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 100470519
Manufacturer Combino Pharm (Malta) Ltd.
Apixaban teva tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Apixaban Teva, 5 mg, coated tablets
Apixaban
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

  • Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
  • If you experience any adverse 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 inhibiting Factor Xa, an important factor in the blood clotting process.

Apixaban Teva is used in adults:

  • To prevent 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 stroke, or to other organs, impairing blood flow to these organs (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 blood clots in the veins of the legs and/or lungs.

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

2. Important information before using Apixabanum Teva

Do not use Apixabanum Teva if:

  • the patient is allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • the patient has active bleeding;
  • the patient has a disease of an organ that increases the risk of major bleeding (such as active or recently diagnosed peptic ulcer of the stomach or intestine, recently diagnosed intracranial haemorrhage);
  • the patient has liver disease leading to an increased risk of bleeding (hepatic coagulopathy);
  • 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 involving bleeding, including those resulting in reduced platelet function;
  • 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;
  • Apixabanum Teva 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 special caution when using Apixabanum Teva

  • 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 a change in treatment is necessary.

If the patient needs to undergo surgery or a procedure that may involve bleeding, 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, ask the doctor.

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

Apixabanum 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 take.
Some medicines may enhance the effect of apixaban, while others may reduce it. The doctor will decide whether the patient should receive apixaban while taking other medicines and how closely monitoring should be performed.

The following medicines may enhance the effect of apixaban 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 when the patient is over 75 years of age and taking acetylsalicylic acid, there may be an increased risk of unwanted bleeding.
  • 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 apixaban’s ability 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 on pregnancy and the unborn child is unknown. This medicine should not be taken during pregnancy. If the patient becomes pregnant while taking apixaban, she should contact her doctor immediately.
It is not known whether apixaban 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 apixaban.

Driving and using machines
Apixaban has no effect or a negligible effect on the ability to drive and use machines.

Apixabanum Teva contains lactose (a 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.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Apixabanum Teva

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor, pharmacist, or nurse.
Dosage
The tablet should be swallowed with water. Apixabanum Teva may be taken with or without food.
To achieve the best treatment results, it is recommended to take the tablets at the same time each day.
If you have difficulty swallowing the tablets whole, speak to your doctor about alternative ways of taking Apixabanum Teva. 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 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 Apixabanum Teva tablets mixed with 60 mL of water or 5% aqueous glucose solution via a nasogastric tube.
Apixabanum Teva should be taken as directed in the following 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 Apixabanum Teva 5 mg tablet twice daily.
The recommended dose is one Apixabanum Teva 2.5 mg tablet twice daily if:

  • the patient has severe kidney function impairment;
  • two or more of the following conditions apply:
  • blood test results suggest reduced kidney function (serum creatinine level is 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 veins of the legs and blood clots in the blood vessels of the lungs
The recommended dose is two tablets of Apixabanum Teva 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 Apixabanum Teva 5 mg twice daily, for example, one tablet in the morning and one in the evening.
Prevention of recurrence of blood clots after completion of 6-month treatment
The recommended dose is one Apixabanum Teva 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 of blood clots and prevention of recurrence of blood clots in veins or in the blood vessels of the lungs.
This medicine should always be taken or administered exactly as directed by your paediatrician or pharmacist. If you are unsure, you should 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 Apixabanum Teva depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two tablets of Apixabanum Teva 5 mg , given 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 Apixabanum Teva 5 mg , given 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 dose adjustments may be necessary with changes in body weight.
Your doctor may change anticoagulant treatment as follows:

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

Patients undergoing cardioversion
Patients who require a cardioversion procedure to restore normal heart rhythm should take Apixabanum Teva at the times specified by the doctor to prevent formation of blood clots in the blood vessels of the brain and other parts of the body.
Taking more than the recommended dose of Apixabanum Teva
If you have taken more than the recommended dose of this medicine, you should 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 Apixabanum Teva, your risk of bleeding may increase. In case of bleeding, surgical treatment, blood transfusion, or other treatment to reverse the effect of the factor Xa inhibitor may be required.
Missing a dose of Apixabanum 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 directed, twice daily.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 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 not more than 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 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 show:
  • increased gamma-glutamyl transferase (GGT) activity.

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

  • Bleeding:
  • into the brain or spinal canal;
  • in the mouth or haemoptysis (coughing up blood);
  • in the abdominal cavity or from the vagina;
  • bright red blood in stool;
  • bleeding occurring 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 in 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 (hypersensitivity) reactions, 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 occur in not more than 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 occur in not 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 (cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots under the skin or 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 to treat or prevent recurrence of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

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

  • Bleeding, including:
  • from the nose;
  • from the gums;
  • blood in urine;
  • subcutaneous haemorrhage 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 in blood (which may affect blood clotting);
  • Nausea;
  • Skin rash;
  • Blood test results may show:
  • increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (AlAT) activity.

