If you have PKU you can not take Parcopa -it would be very dangerous.
Facts:

information below
http://www.pkunews.org/about/intro.htm


What is PKU? Phenylketonuria
By Virginia E. Schuett, MS, RD, Director, National PKU News


PKU (phenylketonuria), in its "classic" form, is a rare, inherited metabolic disease that results in mental retardation and other neurological problems when treatment is not started within the first few weeks of life. When a very strict diet is begun early and well-maintained, effected children can expect normal development and a normal life span. (Not all elevations of blood phenylalanine require treatment; any child with a level less than 6 mg/dl does not need to be on a special diet and is not risk for mental retardation.)

The Enzyme Deficiency
The disease arises from the absence of a single enzyme (phenylalanine hydroxylase). This enzyme normally converts the essential amino acid, phenylalanine, to another amino acid, tyrosine. Failure of the conversion to take place results in a buildup of phenylalanine. Through a mechanism that is not well understood, the excess phenylalanine is toxic to the central nervous system and causes the severe problems normally associated with PKU. Not every child has the same degree of enzyme deficiency, however; some have enough enzyme activity that the diet can be quite liberal, while others must have the very strict diet. The nature of the diet for an individual child must be determined by an experienced PKU treatment program.

Genetics
PKU is carried through an "autosomal recessive" gene. This means that two people who conceive a child must both be "silent carriers" of the gene in order for there to be a chance that the baby will have PKU. When two carriers conceive a child, there is a one in four (or 25%) chance for each pregnancy that the baby will have PKU. The incidence of carriers in the general population is approximately one in fifty people, but the chance that two carriers will mate is only one in 2500. Carrier tests are available only through PKU treatment programs.









Press Release -
- FDA Grants Final Approval for SCHWARZ PHARMA's Parcopa

August 30, 2004

FDA Grants Final Approval for SCHWARZ PHARMA’s Parcopa

Orally-dissolving carbidopa-levodopa is the third launch from SCHWARZ PHARMA's U.S. specialty pharma projects, and establishes a presence in the strategically important neurology area.

SCHWARZ PHARMA has received final approval from the U.S. Food and Drug Administration (FDA) to market Parcopa™ (carbidopa-levodopa orally disintegrating tablets). Parcopa’s unique formulation dissolves rapidly in the mouth, thereby providing patients suffering from Parkinson’s disease with improved access to their medication.

"Our recent clinical study showed that in comparison with their current tablets, Parkinson’s patients had a clear preference for Parcopa for several specific reasons associated with the daily challenges of managing this complex disease. We are very happy that we can now offer this new treatment option, and we are already in the process of launching the product", says Klaus Veitinger, M.D., Member of the Executive Board SCHWARZ PHARMA AG. "Parcopa will establish our presence in the neurology offices and help prepare the launch platform for our future products for Parkinson’s disease and other neurological disorders."

Parkinson’s disease patients experience symptoms such as morning rigidity or “off periods” - episodes of decreased movement or complete immobility - that can make dosing problematic. Unlike conventional carbidopa-levodopa, Parcopa dissolves in the mouth using RapiTab™ technology to deliver medicine without the need for water, providing patients with a convenient means to take their medication.

Parcopa is part of SCHWARZ PHARMA’s specialty pharma projects in the U.S. Out of the nine projects, two – the gastro-intestinal products TriLyte and GlycoLax – were already launched earlier this year. Three additional projects are currently under FDA review and further market launches can be expected over the next 18 months.

SCHWARZ PHARMA’s RapiTab™ technology formulates medicines into orally disintegrating tablets that dissolve rapidly in the mouth. They can be swallowed with or without water and have pleasant tasting flavours such as citrus or mint. RapiTab tablets are convenient and easy for patients to administer, especially when water is not readily available or patients face certain obstacles to dosing. SCHWARZ PHARMA’s RapiTab technology is based on the proprietary DuraSolv Technology developed by and licensed from CIMA LABS INC.

SCHWARZ PHARMA develops innovative drugs with the focus on neurology and urology. There are currently seven projects in clinical development. Submission of approval applications for the Parkinson patch with the compound rotigotine for the treatment of Parkinson’s disease is planned for the current quarter. Harkoseride to treat epilepsy and neuropathic pain and fesoterodine for the treatment of overactive bladder syndrome are currently in phase III, the last development phase.



SCHWARZ PHARMA (headquartered in Monheim, Germany) develops and markets innovative drugs for unmet medical needs with a focus on the therapeutic areas of neurology, urology as well as cardiovascular and gastro-intestinal diseases.The company is investing in research and development projects targeting diseases such as Parkinson's disease, Restless Legs Syndrome, epilepsy, neuropathic pain, overactive bladder syndrome/incontinence and benign prostatic hyperplasia. SCHWARZ PHARMA has a strong multinational presence that includes affiliates in Europe, the U.S. and Asia. Shares of SCHWARZ PHARMA AG are traded on the Frankfurt and Düsseldorf stock exchanges.

Contact: Antje Witte; Phone: +49 2173 48 1866; Internet: www.schwarzpharma.com

This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. These forward-looking statements are subject to various risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks and uncertainties that could cause a material difference in future results include changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. The Company does not undertake any responsibility to update the forward-looking statements contained in this press release.


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Important safety information:

Parcopa Orally Disintegrating Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Parcopa Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Parcopa Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tell your doctor or dentist that you take Parcopa Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.
Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Parcopa Orally Disintegrating Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
Do not suddenly stop taking Parcopa Orally Disintegrating Tablets. Some conditions may become worse when Parcopa Orally Disintegrating Tablets is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects.
Parcopa Orally Disintegrating Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Gradually increase physical activity as your symptoms improve.
A dark color (red, brown, or black) may appear in your saliva, urine, or sweat after taking Parcopa Orally Disintegrating Tablets. This is not harmful.
The effects of Parcopa Orally Disintegrating Tablets might start to wear off between doses. Talk with your doctor if Parcopa Orally Disintegrating Tablets stops working well or if your condition worsens.
Some????????????? of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
Diabetes patients -- Parcopa Orally Disintegrating Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Diabetes patients - Parcopa Orally Disintegrating Tablets may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
Parcopa Orally Disintegrating Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Parcopa Orally Disintegrating Tablets.
Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Parcopa Orally Disintegrating Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Parcopa Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Parcopa Orally Disintegrating Tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Parcopa Orally Disintegrating Tablets while pregnant. It is not known if Parcopa Orally Disintegrating Tablets is found in breast milk. If you are or will be breast-feeding while you are using Parcopa Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Parcopa Orally Disintegrating Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Confusion; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; taste changes; trouble sleeping; upset stomach; urinary tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in vomit; chest pain; confusion; depression; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; muscle pain or unusual stiffness; severe abdominal pain; severe lightheadedness or fainting; sore throat; thoughts of suicide; unexplained fever or sweating; unusual bruising or bleeding; unusual or painful movements or spasms of the face, eyelids, mouth, tongue, arms, hands, or legs; vision changes (blurred/double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Parcopa Orally Disintegrating Tablets:
Store Parcopa Orally Disintegrating Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Parcopa Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:
If you have any questions about Parcopa Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Parcopa Orally Disintegrating Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Parcopa Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: January 2, 2008
Database Edition 08.1.1.001
Copyright © 2008 Wolters Kluwer Health, Inc.

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