Eliquis includes the active substance apixaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots to form by blocking Factor Xa which is a vital element in the formation of blood clotting.

Eliquis is used by adults:

to stop a blood clot from forming in the heart in patients with an irregular heart beat (atrial fibrillation) and at least one other risk cause. The blood clots can break and travel into the brain, which can lead to a stroke or other organs, and hinder normal blood flow to that organ (also called an embolism systemic). A stroke could be life-threatening and requires immediate medical intervention.
in order to eliminate blood clots in leg veins (deep vein thrombosis) and in the blood vessels in your lungs (pulmonary embolism) and to keep blood clots recurring in the blood vessels in your lungs or legs.

you are allergic to apixaban or any other ingredient in this medicine (listed under section 6);
you’re bleeding excessively;
there is a problem in one of your organs that could increase your possibility of bleeding that is serious (such as an active or recent ulcer in your stomach or bowel, recent bleeding from the brain);
you have a liver disease that can increase the risk of bleeding (hepatic coagulopathy);
you’re taking medications to reduce the risk of bleeding (e.g. warfarin, dabigatran, rivaroxaban, or heparin), except when you change your anticoagulant medication, having a venous or arterial line and receiving the drug heparin in order to maintain its open or when a tube is introduced into your blood vessels (catheter ablation) to treat irregular heartbeats (arrhythmia).

Consult your physician, pharmacist or nurse before you start taking this medication If you suffer from one of the following conditions:

an higher risk of bleeding for example:
bleeding disorders, which include conditions resulting in reduced platelet activity;
very high blood pressure, not managed by medical treatments;
you are older than 75 years of age;
you weigh 60kg or less.
a severe kidney disease or the dialysis program;
A liver problem or an underlying history of liver issues;
This medicine will be used with caution in patients suffering from indications of an altered liver function.
If you’ve got an artificial heart valve
If your doctor decides it is likely that the pressure in your blood is instabil or another treatment or surgical procedure to remove the blood clots from your lungs is scheduled.

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Make sure you take special care of Eliquis

If you are aware that you suffer from a disease known as antiphospholipid syndrome (a disease caused by the immune system and can cause an increased risk of blood clots), tell your doctor who will determine if your treatment needs to be modified.

If you’re required to undergo surgery or undergo a procedure that may cause bleeding, your doctor may ask you to discontinue taking this medication for a short while. If you are not sure whether the procedure you are having may cause bleeding , ask your doctor.

This medicine is not recommended for use in adolescents or children who are less than 18 years old.

Tell your doctor, pharmacist or nurse if taking, recently took or are likely to take any other medication.

Certain medicines can increase the effects of Eliquis and some may decrease its effects. Your doctor will determine whether you need to be treated by Eliquis while taking these medications and how closely you need to be monitored.

Certain medications can increase your effects from Eliquis or increase your chance of bleeding that is not desired:

Some medicines are used to treat fungal diseases (e.g., ketoconazole, etc. );
Some antiviral treatments are used to treat HIV or AIDS (e.g. Ritonavir, for instance);
other medications that are used to reduce the risk of blood clotting (e.g. the enoxaparin drug, etc. );
anti-inflammatory or pain medicines (e.g., acetylsalicylic acid as well as naproxen). Particularly, if you’re older than 75 and you take acetylsalicylic Acid, you may have an increased risk of bleeding;
Medicines for high blood pressure or heart issues (e.g. diazem, diltiazem);
antidepressant medications called selective serotonin receptor inhibitors or serotonin norepinephrine reuptake inhibitors.

The following medications may decrease the ability of Eliquis to stop blood clots form:

drugs to stop epilepsy and seizures (e.g. Phenytoin, etc. );
St John’s Wort (a herbal supplement that is used to treat depression);
medicines to treat tuberculosis or other infections (e.g. such as rifampicin).

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

The effects of Eliquis on the pregnancy as well as the unborn baby are not well-studied. It is not recommended to take this medication if you are expecting a baby. Contact your doctor immediately if you fall pregnant while taking this medicine.

It’s not clear it is not known if Eliquis is absorbed into humans’ breastmilk. Contact your physician, pharmacist or nurse for advice prior to taking this medicine while breast-feeding. They can advise you on whether to stop breastfeeding or to stop or not start taking this medication.

Eliquis hasn’t been proven that it can affect your ability drive or use machines.

If you’ve been advised by your doctor that you have an intolerance to some sugars, contact your doctor prior to taking this medicine.

The medicine is less than 1 mmol sodium (23 mg) per tablet. That is , in essence “sodium-free”.

Make sure to take the medicine exactly as your doctor or pharmacist has advised you to. Talk to your doctor or pharmacist If you’re unsure.

Drink the tablet in a drink of water. Eliquis can be taken with or without food.

Take the tablet at similar times throughout the day to ensure the best effect.