Uncommon side 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 eyes;
  • in the mouth or coughing up blood;
  • bright red blood in stool;
  • test results indicating blood in stool or urine;
  • bleeding occurring 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;
  • 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 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 occur in not more than 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 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);
  • Inflammation of blood vessels (vasculitis), which may cause skin rash or raised, flat, red, circular spots under the skin or 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, contact the paediatrician immediately:

  • 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 occur in not more than 1 in 10 people). Generally, side effects observed in children and adolescents treated with Apixabanum Teva were similar to those seen in adults and were mostly mild or moderate in severity. Side effects observed 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;
    • from the nose.

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

  • Bleeding, including:
    • from the gums;
    • blood in urine;
    • subcutaneous haemorrhages (bruising) and swelling;
    • from the intestine or rectum;
    • bright red blood in stool;
    • bleeding after surgery, including subcutaneous haemorrhages (bruising) and swelling, leakage of blood (discharge) from the surgical wound or injection site;
  • Hair loss;
  • Anaemia, which may cause fatigue or paleness;
  • Decreased platelet count in 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 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 show:
    • increased gamma-glutamyl transferase (GGT) activity;
    • 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, tell 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 ;
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apixabanum Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
bottle/blister pack after: EXP. The expiry date refers to the last day of the stated month.
This medicine requires no special storage conditions.
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 Apixabanum Teva contains

  • The active substance is apixaban. Each tablet contains 5 mg of apixaban.
  • Other ingredients are:
  • Tablet core: lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulphate, magnesium stearate (of plant origin).
  • Coating: monohydrate lactose, hypromellose 2910 (15 mPa), titanium dioxide (E 171), triacetin, iron oxide red (E 172). See section 2 "Apixabanum Teva contains lactose (a type of sugar) and sodium".

What Apixabanum Teva looks like and contents of the pack
Apixabanum Teva is a pink, oval, biconvex film-coated tablet approximately 10 mm in length,
5.4 mm in width and 4 mm in thickness.
Apixabanum Teva is available in the following pack sizes:
PVC/PVDC/Aluminium blisters in cardboard boxes containing 60 film-coated tablets.

Patient Warning Card: information for use
Inside the packaging of Apixabanum Teva, along with the patient leaflet, there is a Patient Warning Card, or your doctor may provide you with a similar card.
The Patient Warning Card contains helpful information for the patient and warns other doctors that the patient is taking Apixabanum 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 keep it with you

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Tel. (22) 345 93 00

Manufacturer
Combino Pharm (Malta) Limited
60 Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta

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

| Member country | Product name | |----------------|--------------| | Malta | Apixaban Combino Pharm 5 mg film-coated tablets | | Germany | Apixaban-ratiopharm 5 mg Filmtabletten | | Austria | Apixaban ratiopharm GmbH 5 mg Filmtabletten | | Belgium | Apixaban Teva Generics 5 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten | | Bulgaria | Апиксабан Тева Фарма 5 mg филмирани таблетки
Apixaban Teva Pharma 5 mg film-coated tablets | | Czech Republic | Apixaban Teva CR | | Denmark | Apixaban Teva GmbH | | Estonia | Apixaban Teva Pharma | | Spain | APIXABAN TEVAGEN 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | | Finland | Apixaban ratiopharm GmbH 5 mg tabletti, kalvopäällysteinen | | France | APIXABAN TEVA SANTE 5 mg, comprimé pelliculé | | Croatia | Apiksaban Teva 5 mg filmom obložene tablete | | Hungary | Apixaban Teva GmbH 5 mg filmtabletta | | Ireland | Apixaban 2.5 mg and 5 mg Film-coated Tablets | | Iceland | Apixaban Teva GmbH | | Italy | APIXABAN TEVA ITALIA | | Lithuania | Apixaban TevaPharm 5 mg plėvele dengtos tabletės | | Netherlands | Apixaban Teva 5 mg, filmomhulde tabletten | | Luxembourg | Apixaban-ratiopharm 5 mg Filmtabletten | | Latvia | Apixaban TevaPharm 5 mg apvalkotās tablets | | Norway | Apixaban Teva GmbH | | Poland | Apixabanum Teva | | Portugal | Apixabano Teva | | Romania | Apixaban Teva 5 mg comprimate filmate | | Sweden | Apixaban Teva GmbH | | Slovenia | Apiksaban Teva GmbH 5 mg filmsko obložene tablete | | Slovakia | Apixaban Teva Slovakia 5 mg