Apixaban Tecnigen

Italy
Brand name Apixaban Tecnigen
Form tablets, film-coated
Active substance / Dosage
APIXABAN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AF02
Registration number 050513
Manufacturer TECNIGEN S.R.L.

Table of Contents

Patient Information Leaflet

Apixaban TecniGen 2.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful to them.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban TecniGen contains the active substance apixaban and belongs to a group of medicines
called anticoagulants. This medicine helps prevent blood clots by
blocking factor Xa, which is an important component in blood coagulation.
Apixaban TecniGen is used in adults:

  • to prevent the formation of blood clots (venous thromboembolism [VTE] after hip or knee replacement surgery). After hip or knee surgery, you may be at high risk of developing blood clots in the veins of your leg, which can lead to swelling, with or without pain. If a blood clot travels from the leg to the lungs, it can block blood flow, causing shortness of breath, with or without chest pain. This condition (pulmonary embolism) can be life-threatening and requires immediate medical attention.
  • to prevent the formation of blood clots in the heart of patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots can break loose and travel to the brain, causing a stroke, or to other organs, blocking normal blood flow to that organ (also known as systemic embolism). A 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.

2. What you need to know before taking Apixaban TecniGen

Do not take Apixaban TecniGen if:

  • you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • you have excessive bleeding;
  • you have a disease in an organ of the body that increases the risk of serious bleeding (such as an active or recent ulcer of the stomach or intestine, recent bleeding in the brain);
  • you have a liver disease that increases the risk of bleeding (hepatic coagulopathy);
  • you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have an intravenous or arterial line and receive heparin through this line to keep it open, or if a catheter is inserted into the blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have
any of the following symptoms:

  • an increased risk of bleeding, such as:
  • bleeding disorders, including conditions causing reduced platelet function;
  • very high blood pressure not controlled by medical treatment;
  • you are over 75 years old;
  • you weigh 60 kg or less;
  • severe kidney disease or you are on dialysis;
  • liver problems or a history of liver problems;
  • This medicine will be used with caution in patients showing signs of impaired liver function.
  • you have had a tube (catheter) or an injection in the spine (for anaesthesia or pain relief); your doctor will advise you to take this medicine 5 hours or more after removal of the catheter;
  • if you have a heart valve prosthesis;
  • if your doctor determines that your blood pressure is unstable or if another treatment or surgical procedure is planned to remove a blood clot from the lungs.

Take special care with Apixaban TecniGen

  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment adjustments are needed.

If you need to undergo surgery or a procedure that may cause
bleeding, your doctor may ask you to temporarily stop taking this
medicine for a short period. If you are unsure whether a procedure might cause bleeding,
ask your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and Apixaban TecniGen
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might
take any other medicines.
Some medicines can increase the effects of Apixaban TecniGen and some can
decrease its effects. Your doctor will decide whether you should be treated with Apixaban TecniGen while
taking these medicines and how closely you need to be monitored.
The following medicines can increase the effects of Apixaban TecniGen and increase the
risk of unwanted bleeding:

  • some medicines for fungal infections (e.g. ketoconazole, etc.);
  • some antiviral drugs for HIV/AIDS (e.g. ritonavir);
  • other medicines used to reduce blood clotting (e.g. enoxaparin, etc.);
  • anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, you may have a higher risk of bleeding;
  • medicines for high blood pressure or heart problems (e.g. diltiazem);
  • antidepressants called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
    The following medicines may reduce the ability of Apixaban TecniGen to help prevent blood clots:
  • medicines to prevent epilepsy or seizures (e.g. phenytoin, etc.);
  • St. John’s wort (a herbal supplement used for depression);
  • medicines for the treatment of tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your
doctor, pharmacist, or nurse before taking this medicine.
The effects of Apixaban TecniGen on pregnancy and the fetus are unknown. You should not take
this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while
taking this medicine.
It is not known whether Apixaban TecniGen is excreted in human breast milk. Consult your doctor,
pharmacist, or nurse before taking this medicine during breastfeeding.
They will advise you whether to stop breastfeeding or to stop/avoid starting this
medicine.
Driving and using machines
Apixaban TecniGen has not been shown to impair the ability to drive or use
machinery.
Apixaban TecniGen contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Apixaban TecniGen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, check with your doctor, pharmacist, or nurse.
Dose
Swallow the tablet with a glass of water. Apixaban TecniGen may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best therapeutic effect.

