Apixaban Laboratori Alter: detailed information

Package leaflet: Information for the user

Apixaban Laboratori Alter 2.5 mg hard capsules

apixaban
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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
1. What Apixaban Laboratori Alter is and what it is used for
2. What you need to know before taking Apixaban Laboratori Alter
3. How to take Apixaban Laboratori Alter
4. Possible side effects
5. How to store Apixaban Laboratori Alter
6. Contents of the pack and other information

1. What Apixaban Laboratori Alter is and what it is used for

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

to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After surgery on the hip or knee, you may be at increased risk of developing blood clots in the veins of the legs. This can cause swelling of the legs, 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 in patients with irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs, impairing normal blood supply to those organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
to treat blood clots in the 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 Laboratori Alter

Do not take Apixaban Laboratori Alter 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 leads to an increased risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or a recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (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 conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years old;
if you weigh 60 kg or less;
severe kidney disease or if 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 a tube (catheter) or have received an injection into the spinal column (for anaesthesia or pain relief). Your doctor will instruct you to take this medicine at least 5 hours or more after catheter removal;
you have a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take particular care with Apixaban Laboratori Alter

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 a change in therapy is needed.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Apixaban Laboratori Alter
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Some medicines can increase the effect of Apixaban Laboratori Alter, while others may decrease it. Your doctor will decide whether you should be treated with Apixaban Laboratori Alter when taking these medicines and how closely you need to be monitored.

The following medicines may increase the effect of Apixaban Laboratori Alter and increase the risk of unwanted bleeding:

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

The following medicines may reduce the effect of Apixaban Laboratori Alter in helping to prevent blood clots:

medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John’s wort (a herbal remedy used for depression);
medicines for treating tuberculosis or other infections (e.g., rifampicin).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

The effect of Apixaban Laboratori Alter on pregnancy and the unborn child is unknown. You must 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 Laboratori Alter passes into 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 or not start treatment with this medicine.

Driving and using machines
Apixaban Laboratori Alter has not been shown to affect the ability to drive or operate machinery.

Apixaban Laboratori Alter 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 (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Laboratori Alter

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the capsule with some water. Apixaban Laboratori Alter may be taken with or without food.
Try to take the capsules at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the capsule whole, ask your doctor about other ways to take Apixaban Laboratori Alter. The capsule may be opened and its contents mixed with water, or 5% glucose in water, or apple juice or apple puree, immediately before administration.
If necessary, your doctor may also administer the contents of the Apixaban Laboratori Alter capsule mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Laboratori Alter as recommended:
To prevent blood clots after hip or knee replacement surgery:
The recommended dose is one 2.5 mg Apixaban Laboratori Alter capsule twice daily, for example, one in the morning and one in the evening.
You should take the first capsule 12 to 24 hours after surgery.
If you have had hip surgery, you will usually take the capsules for 32 to 38 days.
If you have had knee surgery, you will usually take the capsules for 10 to 14 days.
To prevent formation of blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor:
The recommended dose is one 5 mg Apixaban Laboratori Alter capsule twice daily.
The recommended dose is one 2.5 mg Apixaban Laboratori Alter capsule twice daily if:

you have severely reduced kidney function; or
you meet two or more of the following criteria:
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 capsule 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 in the blood vessels of the lungs:
The recommended dose is two 5 mg Apixaban Laboratori Alter capsules 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 5 mg Apixaban Laboratori Alter capsule 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 2.5 mg Apixaban Laboratori Alter capsule 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 Laboratori Alter to another anticoagulant medicine
Stop taking Apixaban Laboratori Alter. Start treatment with the other anticoagulant medicine (e.g. heparin) at the time you would have taken your next capsule.
Switching from another anticoagulant medicine to Apixaban Laboratori Alter
Stop taking the other anticoagulant medicine. Start taking Apixaban Laboratori Alter at the time you would have taken your next dose of the other anticoagulant, then continue taking it as usual.
Switching from a vitamin K antagonist anticoagulant (e.g. warfarin) to Apixaban Laboratori Alter
Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to start Apixaban Laboratori Alter.
Switching from Apixaban Laboratori Alter to a vitamin K antagonist anticoagulant (e.g. warfarin)
If your doctor instructs you to start taking a vitamin K antagonist medicine, continue taking Apixaban Laboratori Alter for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you when to stop taking Apixaban Laboratori Alter.
Patients undergoing cardioversion
If your abnormal heartbeat requires correction by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in the blood vessels of the brain and elsewhere in the body.
If you take more Apixaban Laboratori Alter 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 capsules remain.
If you take more Apixaban Laboratori Alter than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments may be needed to reverse the anti-factor Xa anticoagulant activity.
If you forget to take Apixaban Laboratori Alter
Take the missed dose as soon as you remember, and:
take your next dose of Apixaban Laboratori Alter at the usual time.
Then continue as directed.

