Eliquis contains the active substance Apixaban, which is a member of a class of medicines known as anticoagulants. This medication helps prevent blood clots from forming by blocking Factor Xa which is an essential element in the formation of blood clotting.
Eliquis is used by adults:
to stop the formation of a blood clot within the heart of those who have an irregular heartbeat (atrial fibrillation) and at least one additional risk factor. Blood clots could break and spread into the brain, which can lead to a stroke or to other organs and disrupt normal blood flow to that organ (also called embolisms in the system). A stroke can be life-threatening and requires urgent medical attention.
treatment of blood clots that have formed in blood vessels in your legs (deep vein thrombosis) and also in the blood vessels of your lung (pulmonary embolism) and to keep blood clots from occurring again in the blood vessels in your legs and/or lungs.
If you have an allergy to apixaban or any other ingredients of this medicine (listed in the section 6.);
you’re bleeding excessively;
there is a problem in an organ of your body that increases the risk of serious bleeding (such as an active or recent ulcer in your stomach or bowel, recent bleeding in your brain);
you have a liver disease that increases the likelihood for bleeding (hepatic coagulopathy);
You are taking medications to prevent blood clotting (e.g. warfarin, dabigatran, dabigatran, or rivaroxaban) in addition to you change your anticoagulant medication, having a arterial or venous line, and you are given the drug heparin in order to maintain its open or when a tube is placed into your blood vessels (catheter ablation) to treat an irregular heartbeat (arrhythmia).
Speak to your doctor, pharmacist or nurse before you begin taking this medicine if you have any of the following:
An increased risk of bleeding, including:
bleeding disorders, such as those that cause a decrease in platelet activity;
extremely high blood pressure not managed by medical treatments;
You are older than 75 years;
you weigh 60kg or less;
A severe kidney condition or if you are on dialysis;
A liver problem or an underlying history of liver issues;
This medicine will be used cautiously in patients who show evidence of impaired liver function.
If you have prosthetic heart valves;
If your doctor decides it is likely that the pressure in your blood is unstable or any other treatment or surgical procedure to eliminate the blood clots from your lungs is scheduled.
Care is needed with Eliquis
If you suspect that you suffer from a condition known as antiphospholipid syndrome (a disease caused by the immune system and results in an increased risk of blood clots) inform your doctor who will then decide if the treatment is required to be changed.
If you have to undergo surgery or a procedure which could result in bleeding, your physician might suggest that you temporarily stop taking this medicine for a short time. If you’re unsure that a procedure can cause bleeding , ask your doctor.
This medication is not recommended for children or adolescents younger than 18 years old.
Talk to your pharmacist, doctor or nurse if you’re taking, or have recently taken or could be taking any other medicines.
Certain medicines can enhance the effects of Eliquis and some could decrease the effects of Eliquis. Your doctor will determine whether you need to be treated by Eliquis when you are taking these medications and how closely you should be monitored.
The following medicines may increase your effects from Eliquis as well as increase the chance of bleeding that is not desired:
certain medicines to treat fungal infections (e.g., ketoconazole, etc. );
Certain antiviral medications for HIV / AIDS (e.g., ritonavir);
other medicines that are used to decrease blood clotting (e.g., enoxaparin, etc. );
anti-inflammatory and pain medication (e.g. acetylsalicylic acids and naproxen). Particularly, if over 75 years old and are taking acetylsalicylic acid which is a painkiller, you could have an increased chance of bleeding
medications for high blood pressure or heart issues (e.g. Diltiazem, for example);
antidepressant medicines called selective serotonin receptor inhibitors or serotonin norepinephrine re-uptake inhibitors.
The following drugs may hinder the ability of Eliquis to prevent blood clots from developing:
medicines to prevent epilepsy or seizures (e.g. the phenytoin or phenytoin etc. );
St John’s Wort (a herbal supplement to treat depression);
medications to treat tuberculosis or other infections (e.g. Rifampicin, for example).
If you are pregnant or breast-feeding, think you might be pregnant or plan to have the baby, speak to your doctor, pharmacist or nurse for advice prior to taking this medicine.
Effects of Eliquis on pregnancy and the unborn child aren’t well-studied. It is not recommended to take this medicine if expecting a baby. Consult your physician immediately if you fall pregnant while you are taking the medicine.
It is unclear it is not known if Eliquis can be found in the breast milk that humans drink. Contact your physician, pharmacist or nurse for guidance before breastfeeding while taking this medication. They will advise you whether or not to stop breastfeeding or to stop using this medicine.
Eliquis has not been proven that it can affect your ability operate machines or drive.
If you have been told by your doctor that are allergic to certain sugars, contact your doctor before you start taking this medicine.
This medication contains less than 1 mg sodium (23 mg) per tablet, that is , in essence “sodium-free”.
Take this medication exactly as your doctor or pharmacist has told you to. Check with your doctor, pharmacist or nurse in case you’re not sure.
