Apixaban Vivanta

Italy
Brand name Apixaban Vivanta
Form tablets, film-coated
Active substance / Dosage
APIXABAN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AF02
Registration number 051843
Manufacturer VIVANTA GENERICS S.R.O.

Table of Contents

Patient Information Leaflet

Apixaban Vivanta

2.5 mg film-coated tablets
apixaban
Generic medicine
Please read all of this leaflet carefully before you take 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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Apixaban Vivanta 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,
which is an important component in blood coagulation.
Apixaban Vivanta is used in adults:

  • to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. Following surgery on the hip or knee, you may be at increased risk of developing blood clots in the veins of your 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 with at least one additional risk factor. Blood clots may break loose and travel to the brain, causing stroke, or reach other organs and block 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 blood clots from recurring in the blood vessels of the legs and/or lungs.

Apixaban Vivanta is used in children aged 28 days to less than 18 years to treat blood clots and to prevent blood clots from recurring in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you need to know before taking Apixaban Vivanta

Do not take Apixaban Vivanta 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 an organ disease that increases the risk of serious bleeding (such as a recent or active ulcer of the stomach or intestine, or a recent bleed in the brain);
  • you have a liver disease that increases the 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 your blood pressure to be unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Vivanta

  • 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 due 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, please consult your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.

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

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

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

  • certain medicines for fungal infections (e.g., ketoconazole, etc.);
  • certain 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);
  • antidepressants known as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

The following medicines may reduce the effect of Apixaban Vivanta 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 to treat tuberculosis or other infections (e.g., rifampicin).

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

The effects of apixaban during pregnancy and on the unborn child are 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 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 has not shown effects on the ability to drive or use machinery.

Apixaban Vivanta contains lactose (a type of sugar) and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Vivanta

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
please consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with water. Apixaban may be taken with or without food. Try to
take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about alternative ways to take apixaban. The
tablet can be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

  • Crush the tablets with a mortar and pestle.
  • Carefully transfer all of the powder into a suitable container and 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 prepare a mixture.
  • Swallow the mixture.
  • Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer the crushed Apixaban Vivanta tablet mixed with
60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Vivanta as recommended:
To prevent blood clots after hip or knee replacement surgery.
The recommended dose is one 2.5 mg Apixaban Vivanta 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 hip surgery, you will usually take the tablets for 32 to 38
days.
If you have undergone major knee surgery, you will usually take the tablets for 10 to 14
days.
To prevent blood clots in the heart in patients with irregular heartbeat and at least one additional risk factor.
The recommended dose is one 5 mg tablet twice daily.
The recommended dose is one 2.5 mg tablet twice daily if:

  • you have 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 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 in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Vivanta 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 tablet of Apixaban Vivanta 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 tablet of Apixaban Vivanta twice daily, for example, one
in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in veins or blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor or the child's doctor or pharmacist. If you have any doubts, consult your doctor or the child's doctor, pharmacist, or
nurse.
Try to take or administer the dose at the same time each day to achieve the best effect from
treatment.
The dose of Apixaban Vivanta depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with body weight of at least 35 kg is four 2.5 mg tablets of Apixaban Vivanta twice daily for the first 7 days, for example, four in the morning and
four in the evening.
After 7 days, the recommended dose is two 2.5 mg tablets of Apixaban Vivanta twice daily, for
example, two in the morning and two in the evening.
For parents or caregivers: observe the child to ensure they have taken the full dose.
It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

  • Switching from Apixaban Vivanta to another anticoagulant medicine Stop taking Apixaban Vivanta. Start treatment with the anticoagulant medicine (e.g., heparin) at the time you would have taken your next tablet.
  • Switching from another anticoagulant medicine to Apixaban Vivanta Stop taking the anticoagulant medicine. Start treatment with Apixaban Vivanta at the time you would have taken your next dose of the anticoagulant medicine, then continue taking it as usual.
  • Switching from vitamin K antagonist anticoagulant treatment (e.g., warfarin) to Apixaban Vivanta Stop taking the vitamin K antagonist medicine. Your doctor will need to perform blood tests and advise you on when to start treatment with Apixaban Vivanta.
  • Switching from Apixaban Vivanta 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 Vivanta 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 Apixaban Vivanta.

Patients undergoing cardioversion
If your abnormal heart rhythm requires correction through a procedure called
cardioversion, take this medicine exactly as your doctor instructs, to prevent
blood clots in blood vessels in the brain and other parts of the body.
If you take more Apixaban Vivanta than you should
Inform 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 Vivanta than recommended, you may have an increased risk of bleeding.
If bleeding occurs, you may require surgery, a blood transfusion, or other treatments that can reverse the anticoagulant activity against factor Xa.
If you forget to take Apixaban Vivanta

  • If you forget to take your morning dose, take it as soon as you remember, and you may take it together with your evening dose.
  • A forgotten evening dose may be taken only on the same evening. Do not take two doses the next morning; instead, continue with the recommended twice-daily dosing schedule the following day.

