2.5 mg film-coated tablets 
apixaban

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Eliquis is and what it is used for 
2. What you need to know before taking Eliquis 
3. How to take Eliquis 
4. Possible side effects 
5. How to store Eliquis 
6. Contents of the packaging and other information 

1. What Eliquis is and what it is used for

Eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants (blood thinners). This medicine helps prevent blood clots from forming by blocking factor Xa which is an important component in the clotting of the blood.

Eliquis is used for adults:

  • to prevent blood clots (deep vein thrombosis, DVT) from forming after hip or knee joint surgery. After a hip or knee joint operation, you may be at increased risk of getting blood clots in the veins in your legs. It can cause swelling in the legs with or without pain. If a blood clot moves from the legs to the lungs, it can block blood flow and cause shortness of breath with or without chest pain. This condition ( pulmonary embolism ) can be life-threatening and requires immediate medical attention.
  • to prevent blood clots from forming in the heart of patients with an irregular heartbeat ( atrial fibrillation ) and at least one additional risk factor. Blood clots can come loose and be transported to the brain and there cause a stroke, or to other organs and prevent normal blood flow to these organs (which is also called systemic embolism). A stroke can be life-threatening and requires immediate contact with healthcare.
  • to treat blood clots in the veins of the legs (deep vein thrombosis ) and the blood vessels in the lungs ( pulmonary embolism ) and to prevent blood clots from recurring in the blood vessels in the legs and/or lungs.

2. What you need to know before taking Eliquis

Do not take Eliquis if:

  • you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6);
  • you bleed a lot ;
  • you have a disease of an organ in the body, which increases the risk of severe bleeding (such as ongoing or recent ulcers in the stomach or intestines, recent hemorrhages in the brain );
  • you have a liver disease that leads to an increased risk of bleeding ( hepaticcoagulopathy );
  • you are taking medicines to prevent blood clots (eg warfarin, rivaroxaban, dabigatran, or heparin ), except when changing blood thinners, while you have a venous or arterial catheter and you are given heparin to keep it open or if a tube is inserted into the blood vessel (catheter ablation) to treat irregular heartbeat ( arrhythmia ).

Warnings and cautions

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

  • increased risk of bleeding, such as:
    • bleeding disorders, including conditions that result in decreased platelet activity;
    • very high blood pressure not controlled by medication;
    • you are 75 years or older;
    • you weigh 60 kg or less;
  • severe kidney disease, or if you go on dialysis
  • liver problems or previous liver problems
    • This medicine should be used with caution in patients with signs of altered liver function.
  • had a tube ( catheter ) or received an injection in the spine (for anesthesia or pain relief). Your doctor will tell you to take this medicine 5 hours or later after the catheter has been removed.
  • if you have an artificial heart valve
  • if your doctor determines that your blood pressure is unstable or if another treatment or surgery to remove the blood clot from your lungs is planned

Take special care with Eliquis

  • If you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of getting blood clots), tell your doctor, who will decide if treatment may need to be changed.

If you need to have surgery or another procedure that may cause bleeding, your doctor may ask you to temporarily stop taking this medicine for a short time. If you are not sure if a procedure can cause bleeding, consult your doctor.

Children and young people

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

Other medicines and Eliquis

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 Eliquis and some may weaken it. Your doctor will decide if you should be treated with Eliquis when you take such medicines and how closely you need to be monitored.

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

  • certain medicines for fungal infections (eg ketoconazole and others)
  • certain HIV / AIDS antiviral medicines (eg ritonavir)
  • other drugs that reduce the blood’s ability to coagulate (eg enoxaparin and others)
  • anti-inflammatory and analgesic drugs (eg acetylsalicylic acid and naproxen ). Especially if you are older than 75 years and take acetylsalicylic acid, as you may then have an increased risk of bleeding.
  • medicines for high blood pressure or heart problems (eg diltiazem )
  • antidepressant drugs, so-called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors

The following medicines may reduce Eliqui’s ability to prevent blood clots:

  • medicines for epilepsy or seizures (eg phenytoin and others)
  • St. John’s wort (an herbal remedy for mild depression)
  • drugs against tuberculosis and other infectious s (eg, rifampicin)

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant,t or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.