If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop taking Apixaban Laboratori Alter
Do not stop taking this medicine without first talking to your doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Apixaban Laboratori Alter may be given for three different medical conditions. The known side effects and how frequently they occur may differ and are listed separately below. For these conditions, the most common general side effect with this medicine is bleeding, which can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Laboratori Alter is taken to prevent blood clots after hip or knee replacement surgery.

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

Anaemia, which may cause tiredness or pale skin;
Bleeding, including:
- Bruising and swelling;
Nausea (feeling unwell).

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

Reduction in the number of platelets in the blood (which may affect clotting);
Bleeding:
- Occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From the stomach, intestine, or clear/red blood in the stools;
- Blood in the urine;
- Nosebleeds;
- Vaginal bleeding;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, 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 difficulty breathing. Contact your doctor immediately if you experience any of these symptoms.
Bleeding:
- Into the muscle;
- Into 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 haemorrhoids;
- Blood tests showing blood in the stools or urine;
Skin 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 may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Laboratori Alter is taken to prevent blood clots in the heart in 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;
- Nosebleeds;
- From the gums;
- Bruising and swelling;
Anaemia, which may cause tiredness or pale skin;
Low blood pressure, which may cause weakness or a rapid heartbeat;
Nausea (feeling unwell);
Blood tests may show:
- Increased 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 sputum when coughing;
- In the abdomen or from the vagina;
- Clear/red blood in the stools;
- Occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- Blood tests showing blood in the stools or urine;
Reduction in the number of platelets in the blood (which may affect clotting);
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, which may cause yellowing of the skin and eyes;
Skin rash;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may 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 the muscle.

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

Skin 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).

Not known (frequency cannot be estimated from available data)

Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

The following side effects are known to occur when Apixaban Laboratori Alter is taken to treat or prevent recurrence of blood clots in the veins of the legs and in the blood vessels of the lungs.

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

Bleeding, including:
- Nosebleeds;
- From the gums;
- Blood in the urine;
- Bruising and swelling;
- In the stomach, intestine, or rectum;
- In the mouth;
- From the vagina;
Anaemia, which may cause tiredness or pale skin;
Reduction in the number of platelets in the blood (which may affect clotting);
Nausea (feeling unwell);
Skin rash;
Blood tests may show:
- Increased gamma-glutamyl transferase (GGT) or alanine aminotransferase (ALT).

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

Low blood pressure, which may cause weakness or a rapid heartbeat;
Bleeding:
- In the eyes;
- In the mouth or blood in sputum when coughing;
- Clear/red blood in the stools;
- Blood tests showing blood in the stools or urine;
- Occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- From haemorrhoids;
- In the muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may 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;
Blood tests may show:
- Abnormal liver function;
- Increased levels of certain liver enzymes;
- Increased bilirubin, a product of red blood cell breakdown, 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;
Skin 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 may present as skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://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 Laboratori Alter

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.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apixaban Laboratori Alter contains

The active substance is apixaban. Each capsule contains 2.5 mg of apixaban.
The excipients are:
- Capsule contents: lactose (see section 2 "Apixaban Laboratori Alter contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Laboratori Alter contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate (E470b);
- Capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172).
  Description of the appearance of Apixaban Laboratori Alter and package contents
  Hard gelatin capsule (approximately 14 mm) size 4 with a white body and yellow cap.
- Packaged in blisters, contained in cartons of 20 and 60 hard capsules.

Not all pack sizes may be marketed.
Patient Alert Card: managing information
Inside the package of Apixaban Laboratori Alter, 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 may be useful to you
and alerts other physicians that you are taking Apixaban Laboratori Alter. You must always
keep this card with you.

