Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Sintrom (Nicoumalone). If you are concerned about side effects, discuss the risks and benefits of Sintrom (Nicoumalone) with your doctor.

The following side effects have been reported by at least 1% of people taking Sintrom (Nicoumalone). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• Fever
• Hives
• itchy skin
• loss of appetite
• loss of hair
• nausea
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bleeding from cuts that take a long time to stop
• bleeding gums
• Headaches, dizziness, or weakness
• heavier than normal menstrual bleeding
• nosebleeds
• numbness or tingling of the face, hands, or feet
• pain, swelling, or discomfort
• paralysis
• pink or brown urine
• sudden shortness of breath
• unexplained bruising
• unusual pain or swelling

Stop taking the medication and seek immediate medical attention if any of the following occur:

• fainting
• signs of a serious allergic reaction, e.g.:
  • difficulty breathing
  • hives
  • swelling of face or throat
• signs of bleeding, e.g.:
  • bleeding in the eye
  • blood in stools
  • blood in urine
  • blood in vomit or vomit that looks like coffee grounds
  • coughing up blood
  • dark, tarry stools

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sintrom (Nicoumalone).

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:

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.