BromocriptineMgTablet

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BROMOCRIPTINE – ORAL

(BROE-moe-KRIP-teen)

COMMON BRAND NAME(S): Parlodel

USES: Bromocriptine is used alone or with other medications (such as levodopa) to treat Parkinson’s disease. It can improve your ability to move and can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move (“on-off syndrome”).

Bromocriptine is also used to treat high levels of a certain hormone made by the body (prolactin). High levels of prolactin may cause problems such as unwanted breast milk, missed/stopped periods, difficulty becoming pregnant, decreased sperm production, and decreased sexual ability. Bromocriptine may be used to treat a type of tumor which causes the high levels of prolactin (prolactin-secreting adenomas). It can help to reduce the tumor size. Bromocriptine is not recommended for stopping unwanted breast milk after pregnancy, miscarriage, or abortion because of possible serious side effects (such as high blood pressure, seizure, heart attack, stroke).

Bromocriptine is also used to treat high levels of growth hormone (acromegaly).

Bromocriptine is an ergot medication that works by acting like a certain natural substance (dopamine) in the brain. It also prevents the release of certain hormones (growth hormone, prolactin). Bromocriptine can lower these hormone levels, but it does not cure the causes of the increased levels.

HOW TO USE: Take this medication by mouth with food as directed by your doctor, usually 1 or 2 times daily. The dosage is based on your medical condition and response to treatment. For the treatment of acromegaly, the dosage is also based on the growth hormone levels. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as fever, muscle stiffness, and confusion. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Nausea, vomiting, dizziness, drowsiness, lightheadedness, tiredness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people taking bromocriptine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with bromocriptine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

This medication may increase or decrease your blood pressure. Monitor your blood pressure as directed by your doctor. A decrease in blood pressure usually occurs when you are first starting the medication, when your dose is increased, or when you get up suddenly. This effect can cause dizziness, lightheadedness, and fainting. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Tell your doctor right away if you have any serious side effects, including: back pain, swelling of the legs/ankles/feet, change in the amount of urine, persistent runny nose, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, cold or slightly blue fingers/toes, tingling/numbness of hands/feet, mental/mood changes (such as anxiety, confusion, hallucinations, restlessness), unusual strong urges (such as increased gambling, increased sexual urges), slow/fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: severe or persistent headache, seizure, trouble speaking, weakness on one side of the body, vision changes (such as decreased/blurred vision), chest/jaw/left arm pain, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking bromocriptine, tell your doctor or pharmacist if you are allergic to it; or to other ergot medications (such as ergotamine, pergolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain genetic enzyme problems (galactose intolerance, lactase deficiency, glucose-galactose malabsorption), high or low blood pressure, liver disease, heart problems (such as coronary artery disease, heart attack, irregular heartbeat), mental/mood disorders (such as psychosis, depression, schizophrenia), stomach/intestinal problems (such as bleeding, ulcer), blood flow problems (such as peripheral vascular disease, Raynaud’s disease), recent pregnancy (especially with high blood pressure).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. See also Side Effects section.

Bromocriptine can reduce blood flow in the fingers and toes, especially during exposure to cold, increasing the risk of damage (such as frostbite). Keep hands and feet warm during cold weather.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. This medication can cause a dangerous increase in blood pressure during pregnancy. Discuss the risks and benefits with your doctor.

Since this medication may restore fertility in women with high prolactin or growth hormone levels, women who do not want to become pregnant should discuss with their doctor the use of non-hormonal birth control methods (such as condoms, diaphragm) while taking this medication. A pregnancy test is recommended at least once every 4 weeks before your period starts again. If you start having your periods regularly, then a pregnancy test is recommended every time you miss your period. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug may affect breast milk production. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: antipsychotic drugs (such as chlorpromazine, haloperidol, thioridazine), other ergot medications (such as ergotamine), “triptans” (such as sumatriptan, frovatriptan).

Other medications can affect the removal of bromocriptine from your body, which may affect how bromocriptine works. Examples include azole antifungals (such as itraconazole, ketoconazole), boceprevir, cobicistat, delavirdine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as lopinavir, ritonavir), telaprevir, telithromycin, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: mental/mood changes (such as hallucinations, agitation, confusion), severe dizziness, fainting.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, kidney/liver function, eye exams, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

People with Parkinson’s disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson’s disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2015. Copyright(c) 2015 First Databank, Inc.