If you are having difficulty swallowing the tablet completely consult your physician about alternatives to taking Eliquis. The tablet may be crushed and mixed with water, or 5 percent sugar in water the apple juice and apple purée prior to taking it.

Crush the tablets with a pestle and mortar.
Transfer all the powder carefully into a container suitable for the task, and mix it with a little e.g., 30 mL (2 tablespoons) or water, or any of the other liquids discussed in the previous paragraphs to create a mixture.
Suck the mixture in.
Rinse the mortar and the pestle that you used to crush tablets and containers and the container, using a bit of water or any of the other liquids (e.g., 30 milliliters) and then drink the rinse.

If necessary, your doctor can also give you crushing Eliquis tablet mixed in 60 milliliters of liquid or 5 percent glucose in water through a Nasogastric tube.

To prevent the formation of a blood clot in the heart in patients with an irregular heart beat with at minimum one other risk factor.

The recommended dosage includes one tablet Eliquis 5 mg twice each day.

The recommended dose for a tablet is Eliquis 2.5 mg twice every day if:

If you suffer from severely impaired kidney function.
Two or more apply to you:
the results of your blood tests indicate low kidney function (value for serum creatinine 1.5 mg/dL (133 micromole/L) or higher);
you are 80 years old or older;
your weight is 60 kg or less.

The recommended dosage is one tablet twice a day, for instance taking one in the early morning and the other in the evening.

The doctor will decide on the length of time you have to continue treatment for.

For treating blood clots in the veins of your legs as well as blood clots in the blood vessels in your lungs.

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

After 7 days, the suggested dosage should be one tablet Eliquis 5 mg twice a day, for example, first thing in the morning and one at night.

For preventing blood clots from re-occurring following completion of 6 months of treatment

The recommended dosage for adults is one tablet Eliquis 2.5 mg once a day for example one in the morning and another in evening.

Your doctor will determine what length of time you will need to stay in treatment for.

Your physician may modify the anticoagulant medication as follows:

Changing from Eliquis to anticoagulant medicines

Stop taking Eliquis. Start treatment with the anticoagulant medication (for example heparin) at the time you took the next tablet.

Moving from anticoagulant drugs to Eliquis

Stop taking anticoagulant medications. Start treatment with Eliquis when you will have the subsequent dose of the anticoagulant medication, then continue as normal.

Moving from anticoagulant treatment containing Vitamin K antagonist (e.g., warfarin) to Eliquis

Stop taking the medicine that contains vitamin K antagonist. Your doctor should take blood tests and inform you of the best time to begin taking Eliquis.

Switching from Eliquis to anticoagulant treatments that contain vitamin K antagonist (e.g. warfarin, for instance).

If your doctor advises that you must begin taking the medication that contains Vitamin K antagonists, continue to take Eliquis for at least 2 days after your first dose with an antagonist to vitamin K. Your doctor will need to take blood tests and tell you when to stop taking Eliquis.

If your heartbeat is irregular and needs to be brought back to normal, using a process called cardioversion, take this medication at the time your doctor tells you for preventing blood clots within blood vessels in your brain and in other blood vessels throughout your body.

Inform your doctor right away if you have taken more than prescribed dose of Eliquis. Take the medicine pack with you, even if there are no tablets left.

If you are taking more Eliquis than recommended then you could be at risk of an greater risk of bleeding. If bleeding occurs after surgery, blood transfusions or other treatments that alter the anti-factor Xa effect could be required.

You should take the dose as quickly as you remember, and:
The subsequent doses of Eliquis at the normal time;
then continue as normal.

If you’re unsure what to do or not taken your medication for more than a week, talk to your pharmacist, doctor, or nurse.

Do not discontinue taking this medication without speaking to your doctor first, because the risk of creating a blood clot can be higher when you stop treatment too quickly.

If you have further questions regarding the use of this medication, talk to your pharmacist, doctor or nurse.

Like all medications that are prescribed, this one can trigger side effects, although not everybody gets them. The most common general side effect of this medicine is bleeding which may be life-threatening and requires immediate medical attention.

The following adverse effects are known if you are taking Eliquis to prevent the formation of blood clots in the heart of patients with irregular heart beats or at the very least an other risk factors.

Common adverse side effects (may be affecting up to one per 10 persons)

Bleeding, which includes:
with your eyes.
In your stomach, bowel or;
from your rectum;
blood in the urine
off your nose
Remove your gums
Ailment and swelling,
Anaemia which may cause tiredness or paleness
A low blood pressure can make you feel fainter or have a faster heartbeat
Nausea (feeling sick);
Tests of blood may reveal:
an increase in gamma-glutamyltransferase (GGT).

