APIXABAN 2.5 mg Film-coated tablets

Зміст інструкції

1. Apixaban TecniGen film-coated tablets 2.5 mg
   1. What is Apixaban TecniGen 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. Package contents and other information
2. Apixaban TecniGen film-coated tablets 5 mg
   1. What is Apixaban TecniGen 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

Apixaban TecniGen film-coated tablets 2.5 mg

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful to them.
• If you get any side effects, even 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 you take 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 is Apixaban TecniGen and what it is used for

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

• to prevent the formation of blood clots (deep vein thrombosis [DVT] after hip or knee replacement surgery). After hip or knee surgery you may be at high risk of developing blood clots in the leg veins, which can lead to swelling, with or without pain. If a blood clot moves 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 detach and travel to the brain and lead to a stroke or to other organs and prevent 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 leg veins (deep and venous 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 allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• you have excessive blood loss;
• you have a disease in an organof the body that increases the risk of serious bleeding (such as, for example, an active or recent ulcerof the stomach or intestine, recent bleeding in the brain);
• you have a liver diseasethat involves an increased risk of bleeding (hepatic coagulopathy);
• you are taking medicines to prevent blood clotting(e.g. warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while you have a venous or arterial tract and receive heparin through this tract to keep it open, or if a tube 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 experience
any of the following symptoms:

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

Be particularly careful with Apixaban TecniGen

• if you know you have a condition called antiphospholipid syndrome (an autoimmune disorder that causes an increased risk of blood clots), tell your doctor who will decide if it is necessary to modify treatment.

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 not sure whether a procedure may cause bleeding,
ask your doctor.

Children and adolescents
This medicine is not recommended in 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. The doctor will decide if you should be treated with Apixaban TecniGen during
taking these medicinesand how carefully you will need to be monitored.

The following medicines can increase the effects ofApixaban TecniGenand increase the
possibility 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-inflammatoryor painkillers(e.g. acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a greater chance of bleeding;
• medicines for high blood pressure or heart problems(e.g. diltiazem);
• antidepressant medicinescalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors. The following medicines can reduce the ability ofApixaban TecniGento help prevent blood clots from forming:
• 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 tuberculosisor other infections(e.g. rifampicin).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask
your doctor, pharmacist or nurse before taking this medicine.
The effects of Apixaban TecniGenon pregnancy and the fetus are not known. You should not take
this medicine if you are pregnant. Contact your doctor immediatelyif you become pregnant
while taking this medicine.

It is not known whether Apixaban TecniGenis excreted in human breast milk. Ask your doctor,
pharmacist or nurse before taking this medicine while breastfeeding. They will
advise you whether to stop breastfeeding or stop/not start taking this
medicine.

Driving and using machines
Apixaban TecniGenhas not been shown to impair the ability to drive or operate
machinery.

Apixaban TecniGen contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is
essentially "sodium-free".

3. How to take Apixaban TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a glass of water. Apixaban TecniGen can be taken with or without
food. Try to take the tablets at the same time each day to obtain the best
therapeutic effect.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Apixaban
TecniGen. The tablet can be crushed and mixed with water, or 5% glucose in water, or
apple juice or applesauce, immediately before taking it.

Instructions for crushing:

• Crush the tablets with a pestle and mortar.
• Carefully transfer all the powder to a suitable container, then mix the powder with a little, for example, 30 ml (2 tablespoons) of water or one of the other liquids mentioned above to create a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablet and the container with a little water or one of the other liquids (e.g. 30 ml) and swallow the rinse.

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

Take Apixaban TecniGen as recommended for the following:
To prevent the formation of blood clots after hip or knee surgery.
The recommended dose is one Apixaban TecniGen 2.5 mg tablet twice a day. 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 of patients with irregular heartbeat and
at least one additional risk factor.
The recommended dose is one Apixaban TecniGen 5 mgtablet twice a day.
The recommended dose is one Apixaban TecniGen 2.5 mgtablet twice a day 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 value is 1.5 mg/dL (133 micromoles/L) or higher;
• you are 80 years of age or older;
• your weight is equal to or less than 60 kg.

The recommended dose is one tablet twice a day, 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
The recommended dose is two tabletsof Apixaban TecniGen 5 mgtwice a day 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 a day,
for example, one in the morning and one in the evening.
To prevent the recurrence of blood clots after completing 6 months of treatment
The recommended dose is one tabletof Apixaban TecniGen 2.5 mgtwice a day, for
example, one in the morning and one in the evening.
The doctor will decide how long you should continue treatment.