If you have difficulty swallowing the tablet whole, speak to your doctor about other ways to take Apixaban TecniGen. The tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.

Instructions for crushing:

  • Crush the tablets using a mortar and pestle.
  • Carefully transfer all the powder into a suitable container, then mix the powder with a small amount (e.g., 30 mL [2 tablespoons]) of water or one of the other liquids listed above to form a mixture.
  • Swallow the mixture.
  • Rinse the mortar and pestle used for crushing, as well as the container, with a small amount of water or one of the other liquids (e.g., 30 mL) and swallow the rinse.

If necessary, your doctor may also prescribe crushed Apixaban TecniGen tablets mixed in 60 mL of water or 5% glucose in water, administered via a nasogastric tube.

Take Apixaban TecniGen as recommended for the following conditions:

To prevent the formation of blood clots after hip or knee surgery:
The recommended dose is one Apixaban TecniGen 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.
You should take the first tablet 12 to 24 hours after surgery.
If you have undergone major surgery on the hip, you will usually take the tablets for a period of 32 to 38 days.
If you have undergone major surgery on the knee, you will usually take the tablets for a period of 10 to 14 days.

To prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor:
The recommended dose is one Apixaban TecniGen 5 mg tablet twice daily.
The recommended dose is one Apixaban TecniGen 2.5 mg tablet twice daily if:

  • you have severely impaired kidney function;
  • two or more of the following conditions apply to you:
  • blood test results suggest poor kidney function (serum creatinine level is 1.5 mg/dL [133 micromoles/L] or higher);
  • 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 in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

For the treatment of blood clots in the veins of the legs and in the blood vessels of the lungs (deep vein thrombosis and pulmonary embolism):
The recommended dose is two tablets of Apixaban TecniGen 5 mg 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 Apixaban TecniGen 5 mg tablet twice daily, for example, one in the morning and one in the evening.

To prevent recurrence of blood clots after completing 6 months of treatment:
The recommended dose is one tablet of Apixaban TecniGen 2.5 mg twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Your doctor may adjust your anticoagulant treatment as follows:

  • Switching from Apixaban TecniGen to anticoagulant medicines: Stop taking Apixaban TecniGen. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken your next tablet.
  • Switching from anticoagulant medicines to Apixaban TecniGen: Stop taking the anticoagulant medicine. Start treatment with Apixaban TecniGen at the time you would have taken your next anticoagulant dose, then continue as usual.
  • Switching from vitamin K antagonist anticoagulants (e.g., warfarin) to Apixaban TecniGen: Stop taking the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to start taking Apixaban TecniGen.
  • Switching from Apixaban TecniGen to vitamin K antagonist anticoagulant treatment (e.g., warfarin):
    If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban TecniGen for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to stop taking Apixaban TecniGen.

Patients undergoing cardioversion
If your abnormal heart rhythm is to be restored to normal through a procedure called cardioversion, take this medicine at the time prescribed by your doctor to prevent the formation of blood clots in the blood vessels of the brain and other parts of the body.

If you take more Apixaban TecniGen than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Bring the medicine pack with you, even if no tablets remain.
If you take more Apixaban TecniGen than recommended, you may have an increased risk of bleeding. In case of bleeding, surgical interventions, blood transfusions, or other treatments that can reverse anti-factor Xa activity may be required.

If you forget to take Apixaban TecniGen

  • Take the missed dose as soon as you remember, and:
  • take your next dose of Apixaban TecniGen at the usual time;
  • then continue as normal.

