Megestrol

WHY is this medicine prescribed?

Megestrol tablets are used to relieve the symptoms and reduce the suffering caused by advanced breast cancer and advanced endometrial cancer (cancer that begins in the lining of the uterus). Megestrol suspension is used to treat loss of appetite, malnutrition, and severe weight loss in patients with acquired immunodeficiency syndrome (AIDS). Megestrol should not be used to prevent loss of appetite and severe weight loss in patients who have not yet developed this condition. Megestrol is a man-made version of the human hormone progesterone. It treats breast cancer and endometrial cancer by affecting female hormones involved in cancer growth. It increases weight gain by increasing appetite.

Are there OTHER USES for this medicine?

Megestrol is also sometimes used to treat malnutrition in patients with cancer, prostatic hypertrophy (enlargement of a male reproductive gland called the prostate), endometriosis (condition in which the type of tissue that lines the uterus grows in other areas of the body), and endometrial hyperplasia (overgrowth of the lining of the uterus). Talk to your doctor about the risks of using this medication for your condition.

HOW should this medicine be used?

Megestrol comes as a tablet, an oral suspension (liquid), and a concentrated oral suspension (Megace ES) to take by mouth. The tablets and suspension are usually taken several times a day. The concentrated suspension is usually taken once a day. Take megestrol at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take megestrol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

The concentrated suspension is used in different dosages than the regular suspension. Do not switch from one to the other without talking to your doctor.

Do not stop taking megestrol without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking megestrol,

• tell your doctor and pharmacist if you are allergic to megestrol, any other medications, or any of the inactive ingredients in megestrol tablets, suspension, or concentrated suspension. Ask your doctor or pharmacist for a list of the inactive ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention antibiotics, indinavir (Crixivan), and warfarin (Coumadin, Jantoven). Your doctor may need to adjust the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had a blood clot anywhere in the body, a stroke, diabetes, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking megestrol, call your doctor immediately. Megestrol may harm the fetus. Do not breastfeed while you are taking megestrol.

• you should know that megestrol may interfere with the normal menstrual cycle (period) in women. However, you should not assume that you cannot become pregnant. Use a reliable method of birth control to prevent pregnancy.

• talk to your doctor about the risks and benefits of taking megestrol if you are 65 years of age or older. Older adults should not usually take megestrol to treat loss of appetite and weight loss.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Megestrol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• impotence
• decreased sexual desire
• unexpected vaginal bleeding
• difficulty falling asleep or staying asleep
• gas
• rash

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• nausea
• vomiting
• dizziness
• weakness
• blurred vision
• extreme thirst
• frequent urination
• extreme hunger
• leg pain
• difficulty breathing
• sharp, crushing chest pain or heaviness in chest
• slow or difficult speech
• weakness or numbness of an arm or leg

Megestrol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• nausea
• stomach pain
• shortness of breath
• cough
• lack of energy
• unsteady walking
• chest pain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to megestrol.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.