Take the card.
Tear off the text in your language as needed (this will be facilitated by the pre-perforated edge).
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:
Fold the card and keep it with you at all times.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi 7
20144 Milan
Italy
Manufacturer
Laboratorios Alter S.A.
Calle Mateo Inurria 30
28036 - Madrid
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
SPAIN
Apixaban Alter genéricos 2.5 mg capsulas duras EFG
ITALY
Apixaban Laboratori Alter

Patient Information Leaflet: Information for the User

Apixaban Laboratori Alter 5 mg hard capsules

apixaban
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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Apixaban Laboratori Alter is and what it is used for
What you need to know before taking Apixaban Laboratori Alter
How to take Apixaban Laboratori Alter
Possible side effects
How to store Apixaban Laboratori Alter
Contents of the pack and other information

1. What Apixaban Laboratori Alter is and what it is used for

Apixaban Laboratori Alter 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, an important component in blood coagulation.
Apixaban Laboratori Alter is used in adults:

to prevent the formation of blood clots in the heart in patients with irregular heartbeat (atrial fibrillation) and with at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs, blocking normal blood flow to these organs (also known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
to treat 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 should know before taking Apixaban Laboratori Alter

Do not take Apixaban Laboratori Alter 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 leads to an increased risk of severe bleeding (such as a recent or active ulcer of the stomach or intestine, or recent bleeding in the brain);
you have a liver disease that leads to an increased risk of bleeding (hepatic coagulopathy);
you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have an intravenous or arterial catheter and are receiving heparin through it to keep it open, or if a catheter is inserted into one of your blood vessels (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 conditions:

an increased risk of bleeding, such as:
bleeding disorders, including conditions leading to reduced platelet function;
very high blood pressure not controlled by medical treatment;
if you are over 75 years of age;
if you weigh 60 kg or less;
severe kidney disease or if 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 a prosthetic heart valve;
if your doctor finds that your blood pressure is unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned. Be especially careful when using Apixaban Laboratori Alter
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 a change in therapy is needed.

If you are scheduled for 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 Laboratori Alter
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effect of Apixaban Laboratori Alter, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Laboratori Alter when taking these medicines and how closely you should be monitored.
The following medicines may increase the effect of Apixaban Laboratori Alter and increase the risk of unwanted bleeding:

some medicines for fungal infections (e.g., ketoconazole, etc.);
some antiviral medicines for HIV/AIDS (e.g., ritonavir);
other medicines used to reduce blood clotting (e.g., enoxaparin, etc.);
anti-inflammatory drugs or painkillers (e.g., acetylsalicylic acid or naproxen). Particularly if you are over 75 years of age and taking acetylsalicylic acid, you may have a higher risk of bleeding;
medicines for high blood pressure or heart problems (e.g., diltiazem);
antidepressants known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. The following medicines may reduce the effect of Apixaban Laboratori Alter in helping to prevent blood clots:
medicines for epilepsy or seizures (e.g., phenytoin, etc.);
St. John's Wort (a herbal product used for depression);
medicines to treat tuberculosis or other infections (e.g., rifampicin). Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine. The effect of Apixaban Laboratori Alter during pregnancy and on the unborn child is unknown. You must 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 Laboratori Alter passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to discontinue breastfeeding or to discontinue/avoid starting treatment with this medicine. Driving and using machines Apixaban Laboratori Alter has not shown effects on the ability to drive or operate machinery. Apixaban Laboratori Alter contains lactose (a type of sugar) and sodium. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Laboratori Alter

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Dosage
Swallow the capsule with some water. Apixaban Laboratori Alter can be taken with or without food.
Try to take the capsules at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the capsule whole, ask your doctor about other ways to take Apixaban Laboratori Alter. The capsule may be opened and its contents mixed with water, or 5% glucose in water, or apple juice or apple puree, immediately before administration.
If necessary, your doctor may also administer the contents of the Apixaban Laboratori Alter capsule mixed with 60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Laboratori Alter as recommended:
To prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one capsule of Apixaban Laboratori Alter 5 mg twice daily.
The recommended dose is one capsule of Apixaban Laboratori Alter 2.5 mg twice daily if:

you have severely reduced kidney function;
you meet two or more of the following criteria:
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 capsule 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 in the blood vessels of the lungs
The recommended dose is two capsules of Apixaban Laboratori Alter 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 capsule of Apixaban Laboratori Alter 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 capsule of Apixaban Laboratori Alter 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 modify your anticoagulant treatment as follows:

