Sintrom

The dose of acenocoumarol is individualized by your doctor according to blood clotting time as determined by laboratory tests, called an INR, performed at regular intervals. It is very important to keep your lab appointments, as there is a narrow range between too much and too little of the medication. Too much medication may cause you to bleed more. Too little medication may let a harmful clot form.

The usual dose on the first day ranges from 8 mg to 12 mg and on the second day from 4 mg to 8 mg. The usual maintenance dose ranges from 1 mg to 10 mg once daily. Take acenocoumarol at the same time each day.

Different circumstances in your life (e.g., eating certain foods or using certain medications) can cause Sintrom (Nicoumalone) to work more or less effectively. Ask your doctor or pharmacist for a list of these foods and medications.

It is important to manage your lifestyle appropriately when taking acenocoumarol:

• do not make drastic changes in your diet, such as eating large amounts of green, leafy vegetables
• do not attempt to change your weight by dieting without first checking with your health care provider
• do not participate in any activity or sport that may result in serious injury
• avoid drinking alcohol
• avoid cutting yourself

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Sintrom (Nicoumalone) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Sintrom (Nicoumalone) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

1 mg
Each peach coloured, biconvex, round tablet contains acenocoumarol 1 mg. Nonmedicinal ingredients: alcohol, colloidal silicon dioxide, cornstarch, FD&C Yellow No. 6, gelatin, glycerin, lactose, magnesium stearate, and talc. Sintrom (Nicoumalone) does not contain bisulfites, gluten, parabens, sodium, or tartrazine.

4 mg
Each white, flat-faced tablet, debossed with Paladin shield on one side and double scored on the other, contains acenocoumarol 4 mg. Nonmedicinal ingredients: colloidal silicon dioxide, cornstarch, lactose, magnesium stearate, and talc. Sintrom (Nicoumalone) does not contain alcohol, bisulfites, gluten, parabens, sodium, or tartrazine.

Do not take acenocoumarol if you:

• are allergic to acenocoumarol or any ingredients of the medication
• are pregnant
• are receiving injections into a muscle
• are undergoing certain types of anesthesia
• do not have access to laboratory facilities for regular blood testing
• have a medical condition in which the risk of bleeding is greater than the benefits of receiving the medication, including:
  • after surgery, which is associated with increased breakdown of blood clots (e.g., lung, prostate, or uterus surgery)
  • a high risk of abortion, eclampsia, and preeclampsia (complications of pregnancy often associated with sudden onset of very high blood pressure)
  • bleeding tendencies or blood disorders
  • bleeding tendencies associated with active ulcers or bleeding of the stomach, genitourinary, or respiratory tracts, or bleeding associated with many other medical conditions
  • certain types of severe kidney and liver problems
  • recent or planned surgery of the eye or the central nervous system, or surgery associated with trauma resulting in a large open surface
  • severe high blood pressure
• have polyarthritis
• have senility, Alcoholism, psychosis, or other conditions where the person may not be able to cooperate with taking the medication and having the necessary lab tests on a regular basis
• have a vitamin C deficiency

There may be an interaction between acenocoumarol and any of the following:

• Acetaminophen
• alcohol
• Allopurinol
• Amiodarone
• anticancer medications (e.g., Carboplatin, Cyclophosphamide, Fluorouracil)
• Azathioprine
• azithromycin
• "azole" antifungals (e.g., fluconazole, ketoconazole, miconazole)
• barbiturates (e.g., primidone, Phenobarbital)
• birth control pills
• Carbamazepine
• cephalosporins (e.g., cefazolin, cefoperazone, cefotetan, cefoxitin)
• chloral hydrate
• chloramphenicol
• Cholestyramine
• Cimetidine
• clarithromycin
• clofibrate
• corticosteroids (e.g. Prednisone, Dexamethasone)
• Danazol
• delavirdine
• dextran
• diazoxide
• diuretics (e.g. Hydrochlorothiazide)
• erythromycin
• ethacrynic acid
• Fenofibrate
• fluoxymesterone
• Flutamide
• Gemfibrozil
• Glucagon
• griseofulvin
• halothane
• Heparin and low-molecular weight heparins (e.g. Enoxaparin, Dalteparin)
• herbs that affect blood clotting (e.g., St. John's wort, ginseng, ginkgo biloba, coenzyme Q10)
• lidocaine
• long-term use of narcotic pain medications (e.g. Codeine, Oxycodone, Morphine, Hydromorphone)
• MAO inhibitors (e.g., Phenelzine, Tranylcypromine)
• meprobamate

