Apixaban Cipla

Italy
Brand name Apixaban Cipla
Form tablets, film-coated
Active substance / Dosage
APIXABAN
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
B01AF02
Registration number 050716
Manufacturer CIPLA EUROPE NV

Table of Contents

Package leaflet: Information for the user

Apixaban Cipla 2.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, as it may be harmful.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Apixaban Cipla 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 clotting.
Apixaban Cipla 2.5 mg is used in adults:

  • to prevent the formation of blood clots (deep vein thrombosis [DVT]) after hip or knee replacement surgery. After hip or knee surgery, the risk of developing blood clots in the veins of the legs may be higher. 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 can break loose and travel to the brain, causing a stroke, or can reach other organs, blocking normal blood supply 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 Cipla 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 appropriate recommended dose according to body weight, see section 3.

2. What you should know before taking Apixaban Cipla

Do not take Apixaban Cipla 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 a higher risk of serious bleeding (such as an active or recent ulcer in the stomach or intestine, or a recent bleeding in the brain),
  • you have a liver disease that leads to a higher risk of bleeding (hepatic coagulopathy),
  • you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and are receiving heparin through the catheter to keep it open, or if a catheter is placed into a blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the following 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; Apixaban Cipla will be used with caution in patients showing signs of impaired liver function;
  • you have a tube (catheter) or have had an injection into the spinal canal (for anaesthesia or pain relief). Your doctor will instruct you to take Apixaban Cipla at least 5 hours or more after removal of the catheter;
  • 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 Cipla

  • 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 therapy needs to be changed.

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 time. If you are unsure whether a procedure may cause bleeding, ask your doctor.

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

Other medicines and Apixaban Cipla
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effects of Apixaban Cipla, while others can reduce them. Your doctor will decide whether you should be treated with Apixaban Cipla when taking these medicines and how closely you should be monitored.

The following medicines may increase the effects of Apixaban Cipla 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 painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, you may have a higher risk of bleeding,
  • medicines for high blood pressure or heart problems (e.g., diltiazem),
  • antidepressant medicines known as selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Cipla in helping to prevent blood clots:

  • medicines to prevent 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 apixaban if you are pregnant. Contact your doctor immediately if you become pregnant while taking apixaban.
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/avoid starting treatment with apixaban.

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

Apixaban Cipla contains lactose (a type of sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 Cipla

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 tablet with some water. Apixaban Cipla may be taken with or without food.
Try to take the tablets at the same time each day to get the best effect from treatment.
If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Apixaban Cipla. The tablet may be crushed and mixed with water, 5% dextrose solution, apple juice, or apple puree, immediately before administration.
Instructions for crushing the tablet:

  • Crush the tablets using a mortar and pestle.
  • Carefully transfer all the powder into a suitable container and then mix the powder with 60 mL of water or 5% dextrose solution.
  • Gently mix to fully disperse the mixture. Using a polypropylene syringe, administer the mixture immediately via nasogastric tube into the stomach.
  • Add approximately 5 mL of water or 5% dextrose solution to the empty container and flush the tube to administer the remaining dispersion.

If necessary, your doctor may also administer Apixaban Cipla tablets crushed and mixed with 60 mL of water or 5% dextrose solution through a nasogastric tube.
Take Apixaban Cipla as recommended:
To prevent blood clots after hip or knee replacement surgery
The recommended dose is one 2.5 mg tablet of Apixaban Cipla twice daily, for example, one in the morning and one in the evening.
You should take the first dose 12 to 24 hours after surgery.
If you have had surgery on the hip, you will usually take the tablets for 32 to 38 days. If you have had surgery on the knee, 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 2.5 mg tablet of Apixaban Cipla 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 Cipla 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 Cipla 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 Cipla 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 prescribed 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 get the best effect from treatment.
The dose of Apixaban Cipla depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is four 2.5 mg tablets of Apixaban Cipla 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 Cipla twice daily, for example, two in the morning and two in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken.
It is important to attend scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may change your anticoagulant treatment as follows:

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

Patients undergoing cardioversion
If your abnormal heart rhythm needs to be corrected by a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in blood vessels of the brain and elsewhere in your body.
If you take more Apixaban Cipla than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine.
Take the medicine pack with you, even if no tablets are left.
If you take more Apixaban Cipla than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments to reverse anti-factor Xa activity may be needed.
If you forget to take Apixaban Cipla

  • If you forget 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 next morning; instead, continue with your regular twice-daily dosing schedule the following day.