Swallow the tablet with a drink of water. Eliquis can be taken either with or without food.
Make sure to take the pills at regular time every day to have the greatest effect.
If you are having difficulty swallowing the tablet Talk to your physician about other ways to take Eliquis. The tablet can be crushed and mixed with water or 5 percent glucose in water, or Apple juice, or puree of apples immediately before you take it.
Make the tablets crushable using the help of a mortar and pestle.
Put all the powder into a container suitable for the task, and mix the powder using just a bit, e.g., 30 mL (2 tablespoons) water or one of the other liquids listed in the previous paragraphs to create a mixture.
Take a sip of the mix.
Rinse the pestle and mortar that you used to crush the tablet as well as the container, with a little water or one of the other liquids (e.g., 30 mL) and swallow the rinse.
If required, your doctor may also give you your crushed Eliquis tablet mixed with 60 mL of water or 5 percent glucose in water, through a nasogastric tube.
To prevent a blood clot from forming in the heart of those who have an irregular heartbeat as well as at least one other risk element.
The recommended dose for adults is one tablet Eliquis 5 mg two times each day.
The recommended dosage is one tablet of Eliquis 2.5 mg once per day if you:
You have a severely degraded kidney function;
Two or more apply to you:
the results of your blood tests indicate poor kidney function (value in serum creatinine 1.5 mg/dL (133 micromole/L) or more);
If you’re aged 80 or older;
Your weight must be 60 kilograms or lower.
For details on the Eliquis assistance program visit this website.
The recommended dose is two tablets twice per day, for example, one in the morning and another in the evening.
Your doctor will decide how long you must continue treatment for.
For treating blood clots in the veins of your legs and blood clots inside the blood vessels of your lungs
The recommended dosage should be two pills of Eliquis 5 mg two times a each day for the first 7 days, such as two in the early morning and two in the evening.
After 7 days, the recommended dosage will be one tablet Eliquis 5 mg two times a day, for example, at the beginning of the day, and one at night.
To prevent blood clots from repeating after completion of six months of treatment
The recommended dose is one tablet of Eliquis 2.5 mg twice per day, for instance one tablet in the morning and another in evening.
Your doctor will decide how long you must continue treatment for.
Your doctor might change the anticoagulant medication as follows:
Switching From Eliquis to anticoagulant medicines
Stop taking Eliquis. Get started with anticoagulant medications (for example heparin) at the time you would have taken the next tablet.
It is time to switch from anticoagulant medication to Eliquis
Stop taking the anticoagulant medicine. Start treatment with Eliquis at the same time you will have the following dose of anticoagulant medication. Continue as usual.
Switching treatment from anticoagulant 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 advise you on when to begin taking Eliquis.
Moving from Eliquis to anticoagulant treatments that contain vitamin K antagonist (e.g. warfarin, for instance).
If your doctor informs you that you must begin taking the medication containing Vitamin K antagonists keep taking Eliquis for at least two days following your first dose that contains an antagonist to vitamin K. Your doctor needs to do blood-measurements and instruct you when you can stop taking Eliquis.
If your heartbeat is irregular and needs to be brought back to normal by a procedure known as cardioversion, you should take this medicine at the times your physician advises you to that you should, in order to avoid blood clots from blood vessels in your brain and in other blood vessels throughout your body.
Tell your doctor immediately if you have taken more than the prescribed dosage of Eliquis. Take the medicine pack with you even if no tablets remaining.
If you take more Eliquis than is recommended then you could be at risk of an greater chance of bleeding. If bleeding occurs due to surgery, blood transfusions or other treatments to cause the reverse of anti-factor Xa activity might be necessary.
Take the dose as when you remember it and:
You should take your subsequent doses of Eliquis at the normal time;
then continue as normal.
If you’re not sure what to do, or missed more than one dose, ask your pharmacist, doctor, or nurse.
Don’t stop taking this medication without talking to your doctor first, due to the possibility of developing a blood clot might be higher in the event that you stop treatment too early.
If you have any additional questions about the usage of this medication, speak to your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although there are a few who suffer from them. The most common general adverse effect that this medication can cause is bleeding that could be potentially life threatening and require immediate medical attention.
The following side consequences are possible if are taking Eliquis to prevent the formation of blood clots in the heart in people with irregular heart beats and at least one other risk factors.
Common adverse side effects (may cause up to 1 per 10 persons)
Bleeding includes:
in your eyes;
In your stomach or bowel;
from your rectum;
blood in the urine;
from your nose;
away from your gums
Ailment and swelling,
Anaemia can cause tiredness or paleness;
Low blood pressure which may make you feel fainter or have a quickened heartbeat;
Nausea (feeling sick);
Blood tests may show:
an increase in gamma-glutamyltransferase (GGT).