Switching from Apixaban Laboratori Alter to another anticoagulant medicine Stop taking Apixaban Laboratori Alter. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next capsule.
Switching from another anticoagulant medicine to Apixaban Laboratori Alter Stop taking the anticoagulant medicine. Start treatment with Apixaban Laboratori Alter at the time you would have taken your next dose of anticoagulant, then continue taking it as usual.
Switching from an anticoagulant treatment containing a vitamin K antagonist (e.g., warfarin) to Apixaban Laboratori Alter
Stop taking the medicine containing the vitamin K antagonist. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Laboratori Alter.
Switching from Apixaban Laboratori Alter to an anticoagulant treatment containing a vitamin K antagonist (e.g., warfarin)
If your doctor instructs you to start taking a medicine containing a vitamin K antagonist, continue taking Apixaban Laboratori Alter for at least 2 days after the first dose of the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to stop treatment with Apixaban Laboratori Alter.
Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal through a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.

If you take more Apixaban Laboratori Alter than you should
Contact your doctor immediately if you have taken more than the prescribed dose of Apixaban Laboratori Alter. Bring the medicine pack with you, even if no capsules remain.
If you take more Apixaban Laboratori Alter than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments that can reverse the anti-factor Xa activity may be required.
If you forget to take Apixaban Laboratori Alter

Take the missed dose as soon as you remember, and:
take your next dose of Apixaban Laboratori Alter at the usual time;
then continue as directed.
If you are unsure what to do or if you have missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop taking Apixaban Laboratori Alter
Do not stop taking this medicine without first talking to your doctor, as your risk of developing a blood clot may be higher 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 everybody 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 to occur when Apixaban Laboratori Alter is taken to prevent blood clots forming in the heart in 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 pale skin;
Low blood pressure, which may cause weakness or 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 coughed-up mucus when coughing;
- in the abdomen or from the vagina;
- clear/red blood in stools;
- bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- from haemorrhoids;
- tests showing blood in stools or urine;
Reduction in the number of platelets in the blood (which may affect blood clotting);
Blood tests may show:
- abnormalities in liver function;
- increase in certain liver enzymes;
- increase in bilirubin, a product of red blood cell breakdown, 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;
- into the space behind the abdominal cavity;
- into 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 the available data)

Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots, pointed spots, under the skin surface or bruising.

The following side effects are known to occur when Apixaban Laboratori Alter is taken to treat or prevent recurrence 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;
- in the mouth;
- from the vagina;
Anaemia, which may cause tiredness or pale skin;
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 may cause weakness or a fast heartbeat;
Bleeding:
- in the eyes;
- in the mouth or blood in coughed-up mucus when coughing;
- clear/red blood in stools;
- tests showing blood in stools or urine;
- bleeding occurring after any surgery, including bruising and swelling, leakage of blood or fluids from the surgical wound/incision (wound discharge) or from the injection site;
- from haemorrhoids;
- into 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:
- abnormalities in liver function;
- increase in certain liver enzymes;
- increase in bilirubin, a product of red blood cell breakdown, 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 the available data)

Bleeding:
- in the abdomen or into 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 present as skin rashes or small, flat, red, round, pointed spots under the skin surface or bruising.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://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 Laboratori Alter

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 carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Apixaban Laboratori Alter contains

The active substance is apixaban. Each capsule contains 5 mg of apixaban.
The excipients are:
- Capsule contents: lactose (see section 2 "Apixaban Laboratori Alter contains lactose (a type of sugar) and sodium"), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apixaban Laboratori Alter contains lactose (a type of sugar) and sodium"), sodium lauryl sulfate, magnesium stearate;
- Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172). Description of the appearance of Apixaban Laboratori Alter and the contents of the pack Hard gelatin capsule (approximately 17 mm) size 2, with a white body and red cap.
The capsules are contained in blisters, packed in cartons of 28 and 60 hard capsules.

Not all pack sizes may be marketed.
Patient Alert Card: managing information
Inside the packaging of Apixaban Laboratori Alter, 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 may be useful to you and alerts other physicians that you are taking Apixaban Laboratori Alter. You must always carry this card with you.

Take the card.
Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
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:
Fold the card and always keep it with you. Marketing Authorization Holder Laboratori Alter S.r.l. Via Egadi 7 20144 Milano Italy Manufacturer Laboratorios Alter S.A. Calle Mateo Inurria 30 28036 – Madrid Spain

This medicinal product is authorised in the European Economic Area countries under the
following names:
SPAIN
Apixaban Alter genéricos 5 mg hard capsules EFG
ITALY
Apixaban Laboratori Alter