If you are unsure what to do or if you missed more than one dose, consult your doctor, pharmacist, or nurse.
If you stop treatment with Apixaban Cipla
Do not stop taking Apixaban Cipla without first talking to your doctor, as your risk of developing a blood clot may increase if you stop treatment too early.
If you have any questions about using 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 Cipla may be administered for three different medical conditions. The known side effects and their frequency of occurrence may vary and are listed separately below. For these conditions, the most common general side effect of 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 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;
    • In the stomach, intestine, or clear/red blood in faeces;
    • Blood in urine;
    • From the nose;
    • From the vagina;
  • Low blood pressure, which may cause you to feel faint or have 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 breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Bleeding:
    • Into a muscle;
    • In the eyes;
    • From the gums and blood in sputum when coughing;
    • From the rectum;
  • Hair loss

Not known (frequency cannot be estimated from available data)

  • Bleeding:
    • In the brain or spinal cord;
    • In the lungs or throat;
    • In the mouth;
    • In the abdomen or in the space behind the abdominal cavity;
    • From haemorrhoids;
    • Tests showing blood in faeces or urine;
  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a paler 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 urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban 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 intestine;
    • From the rectum;
    • Blood in urine;
    • From the nose;
    • From the gums;
    • Bruising and swelling;
  • Anaemia, which may cause tiredness or pale skin;
  • Low blood pressure, which may cause you to feel faint or have a rapid heartbeat;
  • Nausea (feeling unwell);
  • Blood tests may show:
    • Increased gamma-glutamyltransferase (GGT) levels.

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 faeces;
    • 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 faeces 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 breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.

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

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

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

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

Not known (frequency cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis), which may present as skin rashes or small, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in urine, leading to impaired kidney function (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban is taken to treat or prevent recurrence of blood clots in 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 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 clotting);
  • Nausea (feeling unwell);
  • Skin rash;
  • Blood tests may show:
    • Increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT) levels.

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 faeces;
    • Tests showing blood in faeces 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 a muscle;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms;
  • Blood tests may show:
    • Abnormal liver function;
    • Increased levels of certain liver enzymes;
    • Increased bilirubin, a 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 paler 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 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, the side effects observed in children and adolescents treated with Apixaban Cipla have been of a similar type to those observed 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 urine;
    • Bruising and swelling;
    • From the intestine or rectum;
    • Clear/red blood in faeces;
    • 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 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:
    • Abnormal liver function;
    • Increased levels of certain 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 a muscle;
  • Skin rash that may blister and appear as small targets (dark central spots surrounded by a paler 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-glutamyltransferase (GGT) levels;
    • Tests showing blood in faeces or urine. Bleeding in the kidney, sometimes with blood in 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, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apixaban Cipla

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, bottle, and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apixaban Cipla contains

  • The active substance is apixaban. Each film-coated tablet contains 2.5 mg of apixaban.
  • The excipients are:
    • Tablet core: lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b);
    • Film coating: hypromellose (E464), titanium dioxide (E171), Macrogol 400 (E1521), iron oxide yellow (E172).

Description of the appearance of Apixaban Cipla and pack contents
The film-coated tablets are round, biconvex, yellow in colour and smooth on both sides
[thickness: 3 mm; diameter: 6 mm].
The tablets are packed in blisters within cartons containing 10 film-coated tablets.

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

  1. Take the card.
  2. Tear off the section in your language as needed (this will be facilitated by the pre-perforated edge).
  3. Complete the following sections, or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: .......... mg twice daily
    • Doctor’s name:
    • Doctor’s telephone number:
  4. Fold the card and always keep it with you.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 60C, Bus-1301, 2018 Antwerp, Belgium
Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301, 2018 Antwerp, Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden Apixaban Cipla 2.5 mg filmdragerade tabletter
Germany Apixaban Cipla 2.5 mg Filmtabletten
Denmark Apixaban Cipla 2.5 mg filmovertrukne tabletter
Finland Apixaban Cipla 2.5 mg kalvopäällysteiset tabletit
France Apixaban Cipla 2.5 mg comprimé pelliculé
Italy Apixaban Cipla 2.5 mg compresse rivestite con film
Norway Apixaban Cipla
Poland Apixaban Cipla
Netherlands Apixaban Cipla 2.5 mg filmomhulde tabletten

