Mylan Fenofibrate Micro

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Mylan Fenofibrate Micro. If you are concerned about side effects, discuss the risks and benefits of Mylan Fenofibrate Micro with your doctor.

The following side effects have been reported by at least 1% of people taking Mylan Fenofibrate Micro. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• Diarrhea
• dizziness
• gas
• headache
• nausea
• red, itchy skin
• runny nose
• stomach pain
• tiredness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• severe stomach pain, nausea, or vomiting
• signs of liver problems (e.g., dark urine, general feeling of being unwell, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin)
• unexplained muscle pain, tenderness, weakness, chills, or Fever

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., Hives, swelling of the face or throat, difficulty breathing)
• signs of a blood clot (e.g., breathlessness, coughing up blood; pains in chest, groin, or leg – especially in calf of leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Mylan Fenofibrate Micro.

Each orange, hard gelatin capsule printed with "G" on the cap and "F200" on the body contains 200 mg of micronized fenofibrate. Nonmedicinal ingredients: D&C Red No. 28, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6, gelatin, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, purified talc, shellac, sodium starch glycollate, synthetic black iron oxide, and titanium dioxide.

Do not take micronized fenofibrate if you:

• are allergic to fenofibrate or to any of the ingredients of the medication
• are allergic to other medications of the fibrate class (e.g., Gemfibrozil, Bezafibrate, clofibrate)
• are allergic to peanuts, arachis oil, or soya lecithin
• are pregnant or breast-feeding
• are taking a "statin" cholesterol-lowering medication (e.g., Atorvastatin, Lovastatin) and have or are at risk of developing muscle problems
• has a disorder known as type 1 hyperlipoproteinemia
• have had a severe skin reaction to other fibrates or Ketoprofen
• have liver disease, Kidney Disease, or gallbladder disease
• have acute or chronic pancreatitis
• are less than 18 years of age

There may be an interaction between fenofibrate (micronized) and any of the following:

• Cholestyramine resin
• Colchicine
• Colestipol
• Cyclosporine
• Everolimus
• Ezetimibe
• "statin" medications (e.g., atorvastatin, lovastatin, simvastatin)
• sulfonylureas (e.g. Glyburide, chlorpropamide)
• Tacrolimus
• Ursodiol
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Mylan Fenofibrate Micro. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mylan Fenofibrate Micro.

Blood components: Small, temporary decreases in red and white blood cell counts have been observed in people using Mylan Fenofibrate Micro. Your doctor will check for this with blood tests during the first year of treatment.

Combination therapy: The use of fenofibrate and "statin" medications (e.g., atorvastatin, lovastatin, Simvastatin) at the same time may increase the risk of muscle-related side effects. Talk to your doctor about the risks and benefits of taking the two types of medications together.

Gallbladder disease: For some people, fenofibrate may cause the formation of gallstones. If you experience abdominal or stomach pain, gas, nausea, or bloating (especially after eating high-fat foods), contact your doctor.

Kidney function: If you have reduced kidney function, discuss with your doctor how Mylan Fenofibrate Micro may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fenofibrate Micro, and whether any special monitoring is needed.

Liver function: If you have reduced liver function or liver disease, discuss with your doctor how Mylan Fenofibrate Micro may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fenofibrate Micro, and whether any special monitoring is needed.

Skeletal muscle: Treatment with this type of medication has been associated on rare occasions with muscle pain, usually in people with reduced kidney function. Contact your doctor as soon as possible if you notice unexplained muscle pain, tenderness, or weakness, particularly if you also have malaise (a general feeling of illness) or fever.

Pregnancy: The safety of Mylan Fenofibrate Micro has not been established for pregnant women. Mylan Fenofibrate Micro should not be used by pregnant women.

Breast-feeding: It is not known if fenofibrate passes into breast milk. If you are a breast-feeding mother and are taking fenofibrate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of the medication have not been established for use by children under the age of 18.

Seniors: Seniors are more likely to have reduced kidney function and may need lower doses of Mylan Fenofibrate Micro.