Eliquis contains the active substance known as apixaban. It belongs to a class of drugs known as anticoagulants. This medicine helps to prevent blood clots to form by blocking the formation of Factor Xa which is a vital part of the blood clotting process.
Eliquis is used in adults:
to stop to prevent the formation of blood clots in the heart of people with irregular heartbeats (atrial fibrillation) and at least one other risk cause. Blood clots may break off and travel into the brain, which can lead to a stroke or to other organs and hinder regular blood flow to this organ (also known as embolisms in the system). A stroke can be life-threatening and require immediate medical attention.
to treat blood clots in leg veins (deep vein thrombosis) and in blood vessels in your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in your lungs, legs, or.
you are allergic to apixaban or any of the other ingredients of this medicine (listed at section 6);
If you’re bleeding a lot,
there is a problem in an organ of your body that increases the likelihood of serious bleeding (such as active or recent ulcer in your stomach or your bowel, recent bleeding within the brain);
If you suffer from liver disease, that can increase the likelihood of bleeding (hepatic coagulopathy);
you’re taking medication to prevent the formation of blood clots (e.g. warfarin, dabigatran, dabigatran, or rivaroxaban) in addition to switching anticoagulant treatments, having a venous or arterial line, and you are given the drug heparin so that it remains open or if a tube is introduced into your blood vessel (catheter ablation) to treat irregular heartbeats (arrhythmia).
Speak to your doctor or pharmacist before you begin taking this medicine if you are suffering from one of the following conditions:
an increased risk of bleeding, like:
bleeding disorders, which include conditions that result in a reduction in platelet function;
very high blood pressure, not managed by medical treatments;
you are older than 75 years;
you weigh 60kg or less;
a serious kidney disease, or if you are on dialysis;
A liver issue or a history of liver problems;
This medicine will be used with caution for patients who have evidence of impaired liver function.
If you’ve got an artificial heart valve
If your doctor concludes the blood pressure is unstable or that a surgical procedure to remove the blood clot from your lungs is scheduled.
Care is needed with Eliquis
If you are aware you are suffering from a condition known as antiphospholipid disease (a disease in the immune system which leads to the risk of bleeding clots to increase) consult your physician who will determine if the treatment may need to be altered.
If you need to have surgery or a procedure which may cause bleeding, your doctor may ask you to discontinue taking this medication for a short while. If you’re not certain whether a procedure may cause bleeding , consult your physician.
This medicine should not be used for use in adolescents or children who are less than 18 years of age.
Talk to your pharmacist, doctor or nurse if you are taking, recently took or are likely to take any other medication.
Certain medications may enhance the effects of Eliquis and some may decrease its effects. Your physician will determine if you should be treated by Eliquis when you are taking these medications and how closely you need to be monitored.
Certain medications can increase effect of Eliquis or increase your risk for unwanted bleeding:
Certain medicines to treat fungal infections (e.g., ketoconazole, etc. );
Certain antiviral medications for HIV and AIDS (e.g. or ritonavir);
other drugs that are utilized to reduce bleeding (e.g. the enoxaparin drug, etc. );
anti-inflammatory or pain medications (e.g. Acetylsalicylic Acid or naproxen). Particularly, if you’re older than 75 years and you are taking acetylsalicylic acids or naproxen, you may be at an increased risk of bleeding
medicines for high blood pressure or heart issues (e.g. diazem, diltiazem);
antidepressants known as selective serotonin re-uptake inhibitors or serotonin norepinephrine reuptake inhibitors.
These medications could reduce the capacity of Eliquis to help prevent blood clots from occurring:
medicines to prevent epilepsy or seizures (e.g., phenytoin, etc. );
St John’s Wort (a herbal supplement that is used to treat depression);
drugs to treat tuberculosis and other diseases (e.g. Rifampicin, for example).
If you’re pregnant or breastfeeding, or suspect you may be pregnant or planning to have the baby, speak to your pharmacist, doctor or nurse for advice prior to taking this medication.
The effects of Eliquis on pregnancy and the unborn baby are not yet known. This medication if you are expecting a baby. Inform your doctor right away if you fall pregnant while taking this medicine.
It is unclear the possibility that Eliquis passes into humans’ breastmilk. Consult your physician, pharmacist or nurse for guidance prior to starting this medicine when you are breastfeeding. They can advise you on whether you should stop breastfeeding or to stop or not start taking this medicine.
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Eliquis has not been proven to impair your ability to use or drive machines.
If you have been told by your physician that you have an intolerance to certain sugars, consult your physician prior to taking this medication.
This medication contains less than 1 mmol sodium (23 mg) per tablet. That is to say essentially “sodium-free”.
Take this medication exactly as your doctor or pharmacist has instructed you. Consult your physician, pharmacist or nurse for clarification if you’re not certain.
Drink the tablet in an alcoholic drink. Eliquis can be taken with or without food.
Take your tablet at similar times every day to have the most effective treatment effects.
If you are having difficulty swallowing the tablet in its entirety discuss with your doctor about alternatives to taking Eliquis. Tablets can be crushed and then mixed with water, or 5 percent sugar in water apple juice or apple puree prior to taking it.
Smash the tablets using a pestle and mortar.
Make sure to transfer the powder into a suitable container then mix the powder in some e.g. 30 milliliters (2 tablespoons), water or any other liquids mentioned in the previous paragraphs to create a mixture.
Take a sip of the mix.
Clean the mortar and pestle that you used to crush the tablet and the container and the container, using a bit of water or one of the additional liquids (e.g. 30 milliliters) and swallow the rinse.
If needed, your doctor could also prescribe the crushed Eliquis tablet mixed in 60 mL of water or 5 percent glucose in water, using a Nasogastric tube.
To stop the formation of blood clots in the heart of those who have an irregular heartbeat as well as at least one other risk reason.
The recommended dose includes one tablet Eliquis 5 mg once per day.
The recommended dose includes one tablet Eliquis 2.5 mg twice a day if:
If you suffer from severely impaired kidney function.
Two (or more) of the following apply to you:
your blood test results suggest an insufficient kidney function (value of serum creatinine of 1.5 mg/dL (133 micromole/L) or greater);
you are 80 years old or older.
Your weight is 60kg or less.
The recommended dosage is two tablets twice per day, for instance taking one in the early morning and the other at night.
The doctor will decide on the length of time you have to continue treatment for.
To treat blood clots in the veins of your legs as well as blood clots in the blood vessels in your lungs.
The recommended dosage is two tablets of Eliquis 5 mg two times a day for the first 7 days. For example, two in the early morning and two at night.
After 7 days, the recommended dosage for a tablet is Eliquis 5 mg two times a day, for example, first thing in the morning, and one in the evening.
to prevent blood clots occurring again after six months of treatment
The recommended dosage for adults is one tablet Eliquis 2.5 mg twice per day, for instance one in the morning and another in evening.
Your doctor will decide the length of time you have to continue treatment for.
Your doctor might change your anticoagulant treatment in the following ways:
Changing to Eliquis to anticoagulant medication
Stop taking Eliquis. Get started with anticoagulant medications (for example , heparin) when you will have taken your next tablet.
It is time to switch from anticoagulant medication to Eliquis
Stop taking the anticoagulant medication. Begin treatment with Eliquis at the time you were scheduled to receive the subsequent dose of the anticoagulant medicine and continue with the treatment as usual.
Moving from anticoagulant treatment that contain Vitamin K antagonist (e.g. warfarin) to Eliquis
Stop taking the medicine which contains vitamin K antagonist. Your doctor should take blood tests and inform you of the best time you should begin taking Eliquis.
Switching from Eliquis to anticoagulant treatment containing vitamin K antagonist (e.g., warfarin).
If your doctor informs you that you need to begin taking the medication containing Vitamin K antagonists, continue to take Eliquis for a minimum of 2 days after your first dose of the medicine which contains a vitamin K antagonist. Your doctor will need to take blood-measurements and instruct you when you can stop taking Eliquis.
If you have a heartbeat that is abnormal and requires to be brought back to normal, using a process called cardioversion. Take this medication according to the schedule your physician advises you to for preventing blood clots from the blood vessels of your brain as well as other blood vessels in your body.
Contact your doctor immediately if you have taken more than prescribed dose of Eliquis. Bring the medication pack with you even if no tablets remaining.
If you take more Eliquis than the recommended amount it is possible that you will be at an greater risk of bleeding. If bleeding does occur due to surgery, blood transfusions or other treatments that may reverse anti-factor Xa activity may be required.
You should take the dose as when you remember it and:
Take the next dose of Eliquis at the usual time;
then continue as normal.
If you are not sure what to do or have skipped more than one dosage, consult your pharmacist, doctor, or nurse.
Do not stop taking this medicine without talking to your doctor first, because the risk of creating a blood clot can be higher in the event that you stop treatment too early.
If you have further concerns regarding the use of this medicine, ask your pharmacist, doctor or nurse.
As with all medicines, this medicine can cause side effects, although there are a few who suffer from them. The most frequent adverse effect that this medication can cause is bleeding, which could be potentially life threatening and need immediate medical attention.
The following adverse consequences are possible if use Eliquis to prevent the formation of a blood clot in the heart of patients with irregular heart beats or at the very least an additional risk factor.
Common side effects (may cause up to 1 per 10 persons)
Bleeding can include:
in your eyes.
In your stomach or bowel;
from your rectum
blood in the urine;
off your nose
away from your gums
Ailment and swelling,
Anaemia which may cause tiredness or pallor;
A low blood pressure can make you feel fainter or have a faster heartbeat
Nausea (feeling sick);
Blood tests may show:
an increase in gamma-glutamyltransferase (GGT).
Common adverse side effects (may cause up to 1 100 people)
Bleeding:
within your brain or your spinal column
in your mouth or in your spit when coughing;
to your abdomen, or from the vagina;
bright/red blood in the stools;
bleeding that happens after your surgery which may cause swelling and bruising liquid or blood leaking from the surgical wound/incision (wound discharge) or injection site
from a haemorrhoid;
tests that show blood in the stool or in urine;
A lower number of platelets in your blood (which can affect clotting);
Blood tests can reveal:
Affected liver function
an increase in certain liver enzymes.
An increase in bilirubin which is a product that breaks down red blood cells. It can cause yellowing of the eye and skin.
The rash on the skin;
Itching;
Hair loss;
Reactions to allergens (hypersensitivity) that could cause: swelling of the lips, face mouth, tongue, throat, as well as difficulty breathing. See your physician right away whenever you notice or experience any symptoms.
Rare side effects (may be the cause of up to 1 per 1,000)
Bleeding:
in your lungs or throat;
into the space behind your abdominal cavity;
into a muscle.
Rare adverse consequences (may be the cause of up to one in 10,000 people)
Skin rash that may develop blisters and looks like small areas of targets (central dark spots that are enclosed 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) which may cause skin rashes or pointed, flat or round, red areas on the skin’s surface. Also, it can cause bruises.
The the following side effects can be observed if you take Eliquis to help prevent or treat the recurrence of blood clots in the veins of your legs , as well as blood clots within the blood vessels in your lungs.
Common adverse reactions (may cause up to 1 in 10 people)
Bleeding includes:
by your nose;
Remove your gums
urine blood;
The swelling and bruising may be a problem;
inside your stomach, from your bowels, and your rectum
in your mouth.
Vaginal birth;
Anaemia that can cause fatigue or paleness
A lower number of platelets that are present in your blood (which could affect the clotting process);
Nausea (feeling sick);
Itchy skin;
Blood tests may show:
an increase in gamma-glutamyltransferase (GGT) or alanine aminotransferase (ALT).
Common adverse reactions (may affect up to 1 100 individuals)
A low blood pressure can make you feel faint or experience a rapid heartbeat;
Bleeding:
in your eyes;
in your mouth or in your spit after coughing;
Bright/red blood in the stools;
tests showing blood in the stools or in the urine
bleeding that occurs after any surgery such as swelling and bruising, liquid or blood leaks from the incision (wound secretion) as well as the injection area
from a haemorrhoid;
into a muscle;
Itching;
Hair loss;
The allergic reaction (hypersensitivity) that may result in: swelling of the lips, face or tongue. It can also cause swelling of the mouth, throat and breathing problems. Contact your doctor immediately if you experience any of these 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. It can cause yellowing of the skin and eyes.
Rare adverse reactions (may cause up to 1 out of 1,000)
Bleeding:
in your brain or in the spinal column of your brain;
in your lungs.
Not known (frequency can’t be determined by using data)
Bleeding:
into your abdomen , or the space behind your abdominal cavity.
Skin rash that may develop blisters , and appears like small areas of targets (central dark spots surrounded smaller areas, with 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 the appearance of bruising.
If you experience any side consequences, you should consult your pharmacist, doctor or nurse. This includes any potential side effects not listed in this informational leaflet. You can also report side effects directly (see details below). In reporting side effects, you can help provide more information regarding the safety of this medication.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or go to MHRA Yellow Card or search for MHRA Yellow Card in either the Google Play or Apple App Store
Keep this medication out of sight and reach of children.
Do not use this medicine following the expiry date that is indicated on the carton as well as on the blister following expiration. The expiry date is the date of the final day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist for instructions on how to dispose of medications that you no longer require. These precautions will save the environment.
The active substance is the apixaban. Each tablet contains 5 mg of apixaban.
The other ingredients are:
Tablet base is lactose (see section 2 “Eliquis is a source of lactose (a kind of sugar) and sodium”) Microcrystalline cellulose, the sodium croscarmellose (see 2 “Eliquis is a source of lactose (a type of sugar) and sodium”), sodium laurilsulfate and magnesium stearate (E470b);
Film coat Lactose monohydrate (see section 2 “Eliquis is a mixture of lactose (a type of sugar) and sodium”) (E464), hyperromellose (E464) titanium dioxide (E171) triacetin red iron oxide (E172).
The tablets coated with film are pink, oval (9.73 mm x 5.16 mm) and marked in “894” in one corner and “5” in the other side.
They are available in blisters cartons of 14, 20 28 56 60, 168, and 200 coated film tablets.
Unit dose blisters packed in cartons of 100×1 film-coated tablets to be used in hospitals are also available.