Uncommon adverse effects (may affect up to 1 100 individuals)
Bleeding:
in your brain or your spinal column;
Your mouth is full of blood or in your spit when you cough;
through your abdomen, or from your vagina;
Blood that is bright and red in the stool;
bleeding occurring after your operation including bruising and swelling, liquid or blood leaking from the incision (wound drainage) (or injection area)
from a haemorrhoid
tests that reveal blood in the stool or urine;
The number of platelets is reduced in your blood (which can affect clotting);
The results of blood tests could reveal:
abnormal liver function;
an increase in some liver enzymes.
An increase in bilirubin a breakdown product of red blood cells. It can cause yellowing of the skin and eyes.
Skin rash;
Itching;
Hair loss;
The allergic reaction (hypersensitivity) that may result in: swelling of the face, lips, mouth, tongue and/or throat and difficulty breathing. Contact your doctor immediately when you notice some of these signs.
Rare side effects (may be affecting up to one out of 1,000)
Bleeding:
in your lungs or your throat;
into the abdominal cavity;
into a muscle.
Rare adverse consequences (may cause up to 1 in 10,000)
Skin rash that can form tiny blisters. It appears as if it’s areas of targets (central dark spots that are enclosed by a lighter area with a dark ring around the edge) (erythema multiforme).
Unknown (frequency cannot be estimated using the data available)
Inflammation of blood vessels (vasculitis) which can cause skin rash, flat, pointed and round, red spots on the skin’s surface. It can also cause bleeding.
The the following side effects can be observed in the event that you use Eliquis to combat or stop the re-occurrence of blood clots in the veins of your legs as well as blood clots in the blood vessels of your lungs.
Common side effects (may affect as many as 1 out of 10 individuals)
Bleeding, which includes:
from your nose;
Remove your gums
urine with blood;
bruising and swelling;
in your stomach, your bowel, and from your rectum
in your mouth;
from the vagina;
Anaemia can cause fatigue or pallor.
A lower number of platelets in your blood (which can affect clotting);
Nausea (feeling sick);
Itchy skin;
Blood tests may show:
an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).
Uncommon side effects (may be affecting up to one 100 individuals)
Low blood pressure , which can make you feel faint or experience a faster heartbeat;
Bleeding:
with your eyes.
in your mouth or from your spit when you cough;
bright/red blood in the stools;
tests showing blood in the stool or urine
bleeding that happens after an operation such as swelling and bruising, liquid or blood leaks from the surgical wound/incision (wound secretion) (or injection location);
from a haemorrhoid;
into a muscle;
Itching;
Hair loss;
The allergic reaction (hypersensitivity) that could cause swelling of the face, lips or tongue. It can also cause swelling of the mouth, throat and difficulty breathing. See your doctor right away if you have any of the following symptoms;
The results of blood tests could reveal:
an abnormally low level of liver function
An increase in some liver enzymes.
the increase in bilirubin the breakdown product of red blood cells, which may cause yellowing of the eye and skin.
Rare side effects (may be the cause of up to one out of 1,000)
Bleeding:
inside your brain, or in your spinal column;
in your lungs.
It is not known (frequency cannot be estimated using the data available)
Bleeding:
through your abdomen or into the abdomen cavity.
Skin rash that can form blisters , and appears like small targets (central dark spots that are surrounded by an area that is lighter, and a an elongated dark band around the edge) (erythema multiforme);
Blood vessel inflammation (vasculitis) which may cause skin rashes or pointed flat, red round spots that appear under the skin’s surface. Also, it can cause the appearance of bruising.
If you get any side reactions, consult your pharmacist, doctor or nurse. This includes any possible negative side effects not covered in this informational leaflet. You can also report side adverse effects directly (see details below). By reporting side effects , you can provide more details on the safety and efficacy of this medication.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or you can search for MHRA Yellow Card in either the Google Play or Apple App Store
Keep this medication away from the out of the reach of children.
Don’t use this medication beyond the expiry time which is printed on the carton and also on the blister after expiration. The expiry date is the day that is the end of that month.
This medication does not need any particular storage conditions.
Do not throw away any medicines in your household waste. Ask your pharmacist for instructions on how to dispose of medications that you do not use anymore. This will help to in protecting the environment.
The active ingredient is called apixaban. Each tablet contains 5 mg of apixaban.
The other ingredients are:
Tablet main ingredient Lactose (see section 2 “Eliquis has lactose (a kind of sugar) and sodium”) Microcrystalline cellulose, Croscarmellose sodium (see section 2 “Eliquis contains lactose (a kind of sugar) and sodium”), sodium laurilsulfate and magnesium stearate (E470b);
Film coat Lactose monohydrate (see section 2 “Eliquis is a mixture of lactose (a kind of sugar) and sodium”) and the hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
The tablet coated in film is pink oval (9.73 millimeters) in size) and rectangular (9.5 x 5.16 mm) and are branded using “894” on one side along with “5” on the opposite side.
They are packaged in 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.