This medication guide provides information about the Parlodel brand of bromocriptine. Cycloset is another brand of bromocriptine that is not covered in this medication guide.

The Parlodel brand of bromocriptine is used to treat certain conditions caused by a hormone imbalance in which there is too much prolactin in the blood (hyperprolactinemia). High prolactin levels may cause sexual problems, hot flashes, menstrual problems or infertility in women, muscle loss in men, breast enlargement in men and women, and lack of sexual development in adolescents. Parlodel is also used to treat these disorders when they are caused by a noncancerous tumor of the pituitary gland that can overproduce prolactin.

Parlodel is sometimes used together with surgery or radiation in treating acromegaly, a condition caused by a pituitary gland tumor that produces too much growth hormone.

Parlodel is also used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

Bromocriptine may also be used for purposes not listed in this medication guide.

You should not use Parlodel if you have uncontrolled high blood pressure, if you have high blood pressure caused by pregnancy (eclampsia or preeclampsia), or if you recently had a baby and you have a history of coronary artery disease or severe heart disease. You may need to stop taking Parlodel if you become pregnant during treatment. Follow your doctor's instructions.

Parlodel may cause you to fall asleep suddenly, even after feeling alert. Avoid driving or other hazardous activity until you know how this medicine will affect you.

Do not breastfeed.

Tell your doctor right away if you become pregnant while taking bromocriptine.

Bromocriptine (Parlodel) comes as a capsule and a tablet to take by mouth. Bromocriptine (Cycloset) comes as a tablet to take by mouth. When bromocriptine (Parlodel) is used to treat hyperprolactinemia, it is usually taken once a day with food. When bromocriptine (Parlodel) is used to treat acromegaly, it is usually taken once a day at bedtime with food. When bromocriptine (Parlodel) is used to treat Parkinson's disease, it is usually taken twice a day with food. Bromocriptine (Cycloset) is usually taken once a day with food within 2 hours of waking in the morning. Take bromocriptine 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 bromocriptine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of bromocriptine and gradually increase your dose, not more than once every 2 to 28 days. The timing of the dose increases depends on the condition being treated and on your response to the medication.

Bromocriptine may help to control your condition but will not cure it. It may take some time for you to feel the full benefit of bromocriptine. Do not stop taking bromocriptine without talking to your doctor. If you suddenly stop taking bromocriptine, you may experience a lack of interest or concern for usual activities or things you usually care about, anxiety, depression, tiredness, difficulty falling asleep or staying asleep, sweating, or pain. Your doctor will probably decrease your dose gradually.

If you are taking bromocriptine (Cycloset) for diabetes, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take Parlodel with food, even if you take it at bedtime.

You will need frequent medical tests.

You should not stop using Parlodel suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use this medicine if you are allergic to bromocriptine or to an ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

You should not use Parlodel if:

• you are breastfeeding;

• you have uncontrolled high blood pressure (hypertension);

• you have hypertension caused by pregnancy (including eclampsia and preeclampsia); or

• you recently had a baby and you have a history of coronary artery disease or severe heart disease.

Bromocriptine may contain lactose. Before taking Parlodel, tell your doctor if you have a hereditary form of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

Tell your doctor if you have ever had:

• high or low blood pressure, heart disease, or a heart attack;

• liver or kidney disease;

• a tumor of the pituitary gland;

• a stomach ulcer, stomach or intestinal bleeding; or

• mental illness or psychosis.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. A pituitary tumor in the mother can expand during pregnancy. High blood pressure can also occur during pregnancy and bromocriptine could be dangerous if taken by a pregnant woman with high blood pressure.

Some women take Parlodel in order to normalize menstrual periods and increase their chances of becoming pregnant. Tell your doctor as soon as you become pregnant. You may need to stop taking Parlodel.

If you are not taking Parlodel to help you get pregnant, use a barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy during treatment. Your doctor may also want you to have a pregnancy test every 4 weeks during treatment.

Do not breastfeed while using this medicine.

Parlodel should not be given to a child younger than 11 years old.

Take the medicine with food as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, constipation, sweating, pale skin, dizziness, drowsiness, yawning, confusion, hallucinations, and fainting.

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 light, excess heat, and moisture (not in the bathroom).

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.

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

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bromocriptine may cause serious side effects. Call your doctor at once if you have:

• numbness, pain, and paleness or discoloration in your fingers or toes (especially in cold weather);

• vision problems, constant runny nose;

• chest pain, pain when you breathe, fast heart rate, rapid breathing, feeling short of breath (especially when lying down);

• back pain, swelling in your ankles or feet, urinating less than usual or not at all;

• confusion, hallucinations, feeling like you might pass out;

• muscle movements you cannot control, loss of balance or coordination; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Parlodel may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects of bromocriptine may include:

• dizziness;

• headache;

• hallucinations;

• nausea, constipation; or

• abnormal involuntary movements.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect Parlodel, especially medicines to treat:

• migraine headaches;

• infections;

• psychotic conditions such as bipolar disorder or schizophrenia;

• Parkinson's disease;

• restless leg syndrome; or

• acromegaly (too much growth hormone).

This list is not complete and many other drugs may affect Parlodel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Parlodel can make certain migraine headache medicines less effective when taken at the same time. Avoid taking Parlodel within 6 hours before or 6 hours after you take an ergot headache medicine (such as dihydroergotamine, ergotamine, ergonovine, methylergonovine).

Many other drugs can interact with bromocriptine. Below is just a partial list. Tell your doctor if you are using:

• an antidepressant, a sedative or opioid medication, medicines to treat psychiatric disorders;

• an antibiotic or antifungal medication, anti-malaria drugs;

• asthma or allergy medication;

• cancer medicine, medicines used to prevent organ transplant rejection;

• cholesterol-lowering drugs such as simvastatin (Zocor);

• an oral diabetes medication;

• heart or blood pressure medications, heart rhythm medication;

• HIV or AIDS medications;

• seizure medications;

• sildenafil (Viagra) and other erectile dysfunction medicines; or

• stomach acid reducers.

This list is not complete and there are many other drugs that can interact with bromocriptine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Keep all appointments with your doctor, eye doctor, and the laboratory. Your blood pressure should be checked periodically. Your doctor may order regular eye examinations and certain lab tests to check your body's response to bromocriptine. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to bromocriptine (Cycloset). Your doctor will also tell you how to check your response to bromocriptine (Cycloset) by measuring your blood or urine sugar levels at home. Follow these directions carefully.

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.