INTRODUCTION

ELIQUIS 2.5 contains apixaban which belongs to the group of medicines called anticoagulants. A blood clot which blocks an artery (blood vessel) is called an embolism and if the embolism occurs in the arteries of the brain it can cause a stroke. Anticoagulants slow down the time it takes for blood to clot and reduce the risk of embolism.

This medicine is used to reduce the risk of blood clots formation in heart of the patients with atrial fibrillation (an abnormal heartbeat) and other risk factors for stroke. These blood clots might break and travel to the brain, leading to a stroke or to other organs and prevent their normal blood flow (systemic embolism).

ELIQUIS 2.5 can also be used to treat other blood clotting conditions like deep vein thrombosis (blood clots in veins of legs) and pulmonary embolism (blood clot in blood vessels of lungs), and also prevents its recurrence in patients with or without hip or knee replacement operations. This medicine can be taken with or without food.

The most common side effects of taking this medicine are bleeding in eyes, nose, gums, stomach, rectum or vagina. Do not take this medicine, if you have any bleeding disorders. Discuss the risks and benefits with your doctor. Before taking this medicine inform your doctor if you are pregnant, breastfeeding or having any serious kidney or liver disease. This medicine is not recommended for use in children and adolescents under 18 years of age. Consult your doctor before taking.

USES OF ELIQUIS 2.5

• Prevents formation of blood clot in the heart of the patients with an irregular heartbeat (atrial fibrillation)
• Treats and prevents deep vein thrombosis (blood clots in veins of legs)
• Treats and prevents pulmonary embolism (blood clot in blood vessels of lungs) in patients with or without hip or knee replacement operations

HOW ELIQUIS 2.5 WORKS

ELIQUIS 2.5 selectively inhibits both the free- and clot-bound forms of coagulation factor Xa and the activity of prothrombinase which prevents the conversion of prothrombin into thrombin and thus preventing formation of blood clot.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. It can be taken with or without food. Your doctor will decide the correct dose for you depending upon your condition. Swallow the medicine as whole with a glass of water.

SIDE EFFECTS OF ELIQUIS 2.5

HOW TO MANAGE SIDE EFFECTS

Feeling sick (nausea):

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines used to treat fungal infections (e.g., ketoconazole)
• medicines used to treat HIV infections (e.g., ritonavir)
• medicines used to treat tuberculosis or other infections (e.g., rifampicin)
• other medicines used to reduce blood clotting (e.g., enoxaparin, warfarin, rivaroxaban, dabigatran or heparin)
• medicines used to reduce pain or inflammation (e.g., acetylsalicylic acid or naproxen).
• medicines used for high blood pressure or heart problems (e.g., diltiazem)
• medicines used to treat depression (e.g.  fluoxetine, sertraline, imipramine, St John’s Wort)
• medicines used to prevent epilepsy or seizures (e.g., phenytoin, etc.)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT ELIQUIS 2.5

Can ELIQUIS 2.5 cause low platelet count?

Yes. This medicine may cause reduced platelet count in blood in some individuals. Consult your doctor for advice.

Should patients stop taking ELIQUIS 2.5 if they are going to have a dental or medical procedure?

This medicine may need to be stopped for one or two days before any planned surgery, dental or medical procedure. Follow the instructions given by the physician. You should not stop taking this medicine without first talking to your doctor or dentist.

When and how do I take this medicine?

Always take this medicine as instructed by your doctor. If you do not take this medicine regularly there is a risk of increase in clot formation.

REFERENCES

1. Keith A.A. Fox, Harvey D. White, Bernard J. Gersh and Lionel H. Opie. Antithrombotic Agents: Platelet Inhibitors, Acute Anticoagulants, Fibrinolytics and Chronic Anticoagulants. Drugs for the heart. 8th Edition. 2013. Page - 366-367.

2. Gerald G. Briggs, Roger K. Freeman. A. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation, Tenth Edition. 2015. Page - 253-254.

3. James L. Zehnder. Drugs Used in Disorders of Coagulation. Basic & Clinical Pharmacology. Fourteenth Edition. McGraw-Hill Education 2018. Page – 616-617.

4. Academic and Community Cancer Research United. Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on August 2020] [Accessed 27th October 2020] https://clinicaltrials.gov/ct2/show/NCT02585713

5. Bristol-Myers Squibb. Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on April 2014] [Accessed 27th October 2020] https://clinicaltrials.gov/ct2/show/NCT00643201

6. Aliaksandr Budovich, Olga Zargarova, and Anna Nogid. Role of Apixaban (Eliquis) in the Treatment And Prevention of Thromboembolic Disease. NCBI; PMC U.S. National Library of Medicine, National Institute of Health. April 2013. [Accessed 27th October 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3684191/

7. Catalent Anagni S.R.L., Pfizer Manufacturing Deutschland GmbH, Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing Plaza 254. [Revised on August 2020] [Accessed 27th October 2020] https://www.medicines.org.uk/emc/files/pil.2878.pdf

8. Catalent Anagni S.R.L., Pfizer Manufacturing Deutschland GmbH, Swords Laboratories T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing Plaza 254. [Revised on August 2020] [Accessed 27th October 2020] https://www.medicines.org.uk/emc/files/pil.4756.pdf

9. Bristol-Myers Squibb Company. [Revised on December 2012] [Accessed 27th October 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf