INTRODUCTION

ARTIFLO contains Nicoumalone which belongs to the group of medicines called Anti-coagulants. It is used to treat or prevent the formation of blood clots in the body. Blood clots (also known as thrombosis) are semi-solid masses of blood cells deposited within the blood vessels. It happens due to excessive clumping of platelets (blood cells) or other blood proteins within the blood vessels. As a result, it blocks them and reduce blood flow within them, leading to various complications such as deep vein thrombosis (blood clot in veins of legs), pulmonary embolism (blood clot in veins of lungs), heart attack, abnormal heart rate or stroke. ARTIFLO can also be used as an adjunct in the treatment of coronary occlusion (block in heart which reduces oxygen and blood supply leading to heart attack) and transient cerebral ischemic attacks (mini stroke, caused by blockage in the blood vessel supplying the brain).

Nicoumalone is a blood thinning medication. It works by preventing the formation of blood clots within the blood vessels. It blocks the actions of certain blood proteins and enzymes that forms blood clots in the body. As a result, it reduces the risk of heart attack and other serious complications such as stroke, deep vein thrombosis or pulmonary embolism. ARTIFLO cannot not dissolve an existing blood clot, but it can prevent them from growing larger. During treatment with ARTIFLO, your doctor would regularly monitor your blood clotting time to avoid the risk of unwanted side effects.

Before taking ARTIFLO inform your doctor if you have any liver, kidney, or heart problems. Avoid drinking alcohol or cranberry juice while taking ARTIFLO. Inform your doctor if you are scheduled for any upcoming surgeries or if you had met with any accident recently. ARTIFLO is generally not recommended for use in pregnant women due to increased risk of bleeding at the time of childbirth. It should be used with caution in children and in elderly patients. The most common side effect of ARTIFLO is increased bleeding tendency (even after minor cuts or wounds). Consult your doctor if your bleeding becomes uncontrollable.

USES OF ARTIFLO

• Treats or prevents the formation of blood clots

HOW ARTIFLO WORKS

ARTIFLO is a blood thinning medication. It works by preventing the formation of blood clots within the blood vessels. It blocks the actions of certain blood proteins and enzymes (such as vitamin k reductase, prothrombin, coagulation factors VII, IX, X and protein C) that forms blood clots in the body. As a result, it improves blood flow and oxygen supply through the blood vessels and reduce the symptoms of blood clotting disorders such as deep vein thrombosis, pulmonary embolism, heart attack, abnormal heart rate or stroke.

DIRECTIONS FOR USE

Take ARTIFLO as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ARTIFLO

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily and spicy food.

Loss of appetite:

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

• other medicines used to prevent blood clots (Ex. heparin, dipyridamole, clopidogrel, ticlopidine, ateplase or reteplase)
• medicines used to treat bacterial infections (Ex. clindamycin, clarithromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, sulfasalazine, clavulanic acid, cephalosporins, ciprofloxacin, norfloxacin and ofloxacin)
• medicines used to treat anxiety or depression (Ex. viloxazine, citalopram, fluoxetine, sertraline, paroxetine, or St. John’s Wort)
• rifampicin (used to treat tuberculosis)
• medicines used to treat pain or fever (Ex. aspirin, paracetamol, tramadol, phenylbutazone, celecoxib)
• allopurinol or sulfinpyrazone (used to treat gout)
• immunosuppressants (medicines used to suppress immune function) Ex. methylprednisolone or prednisolone
• anabolic steroids (medicines used to treat hormonal disorders). Ex nandrolone, oxandrolone
• medicines used to treat irregular heartbeat (Ex. amiodarone and quinidine)
• medicines used to treat diabetes (Ex. tolbutamide, chlorpropamide, glimepiride)
• thyroid hormones (used to treat thyroid deficiency states) Ex. levothyroxine or dextrothyroxine
• medicines used to treat stomach problems (Ex. cimetidine, ranitidine, omeprazole, cisapride)
• medicines used to control blood cholesterol levels (Ex. atorvastatin, fluvastatin, simvastatin fenofibrate, gemfibrozil, or cholestyramine)
• disulfiram (a medicine used to control alcohol abuse)
• etacrynic acid (a medicine used to treat water retention or high blood pressure)
• glucagon (a medicine used to treat low blood sugar levels)
• medicines used to treat fungal infections (Ex. econazole, miconazole, ketoconazole, fluconazole or griseofulvin)
• metronidazole (a medicine used to treat protozoal infections)
• glucosamine (a medicine used to treat bone problems)
• medicines used to treat cancer (Ex. 5-fluorouracil, azathioprine, aminoglutethimide, mercaptopurine, or tamoxifen)
• medicines used to treat HIV infection (Ex. indinavir, ritonavir, nelfinavir or saquinavir)
• oral contraceptives (birth control pills) Ex. drospirenone, ethinylestradiol
• diuretics (medicines used to increase urine output) Ex. bendroflumethiazide, metolazone
• medicines used to treat epilepsy (Ex. phenobarbital, phenytoin, carbamazepine)
• supplements containing vitamin E or vitamin K

B. Drug - Food interaction:

Avoid drinking cranberry juice or taking other cranberry products such as capsules or concentrates while taking ARTIFLO.

