Apixaban teva

Poland
Brand name Apixaban teva
Form tablets, film-coated
Active substance / Dosage
apixaban · 5 mg
Prescription type Prescription only
ATC code
B01AF02
Registration number 100421862
Manufacturer Balkanpharma-Dupnitsa AD
Apixaban teva tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Apixaban Teva, 5 mg, coated tablets
Apixabanum
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 only. 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.

Contents of the leaflet

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

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

Apixaban Teva 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 of the blood clotting process.
Apixaban Teva is used in adults:

  • to prevent blood clots forming 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 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 blood clots in the veins of the legs and (or) lungs.

Apixaban Teva is used in children from 28 days of age up to below 18 years of age, for the treatment of blood clots and to prevent recurrence of blood clots in the 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 Teva

When not to use Apixaban Teva:

  • 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,

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  • if the patient has an organ disease that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage),
  • 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 when switching anticoagulant therapy, when a venous or arterial line has been inserted and heparin is administered through the 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 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 weighs 60 kg or less
  • severe kidney disease or if the patient is on dialysis
  • liver problems or history of liver problems.
    • 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 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 Teva

  • if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform their doctor, who will decide whether treatment needs to be adjusted.

If surgery or a procedure that may involve 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 involve bleeding, consult the doctor.
Children and adolescents
Use of this medicine is not recommended in children and adolescents with body weight below 35 kg.
Apixaban Teva 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 use.
Some medicines may enhance the effect of Apixaban Teva, while others may reduce its effect.
The doctor will decide whether the patient should receive Apixaban Teva while taking other medicines and how closely monitoring should be performed.
The following medicines may enhance the effect of Apixaban Teva 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)

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  • 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 when 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)
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors.

The following medicines may reduce the ability of Apixaban Teva to prevent clot formation:

  • 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 become pregnant, she should consult her doctor, pharmacist or nurse before using this medicine.
The effect of apixaban on pregnancy and unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking this medicine, she should immediately contact her doctor.
It is not known whether apixaban passes into human milk. Consult your doctor, pharmacist or nurse before using this medicine while breastfeeding. The patient may be advised to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine.
Driving and using machines
Apixaban has no effect or a negligible effect on the ability to drive motor vehicles and operate machinery.
Apixaban Teva contains lactose (a 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.
This 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 Teva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
please consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban Teva can be taken with or without food. For optimal treatment results,
it is recommended to take the tablets at the same times each day.
If you have difficulty swallowing the tablets whole, discuss alternative methods of taking Apixaban Teva with your 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.

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  • Carefully transfer the powder to a suitable container and mix it with a small amount (e.g., 30 mL [2 tablespoons]) of water or another liquid listed above to form a mixture.
  • Swallow the mixture.
  • Rinse the mortar, pestle, and container used to crush the tablet with a small amount of water or another liquid (e.g., 30 mL) and swallow the rinse liquid.

If necessary, your doctor may administer crushed Apixaban Teva tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixaban Teva should be taken as follows for the specified indications:
Prevention of blood clots in the heart in patients with irregular heart rhythm
(atrial fibrillation) and at least one additional risk factor
The recommended dose is one 5 mg tablet twice daily.
The recommended dose is one 2.5 mg tablet twice daily if:

  • you have severe kidney function impairment, or
  • two or more of the following conditions are met:
    • blood test results indicate reduced kidney function (serum creatinine level ≥1.5 mg/dL [133 micromoles/L]),
    • 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 tablet in the morning and one in the evening. Your 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 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 5 mg tablet twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrent blood clots after completing 6 months of treatment
The recommended dose is one 2.5 mg tablet 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 and prevention of blood clots in the veins or blood vessels of the lungs.
This medicine should always be taken or administered exactly as prescribed by your paediatrician or pharmacist. If you are unsure, consult your paediatrician, 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 Teva 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 5 mg tablets of Apixaban Teva,
twice daily for the first 7 days, for example, two in the morning and two in the
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evening. After 7 days, the recommended dose is one 5 mg tablet of Apixaban Teva,
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 medical appointments, as the dose may need to be adjusted as the patient's body weight changes.
Your doctor may change anticoagulant treatment as follows:

  • Switching from Apixaban Teva to other anticoagulant medicines Discontinue Apixaban Teva. Start treatment with other anticoagulant medicines (e.g., heparin) at the time the next tablet was due.
  • Switching from other anticoagulant medicines to Apixaban Teva Discontinue the other anticoagulant medicines. Start treatment with Apixaban Teva at the time the next dose of the previous anticoagulant was due, and continue regular dosing thereafter.
  • Switching from anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) to Apixaban Teva Discontinue the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to start taking Apixaban Teva.
  • Switching from Apixaban Teva to anticoagulant treatment including a vitamin K antagonist (e.g., warfarin) If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Teva for at least 2 days after taking the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and inform you when to stop taking Apixaban Teva.

Patients undergoing cardioversion
Patients who require cardioversion to restore normal heart rhythm should take this medicine at the times specified by their doctor to prevent the 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 Teva
If you have taken more than the recommended dose of this medicine, contact your doctor immediately.
Bring the medicine packaging with you, even if it is empty.
If you have taken more than the recommended dose of Apixaban Teva, your risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the anti-Xa effect may be required.
Missing a dose of Apixaban Teva

  • If you miss a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
  • A missed evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue taking the medicine the next day as prescribed, twice daily.

If you have any doubts about using the medicine or if you miss more than one dose,
consult your doctor, pharmacist, or nurse.
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Stopping Apixaban Teva
DO NOT stop taking this medicine without consulting your doctor, as stopping treatment prematurely may increase the risk of developing blood clots.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

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

  • Bleeding, including:
    • into the eye
    • into the stomach or intestine
    • from the rectum
    • blood in urine
    • from the nose
    • from the gums
    • subcutaneous bleeding (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 indicate:
    • increased gamma-glutamyl transferase (GGT) activity.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

  • Bleeding:
    • into the brain or spinal canal
    • in the mouth or coughing up blood
    • in the abdominal cavity or from the vagina
    • bright red blood in stool
    • bleeding after surgery, including 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 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

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  • Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, contact a doctor immediately.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

  • Bleeding:
    • in the lungs or throat
    • into the retroperitoneal space (behind the abdominal cavity)
    • into muscles.

Very rare adverse reactions (may occur in no more than 1 in 10,000 people)

  • Skin rash, which may develop blisters and 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 (frequency cannot be estimated from available data)

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

The following adverse reactions may occur when taking apixaban 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 reactions (may occur in up to 1 in 10 people)

  • Bleeding, including:
    • from the nose
    • from the gums
    • blood in urine
    • subcutaneous bleeding (bruising) and swelling
    • in the stomach, intestine, or from the rectum
    • in the mouth
    • from the vagina
  • 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 (ALT) activity.

Uncommon adverse reactions (may occur in 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 coughing up blood
    • bright red blood in stool
    • test results indicating blood in stool or urine
    • bleeding after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound/incision site (wound discharge) or injection site
    • from haemorrhoids
    • into muscles
  • Itching

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  • Hair loss
  • Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. If any of these symptoms are observed, contact a doctor immediately.
  • 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 reactions (may occur in up to 1 in 1,000 people)

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

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

  • Bleeding:
    • into the abdominal cavity or retroperitoneal space
  • Skin rash, which may develop blisters and 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 (inflammation of blood vessels), which may cause skin rash or raised, flat, red, circular spots under the skin, or bruising.
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Additional adverse reactions in children and adolescents
If any of the following symptoms occur, contact a paediatrician immediately:

  • Allergic (hypersensitivity) reactions, which may cause: swelling of the face, lips, mouth, tongue and (or) throat, and breathing difficulties. The frequency of these adverse reactions is classified as "common" (may occur in up to 1 in 10 people). Generally, adverse reactions observed in children and adolescents treated with Apixaban Teva were similar to those seen in adults and were mostly mild or moderate in severity. Adverse reactions reported more frequently in children and adolescents include nosebleeds and abnormal vaginal bleeding.

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

  • Bleeding, including:
    • from the vagina;
    • from the nose.

Common adverse reactions (may occur in up to 1 in 10 people)

  • Bleeding, including:
    • from the gums;
    • blood in urine;
    • subcutaneous bleeding (bruising) and swelling;
    • from the intestine or rectum;
    • bright red blood in stool;
    • bleeding after surgery, including subcutaneous bleeding (bruising) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
  • Hair loss;

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  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count (which may affect blood 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 when coughing;
    • in the brain or spine;
    • in the lungs;
    • in muscle;
  • Skin rash, which may develop blisters and 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, circular spots under the skin 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can 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 ;
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Apixaban Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle and blister pack following: EXP. The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
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Medicines must not be disposed of via wastewater 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 Teva contains

  • The active substance is apixaban. Each tablet contains 5 mg of apixaban.
  • The other ingredients are:
    • Tablet core: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulphate, magnesium stearate.
    • Coating: monohydrate lactose (see section 2), hypromellose 2910 (6 MPA.S), titanium dioxide (E 171), macrogol MW3350, triacetin, iron oxide red (E 172).

What Apixaban Teva looks like and contents of the pack
Light pink, oval, film-coated tablets, with the imprint "TV" on one side and "G2" on the other side. Dimensions: length 9.9 - 10.5 mm, width 5.0 - 5.6 mm, thickness 4.2 - 4.8 mm.
Single-dose transparent blisters made of PVC/PE/PVDC/Aluminium, in a cardboard box containing: 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 100 x 1, 120 x 1, 168 x 1, 200 x 1 coated tablets.
White HDPE bottle with white PP screw cap with child-resistant closure, containing 180, 200 and 500 coated tablets, in a cardboard box.
White HDPE bottle with white PP screw cap with child-resistant closure, with cotton wool seal, containing 180, 200 and 500 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Patient Alert Card: information for use
Inside the packaging of Apixaban Teva, next to 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 physicians that the patient is taking Apixaban Teva. You should always carry this card with you.

  1. Take the card
  2. 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:
  3. Fold the card and always carry it with you

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
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Importer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa, 2600,
Bulgaria

For further information, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Austria | Apixaban ratiopharm 5 mg Filmtabletten | | Belgium | Apixaban Teva 5 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten | | Bulgaria | Апиксабан Тева 5 mg филмирани таблетки | | Czech Republic | Apixaban Teva | | Germany | Apixaban-ratiopharm 5 mg Filmtabletten | | Denmark | Apixaban Teva | | Estonia | Apixaban Teva | | Spain | Apixaban Teva 5 mg comprimidos recubiertos con película EFG | | Finland | Apixaban ratiopharm 5 mg tabletti, kalvopäällysteinen | | France | Apixaban TEVA 5 mg, comprimé pelliculé | | Croatia | Apiksaban Teva GmbH 5 mg filmom obložene tablete | | Hungary | Apixaban Teva 5 mg filmtabletta | | Ireland | Apixaban Teva 5 mg film-coated tablets | | Iceland | Apixaban Teva | | Italy | APIXABAN TEVA | | Lithuania | Apixaban Teva 5 mg plėvele dengtos tabletės | | Latvia | Apixaban Teva 5 mg apvalkotās tabletes | | Luxembourg | Apixaban-ratiopharm 5 mg Filmtabletten | | Netherlands | Apixaban Teva 5 mg, filmomhulde tabletten | | Norway | Apixaban Teva | | Romania | Apixaban Teva BV 5 mg Film-coated tablets | | Poland | Apixaban Teva | | Sweden | Apixaban Teva 2.5 mg, 5 mg filmdragerade tabletter | | Slovenia | Apiksaban Teva 5 mg filmsko obložene tablete | | Slovakia | Apixaban Teva 5 mg | | United Kingdom | Apixaban Teva 2.5 mg and 5 mg Film-coated Tablets |

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