Milk Thistle, Silybum marianum tablets and capsules

What is milk thistle?

MILK THISTLE, also called Silybum marianum, (Legalon®, Thisylin® and many others) is a dietary supplement (herbal remedy) that is being promoted to maintain healthy liver function. This herb is not FDA approved at this time. Evidence suggests milk thistle may be helpful for some people with liver disease, but it should be used under the prescription of a health care prescriber. Milk thistle is not a cure for liver disease. Many different products containing milk thistle in combination with other herbs are available, including Thistleplex™ and ThistleComp™.

What should my health care professional know before I use milk thistle?

It is important for you to tell your prescriber or other health care professional that you are using milk thistle. Some herbs exert potent effects and may interact with other drugs you are taking.

You should discuss milk thistle with your health care professional BEFORE taking it if you have any of these conditions:

• are a frequent drinker of alcoholic beverages

• jaundice

• kidney disease

• liver disease

• an unusual or allergic reaction to milk thistle, ragweed, other herbs, plants, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This herb should be taken orally (i.e., swallowed), with a full glass of liquid, prior to a meal. Follow the directions on the package labeling, or talk to your health care professional.

Contact your pediatrician or health care professional regarding the use of this herb in children. Special care may be needed.

What if I miss a dose?

Missing a dose is probably not harmful. If you miss a dose, simply resume taking it on your previous schedule. Do not take double doses to catch up, however.

What drug(s) may interact with milk thistle?

• alcohol and alcoholic beverages

For many herbs, interactions with other medications are unknown. That is why you should always be careful when mixing herbal remedies with traditional medications. If you take any other medications, consult with your health care professional prior to taking milk thistle.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking milk thistle?

Since milk thistle is derived from a plant, allergic reactions are possible. Stop using this herb if you develop a rash or any other unusual reaction. You may want to see your health care professional, or inform them that this occurred.

If you are taking milk thistle for liver disease, you should notify your health care professional immediately if you develop a dark or brown color to the urine, if the size of the abdomen increases or you gain weight suddenly, if you have yellowing of the skin or eyes, or if you experience shortness of breath. These symptoms may indicate a worsening of the liver problem. Self-treatment of the symptoms of hepatic disease with milk thistle may delay proper medical treatment.

Different brands of milk thistle might contain different amounts of active ingredient so be careful to use the same brand. It is recommended that you use a brand from a reliable manufacturer and one that has been standardized. A standardized product is more likely to contain the same amount of herb from dose to dose. Your health care professional or pharmacist can assist you in finding a standardized product.

If you are scheduled to have surgery, let your surgeon know you are taking milk thistle.

What side effects may I notice from using milk thistle?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• abdominal pain

• diarrhea that continues or gets worse

• difficulty breathing or shortness of breath

• skin rash, itching, or bruising

• sweating

• weakness

• vomiting

• any other unusual symptoms

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• mild diarrhea or laxative-like effect

• nausea or upset stomach

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature; do not freeze. Protect from light. Throw away any unused medicine after the expiration date.

GENERAL INFORMATION REGARDING DIETARY SUPPLEMENTS:

Dietary supplements include amino acids, vitamins, minerals, herbs, botanicals, and other plant-derived substances, and extracts of these substances. These products are easy to identify as they must state "Dietary Supplement" on the label. A "Supplement Facts" panel is provided on the label for most products. Supplements are not drugs and are not regulated like drugs. You should note that rigid quality control standards are not required for dietary supplements. Big differences in potency and purity of these products can occur. Scientific data to support the use of a dietary supplement for a certain disease or ailment may not be available. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

• Always read product labels and follow directions.

• "Natural" doesn't mean a product is safe for humans to take.

• Look for products containing ingredients with the "USP" notation. This indicates the manufacturer followed the standards of the US Pharmacopoeia.

• Supplements produced or distributed by a nationally known food or drug company are more likely to be made under tight controls as these companies have standards in place for their other products. You can write to the company for more information about how the product was made.