If you are unsure what to do or have missed more than one dose, contact your doctor, pharmacist, or nurse.

If you stop taking Apixaban TecniGen
Do not stop taking this medicine without first discussing it with your doctor, as the risk of developing a blood clot may be higher if you stop treatment too early.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this drug can cause side effects, although not everyone experiences them. Apixaban TecniGen may be administered for three different medical conditions. The known side effects and their frequency for each of these medical conditions may differ and are listed separately below. For these conditions, the most common general side effect of this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known if you are taking Apixaban TecniGen to prevent blood clots after hip or knee surgery.

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

  • Anaemia, which may cause fatigue or paleness.
  • Bleeding, including:
    • Bruising and swelling.
  • Nausea (feeling unwell).

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

  • Reduced number of platelets in the blood (which may affect blood clotting).
  • Bleeding:
    • Occurring after surgery, including bruising and swelling, bleeding or discharge from the surgical wound/incision (wound secretion) or from the injection site;
    • In the stomach, intestines, or red blood in the stools;
    • In the urine;
    • From the nose;
    • From the vagina.
  • Low blood pressure, which may make you feel weak or cause a rapid heartbeat.
  • Blood tests may show:
    • Abnormal liver function;
    • Increased levels of certain liver enzymes;
    • Increased bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.
  • Itching.

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

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Bleeding:
    • Into a muscle;
    • In the eyes;
    • From the gums and blood in sputum when coughing;
    • From the rectum.
  • Hair loss.

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • In the brain or spinal cord;
    • In the lungs or throat;
    • In the mouth;
    • In the abdomen or in the space behind the abdominal cavity;
    • From a haemorrhoid;
    • Tests indicating blood in stools or urine;
    • Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis) which may cause a rash or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known if you are taking Apixaban TecniGen to treat or prevent blood clots in the heart of patients with irregular heartbeat and at least one additional risk factor.

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

  • Bleeding, including:
    • In the eyes;
    • In the stomach or intestines;
    • From the rectum;
    • In the urine;
    • From the nose;
    • From the gums;
    • Bruising and swelling.
  • Anaemia, which may cause fatigue or paleness.
  • Low blood pressure, which may make you feel weak or cause a rapid heartbeat;
  • Nausea (feeling unwell).
  • Blood tests may show:
    • Increased gamma-glutamyltransferase (GGT).

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

  • Bleeding:
    • In the brain or spinal cord;
    • In the mouth or blood in saliva when coughing;
    • In the abdomen or from the vagina;
    • Bright red blood in stools;
    • Occurring after surgery, including bruising and swelling, bleeding or discharge from the surgical wound/incision (wound secretion) or from the injection site;
    • From a haemorrhoid;
    • Tests showing blood in stools or urine.
  • Reduced number of platelets in the blood (which may affect blood clotting).
  • Blood tests may show:
    • Abnormal liver function;
    • Increased levels of certain liver enzymes;
    • Increased bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes;
  • Rash;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.

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

  • Bleeding:
    • In the lungs or throat;
    • In the space behind the abdominal cavity;
    • Into a muscle.

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

  • Rash which may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);

Not known (frequency cannot be estimated from available data):

  • Inflammation of blood vessels (vasculitis) which may cause a rash or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known if you are taking Apixaban TecniGen 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 affect up to 1 in 10 people)

  • Bleeding, including:
    • From the nose;
    • From the gums;
    • In the urine;
    • Bruising and swelling;
    • In the stomach, intestines, or from the rectum;
    • In the mouth;
    • From the vagina;
  • Anaemia, which may cause fatigue or paleness.
  • Reduced number of platelets in the blood (which may affect blood clotting).
  • Nausea (feeling unwell).
  • Rash.
  • Blood tests may show:
    • Increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure, which may make you feel weak or cause a rapid heartbeat.
  • Bleeding:
    • In the eyes;
    • In the mouth or blood in saliva when coughing;
    • Bright red blood in stools;
    • Tests showing blood in stools or urine;
    • Occurring after surgery, including bruising and swelling, bleeding or discharge from the surgical wound/incision (wound secretion) or from the injection site;
    • From a haemorrhoid;
    • Into a muscle;
  • Itching;
  • Hair loss.
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Blood tests may show:
    • Abnormal liver function;
    • Increased levels of certain liver enzymes;
    • Increased bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

  • In the brain or spinal cord;
  • In the lungs.