Eliqui’s effects on pregnancy and the unborn baby are not known. You should not take this medicine if you are pregnant. Contact your doctor immediately if you become pregnant while being treated with this medicine.

It is not known if Eliquis passes into breast milk. If you are breast-feeding, ask your doctor, pharmacist, or nurse before taking this medicine. They will advise you to either stop breast-feeding or to stop / not start this medicine.

Driving and using machines

Eliquis has no or negligible effect on the ability to drive and use machines.

Eliquis contains lactose (a sugar) and sodium.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Eliquis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Dosage

Swallow the tablet with a glass of water. Eliquis 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, talk to your doctor about other ways to take Eliquis. The tablet can be crushed and mixed with water, or 5% glucose solution, or apple juice or apple puree, immediately before taking it.

Instructions for crushing:

  • Crush the tablets in a mortar.
  • Gently transfer the powder to a suitable container and then mix the powder with a little (eg 30 ml (2 tbsp)) water or any of the other liquids mentioned above to prepare a mixture.
  • Swallow mixture one.
  • Rinse the mortar you used to crush the tablet and the container with a little water or one of the other liquids (eg 30ml), and swallow the rinsing liquid.

If necessary, your doctor may also give you the crushed Eliquit tablet mixed in 60 ml of water or 5% glucose solution, through a tube through your nose to your stomach.

Take Eliquis as recommended for the following:

To prevent blood clots from forming after hip or knee joint surgery.

The recommended dose is one Eliquis 2.5 mg tablet twice daily. For example, one in the morning and one in the evening.

You should take the first tablet within 12 to 24 hours after the operation.

If you have had major hip surgery, you will usually take the tablets for 32 to 38 days.

If you have had major knee surgery, you will usually take the tablets for 10 to 14 days.

To prevent blood clots from forming in the heart of patients with an irregular heartbeat and at least one additional risk factor.

The recommended dose is one Eliquis 5 mg tablet twice daily.

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

  • you have severe renal impairment
  • if two or more of the following agreement with you:
    • your blood test results indicate poor kidney function (serum creatinine value is 1.5 mg/dl (133 µmol / l) or higher)
    • you are 80 years or older
    • you weigh 60 kg or less

The recommended dose is one tablet twice daily, such as one in the morning and one in the evening. Your doctor will decide how long you need to continue treatment.

To treat blood clots in the veins of the legs and blood clots in the lungs

The recommended dose is two tablets of Eliquis 5 mg twice daily for the first 7 days, for example, two in the morning and two in the evening.

After 7 days, the recommended dose is one Eliquis 5 mg tablet twice daily, for example, one in the morning and one in the evening.

To prevent blood clots from recurring after 6 months of treatment

The recommended dose is one Eliquis 2.5 mg tablet twice daily, for example, one in the morning and one in the evening.

Your doctor will decide how long you need to continue treatment.

Your doctor may replace your blood-thinning treatment as follows:

  • Switching from Eliquis to another blood-thinning medicine 
    Stop taking Eliquis. Start treatment with another blood-thinning medicine (such as heparin ) at the time you should have taken the next tablet.
  • Switching from another blood-thinning medicine to EliquisStop taking other blood-thinning medications. Start treatment with Eliquis at the time you should have received the next dose of blood thinner, then continue as instructed.
  • Switching from blood-thinning treatment containing vitamin K antagonist (eg warfarin ) to EliquisStop taking the medicine that contains the vitamin K antagonist. Your doctor will need to take blood samples and inform you when to start taking Eliquis.
  • Switching from Eliquis to blood thinners containing vitamin K antagonist (eg warfarin )If your doctor tells you to start taking the medicine that contains a vitamin K antagonist, you should continue to take Eliquis for at least 2 days after your first dose of the medicine that contains a vitamin K antagonist. Your doctor will need to take blood samples and inform you when to stop taking Eliquis.