Package leaflet: information for the user

Apixaban Cipla 5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

7. What Apixaban Cipla is and what it is used for

Apixaban Cipla 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 the blood clotting process.
Apixaban Cipla 2.5 mg 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 can break loose and travel to the brain causing a stroke, or can travel to other organs, blocking normal blood flow to these organs (known as systemic embolism). A stroke can be life-threatening and requires immediate medical attention.
  • to treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

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

8. What you should know before taking Apixaban Cipla

Do not take Apixaban Cipla 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 an active or recent ulcer of the stomach or intestine, 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 clotting (e.g., warfarin, rivaroxaban, dabigatran, or heparin), except when switching anticoagulant therapy, while having a venous or arterial catheter and receiving heparin through this route to keep it open, or if a catheter is inserted into a blood vessel (transcatheter ablation) to treat an irregular heartbeat (arrhythmia).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you have any of the
following 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 you are on dialysis;
  • liver problems or a history of liver problems; Apixaban Cipla will be used with caution in patients showing signs of impaired liver function;
  • you have a tube (catheter) or have had an injection into the spine (for anaesthesia or pain relief). Your doctor will instruct you to take Apixaban Cipla at least 5 hours or more after removal of the catheter;
  • 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 special care with Apixaban Cipla

  • 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 therapy needs to be changed.

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 time. If you are unsure whether a procedure may cause bleeding, ask your doctor.
Children and adolescents
Apixaban is not recommended in children and adolescents with body weight below 35 kg.
Other medicines and Apixaban Cipla
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Some medicines can increase the effects of Apixaban Cipla and others can reduce them. Your
doctor will decide whether you should be treated with Apixaban Cipla when taking these medicines and how closely you should be monitored.
The following medicines may increase the effects of Apixaban Cipla 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 painkillers (e.g., acetylsalicylic acid or naproxen). In particular, if you are over 75 years old and taking acetylsalicylic acid, you may have a higher risk of bleeding,
  • medicines for high blood pressure or heart problems (e.g., diltiazem),
  • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.

The following medicines may reduce the effects of Apixaban Cipla in helping to prevent blood
clots:

  • medicines to prevent 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,
ask your doctor, pharmacist, or nurse for advice before taking this medicine.
The effects of apixaban during pregnancy and on the unborn child are unknown. You must not take apixaban if you are pregnant. Contact your doctor immediately if you become pregnant while taking apixaban.
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 apixaban.
Driving and using machines
Apixaban Cipla has not shown any effects on the ability to drive or operate machinery.
Apixaban Cipla contains lactose (a type of sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

9. How to take Apixaban Cipla

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

  • Crush the tablets using a mortar and pestle.
  • Carefully transfer all the powder into a suitable container and then mix the powder with 60 mL of water or 5% dextrose solution.
  • Gently mix to fully disperse the mixture. Using a polypropylene syringe, immediately administer the mixture via a nasogastric tube into the stomach.
  • Add approximately 5 mL of water or 5% dextrose solution to the empty container and flush the tube to administer any remaining dispersion.

If necessary, your doctor may also administer the crushed Apixaban Cipla tablet mixed with 60 mL of water or 5% dextrose solution through a nasogastric tube.
Take Apixaban Cipla as recommended:
To prevent blood clots forming in the heart in patients with irregular heartbeat and at least one additional risk factor
The recommended dose is one 5 mg tablet of Apixaban Cipla twice daily.
The recommended dose is one 2.5 mg tablet of Apixaban Cipla 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 Cipla 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 Cipla 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 Cipla 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 blood vessels of the lungs.
Take or administer this medicine exactly as instructed by your doctor, the child’s doctor, or pharmacist. If you have any doubts, consult your doctor, 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 Cipla depends on body weight and will be calculated by the doctor.
The recommended dose for children and adolescents weighing at least 35 kg is two 5 mg tablets of Apixaban Cipla 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 Cipla twice daily, for example, one in the morning and one in the evening.
For parents or caregivers: observe the child to ensure the full dose has been taken.
It is important to keep scheduled medical appointments, as the dose may need to be adjusted as body weight changes.
Your doctor may change your anticoagulant treatment as follows:

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

Patients undergoing cardioversion
If your abnormal heartbeat needs to be restored to normal rhythm using a procedure called cardioversion, take this medicine exactly as your doctor instructs, to prevent blood clots in the blood vessels of your brain and other parts of your body.
If you take more Apixaban Cipla than you should
Contact your doctor immediately if you have taken more than the prescribed dose of this medicine.
Take the medicine pack with you, even if no tablets are left.
If you take more Apixaban Cipla than recommended, you may have an increased risk of bleeding. If bleeding occurs, surgery, blood transfusion, or other treatments to reverse the anti-factor Xa activity may be needed.
If you forget to take Apixaban Cipla

  • 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 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 treatment with Apixaban Cipla
    Do not stop taking Apixaban Cipla 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 questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common 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 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 make you feel faint or have a rapid heartbeat;
  • Nausea (feeling unwell);
  • Blood tests may show:
  • increased gamma-glutamyltransferase (GGT).