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • In the abdomen or in the space behind the abdominal cavity;
  • Rash which may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis) which may cause a rash or small, flat, red, round spots under the skin surface or bruising.

Reporting of side effects
If you experience any side effect, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban TecniGen

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 after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Apixaban TecniGen contains

  • The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
  • The other components are: Tablet core: anhydrous lactose; microcrystalline cellulose (type 14); microcrystalline cellulose (type 101); sodium croscarmellose; sodium lauryl sulphate; magnesium stearate. See section 2. Apixaban TecniGen contains lactose (a type of sugar) and sodium. Tablet coating: monohydrate lactose; hypromellose (E464); titanium dioxide (E171); triacetin; red iron oxide (E172).

Description of the appearance of Apixaban TecniGen and contents of the pack
The film-coated tablets are yellow, round, with a diameter of 6.0 mm ± 0.2 mm.
They are available in blisters packed in cartons containing 10, 20 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient alert card: management information
Inside the package of Apixaban TecniGen, together with the package leaflet, you will find a patient alert card or your doctor may provide you with a similar one.
This patient alert card includes information that will be useful for you and will inform other doctors that you are taking Apixaban TecniGen. You should always carry this card with you.

  1. Take the card.
  2. Tear off the tab as needed (this is facilitated by the perforated edges).
  3. Complete the following sections or ask your doctor to do so:
    • 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 and Manufacturer
Marketing Authorisation Holder
Tecnigen srl
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI), Italy.
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra, Portugal.

This medicinal product is authorised in the EEA Member States under the following names:
Italy - Apixaban Tecnigen.
Portugal - Apixabano Tecnigen.
Spain - Apixabán TecniGen 2,5 mg comprimidos recubiertos con película EFG.
Spain - Apixabán TecniGen 5 mg comprimidos recubiertos con película EFG.
[To be completed at national level]
[To be completed at national level]

Package leaflet: Information for the user

Apixaban TecniGen 5 mg film-coated tablets

Generic medicine
Please read 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 questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful to them.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban TecniGen contains the active substance apixaban and belongs to a group of medicines
called anticoagulants. This medicine helps prevent the formation of blood clots
by blocking factor Xa, which is an important component in blood coagulation.
Apixaban TecniGen is used in adults:

  • to prevent the formation of blood clots in the heart of patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing a stroke, or to other organs, blocking blood flow to that organ (also known as systemic embolism). This condition can be life-threatening and requires immediate medical attention.
  • to prevent the formation of blood clots in the 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.

2. What you need to know before taking Apixaban TecniGen

Do not take Apixaban TecniGen if:

  • you are allergic to apixaban or to any of the other ingredients of this medicine (listed in section 6);
  • you have excessive bleeding;
  • you have a disease in an organ of the body that increases the risk of serious bleeding (such as, for example, an active or recent ulcer of the stomach or intestine, recent bleeding in the brain);
  • you have a liver disease that causes an increased risk of bleeding

(hepatic coagulopathy);

  • you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, dabigatran or heparin), except when switching anticoagulant therapy, while you have an intravenous or arterial line and are receiving heparin through this line to keep it open, or if a catheter is inserted into the blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if you have
any of the following symptoms:

  • an increased risk of bleeding, such as:
  • coagulation disorders, including conditions causing reduced platelet function;
  • very high blood pressure not controlled by medical treatment;
  • you are over 75 years old;
  • you weigh 60 kg or less;
  • severe kidney disease or if you are on dialysis;
  • a liver problem or history of liver problems;
  • This medicine should be used with caution in patients showing signs of impaired liver function.
  • if you have a heart valve prosthesis;
  • if your doctor determines that your blood pressure is unstable or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban TecniGen

  • if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment adjustment is needed. If you need to undergo surgery or a procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short period. If you are unsure whether a procedure may cause bleeding, consult your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and Apixaban TecniGen
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Some medicines can increase the effects of Apixaban TecniGen and some can
decrease its effects. Your doctor will decide whether you should be treated with Apixaban TecniGen
while taking these medicines and how closely you need to be monitored.
The following medicines may increase the effects of Apixaban TecniGen and increase the
risk of unwanted bleeding:

  • some medicines for fungal infections (e.g. ketoconazole, etc.);
  • some antiviral drugs for HIV/AIDS (e.g. ritonavir);
  • other medicines used to reduce blood clotting (e.g. enoxaparin, etc.);
  • anti-inflammatory medicines or painkillers (e.g. acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, you may have a higher risk of bleeding;
  • medicines for high blood pressure or heart problems (e.g. diltiazem);
  • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

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

  • medicines to prevent epilepsy or seizures (e.g. phenytoin, etc.);
  • St. John's Wort (a herbal supplement used for depression);
  • medicines for the treatment of tuberculosis or other infections (e.g. rifampicin).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning a pregnancy, consult your
doctor, pharmacist or nurse before taking this medicine.
The effects of Apixaban TecniGen on pregnancy and the fetus are unknown. You should not take
this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while
taking this medicine.
It is not known whether Apixaban TecniGen is excreted in human breast milk. Consult your doctor,
pharmacist or nurse before taking this medicine during breastfeeding. They
will advise you whether to stop breastfeeding or to stop/start taking this
medicine.
Driving and using machines
Apixaban TecniGen has not been shown to impair the ability to drive or use
machinery.
Apixaban TecniGen contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to take Apixaban TecniGen

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, check with your doctor, pharmacist, or nurse.

Dosage
Swallow the tablet with a glass of water. Apixaban TecniGen may be taken with or without food.
Try to take the tablets at the same time each day to achieve the best therapeutic effect.

If you have difficulty swallowing the tablet whole, speak with your doctor about other ways to take Apixaban TecniGen. The tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree immediately before administration.

Instructions for crushing:

  • Crush the tablets using a mortar and pestle.
  • Carefully transfer all the powder into a suitable container and mix it with a small amount (e.g., 30 ml [2 tablespoons]) of water or one of the other liquids listed above to form a mixture.
  • Swallow the mixture.
  • Rinse the mortar and pestle and the container used to crush the tablet with a small amount of water or one of the other liquids (e.g., 30 ml) and swallow the rinse.

If necessary, your doctor may also prescribe crushed Apixaban TecniGen tablets mixed in 60 ml of water or 5% glucose in water, administered via a nasogastric tube.

Take Apixaban TecniGen as recommended for the following conditions:

To prevent blood clots in the heart of patients with irregular heartbeat and at least one additional risk factor:
The recommended dose is one Apixaban TecniGen 5 mg tablet twice daily.

The recommended dose is one Apixaban TecniGen 2.5 mg tablet twice daily if:

  • you have severe renal impairment;
  • you meet two or more of the following criteria:
    • your blood test results show poor kidney function (serum creatinine level ≥1.5 mg/dL [≥133 micromol/L]);
    • you are 80 years of age or older;
    • your body weight is ≤60 kg.

The recommended dose is one tablet twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

To treat 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 TecniGen 5 mg twice daily for the first 7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tablet of Apixaban TecniGen 5 mg twice daily, for example, one in the morning and one in the evening.

To prevent recurrence of blood clots after completing 6 months of treatment:
The recommended dose is one tablet of Apixaban TecniGen 2.5 mg twice daily, for example, one in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.