Patients undergoing conversion

If your irregular heartbeat needs to be restored to a normal rhythm through a procedure called conversion, you should take this medicine at the times your doctor tells you to prevent blood clots in the blood vessels of the brain and other blood vessels in your body.

If you take more Eliquis than you should

Tell your doctor immediately if you have taken more of this medicine than the prescribed dose. Take the medicine pack with you, even if the tablets are out of stock.

If you take more Eliquis than recommended, you may be at increased risk of bleeding. If bleeding occurs, surgery, blood transfusions, or other treatment that may reverse anti-factor Xa activity may be required.

If you forget to take Eliquis

  • Take a dose as soon as you remember and:
    • take the next dose of Eliquis at the usual time
    • then continue as usual.

If you do not know what to do or if you have missed more than one dose, ask your doctor, pharmacist, or nurse.

If you stop taking Eliquis

Do not stop taking this medicine without talking to your doctor first. The risk of blood clots can increase if you stop treatment too soon.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Eliquis can be given in three different medical conditions. The known side effects, and the frequencies at which they occur, in these medical conditions, may vary and are listed separately below. In these conditions, the most common side effect of this drug is bleeding, which can be life-threatening and require immediate medical attention.

The following side effects are known during treatment with Eliquis to prevent the formation of blood clots after knee or hip surgery.

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

  • Anemia, which may cause fatigue or paleness.
  • Bleeding, including:
    • bruising and swelling
  • Nausea

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

  • Reduced platelet count (may affect blood clotting ability)
  • Bleeding:
    • occurring after the surgery, including bruising and swelling, blood or leaking fluid from surgical wound/incision (wound fluid) or injection site
    • in the stomach, intestines, or light / red blood in the stool
    • blood in the urine
    • from the nose
    • from the vagina
  • Low blood pressure can cause fainting or palpitations
  • Blood tests may show:
    • abnormal liver function
    • elevated levels of certain liver enzymes
    • increased bilirubin, a breakdown product of red blood cells that can cause yellowing of the skin and eyes.
  • Itching

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

  • Allergic reactions (hypersensitivity) may cause swelling of the face, lips, mouth, tongue, and/or throat as well as difficulty breathing. Contact your doctor immediately if you get any of these symptoms.
  • Bleeding:
    • in a muscle
    • in the eyes
    • from the gums, as well as blood in the saliva when coughing
    • from the rectum
  • Hair loss

No known frequency (frequency can not be calculated from available data)

  • Bleeding:
    • in the brain or the spine,
    • in the lungs or throat
    • in the mouth
    • in the abdomen or space behind the abdominal cavity
    • from a hemorrhoid
    • blood in the stool or urine detected during laboratory tests
  • Rash

The following side effects are known during treatment with Eliquis to prevent the formation of blood clots in the heart in patients with an irregular heartbeat and at least one additional risk factor.

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

  • Bleeding, including:
    • in the eyes
    • in the stomach or intestine
    • from the rectum
    • blood in the urine
    • from the nose
    • from the gums
    • bruising and swelling
  • Anemia, which may cause fatigue or paleness
  • Low blood pressure can cause fainting or palpitations
  • Nausea
  • Blood tests may show:
    • elevated gamma gamma-glutamyltransferase)

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

  • Bleeding:
    • in the brain or spine
    • in the mouth or blood in the saliva when coughing
    • in the stomach or from the vagina
    • light / red blood in the stool
    • bleeding that occurs after surgery, including bruising and swelling, blood or leaking fluid from the surgical wound/incision (wound fluid) or injection site
    • from a hemorrhoid
    • blood in the stool or the urine detected during laboratory tests
  • Reduced platelet count (may affect blood clotting ability)
  • Blood tests may show:
    • abnormal liver function
    • elevated levels of certain liver enzymes
    • increased bilirubin, a breakdown product of red blood cells that can cause yellowing of the skin and eyes
  • Rash
  • Itching
  • Hair loss
  • Allergic reactions (hypersensitivity) may cause swelling of the face, lips, mouth, tongue, and/or throat as well as difficulty breathing. Contact your doctor immediately if you get 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

The following side effects are known during treatment with Eliquis to treat or prevent the recurrence of blood clots in the veins of the legs and blood clots in the blood vessels in the lungs.

