's blood vessels and other blood vessels in the body.
Taking more than the recommended dose of Apixaban Gedeon Richter
If a patient has taken more than the recommended dose of this medicine, contact a doctor immediately. Take the medicine packaging with you, even if no tablets remain.
If a patient has taken more than the recommended dose of Apixaban Gedeon Richter, the risk of bleeding may be increased. In case of bleeding, surgical treatment, blood transfusion or other treatment to reverse the effect directed against factor Xa may be necessary.
Missed dose of Apixaban Gedeon Richter

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 the same evening. Do not take two doses the next morning instead; continue taking the medicine the next day as directed, twice daily.

If in doubt about use of the medicine or if more than one dose is missed, consult a doctor, pharmacist or nurse.
Stopping Apixaban Gedeon Richter
Do not stop taking this medicine without consulting a doctor, as the risk of blood clots may be higher if Apixaban Gedeon Richter is stopped prematurely.
If there are any further doubts about using this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Apixaban Gedeon Richter may be used in three different medical conditions. Known side effects and their frequency of occurrence may differ for each of these conditions and are listed separately below. In these conditions, the most common general side effect of 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 Gedeon Richter to prevent blood clots after hip or knee replacement surgery.

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

Anaemia, which may cause fatigue or paleness;
Bleeding including:
bruising (subcutaneous haemorrhage) and swelling;
Nausea.

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

Decreased platelet count (which may affect blood clotting);
Bleeding:
after surgery, including bruising (subcutaneous haemorrhage) 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;
vaginal bleeding;
Low blood pressure, which may lead to fainting or rapid heartbeat;
Blood test results may indicate:
liver function abnormalities;
increased activity of certain liver enzymes;
increased bilirubin levels, a product of destroyed red blood cells, which may cause yellowing of the skin and eyes;
Itching.

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

Allergic reactions (hypersensitivity) which may cause: facial swelling, swelling of the lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice;
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, sometimes with blistering, resembling 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 haemorrhage);
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects may occur when taking Apixaban Gedeon Richter to prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.

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

Bleeding, including:
into the eye;
in the stomach or intestine;
from the rectum;
blood in urine;
nosebleeds;
bleeding 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 side effects (may occur in 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 vagina;
bright red blood in stool;
post-surgical bleeding, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from 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: facial swelling, swelling of the lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice.

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

Bleeding:
in the lungs or throat;
into the retroperitoneal space;
into muscle.

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

Skin rash, sometimes with blistering, resembling 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 haemorrhage);
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

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

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

Bleeding, including:
nosebleeds;
bleeding from gums;
blood in urine;
bruising (subcutaneous haemorrhage) and swelling;
in the stomach, intestines, or from the rectum;
in the mouth;
vaginal bleeding;
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 side effects (may occur in up to 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;
post-surgical bleeding, including bruising (subcutaneous haemorrhage) and swelling, leakage of blood or fluid from surgical wound/incision site (wound discharge) or injection site;
from haemorrhoids;
into muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: facial swelling, swelling of the lips, mouth, tongue and/or throat, and breathing difficulties. If any of these symptoms occur, seek immediate medical advice;
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 side effects (may occur in up to 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, sometimes with blistering, resembling 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 haemorrhage);
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional side effects in children and adolescents
If any of the following symptoms occur, seek immediate medical advice:

Allergic reactions (hypersensitivity) which may cause: facial swelling, swelling of the lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these side effects is classified as "common" (may occur in up to 1 in 10 people). Generally, side effects observed in children and adolescents treated with apixaban 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 occur in more than 1 in 10 people)

Bleeding, including:
from the vagina;
nosebleeds.

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

Bleeding, including:
from gums;
blood in urine;
bruising (bruises) and swelling;
from intestine or rectum;
bright red blood in stool;
post-surgical bleeding, including bruising (bruises) and swelling, leakage of blood or fluid (discharge) from surgical wound or injection site;
Hair loss;
Anaemia, which may cause fatigue or paleness;
Decreased platelet count (which may affect coagulability);
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;
in the brain or spine;
in the lungs;
in muscle;
Skin rash, sometimes with blistering, resembling 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 faeces or urine;
Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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.
Side effects can also be reported to the marketing authorisation holder.

5. How to store Apixaban Gedeon Richter

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 pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban Gedeon Richter contains

The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
Other ingredients are:
- Tablet core: microcrystalline cellulose, anhydrous lactose (see section 2 “Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium *”), sodium croscarmellose (see section 2 “Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium *”), sodium lauryl sulfate, magnesium stearate;
- Coating: hypromellose 15 mPas, monohydrate lactose (see section 2 “Apixaban Gedeon Richter contains lactose (a type of sugar) and sodium *”), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Apixaban Gedeon Richter looks like and contents of the pack
The coated tablets are yellow, round, biconvex, with a diameter of approximately 6 mm,
imprinted with the code “L0” on one side.
The tablets are packed in blisters within cardboard boxes containing 20, 60 or 168 coated tablets.
Not all pack sizes may be marketed.
Patient Warning Card: information for use
Inside the packaging of Apixaban Gedeon Richter, alongside the patient leaflet, a Patient Warning Card is included, or your physician may provide you with a similar card.
The Patient Warning Card contains helpful information for the patient and serves to alert other healthcare professionals that the patient is taking Apixaban Gedeon Richter. You should always carry this card with you.

Take the card.
If necessary, separate the appropriate language section (facilitated by perforated edges).
Complete the following sections, or ask your doctor to complete them:
- Name:
- Date of birth:
- Indication:
- Dose: ................. mg twice daily
- Doctor’s name:
- Doctor’s telephone number:
Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: АПИКСАБАН ГЕДЕОН РИХТЕР 2,5 mg филмирани таблетки
Czech Republic: APIXABAN GEDEON RICHTER
Estonia: APIXABAN GEDEON RICHTER
Hungary: APIXABAN GEDEON RICHTER 2,5 mg filmtabletta
Lithuania: APIXABAN GEDEON RICHTER 2,5 mg plėvele dengtos tabletės
Poland: APIXABAN GEDEON RICHTER
Romania: APIXABAN GEDEON RICHTER 2,5 mg comprimate filmate
Slovakia: APIXABAN GEDEON RICHTER 2,5 mg filmom obalené tablety
For further information about this medicinal product, please contact:
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]