Tasmar

DRUG DESCRIPTION

TASMAR® (tolcapone) is available as tablets containing 100 mg or 200 mg tolcapone.

Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson'sbidopa therapy. It is a yellow,as odorless,an adjunct non- to hygroscopic, crystalline compound with a relative molecular mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is:

 TASMAR® (tolcapone)  Structural Formula Illustration

Inactive ingredients

Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone K-30, sodium starch glycolate, talc and magnesium stearate. Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethylcellulose, triacetin and sodium lauryl sulfate, with the following dye systems: 100 mg — yellow and red iron oxide; 200 mg — red iron oxide.

What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out;
  • fever, stiff muscles, confusion, and sweating (especially when you first start taking tolcapone);
  • ...

Read All Potential Side Effects and See Pictures of Tasmar »

What are the precautions when taking tolcapone (Tasmar)?

See also Warning section.

Before taking tolcapone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcoholism, low blood pressure, Parkinson's with severe movement problems, liver problems, history of a certain muscle problem (rhabdomyolysis), fever and confusion caused by any drug.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic...

Read All Potential Precautions of Tasmar »


Tasmar Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, unwanted/uncontrolled movements, diarrhea, headache, drowsiness, trouble sleeping, increased number of dreams, increased sweating, dry mouth, gas, and abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized.

Your urine may change color (such as increased yellow color). This effect is harmless.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), unusual urges (such as increased gambling, sexual urges), fever, muscle stiffness, fast/irregular heartbeat, chest pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, sore/painful muscles, muscle weakness, trouble breathing, pain with breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking tolcapone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcoholism, low blood pressure, Parkinson's with severe movement problems, liver problems, history of a certain muscle problem (rhabdomyolysis), fever and confusion caused by any drug.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, and hallucinations.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Tasmar Patient Information Including Side Effects

Brand Names: Tasmar

Generic Name: tolcapone (Pronunciation: TOLE ka pone)

  • What is tolcapone (Tasmar)?
  • What are the possible side effects of tolcapone (Tasmar)?
  • What is the most important information I should know about tolcapone (Tasmar)?
  • What should I discuss with my healthcare provider before taking tolcapone (Tasmar)?
  • How should I take tolcapone (Tasmar)?
  • What happens if I miss a dose (Tasmar)?
  • What happens if I overdose (Tasmar)?
  • What should I avoid while taking tolcapone (Tasmar)?
  • What other drugs will affect tolcapone (Tasmar)?
  • Where can I get more information?

What is tolcapone (Tasmar)?

When used with carbidopa and levodopa (Atamet, Parcopa, Sinemet), tolcapone increases levels of levodopa in the body.

Tolcapone is used together with carbidopa and levodopa to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

This medication is usually reserved for use only in people who have used carbidopa and levodopa without success in treating their Parkinson's disease.

Tolcapone is usually given to people who are already taking carbidopa and levodopa but have not had successful treatment of symptoms.

Tolcapone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of tolcapone (Tasmar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out;
  • fever, stiff muscles, confusion, and sweating (especially when you first start taking tolcapone);
  • hallucinations;
  • tremors (uncontrolled shaking);
  • tight feeling in your chest, trouble breathing;
  • pain or burning when you urinate;
  • severe or ongoing diarrhea; or
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • diarrhea or constipation;
  • dry mouth;
  • headache, tired feeling;
  • unusual skin changes;
  • dizziness, drowsiness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • sleep problems (insomnia), dreaming more than usual; or
  • agitation or anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tolcapone (Tasmar)?

You should not use this medication if you are allergic to tolcapone, if you have liver disease, or if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Serious or fatal side effects on the liver have occurred in some people taking this medication. You may be required to read and sign a Patient Consent form before you get a prescription for tolcapone.

Call your doctor at once if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage.

Avoid drinking alcohol, which can increase some of the side effects of tolcapone.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tolcapone. Tell your doctor if you regularly use any of these other medicines.

Do not stop using tolcapone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using tolcapone.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking tolcapone.

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