ELIQUIS 5 mg. 60 tablets
Eliquis contains the active substance apixaban and belongs to a group of medicines called anticoagulants. This drug helps to prevent the formation of blood clots by inhibiting Factor Xa, which is an important component for blood coagulation.
Eliquis is used in adults to prevent the formation of a blood clot in the heart in patients with abnormal heart rhythm (atrial fibrillation) and at least one additional risk factor. Blood clots can break away, to reach the brain and cause a stroke, or to other organs and interfere with normal blood flow to the body (also known as systemic embolism). Stroke can be life-threatening and requires immediate medical attention.
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);
if you have bleeding;
if you have a disease in an organ of your body, which increases the risk of bleeding (eg active or recent ulcers of the stomach or intestines, recent bleeding in the brain);
if you have liver disease, leading to increased risk of bleeding (hepatic coagulopathy);
if you are taking medicines to prevent blood clotting (eg. warfarin rivaroksiban, dabigatran or heparin), unless you change anticoagulation treatment or until you have included venous or arterial catheter and get through it heparin to not clog.
Warnings and Precautions
Talk to your doctor before taking this medicine if any of the following apply to you:
increased risk of bleeding, for example:
bleeding disorders, including conditions leading to reduced activity of the platelets;
very high blood pressure, uncontrolled by medication;
if you have severe kidney disease or if you are on dialysis;
if you have liver problems or a history of liver problems;
Eliquis will be used with caution in patients with symptoms of hepatic dysfunction;
If you need to make a surgery or procedure that may lead to bleeding, your doctor may tell you to temporarily stop taking this medicine for a short period. Ask your doctor if you are unsure whether a procedure can cause bleeding.
Children and adolescents
Eliquis is not recommended in children and adolescents under 18 years of age.
Other medicines and Eliquis
Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines.
Some medicines may enhance the effect of Eliquis, while others may reduce this effect. Your doctor will decide whether you should be treated with Eliquis while taking these drugs and how strictly to be monitored by your condition.
The following medicines may enhance the effect of Eliquis and increase the possibility of adverse bleeding:
some drugs for fungal infections (eg. ketoconazole, etc.);
some antiviral drugs for HIV / AIDS (eg. ritonavir);
other medicines to reduce blood clotting (eg. enoxaparin, etc.);
or anti-inflammatory painkillers (eg. aspirin or naproxen). Especially if you are over 75 years and taking aspirin can have a greater likelihood of bleeding;
medicines for high blood pressure or heart problems (eg. diltiazem).
The following medicines may reduce the ability of Eliquis to prevent blood clots:
drugs for the treatment of epilepsy or seizures (eg. phenytoin and the like.);
St. John's Wort (an herbal supplement used for depression);
drugs for treatment of tuberculosis and other infections (e. rifampicin).
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor, pharmacist or nurse before taking this medicine.
It is not known what may be the effects of taking Eliquis on pregnancy and the unborn child. You should not take Eliquis, if you are pregnant. Contact your doctor immediately if you become pregnant during treatment with Eliquis.
It is not known whether Eliquis passes into breast milk. Ask your doctor, pharmacist or nurse before taking this medication while breastfeeding. They will advise whether to discontinue nursing or to stop Eliquis.
Driving and using machines
There is no evidence that Eliquis may impair your ability to drive or operate machinery.
Eliquis contains lactose (a type of sugar).
If your doctor told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Eliquis
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor, pharmacist or nurse.
The recommended dose is one tablet twice a day, for example one tablet in the morning and one in the evening. Try to take your tablets at the same time each day to treatment has the best effect.
Swallow the tablet with water. Eliquis may be taken with or without food.
The recommended dose is one tablet Eliquis 5 mg twice a day.
The recommended dose is one tablet Eliquis 2,5 mg twice a day if:
have severely reduced kidney function;
two or more of these are useful in the search:
the results of your blood tests suggest reduced renal function (serum creatinine is 1,5 mg / dL (133 micromoles / l) or more);
You are 80 years old or more;
your weight is 60 kg or less.
Your doctor may change your anticoagulant treatment, as follows:
Switching from Eliquis to anticoagulant drugs:
Stop taking Eliquis. Start treatment with anti-coagulants (eg heparin) at the time, which should take the next tablet.
Passage of anti-clotting drugs to Eliquis:
Stop taking anti-clotting drugs. Start treatment with Eliquis at the time he would have had to take the next dose of anti-clotting drugs, then proceed as usual.
Changing from anticoagulant treatment containing vitamin K antagonist (eg. Warfarin) to Eliquis:
Stop taking the medicine containing vitamin K antagonists will need Your doctor may do blood tests and instruct you when to start taking Eliquis.
Switching from Eliquis to anticoagulant treatment containing vitamin K antagonist (eg. Warfarin):
If your doctor tells you that it is necessary to start taking medicines containing vitamin K antagonist, continue taking Eliquis at least 2 days after your first dose of medication containing vitamin K antagonists Your doctor should do blood tests and to tell you when to stop taking Eliquis.
If you take more dose Eliquis
Tell your doctor immediately if you take more than the prescribed dose Eliquis. Take the medicine pack with you, even if there are not other tablets.
If you take more than the recommended dose Eliquis, the risk of bleeding may increase. If there is bleeding may need surgery or blood transfusion.
If you forget to take Eliquis
Take the tablet as soon as you remember:
Eliquis take the next tablet at the usual time;
then continue as usual.
If you are not sure what to do or you miss more than one dose, ask your doctor, pharmacist or nurse.
If you stop taking Eliquis
Do not stop taking Eliquis without consulting with your doctor, because the risk of a blood clot may be higher if you stop treatment early.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common major side effect of Eliquis is bleeding, which can potentially be life-threatening and requires immediate medical attention.
Common side effects (may affect up to 1 in 10 people):
stomach, intestinal or dark / black blood in the stool;
Blood found in the urine on laboratory testing;
bruising and swelling.
Uncommon side effects (may affect up to 1 in 100 people):
in the brain or spine;
mouth or blood in sputum when coughing;
in the abdomen, in the rectum or vagina;
light / red blood in the stool;
bleeding occurring after surgery, including bruising and swelling, leakage of blood or fluid from the surgical wound / incision (Ranev matter) or injection site;
Allergic reactions (hypersensitivity), which may cause: swelling of the face, lips, mouth, tongue and / or throat and difficulty breathing. Tell your doctor immediately if you experience any of these symptoms.
Rare side effects (may affect up to 1 in 1000 people):
bleeding in the lungs or throat;
bleeding into the space located at the back of the abdominal cavity.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
5. How to store Eliquis
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton 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 medications in 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 pack and other information
The active substance is apixaban. Each tablet contains 5 mg of apixaban.
Other ingredients are:
Tablet core: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b).
The coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172).
Eliquis looks like and contents of the pack
The film-coated tablets are pink, round and marked "894" on one side and "5" on the other.
The tablets are packaged in blisters in cartons of 14, 20, 56, 60, 168 and 200 tablets.
There are unit dose blisters in cardboard boxes with 100 x 1 tablet for delivery in hospitals.
Not all pack sizes may be marketed.