Red Yeast Rice capsules

What is this medicine?

RED YEAST RICE (red yeest rahys) is intended to be used by healthy adults to help lower blood cholesterol in conjunction with a healthy diet and a regular exercise program. The FDA has not approved this supplement for any medical use. If medical treatment is needed for cholesterol control or any other disease, you should contact your doctor or health care professional regarding the use of this product.

This supplement may be used for other purposes; ask your health care provider or pharmacist if you have questions.

How should I use this medicine?

Take this supplement by mouth with a glass of water. Follow the directions on the package labeling, or take as directed by your health care professional. Do not take this supplement more often than directed.

Contact your pediatrician or health care professional regarding the use of this supplement in children. Special care may be needed. This supplement is not recommended for use in children.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• fever

• joint pain

• muscle cramps, pain

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

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

• constipation

• headache

• stomach gas, pain, upset

• nausea

• trouble sleeping

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• clarithromycin

• delavirdine

• erythromycin

• grapefruit juice

• protease inhibitors used to treat HIV infection

• medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole

• mibefradil

• nefazodone

• other medicines for high cholesterol

• telithromycin

• troleandomycin

This medicine may also interact with the following medications:

• alcohol

• amiodarone

• colchicine

• cyclosporine

• danazol

• diltiazem

• fenofibrate

• fluconazole

• gemfibrozil

• mifepristone, RU-486

• niacin

• St. John's wort

• verapamil

• voriconazole

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• frequently drink alcoholic beverages

• kidney disease

• liver disease

• muscle aches or weakness

• other medical condition

• an unusual or allergic reaction to red yeast rice, went yeast, lovastatin, other 'statin' medications, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check-ups. You may need regular tests to make sure your liver is working properly.

Tell you doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

Some drugs may increase the risk of side effects from this supplement. If you are given certain antibiotics or antifungals, you should stop taking this supplement during those treatments. Check with your doctor or pharmacist for advice.

If you are scheduled for any medical or dental procedure, tell your healthcare provider that you are taking this supplement. You may need to stop taking this supplement before the procedure.

Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

Herbal or dietary supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. 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 does not mean a product is safe for humans to take.

• Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.

• Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.