The doctor may modify the anticoagulant treatment as follows:

• Switching from Apixaban TecniGen to anticoagulant medicinesStop taking Apixaban TecniGen. Start treatment with anticoagulant medicines (e.g. heparin) at the time you would have taken the next tablet.
• Switching from anticoagulant medicines to Apixaban TecniGenStop taking anticoagulant medicines. Start treatment with Apixaban TecniGen at the time you would have been due to take the next dose of anticoagulant medicine, then continue as normal.
• Switching from treatment with anticoagulants containing vitamin K antagonists (e.g.warfarin) to Apixaban TecniGenStop taking the medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and tell you when to start taking Apixaban TecniGen.
• Switching from Apixaban TecniGen to anticoagulant treatment containing a

vitamin K antagonist (e.g. warfarin).
If the doctor tells you that you need to start taking the medicine containing a vitamin K antagonist,
continue taking Apixaban TecniGen for at least 2 days after the first dose of the
medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and tell you when to stop taking Apixaban TecniGen.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by 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 in other blood vessels of the body.

If you take more Apixaban TecniGen than you should
Tell your doctor immediatelyif you have taken more than the prescribed dose of this medicine. Bring
the medicine package with you, even if there are no tablets left.
If you take more Apixaban TecniGenthan recommended, you may have a higher risk of
bleeding. In case of bleeding, surgical interventions, blood transfusions or other treatments that can reverse the activity of the anti-Xa factor may be necessary.

If you forget to take Apixaban TecniGen

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

If you are unsure of what to do or have forgotten more than one dose, consult your doctor, pharmacist or
nurse.

If you stop taking Apixaban TecniGen
Do not stop taking this medicine without first talking to your doctor, as the risk
of developing a blood clot may be greater if you stop treatment too
early.
If you have any doubts about using 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.
Apixaban TecniGen can be given for three different medical conditions. The known side effects and how
often they occur for each of these conditions can differ and are listed separately below. For these
conditions, the most common overall 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 take Apixaban TecniGen to prevent blood clots from forming
after hip or knee surgery.

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

• Anemia which can cause tiredness or paleness.
• Bleeding including:
• bruising and swelling.
• Nausea (feeling sick).

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

• Reduced number of platelets in the blood (which may affect blood clotting).
• Bleeding:
• that occurs after the operation, including bruising and swelling, leakage of blood or fluid from the
  wound/surgical incision (wound secretion) or from the injection site;
• in the stomach, intestine or bright red blood in the stools;
• in the urine;
• from the nose;
• from the vagina.
• Low blood pressure which can make you feel weak or have a fast heartbeat.
• Blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the
  skin and eyes.
• Itching.

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

• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or
  throat and difficulty breathing. Contact yourdoctor immediatelyif you experience any of these
  symptoms.
• Bleeding:
• in a muscle;
• in the eyes;
• from the gums and blood in your saliva 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 the space behind the abdominal cavity;
• from a haemorrhoid;
• tests indicating blood in the stools or urine;
• rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a
  dark ring around the edge) (erythemamultiforme);
• Inflammation of blood vessels (vasculitis) which can cause rash or pinpoint, flat, red, round spots
  under the skin or bruising.

The following side effects are known if you take Apixaban TecniGen to treat or prevent the
occurrence of 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 intestine;
• from the rectum;
• blood in the urine;
• from the nose;
• from the gums;
• bruising and swelling.
• Anemia which can cause tiredness or paleness.
• Low blood pressure which can make you feel weak or have a fast heartbeat;
• Nausea (feeling sick).
• Blood tests may show:
• an increase in gamma-glutamyl transferase (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 the saliva when coughing;
• in the abdomen or from the vagina;
• bright red/fresh blood in the stools;
• bleeding that occurs after the operation, including bruising and swelling, leakage of blood or fluid from
  the wound/surgical incision (wound secretion) or from the injection site;
• from a haemorrhoid;
• tests showing blood in the stools or urine.
• Reduced number of platelets in the blood (which may affect blood clotting).
• Blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the
  skin and eyes;
• Rash;
• Itching;
• Hair loss;
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or
  throat and difficulty breathing. 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;
• in a muscle.