• Mercaptopurine
• Metronidazole
• mexilitine
• miconazole
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen, Celecoxib, Mefenamic acid)
• Pentoxifylline
• phenylbutazone
• Phenytoin
• potassium iodide
• Primaquine
• Propafenone
• propoxyphene
• Propylthiouracil
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifabutin
• rifampin
• salicylates (e.g., aminosalicylic acid, sodium salicylate, acetylsalicylic acid [Asa], methyl salicylate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Duloxetine, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram)
• "statins" (e.g., Fluvastatin, Lovastatin, Simvastatin)
• streptokinase
• Sulfinpyrazone
• sulfonamides (e.g., sulfamethoxazole)
• sulfonylureas (e.g., Glyburide, chlorpropamide, Tolbutamide)
• Tamoxifen
• testosterone
• tetracyclines (e.g., doxycycline, Minocycline, Tetracycline)
• thiabendazole
• Thyroid hormones (e.g., Levothyroxine, Liothyronine, thyroid)
• Ticlopidine
• tissue plasminogen activator (t-PA)
• urokinase
• vitamin E
• vitamin K
• Warfarin
• zafirkulast

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sintrom (Nicoumalone). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Sintrom (Nicoumalone).

Bleeding: The most serious risk associated with acenocoumarol is bleeding in any tissue or organ. The risk of bleeding is related to the level of intensity and the duration of treatment.

It is extremely important to have regular blood tests (as recommended by your doctor) to measure your INR level. Your health care provider will adjust the dose of acenocoumarol depending on your INR level to ensure you are not receiving too little medication (which may result in blood clots forming) or too much medication (which may result in bleeding).

Kidney problems: If you have kidney problems, discuss with your doctor how Sintrom (Nicoumalone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sintrom (Nicoumalone), and whether any special monitoring is needed.

Liver problems: If you have liver problems, discuss with your doctor how Sintrom (Nicoumalone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sintrom (Nicoumalone), and whether any special monitoring is needed.

Medical alert: In case of injury or accident, people taking Sintrom (Nicoumalone) should carry a card or wear other identification (e.g., bracelet or necklace) that states they are taking Sintrom (Nicoumalone).

Medical conditions and other medications: Many medical conditions and medications affect the way acenocoumarol works and affect the dosing of Sintrom (Nicoumalone). If you have a medical condition and are taking medications, discuss with your doctor how Sintrom (Nicoumalone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sintrom (Nicoumalone), and whether any special monitoring is needed.

Always check with your doctor or pharmacist before taking any new prescription or over-the-counter medication, supplement, or herbal product.

Medical procedures: Before undergoing any medical test or procedure (e.g., minor surgery, tooth extractions, angiography), be sure to tell your health care providers that you are taking Sintrom (Nicoumalone).

Stopping the medication: If your doctor has told you that you can stop acenocoumarol, they may recommend that you decrease your dose slowly over time. Do not suddenly stop taking Sintrom (Nicoumalone) without discussing with your doctor first.

Pregnancy: Acenocoumarol should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sintrom (Nicoumalone), contact your doctor immediately.

Breast-feeding: Acenocoumarol passes into breast milk. If you are a breast-feeding mother and are taking Sintrom (Nicoumalone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of taking Sintrom (Nicoumalone) have not been established for children.

Seniors: Seniors taking Sintrom (Nicoumalone) may be more sensitive to side effects and may need closer monitoring by their doctors.