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 Vivanta
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 treatment is stopped too early.
If you have any questions 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 Vivanta may be prescribed for three different medical conditions. The known side effects and their frequency may differ for each of these conditions and are listed separately below. For these conditions, 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 Vivanta 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 blood 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;
    • From the nose;
    • From the vagina;
  • Low blood pressure, which may cause weakness or a rapid heartbeat;
  • Blood tests may show:
    • Liver function abnormalities;
    • Increased 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 breathing difficulties. 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;
    • Tests showing blood in the stools or urine;
  • Skin rash that may form blisters 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;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when Apixaban Vivanta 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;
    • 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 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;
    • Tests showing blood in the stools or urine;
  • Reduction in the number of platelets in the blood (which may affect blood clotting);
  • Blood tests may show:
    • Liver function abnormalities;
    • Increased 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 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 the muscle.

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

  • Skin rash that may form blisters 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;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when Apixaban Vivanta 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, intestine, 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 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:
    • Into the eyes;
    • In the mouth or blood in sputum when coughing;
    • Clear/red blood in the stools;
    • 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;
    • Into the 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;
    • Increased 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 form blisters 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;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of these symptoms:

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, side effects observed in children and adolescents treated with apixaban have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed most frequently in children and adolescents have been nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

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

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

  • Bleeding, including:
    • From the gums;
    • Blood in the urine;
    • Bruising and swelling;
    • From the intestine or rectum;
    • Clear/red blood in the stools;
    • Occurring after any surgery, including bruising and swelling, leakage of blood from the surgical wound/incision (wound discharge) or from the injection site;
  • Hair loss;
  • Anaemia, which may cause tiredness or pale skin;
  • Reduction in the number of platelets in the child’s blood (which may affect blood clotting);
  • Nausea (feeling unwell);
  • Skin rash;
  • Itching;
  • Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
  • Blood tests may show:
    • Liver function abnormalities;
    • Increased liver enzymes;
    • Increased alanine aminotransferase (ALT).

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • In the abdomen or in the space behind the abdominal cavity;
    • In the stomach;
    • In the eyes;
    • In the mouth;
    • From haemorrhoids;
    • In the mouth or blood in sputum when coughing;
    • In the brain or spinal cord;
    • In the lungs;
    • Into the muscle;
  • Skin rash that may form blisters 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;
  • Blood tests may show:
    • Increased gamma-glutamyl transferase (GGT);
    • Tests showing blood in the stools or urine;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Vivanta

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.
No special storage conditions are required for this medicine.
Do not dispose of medicines 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 Vivanta contains

  • The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
  • The other components are:
  • Tablet core: monohydrate lactose (see section 2), microcrystalline cellulose (E460), croscarmellose sodium (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b).
  • Film coating: monohydrate lactose (see section 2), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

Description of the appearance of Apixaban Vivanta and contents of the pack
The film-coated tablets are yellow, round (approximately 6 mm in diameter), biconvex, with
“M” engraved on one side and “2.5” on the other side.
The product is available in blisters in packs of 10, 20, 60, 168 and 200 film-coated tablets.
Patient Alert Card: managing information
Inside the Apixaban Vivanta packaging, together with the package leaflet, you will find a Patient Alert Card or your doctor may have given you a similar one.
This Patient Alert Card includes information that may be useful to you and alerts other doctors that you are taking Apixaban Vivanta.
You must always carry this card with you.

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

Marketing Authorization Holder
Vivanta Generics s.r.o.
Trtinova 260/1, Cakovice,
19600, Prague 9
Czech Republic
Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA3000, Malta
MSN Labs Europe Limited
KW20A Corradino Park, Paola, PLA3000, Malta
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Sweden: Apixaban Vivanta, filmdragerade tabletter
Netherlands: Apixaban Vivanta, filmomhulde tabletten
Spain: Apixaban Vivanta comprimidos recubiertos con película EFG
Italy: Apixaban Vivanta
Norway: Apixaban Vivanta
Denmark: Apixaban Vivanta
Germany: Apixaban Vivanta Filmtabletten

Package leaflet: Information for the patient

Apixaban Vivanta

5 mg film-coated tablets
apixaban
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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • 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 Vivanta is and what it is used for
  2. What you need to know before taking Apixaban Vivanta
  3. How to take Apixaban Vivanta
  4. Possible side effects
  5. How to store Apixaban Vivanta
  6. Package contents and other information

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

Apixaban Vivanta 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 in blood coagulation.
Apixaban Vivanta 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 and block normal blood flow 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 blood clots from recurring in the blood vessels of the legs and/or lungs.