Overdosage:

If you or anyone else accidentally took more ARTIFLO, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include nosebleeds, bleeding gums, vomiting, or coughing up blood, bloody urine, bloody and black tarry stools, genital bleeding, excessive mensural bleeding, large bruises, bleeding into the joints causing tightness, swelling and pain, increased heartbeat, decreased blood pressure which can make you feel dizzy and can make you skin pale, cold and sweaty. You may also experience vomiting, diarrhea or stomach pain.

SYNOPSIS

MORE INFORMATION

• Keep ARTIFLO out of reach of children
• Store in room temperature

FAQs ABOUT ARTIFLO

How to take ARTIFLO?

Take ARTIFLO as prescribed by your physician. It can be taken at the same time every day. Swallow ARTIFLO with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

How ARTIFLO works on my body?

ARTIFLO is a blood thinning medication. It works by preventing the formation of blood clots within the blood vessels. It blocks the actions of certain blood proteins and enzymes that causes blood clots in the body. As a result, it improves the blood flow and oxygen supply through the blood vessels of major organs (heart, brain, and lungs) and improve the symptoms of blood clot disorders.

Is ARTIFLO safe to use during pregnancy?

If you are pregnant or think you may be pregnant consult your doctor before taking ARTIFLO. ARTIFLO has a potential to affect the growing baby and so your doctor will decide whether you should use ARTIFLO or not depending upon your health condition.

Can ARTIFLO be taken along with alcohol?

No. Avoid consumption of alcohol while taking ARTIFLO because it may interfere with its actions and may lead to unwanted side effects.

What can I do if I forget to take ARTIFLO on time?

If you forgot to take ARTIFLO, take it as soon as you remember. If it’s time for the next dose, skip the missed one and take the next dose on time. Never take a double dose to compensate the missed dose as it could lead to toxicity.

Can I take antibiotics along with ARTIFLO?

It is always advisable to consult your doctor before taking any medicines along with ARTIFLO. Studies have shown that the use of antibiotics simultaneously with anticoagulants like nicoumalone, increases the risk of bleeding in patients, and so concomitant use of antibiotics along with ARTIFLO should be avoided without proper medical supervision.

Why am I not supposed to undergo any surgery while taking ARTIFLO?

It is because ARTIFLO increases your tendency to bleed. As surgeries are always associated with increased risk of bleeding, concomitant use of ARTIFLO with surgeries may make you bleed more than usual. Therefore, it is important to inform your doctor about the use of ARTIFLO before undergoing any surgeries (including minor surgeries) to avoid the risk of excessive bleeding.

Is ARTIFLO safe to use in children?

ARTIFLO should be used with caution in children and adolescents (below 18 years of age). Therefore, consult your doctor for advice before taking.

How long should I take ARTIFLO?

You should continue to take ARTIFLO unless your doctor tells you to stop. Failure to complete the suggested course may not help you in treating the condition properly.

What are the side effects caused due to long term use of ARTIFLO?

ARTIFLO may increase the risk of bleeding. It may make you bleed more easily even after minor cuts, injuries, or wounds, and therefore patients must be advised not to undergo even minor surgeries. It may also cause heavy menstrual period or internal bleeding which can be reflected as blood in vomiting, bloody urine or stools, bloody eyes, or blurred vision. To avoid this your doctor would periodically measure your blood clotting time during treatment with ARTIFLO. Therefore, do not miss your regular hospital visits and take this medicine only as advised by your physician. Consult your doctor if you experience any unusual bleeding over a prolonged period.

How long will it take for ARTIFLO to start working?

It may take around 3-4 days for ARTIFLO to start working. If immediate blood thinning is necessary, your doctor may prescribe you with other potent anticoagulants (like heparin or warfarin) along with ARTIFLO during the initial days. Therefore, consult your doctor for advice.

REFERENCES

1. K.D. Tripathi MD. Drugs Affecting Coagulation Bleeding and Thrombosis. Essentials of Medical Pharmacology. Seventh Edition. 2019. Page 620-623.

2. Abhijit Trailokya, JS Hiremath, JPS Sawhney, YK Mishra, Vivek Kanhere R Srinivasa, Mangesh Tiwaskar. Acenocoumarol - A review of anticoagulant efficacy and safety. Journal of Association of Physicians of India [Revised in December 2015]. [Accessed on 6th May 2022] https://www.japi.org/q2e45484/acenocoumarol-a-review-of-anticoagulant-efficacy-and-safety

3. Norgine Pharmaceuticals Limited. Electronic Medicines Compendium (EMC). [Revised in July 2020] [Accessed on 6th May 2022] https://www.medicines.org.uk/emc/files/pil.2058.pdf

4. Paladin Labs Inc. [Revised on 22nd May 2009]. [Accessed on 6th May 2022] https://www.paladin-labs.com/our_products/Sintrom_en.pdf

5. Abbott Healthcare Pvt Ltd. [Revised in July 2019]. Accessed on 6th May 2022] acitrom.com/api.html