Your doctor may adjust anticoagulant treatment as follows:

  • Switching from Apixaban TecniGen to anticoagulant medicines: Stop taking Apixaban TecniGen. Start treatment with anticoagulant medicines (e.g., heparin) at the time you would have taken your next tablet.
  • Switching from anticoagulant medicines to Apixaban TecniGen: Stop taking anticoagulant medicines. Start treatment with Apixaban TecniGen at the time you would have taken your next dose of anticoagulant medicine, then continue as usual.
  • Switching from anticoagulant treatment containing vitamin K antagonists (e.g., warfarin) to Apixaban TecniGen: Stop taking the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to start taking Apixaban TecniGen.
  • Switching from Apixaban TecniGen to anticoagulant treatment containing a vitamin K antagonist (e.g., warfarin): If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban TecniGen for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will perform blood tests and advise you when to stop taking Apixaban TecniGen.

Patients undergoing cardioversion
If your abnormal heart rhythm is to be restored to normal through a procedure called cardioversion, take this medicine at the time prescribed by your doctor to prevent blood clots in the blood vessels of the brain and elsewhere in the body.

If you take more Apixaban TecniGen than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine. Take the medicine pack with you, even if no tablets are left.
If you take more Apixaban TecniGen than recommended, you may have an increased risk of bleeding. In case of bleeding, surgical procedures, blood transfusions, or other treatments that can reverse anti-factor Xa activity may be required.

If you forget to take Apixaban TecniGen

  • Take the missed dose as soon as you remember, and:
  • take your next dose of Apixaban TecniGen at the usual time;
  • then continue as normal.

If you are unsure what to do or have missed more than one dose, contact your doctor, pharmacist, or nurse.

If you stop taking Apixaban TecniGen
Do not stop taking this medicine without first discussing it with your doctor, as stopping treatment too early may increase your risk of developing a blood clot.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common general side effect with this medicine is bleeding, which may potentially be life-threatening and requires immediate medical attention.

The following side effects are known when taking Apixaban TecniGen to prevent blood clots forming in the heart of patients with irregular heartbeat and at least one additional risk factor.

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

  • Bleeding, including:
    • in the eyes;
    • in the stomach or intestines;
    • from the rectum;
    • blood in the urine;
    • from the nose;
    • from the gums;
    • bruising and swelling.
  • Anaemia, which may cause tiredness or paleness.
  • Low blood pressure, which may make you feel weak or cause a rapid heartbeat.
  • Nausea (feeling unwell).
  • Blood tests may show:
    • an increase in gamma-glutamyltransferase (GGT).

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

  • Bleeding:
    • in the brain or spinal cord;
    • in the mouth or blood in saliva when coughing;
    • in the abdomen or from the vagina;
    • bright red blood in stools;
    • bleeding occurring after any surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
    • from a haemorrhoid.
  • Tests showing blood in stools or urine.
  • Reduced number of platelets in the blood (which may affect clotting).
  • Blood tests may show:
    • liver function abnormalities;
    • an increase in some liver enzymes;
    • an increase in bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.
  • Rash.
  • Itching.
  • Hair loss.
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.

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

  • Bleeding:
    • in the lungs or throat;
    • in the space behind the abdominal cavity (retroperitoneal space);
    • in a muscle.

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

  • Rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis) which may cause rash or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known when taking Apixaban TecniGen to treat or prevent the occurrence of blood clots in the veins of the legs and blood vessels of the lungs.

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

  • Bleeding, including:
    • from the nose;
    • from the gums;
    • blood in the urine;
    • bruising and swelling;
    • in the stomach, intestines, or from the rectum;
    • from the mouth;
    • from the vagina.
  • Anaemia, which may cause tiredness or paleness.
  • Decreased platelet count in the blood (which may affect clotting).
  • Nausea (feeling unwell).
  • Rash.
  • Blood tests may show:
    • an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure, which may make you feel tired or cause a rapid heartbeat.
  • Bleeding:
    • in the eyes;
    • in the mouth or blood in saliva when coughing;
    • in the brain or spinal cord;
    • bright red blood in stools;
    • in the abdomen or from the vagina;
    • tests showing blood in stools or urine;
    • bleeding occurring after any surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
    • from a haemorrhoid;
    • in a muscle.
  • Itching.
  • Hair loss.
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Blood tests may show:
    • liver function abnormalities;
    • an increase in some liver enzymes;
    • an increase in bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

  • Bleeding:
    • in the brain or spinal cord;
    • in the lungs.

