Details for: COMTAN

As with all medicines, patients treated with COMTAN* may experience side effects, although not everybody gets them. These side effects are most likely to occur when you begin treatment with COMTAN* and are usually mild to moderate and rarely necessitate discontinuation of the treatment.

If you experience any of the side effects listed below, tell your doctor immediately.

Very common side effects (affect more than 1 patient in 10)

• Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
• feeling sick (nausea);
• harmless reddish-brown discoloration of urine. COMTAN* may also cause darkening of sweat and saliva.

Common side effects (affect 1 to 10 patients in 100)

• Excessive movements of the body (hyperkinesias);
• headache;
• fever;
• tremor;
• prolonged muscle cramps (dystonia), leg cramps;
• hallucinations (seeing/hearing/feeling/smelling things that are not really there), confusion;
• heart or artery disease events other than a heart attack (e.g., chest pain, swelling or blue coloration of the extremities, shortness of breath on exertion, angina, disease of the heart valves or other conditions identified by your physician);
• worsening of symptoms of Parkinson’s disease;
• being sick (vomiting), diarrhea, abdominal pain, constipation, dry mouth;
• decrease in blood pressure when standing up rapidly after sitting or lying down, with or without symptoms such as dizziness or light headedness, increased sweating, falling, fainting;
• dizziness, tiredness, increased sweating, falling;
• vertigo (sensation of spinning or whirling motion);
• sleeplessness, nightmares.

Uncommon (affects 1 to 10 patients in 1,000)

• Heart attack (chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating).

Rare side effects (affect 1 to 10 patients in 10,000)

• Abnormal results in liver function tests.

Very rare side effects (affect less than 1 patient in 10,000)

• Inflammation of the colon (colitis) which may cause severe diarrhea or weight loss;
• agitation;
• decreased appetite, weight loss;
• hives;
• discoloration of the skin, hair, beard and nails;
• Excessive daytime sleepiness and sleep onset episodes;
• Neuroleptic Malignant Syndrome (NMS), which can cause symptoms of stiffness, muscle twitching, shaking, agitation, confusion, coma, high body temperature, increased heart rate, and unstable blood pressure;
• inflammation of the liver (hepatitis), which can cause increasing loss of appetite, weakness, exhaustion, weight loss in a relatively short period of time, yellowing of your skin, hair, nail, or the white of your eyes, dark colored urine;
• serious skin reactions (rash that might be severe, red skin, blistering of the lips, eyes or mouth, peeling skin).
• severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems;
• allergic reactions (symptoms may include redness, itching, rash, swelling of your skin, hives, swelling around the eyes, lips; swelling of hands, feet, face, tongue or throat; any trouble breathing or swallowing not present before using this medicine).

Together with levodopa, COMTAN* may lower your blood pressure and cause postural (orthostatic) hypotension (a decrease in your blood pressure when standing up rapidly after sitting or lying down), with or without symptoms such as dizziness, nausea, syncope (fainting) and sweating. Hypotension may occur more frequently during the start of treatment with COMTAN*. Therefore, you should avoid standing rapidly after sitting or lying down, especially after prolonged periods. You should also be careful if you are taking other medicinal products which may cause dizziness or light-headedness (low blood pressure) when rising from a chair or bed.

Severe diarrhea while taking COMTAN* can cause significant loss of weight for some individuals. In some cases diarrhea and weight loss have been caused by inflammation of the colon that occurred during treatment with COMTAN*. Therefore, it is important to tell your doctor if you have diarrhea so that the cause of your symptoms can be determined. Your weight should also be closely monitored. Your treatment may need to be adjusted to avoid diarrhea and excessive weight loss.

If you experience increasing loss of appetite, weakness, exhaustion and weight loss in a relatively short period of time after starting treatment with entacapone, contact your doctor. He/she may decide to do a general medical evaluation, including blood tests to check liver function.

Abnormal results of blood tests, such as decrease in red blood cells, have been observed in people taking COMTAN*.

COMTAN* may also cause other adverse events. If you have any questions or concerns about these effects you should talk to your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking COMTAN*, contact your doctor or pharmacist.