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

• rash that may blister and appear as small targets (dark spots central surrounded by a lighter area, with a
  dark ring around the edge) (erythemamultiforme);

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

• Inflammation of blood vessels (vasculitis) which can cause rash or pinpoint, flat, red, round spots
  under the skin or bruising. The following side effects are known if you take 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, intestine, from the rectum;
• in the mouth;
• from the vagina;
• Anemia which can cause tiredness or paleness.
• Reduction in the number of platelets in the blood (which may affect blood clotting).
• Nausea (feeling sick).
• Rash.
• Blood tests may show:
• an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

• Low blood pressure which can make you feel weak or have a fast heartbeat.
• Bleeding:
• in the eyes;
• in the mouth or blood in the saliva when coughing;
• bright red blood in the stools;
• tests showing blood in the stools or urine;
• bleeding that occurs after the operation, including bruising and swelling, leakage of blood or fluid from
  the wound/surgical incision (wound secretion) or from the injection site;
• from a haemorrhoid;
• in a muscle;
• itching;
• hair loss.
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or
  throat and difficulty breathing. Contact yourdoctor immediatelyif you experience any of these
  symptoms.
• Blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can 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 the space behind the abdominal cavity;
• rash that may blister and appear as small targets (dark spots central surrounded by a lighter area, with a
  dark ring around the edge) (erythema multiforme);
• Inflammation of blood vessels (vasculitis) which can cause rash or pinpoint, flat, red, round spots
  under the skin or bruising.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through 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 which is stated on the package and on the 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 in 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 ingredient is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
• The other ingredients 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: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin; red iron oxide (E172).

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

Patient alert card: information on management
of alert for the patient or your doctor may provide you with a similar card.
This patient alert card includes information that will be useful to you and will warn other
doctors that you are taking Apixaban TecniGen. You should keep this card with you at all times.

• 1. Take the card.
• 2. Separate the language as needed (this is facilitated by perforated edges).
• 3. Complete the following sections or ask your doctor to do so:
• Name:
• Date of birth:
• Indication:
• Dose: ___mg twice a day
• Doctor's name:
• Doctor's phone number:
• 4. Fold the card and carry it with you at all times.

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 authorised in the Member States of the EEA with the following denominations:
Italy - Apixaban Tecnigen.
Portugal - Apixabano Tecnigen.
Spain - Apixabán TecniGen 2.5 mg film-coated tablets EFG.
Spain - Apixabán TecniGen 5 mg film-coated tablets EFG.

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

Apixaban TecniGen film-coated tablets 5 mg

Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful to them.
• If you get any side effects, even 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 you take 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 is Apixaban TecniGen 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 to prevent the formation of blood clots
by blocking factor Xa, which is an important component of 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 can break off and move to the brain and cause a stroke or to other organs and can block 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 lung (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 allergicto apixaban or any of the other ingredients of this medicine (listed in section 6);
• you have excessive blood loss;
• you have a disease in an organof the body that increases the risk of serious bleeding (such as, for example, an active or recent ulcerof the stomach or intestine, recent bleeding in the brain);
• you have a liver diseasethat involves an increased risk of bleeding

(hepatic coagulopathy);

• you are taking medicines to prevent blood clotting(e.g. warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while you have a venous or arterial tract and receive heparin through this tract to keep it open, or if a tube 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 experience
any of the following symptoms:

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

Be particularly careful with Apixaban TecniGen

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that causes an increased risk of blood clots), tell your doctor who will decide if you need to change treatment. 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, ask your doctor.

Children and adolescents
This medicine is not recommended in 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 may
take any other medicines.

Some medicines can increase the effects of Apixaban TecniGen and some can
decrease the effects. The doctor will decide if you should be treated with Apixaban TecniGen during
taking these medicinesand how carefully you will need to be monitored.

The following medicines can increase the effects ofApixaban TecniGenand increase the
possibility 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-inflammatoryor painkillers(e.g. acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and are taking acetylsalicylic acid, you may have a greater chance of bleeding;
• medicines for high blood pressure or heart problems(e.g. diltiazem);
• antidepressant drugscalled selective serotonin reuptake inhibitorsor serotonin and norepinephrine reuptake inhibitors.

The following medicines can reduce the ability of Apixaban TecniGento help prevent
blood clot formation:

• 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 tuberculosisor other infections(e.g. rifampicin).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become
pregnant, ask your doctor, pharmacist or nurse for advice before taking this medicine.
The effects of Apixaban TecniGenon pregnancy and the fetus are not known. You should not take
this medicine if you are pregnant. Contact your doctor immediatelyif you become pregnant
while taking this medicine.
It is not known whether Apixaban TecniGenis excreted in human milk. Ask your doctor,
pharmacist or nurse for advice before taking this medicine while breastfeeding. They will
advise you whether to stop breastfeeding or stop/not start taking this medicine.