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

  • Bleeding:
  • in the brain or spinal cord;
  • in the mouth or blood in coughed-up phlegm;
  • 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;
  • Decrease in the number of platelets in the blood (which may affect blood clotting);
  • Blood tests may show:
  • abnormal liver function;
  • increase in some liver enzymes;
  • increase in 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;
  • in a muscle.

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

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

Not known (frequency cannot be estimated from available data)

  • Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

The following side effects are known to occur when apixaban 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;
  • Decrease in the number of platelets in the blood (which may affect blood clotting);
  • Nausea (feeling unwell);
  • Skin rash;
  • Blood tests may show:
  • increased gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

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

  • Low blood pressure, which may cause weakness or a rapid heartbeat;
  • Bleeding:
  • in the eyes;
  • in the mouth or blood in coughed-up phlegm;
  • 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 a muscle;
  • Itching;
  • Hair loss;
  • Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips, mouth, tongue and/or throat and breathing difficulties. Contact your doctor immediately if you experience any of these symptoms.
  • Blood tests may show:
  • abnormal liver function;
  • increase in some 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 available data)

  • Bleeding:
  • in the abdomen or in the space behind the abdominal cavity;
  • Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising;
  • Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (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 Cipla 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 intestines 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;
  • Decrease 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:
  • abnormalities in liver function;
  • increase in some liver enzymes;
  • increase in 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 coughed-up phlegm;
  • in the brain or spinal cord;
  • in the lungs;
  • in a muscle;
  • Skin rash which may blister and appear as small target-like spots (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
  • Inflammation of blood vessels (vasculitis), which may present as skin rashes or sharp, flat, red, round spots under the skin surface or bruising;
  • Blood tests may show:
  • increased gamma-glutamyltransferase (GGT);
  • tests showing blood in the stools or urine. Bleeding in the kidney, sometimes with blood in the urine, leading to the kidneys being unable to function properly (anticoagulant-related nephropathy).

Reporting of side effects
If you or your child get any side effects, 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store Apixaban Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Apixaban Cipla contains

  • The active substance is apixaban. Each film-coated tablet contains 5 mg of apixaban.
  • The excipients are:
    • Tablet core: monohydrate lactose (see section 2 “Apixaban Cipla contains lactose (a type of sugar) and sodium”), microcrystalline cellulose (E460), sodium croscarmellose (E468), sodium lauryl sulfate (E487), magnesium stearate (E470b);
    • Film coating: hypromellose (E464), titanium dioxide (E171), Macrogol 400 (E1521), red iron oxide (E172).

Description of the appearance of Apixaban Cipla and package contents
The film-coated tablets are biconvex ovals, pink in colour, smooth on both sides
[thickness: 4 mm; length: 10 mm and width: 5 mm].
The tablets are packaged in blisters within cartons containing 14 film-coated tablets.

Patient Alert Card: managing information
Inside the packaging of Apixaban Cipla, 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 Cipla. You must always carry this card with you.

  1. Take the card.
  2. Separate the text in your language as needed (this will be facilitated by the pre-perforated edge).
  3. Complete the following sections or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: .......... mg twice daily
    • Doctor’s name:
    • Doctor’s telephone number:
  4. Fold the card and always keep it with you.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Cipla Europe NV
De Keyserlei 60C, Bus-1301, 2018 Antwerp, Belgium
Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301, 2018 Antwerp, Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Sweden Apixaban Cipla 5 mg filmdragerade tabletter
Germany Apixaban Cipla 5 mg Filmtabletten
Denmark Apixaban Cipla 5 mg filmovertrukne tabletter
Finland Apixaban Cipla 5 mg kalvopäällysteiset tabletit
France Apixaban Cipla 5 mg comprimé pelliculé
Italy Apixaban Cipla 5 mg compresse rivestite con film
Norway Apixaban Cipla
Poland Apixaban Cipla
Netherlands Apixaban Cipla 5 mg filmomhulde tabletten