Common adverse reactions (may affect as many as 1 in 100 people)

Bleeding:
within your brain or the spinal column of your brain;
Your mouth is full of blood or in your spit when coughing;
into your abdomen, or from your vagina;
Bright/red blood in the stool;
bleeding that occurs after the operation such as swelling and bruising, liquid or blood leaking out of the surgical incision (wound drainage) or injection site
from a haemorrhoid;
tests that reveal blood in the urine or in the stools;
A lower number of platelets that are present in your blood (which can affect clotting);
Tests of blood may reveal:
Affected liver function
An increase in some liver enzymes.
an increase in bilirubin, a breakdown product of red blood cells. This can cause yellowing of the skin and eyes.
Itchy skin;
Itching;
Hair loss;
Allergy reactions (hypersensitivity) that may result in swelling of the lips, face, mouth, tongue and/or throat, and breathing difficulties. See your physician right away whenever you notice some of these signs.

Rare side effects (may be affecting up to one of 1,000)

Bleeding:
within your lungs or throat;
into the space behind your abdominal cavity;
into a muscle.

Very rare adverse negative effects (may affect up to 1 of 10,000 people)

The skin rash can develop blisters , and appears like small target (central dark spots, surrounded by a pale area with a dark ring around the edge) (erythema multiforme).

Unknown (frequency can’t be determined using the data available)

Inflammation of blood vessels (vasculitis) that can cause skin rash, pointed, flat, red, round spots under the skin’s surface. It can also cause the appearance of bruising.

The adverse reactions listed below are common when you take Eliquis to combat or stop the re-occurrence of blood clots within the veins of your legs and blood clots in the blood vessels of your lungs.

Common adverse reactions (may cause up to 1 of 10 people)

Bleeding can include:
away from your nose
from your gums;
blood in the urine;
bruising and swelling;
inside your stomach, from your bowels, and your rectum
in your mouth;
via the vagina
Anaemia which may cause tiredness or paleness;
Reduced number of platelets that are present in your blood (which could affect the clotting process);
Nausea (feeling sick);
The rash on the skin;
Blood tests can reveal:
an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).

Uncommon adverse effects (may affect up to 1 in 100 individuals)

A low blood pressure can cause you to feel faint or experience a rapid heartbeat;
Bleeding:
with your eyes.
in your mouth or from your spit when you cough;
red blood that appears in the stool;
tests that detect blood in stools or in the urine;
bleeding that occurs after any surgery including swelling and bruising bleeding of liquid or blood from the surgical wound/incision (wound discharge) or injection site;
from a haemorrhoid;
into a muscle;
Itching;
Hair loss;
Allergic reactions (hypersensitivity) which may cause: swelling of the face, lips mouth, tongue, throat, as well as difficulty breathing. See your doctor right away if you have any of the following symptoms.
Blood tests can reveal:
Affected liver function
An increase in some liver enzymes.
the increase in bilirubin the breakdown product of red blood cells, which causes yellowing of the eyes and skin.

Rare side effects (may be the cause of up to one out of 1,000)

Bleeding:

in your brain or in your spinal column;
in your lungs.

Not yet known (frequency can’t be determined using the data available)

Bleeding:
into your abdomen or the abdomen cavity.
Skin rash that may develop blisters that look like small targets (central dark spots that are surrounded by an area that is lighter, and a darker ring at the edges) (erythema multiforme);
Blood vessel inflammation (vasculitis) that can cause skin rashes, or pointed red, flat round spots under the skin’s surface. Also, it can cause bruises.

If you suffer from any side consequences, you should consult your doctor, pharmacist, or nurse. This includes any possible adverse effects that are not mentioned in this document. You can also report side reactions directly (see further details below). By reporting side effects you can assist in providing more information on the safety of this drug.

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or go to MHRA Yellow Card or search for MHRA Yellow Card in Google Play or Apple App Store. Google Play or Apple App Store

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed in the carton as well as on the blister after expiration. The expiry date refers to the day that is the end of that month.

This medication does not need any special storage conditions.

Do not dispose of medicine in household waste. Ask your pharmacist for instructions on how to dispose of medications that you no longer require. These measures will help in protecting the environment.

The active substance is APIXBAN. Each tablet includes 5 mg of apixaban.
Other ingredients include:
Tablet core: lactose (see the section 2 “Eliquis includes lactose (a type of sugar) and sodium”) microcrystalline cellulose and the sodium croscarmellose (see the section 2 “Eliquis contains lactose (a kind of sugar) and sodium”) as well as sodium laurilsulfate; magnesium stearate (E470b);
Film coat Film coat: lactose monohydrate (see section 2 “Eliquis includes lactose (a kind of sugar) and sodium”) as well as hyporomellose (E464), titanium dioxide (E171) triacetin the red oxide of iron (E172).

The film coated tablets are pink, oval (9.73 mm 5.16 mm) 5.16 mm) and are marked with “894” on one side along with “5” in the opposite side.

They are available in blisters cartons of 14, 20 28 56 60, 168, and 200 film-coated tablets.
Unit dose blisters in cartons of 100×1 film-coated tablets that can be delivered to hospitals are also on offer.

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