Driving and using machines
Apixaban TecniGenhas not been shown to impair the ability to drive or operate
machinery.

Apixaban TecniGen contains lactose (a type of sugar) and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is
essentially "sodium-free".

3. How to take Apixaban TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, check with your doctor, pharmacist or nurse.

Dosage
Swallow the tablet with a sip of water. Apixaban TecniGencan be taken with or without
food. Try to take the tablets at the same time each day to obtain the best
therapeutic effect.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Apixaban
TecniGen.The tablet can be crushed and mixed with water, or 5% glucose in water, or
apple juice or applesauce, immediately before taking it.

Instructions for crushing:

• crush the tablets with a pestle and mortar.
• Carefully transfer all the powder to a suitable container, then mix the powder with a little, for example, 30 ml (2 tablespoons), of water or one of the other liquids mentioned above to create a mixture.
• Swallow the mixture.
• Rinse the pestle and mortar used to crush the tablet and the container with a little water or one of the other liquids (e.g. 30 ml) and swallow the rinse.

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

Take Apixaban TecniGen as recommended for the following:
To prevent the formation of blood clots in the heart of patients with irregular heartbeat and at least one
additional risk factor .
The recommended dose is one tablet of Apixaban TecniGen 5 mgtwice a day.
The recommended dose is one tablet of Apixaban TecniGen 2.5 mgtwice a day if:

• you have severe renal impairment;
• two or more of the following apply to you:
• your blood test results show poor kidney function (creatinine value equal to 1.5 mg/dL (133 micromole/L or more);
• if you are 80 years of age or older;
• your weight is equal to or less than 60 kg.

The recommended dose is one tablet twice a day, for example, one in the morning and one in the evening.
The doctor will decide how long you should continue the 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 tabletsof Apixaban TecniGen 5 mg twice a day for the first
7 days, for example, two in the morning and two in the evening.
After 7 days, the recommended dose is one tabletof Apixaban TecniGen 5 mg twice a
day, for example, one in the morning and one in the evening.
To treat the recurrence of blood clots after completion of 6 months of treatment
The recommended dose is one tablet of Apixaban TecniGen 2.5 mg twice a day, for example,
one in the morning and one in the evening.
Your doctor will decide how long you should continue the treatment.

The doctor may modify the anticoagulant treatment as follows:

• Switching from Apixaban TecniGen to anticoagulant medicinesStop taking Apixaban TecniGen.Start treatment with anticoagulant medicines (e.g. heparin) at the time you would have taken the next tablet.
• Switching from anticoagulant medicines to Apixaban TecniGenStop taking anticoagulant drugs. Start treatment with Apixaban TecniGenat the time you would have been due to take the next dose of anticoagulant medicine, then continue as normal.
• Switching from treatment with anticoagulants containing vitamin K antagonists (e.g.warfarin) toApixaban TecniGenStop taking the medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and tell you when to start taking Apixaban TecniGen.
• Switching from Apixaban TecniGen to anticoagulant treatment containing vitamin K antagonist (e.g. warfarin). If your doctor tells you that you need to start taking the medicine containing a vitamin K antagonist, continue to take Apixaban TecniGen for at least 2 days after the first dose of the medicine containing a vitamin K antagonist. The doctor will need to perform blood tests and tell you when to stop taking Apixaban TecniGen.

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by 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 in other blood vessels of the body.

If you take more Apixaban TecniGen than you should
Tell your doctor immediatelyif you have taken more than the prescribed dose of this medicine. Bring
the medicine package with you, even if there are no tablets left.
If you take more Apixaban TecniGenthan recommended, you may have a greater risk of
bleeding. In case of bleeding, surgical interventions, blood transfusions or other treatments that can reverse the activity of factor Xa inhibitors may be necessary.

If you forget to take Apixaban TecniGen

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

If you are not sure what to do or have forgotten more than one dose, contact your doctor, pharmacist or
nurse.

If you stop taking Apixaban TecniGen
Do not stop taking this medicine without first talking to your doctor, as the risk
of developing a blood clot may be greater if you stop treatment too
early.
If you have any questions about using this medicine, contact 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 of this medicine is bleeding, which can be potentially life-threatening and requires immediate medical attention.
The following side effects are known if you take Apixaban TecniGen to prevent blood clot formation 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;
• Anemia which can cause fatigue or paleness.
• Low blood pressure which may make you feel weak or have a fast heartbeat.
• Nausea (feeling unwell).
• Blood tests may show:
• an increase in gamma-glutamyl transferase (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 the saliva when coughing;
• in the abdomen or from the vagina;
• bright red blood in the stool;
• bleeding that occurs after any surgery, including bruising and swelling,

blood or fluid leaking from the surgical wound/incision (wound secretion)
or from the injection site;

• from a hemorrhoid;
• tests showing blood in the stool or urine;
• reduced number of platelets in the blood (which can affect clotting);
• blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes;
• rash;
• itching;
• hair loss;
• allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact yourdoctor immediatelyif you experience any of these symptoms.

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

• Bleeding:
• in the lungs or throat;
• in the space behind the abdominal cavity;
• in a muscle. Very rare side effects (may affect up to 1 in 10,000)
• Rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythemamultiforme); Not known (frequency cannot be estimated based on available data)
• Inflammation of blood vessels ( vasculitis) which can cause rash or pinpoint, flat, red, round spots under the skin surface or bruising. The following side effects are known if you take Apixaban TecniGen to treat or prevent the appearance of blood clots in the veins of the legs and blood vessels in 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, from the rectum;
• from the mouth;
• from the vagina.
• Anemia which can cause fatigue or paleness.
• Reduced number of platelets in the blood (which can affect clotting).
• Nausea (feeling unwell).
• Rash.
• Blood tests may show:
• an increase in gamma-glutamyl transferase (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 have a fast heartbeat.
• Bleeding:
• in the eyes;
• in the mouth or blood in the saliva when coughing;
• in the brain or spinal cord;
• bright red blood in the stool;
• in the abdomen or from the vagina;
• tests showing blood in the stool or urine;
• bleeding that occurs after any surgery, including bruising and swelling, blood or fluid leaking from the surgical wound/incision (wound secretion) or from the injection site;
• from a hemorrhoid;
• in a muscle.
• Itching.
• Hair loss.
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact yourdoctor immediatelyif you experience any of these symptoms.
• Blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.

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

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

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

• rash that may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythemamultiforme).

Not known (frequency cannot be estimated from available data)

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

The following side effects are known if you take Apixaban TecniGento 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):

• Bleeding including:
• from the nose;
• from the gums;
• blood in the urine;
• bruising and swelling;
• in the stomach, intestines, from the rectum;
• in the mouth;
• from the vagina.
• Anemia which can cause fatigue or paleness.
• Reduced number of platelets in the blood (which can affect clotting).
• Nausea (feeling unwell).
• Rash.
• Blood tests may show:
• an increase in gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

• Low blood pressure which may make you feel weak or have a fast heartbeat
• Bleeding:
• in the eyes;
• in the mouth or blood in the saliva when coughing;
• bright red blood in the stool;
• tests showing blood in the stool or urine;
• bleeding that occurs after surgery, including bruising and swelling, blood or fluid leaking from the surgical wound/incision (wound secretion) or from the injection site;
• from a hemorrhoid;
• in a muscle.
• Itching.
• Hair loss.
• Allergic reactions (hypersensitivity) which can cause: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact yourdoctor immediatelyif you experience any of these symptoms.
• Blood tests may show:
• Abnormal liver function;
• an increase in certain liver enzymes;
• an increase in bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes.

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

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

Not known (frequency cannot be estimated based on available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the box and on the blister after
"EXP". The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Apixaban TecniGen contains.

• The active ingredient is apixaban. Each film-coated tablet contains 5 mg of apixaban.
• The other ingredients 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: lactose monohydrate; 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, the blisters are 11.0 mm + 0.2 mm in length and
6.2 mm + 0.2 mm in width.
They are available in blister packs in cartons of 20, 28 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Patient alert card: information on management
of alert for the patient or your doctor may provide you with a similar card.
This patient alert card includes information that will be useful to you and will warn other
doctors that you are taking Apixaban TecniGen. You should keep this card with you at all times.

• 1. Take the card.
• 2. Separate the language 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 a day
• Doctor's name:
• Doctor's telephone number:
• 4. Fold the card and carry it with you at all times.

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 Member States of the EEA with the following denominations:
Italy - Apixaban Tecnigen.
Portugal - Apixabano Tecnigen.
Spain - Apixabán TecniGen 2.5 mg film-coated tablets EFG.
Spain - Apixabán TecniGen 5 mg film-coated tablets EFG.

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