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

  • Rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).

Not known (frequency cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis) which may cause rash or small, flat, red, round, pointed spots under the skin surface or bruising.

The following side effects are known when taking Apixaban TecniGen to treat or prevent the recurrence of blood clots in the veins of the legs and blood clots in the blood vessels of the lungs.

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

  • Bleeding, including:
    • from the nose;
    • from the gums;
    • blood in the urine;
    • bruising and swelling;
    • in the stomach, intestines, or from the rectum;
    • in the mouth;
    • from the vagina.
  • Anaemia, which may cause tiredness or paleness.
  • Decreased platelet count in the blood (which may affect clotting).
  • Nausea (feeling unwell).
  • Rash.
  • Blood tests may show:
    • an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure, which may make you feel weak or cause a rapid heartbeat.
  • Bleeding:
    • in the eyes;
    • in the mouth or blood in saliva when coughing;
    • bright red blood in stools;
    • tests showing blood in stools or urine;
    • bleeding occurring after surgery, including bruising and swelling, bleeding or fluid leakage from the surgical wound/incision (wound discharge) or from the injection site;
    • from a haemorrhoid;
    • in a muscle.
  • Itching.
  • Hair loss.
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Blood tests may show:
    • liver function abnormalities;
    • an increase in some liver enzymes;
    • an increase in bilirubin, a breakdown product of red blood cells, which may cause yellowing of the skin and eyes.

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

  • Bleeding:
    • in the brain or spinal cord;
    • in the lungs.

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • in the abdomen or in the space behind the abdominal cavity (retroperitoneal space).
  • Rash which may blister and appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).
  • Inflammation of blood vessels (vasculitis) which may cause rash or small, flat, red, round, pointed spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban TecniGen

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 after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Apixaban TecniGen contains

  • The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
  • The other components are:
    Tablet core: anhydrous lactose; microcrystalline cellulose (type 14); microcrystalline cellulose (type 101); sodium croscarmellose; sodium lauryl sulfate; magnesium stearate. See section 2. Apixaban TecniGen contains lactose (a type of sugar) and sodium.
    Tablet coating: monohydrate lactose; hypromellose (E464); titanium dioxide (E171); triacetin; red iron oxide (E172).

Description of the appearance of Apixaban TecniGen and contents of the pack
The film-coated tablets are pink, oval-shaped, with a length of 11.0 mm ± 0.2 mm and a width of 6.2 mm ± 0.2 mm.
They are available in blister packs within cartons containing 20, 28, or 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient alert card: management information
Inside the packaging of Apixaban TecniGen, together with the package leaflet, you will find a patient alert card, or your doctor may provide you with a similar card.
This patient alert card includes information that will be useful to you and will inform other healthcare professionals that you are taking Apixaban TecniGen. You should always carry this card with you.

  1. Take the card.
  2. Tear along the perforated edge as needed (this is facilitated by the perforated borders).
  3. Complete the following sections, or ask your doctor to do so:
    • 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen srl
Via Galileo Galilei 40
20092 Cinisello Balsamo (MI), Italy.

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra, Portugal.

This medicinal product is authorized in the EEA Member States under the following names:
Italy - Apixaban Tecnigen.
Portugal - Apixabano Tecnigen.
Spain - Apixabán TecniGen 2,5 mg comprimidos recubiertos con película EFG.
Spain - Apixabán TecniGen 5 mg comprimidos recubiertos con película EFG.

[To be completed at national level]
[To be completed at national level]