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

  • Bleeding, including:
    • from the nose
    • from the gums
    • blood in the urine
    • bruising and swelling
    • in the stomach, intestines, from the rectum
    • in the mouth
    • from the vagina
  • Anemia, which may cause fatigue or paleness
  • Reduced platelet count (may affect blood clotting ability)
  • Nausea
  • Rash
  • Blood tests may show:
    • elevated gamma-glutamyl transferase (GGT) or alanine aminotransferase ( ALT )

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

  • Low blood pressure can cause fainting or palpitations
  • Bleeding:
    • in the eyes
    • in the mouth or blood in the saliva when coughing
    • light / red blood in the stool
    • blood in the stool or the urine detected during laboratory tests
    • bleeding that occurs after surgery, including bruising and swelling, blood or leaking fluid from the surgical wound/incision (wound fluid) or injection site
    • from a hemorrhoid
    • in a muscle
  • Itching
  • Hair loss
  • Allergic reactions (hypersensitivity) may cause swelling of the face, lips, mouth, tongue, and/or throat as well as difficulty breathing. Contact your doctor immediately if you get any of these symptoms.
  • Blood tests may show:
    • abnormal liver function
    • elevated levels of certain liver enzymes
    • increased bilirubin, a breakdown product of red blood cells that can cause yellowing of the skin and eyes.

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

  • Bleeding:
    • in the brain or the spine
    • in the lungs

No known frequency (frequency can not be calculated from available data)

  • Bleeding:
    • in the abdomen or space behind the abdominal cavity

5. How to store Eliquis

Keep out of 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 expiration date is the last day of the specified month.

This medicine has no special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is apixaban. Each tablet contains 2.5 mg of apixaban.
  • Other ingredients are:
    • Tablet core: lactose (see section 2 “Eliquis contains lactose (a sugar) and sodium”), microcrystalline cellulose, croscarmellose sodium (see section 2 “Eliquis contains lactose (a sugar) and sodium”), sodium lauryl sulphate, magnesium stearate (E470b).
    • Film coating: lactose monohydrate (see section 2 “Eliquis contains lactose (a sugar) and sodium”), hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

The film-coated tablets are yellow, round (5.95 mm in diameter), and marked with “893” on one side and “2½” on the other side.

  • They come in blisters in cartons of 10, 20, 60, 168, and 200 film-coated tablets.
  • Single-dose blisters in cartons of 60×1 and 100×1 film-coated tablets for hospital use are also available.

Not all pack sizes may be marketed.

Patient card: instructions for handling

The package with Eliquis contains a patient card together with the package leaflet, or your doctor may give you a similar card.

This patient information card may be helpful for you and inform other physicians that you are taking Eliquis. You should always have this card with you.

  1. Take the card
  2. Tear off the part with your tongue (this is facilitated by the perforated edges)
  3. Fill in the following information or ask your doctor to do so:
    • Name:
    • Date of birth:
    • Indication:
    • Dose: …….. mg twice daily
    • Doctor’s name:
    • Doctor’s phone number:
  4. Fold the card and always have it with you

Marketing Authorization Holder

Bristol-Myers Squibb / Pfizer EEIG

Plaza 254 
Blanchardstown Corporate Park 2 
Dublin 15, D15 T867

Ireland

Manufacturer

CATALENT ANAGNI SRL

Loc. Fontana del Ceraso snc

Strada Provinciale Casilina, 41

03012 Anagni (FR)

Italy

Pfizer Manufacturing Deutschland GmbH

Company Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

Swords Laboratories T / A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing 
Plaza 254 
Blanchardstown Corporate Park 2 
Dublin 15, D15 T867

Ireland

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Muhammad Nadeem

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