Apixaban Vivanta is used in children aged from 28 days to less than 18 years to treat blood clots and to prevent blood clots from recurring in the veins or blood vessels of the lungs.
For the recommended dose according to body weight, see section 3.

2. What you need to know before taking Apixaban Vivanta

Do not take Apixaban Vivanta 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, 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 of age;
  • if you weigh 60 kg or less;
  • a 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 your blood pressure to be unstable, or if another treatment or surgical procedure to remove a blood clot from the lungs is planned.

Take special care with Apixaban Vivanta

  • 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 you need to change your treatment.

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 may cause bleeding, ask your doctor.

Children and adolescents
This medicine is not recommended for children and adolescents weighing less than 35 kg.

Other medicines and Apixaban Vivanta
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 Vivanta, while others can reduce it. Your doctor will decide whether you should be treated with Apixaban Vivanta when taking these medicines and how closely you should be monitored.

The following medicines may increase the effect of Apixaban Vivanta 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 or pain-relieving medicines (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years of age and taking acetylsalicylic acid, your risk of bleeding may be higher;
  • 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 Vivanta 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 to treat tuberculosis or other infections (e.g., rifampicin).

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

The effect of apixaban 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 passes into breast milk. Consult your doctor, pharmacist, or nurse before taking this medicine while breastfeeding. They will advise you whether to stop breastfeeding or to stop or not start treatment with this medicine.

Driving and using machines
Apixaban has not shown effects on the ability to drive or operate machinery.

Apixaban Vivanta contains lactose (a type of sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Apixaban Vivanta

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor, pharmacist, or nurse.
Dosage
Swallow the tablet with some water. Apixaban may be taken with or without food. Try to
take the tablets at the same time each day to achieve the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take apixaban. The
tablet may be crushed and mixed with water, 5% glucose in water, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

  • Crush the tablets with a mortar and pestle.
  • Carefully transfer all of the powder into a suitable container and 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 prepare a mixture.
  • Swallow the mixture.
  • Rinse the mortar and pestle used to crush the tablet and the container with a small amount of water (e.g., 30 mL) or one of the other liquids, and swallow the rinse.

If necessary, your doctor may also administer the crushed Apixaban Vivanta tablet mixed with
60 mL of water or 5% glucose in water through a nasogastric tube.
Take Apixaban Vivanta as recommended:
To prevent the formation of blood clots in the heart in patients with irregular heartbeat and with
at least one additional risk factor.
The recommended dose is one 5 mg tablet twice daily.
The recommended dose is one 2.5 mg tablet twice daily if:

  • you have 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 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 in the blood vessels of the lungs
The recommended dose is two 5 mg tablets of Apixaban Vivanta 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 tablet of Apixaban Vivanta 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 tablet of Apixaban Vivanta twice daily, for example, one
in the morning and one in the evening.
Your doctor will decide how long you should continue treatment.
Use in children and adolescents
To treat blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs.
Take or administer this medicine exactly as directed by your doctor or the child's doctor or pharmacist. If you have any doubts, consult your doctor or the child's doctor, pharmacist, or
nurse.
Try to take or administer the dose at the same time each day to achieve the best effect from
treatment.
The dose of Apixaban Vivanta depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents with body weight of at least 35 kg is two 5 mg tablets of
Apixaban Vivanta 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 tablet of Apixaban Vivanta twice daily, for
example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure they have taken the full dose.
It is important to attend scheduled medical appointments because the dose may need to be adjusted as body weight changes.
Your doctor may modify your anticoagulant treatment as follows:

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

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal by a procedure called
cardioversion, take this medicine at the times your doctor tells you to take it, to prevent
blood clots in the blood vessels of the brain and in other blood vessels of your body.
If you take more Apixaban Vivanta than you should
Inform your doctor immediately if you have taken more than the prescribed dose of Apixaban Vivanta. Bring the medicine pack with you, even if no tablets remain.
If you take more Apixaban Vivanta than recommended, you may have an increased risk of bleeding.
If bleeding occurs, surgery, transfusion, or other treatments that can reverse the anticoagulant activity against factor Xa may be required.
If you forget to take Apixaban Vivanta

  • If you forget to take a morning dose, take it as soon as you remember, and you may take it together with your evening dose.
  • A forgotten evening dose may be taken only on the same evening. Do not take two doses the following morning; instead, continue with the recommended twice-daily dosing schedule the next day.

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 Vivanta
Do not stop taking this medicine without first talking to 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 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 can potentially be life-threatening and requires immediate medical attention.

The following side effects are known to occur when Apixaban Vivanta 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 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 coughed-up mucus (sputum);
    • in the abdomen or from the vagina;
    • bright red blood in the 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 the stools or urine;
  • Decreased platelet count in the blood (which may affect blood clotting);
  • Blood tests may show:
    • liver function abnormalities;
    • increased levels of certain liver enzymes;
    • increased 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;
    • in the space behind the abdominal cavity (retroperitoneal space);
    • in the muscle.

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

  • Rash that may blister and appears 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 under the skin surface or bruising;
  • Kidney bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when Apixaban Vivanta 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;
  • Decreased platelet count in the blood (which may affect blood clotting);
  • Nausea (feeling unwell);
  • 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 coughed-up mucus (sputum);
    • bright red blood in the stools;
    • tests showing blood in the stools or urine;
    • 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;
    • in the 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;
    • 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 the available data)

  • Bleeding:
    • in the abdomen or in the space behind the abdominal cavity (retroperitoneal space).
  • Rash that may blister and appears 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 spots under the skin surface or bruising;
  • Kidney bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Other side effects in children and adolescents
Contact the child’s doctor immediately if you notice any of the following symptoms:

  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and breathing difficulties. The frequency of these side effects is common (may affect up to 1 in 10 people).

In general, side effects observed in children and adolescents treated with apixaban have been similar to those seen in adults and have mainly been mild to moderate in severity. The side effects observed more frequently in children and adolescents were nosebleeds and abnormal vaginal bleeding.

Very common side effects (may affect more than 1 in 10 people)

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

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

  • Bleeding, including:
    • from the gums;
    • blood in the urine;
    • bruising and swelling;
    • from the intestine or rectum;
    • bright red blood in the stools;
    • bleeding occurring after any surgery, including bruising and swelling, leakage of blood from the surgical wound/incision (wound discharge) or from the injection site;
  • Hair loss;
  • Anaemia, which may cause tiredness or pale skin;
  • Decreased platelet count in the child’s blood (which may affect blood clotting);
  • Nausea (feeling unwell);
  • Rash;
  • Itching;
  • Low blood pressure, which may cause the child to feel weak or have a rapid heartbeat;
  • Blood tests may show:
    • liver function abnormalities;
    • increased levels of certain liver enzymes;
    • increased alanine aminotransferase (ALT).

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

  • Bleeding:
    • in the abdomen or in the space behind the abdominal cavity (retroperitoneal space);
    • in the stomach;
    • in the eyes;
    • in the mouth;
    • from haemorrhoids;
    • in the mouth or blood in coughed-up mucus (sputum);
    • in the brain or spinal cord;
    • in the lungs;
    • in the muscle;
  • Rash that may blister and appears 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 spots under the skin surface or bruising;
  • Blood tests may show:
    • increased gamma-glutamyl transferase (GGT);
    • tests showing blood in the stools or urine.
  • Kidney bleeding, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Vivanta

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 no longer required. This will help protect the environment.

6. Package contents and other information

What Apixaban Vivanta contains

  • The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
  • The other components are:
  • Tablet core: monohydrate lactose (see section 2), microcrystalline cellulose (E460), croscarmellose sodium (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b).
  • Film coating: monohydrate lactose (see section 2), hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).

Description of the appearance of Apixaban Vivanta and package contents
The film-coated tablets are pink, oval-shaped (approximately 10 x 5 mm), biconvex, with "M" engraved on one side and "5" on the other.
The product is available in blister packs in cardboard boxes containing 14, 20, 28, 56, 60, 168, and 200 film-coated tablets.

Patient Alert Card: managing information
Inside the Apixaban Vivanta packaging, together with the package leaflet, you will find a Patient Alert Card, or your doctor may have given you a similar one.
This Patient Alert Card contains important information that may be helpful to you and alerts other physicians that you are taking Apixaban Vivanta. You must always carry this card with you.

  1. Take the card.
  2. Complete the following sections or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: ......mg twice daily
    • Physician's name:
    • Physician's telephone number:
  3. Fold the card and always keep it with you.

Marketing Authorization Holder
Vivanta Generics s.r.o.
Trtinova 260/1, Cakovice,
19600, Prague 9
Czech Republic

Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola, PLA3000, Malta
MSN Labs Europe Limited
KW20A Corradino Park, Paola, PLA3000, Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden: Apixaban Vivanta, 5 mg filmdragerade tabletter
Netherlands: Apixaban Vivanta, 5 mg filmomhulde tabletten
Spain: Apixaban Vivanta 5 mg comprimidos recubiertos con película EFG
Italy: Apixaban Vivanta
Norway: Apixaban Vivanta 5mg
Denmark: Apixaban Vivanta
Germany: Apixaban Vivanta 5 mg Filmtabletten