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WHAT ARE THE SIDE EFFECTS OF PARLODEL® (BROMOCRIPTINE MESYLATE)?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Parlodel

As with all medicines, patients treated with Parlodel® (bromocriptine mesylate) may have side effects, although not everyone gets them. Sometimes you may need medical treatment if you experience side effects.

The side effects listed below have been reported from patients taking Parlodel. Your doctor may be able to reduce some side effects by lowering your dose of Parlodel.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects:

  • Nausea or vomiting
  • Headache
  • Dizziness or light-headedness, especially upon standing
  • Fatigue
  • Drowsiness or sleepiness (if you have extreme sleepiness or sudden onset of sleep in the middle of daytime activities, tell your doctor immediately)
  • Unexplained shortness of breath or difficulty breathing
  • Sinus congestion
  • Constipation
  • Diarrhea
  • Nervousness
  • Difficulty sleeping or restlessness
  • Physical excitement or muscular activity associated with anxiety, or mental tension such as pacing, tapping of feet, or another repeated action
  • Feeling unsteady on your feet
  • Depression
  • Dry mouth, metallic taste
  • Sore eyes or blurred vision
  • Hair loss
  • Burning sensation in the breasts
  • Leg cramps or burning sensation in the feet
  • Painful, tingling or pale fingers and toes when exposed to cold
  • Buzzing, hissing, whistling, ringing, or other persistent noise in the ears
  • Uncontrolled body movements (such as uncontrollable twitching, jerking, or writhing)
  • An irregular, slow, or fast heart beat
  • Heartburn, recurrent stomach pain
  • Swelling of the arms or feet due to fluid buildup
  • Sudden watery discharge from your nose
  • Skin rash or itchiness
  • Lower back pain, swollen legs, and pain when passing urine
  • Behavioral changes such as self-harm, urge to gamble, failure to resist temptation or impulse, or increased sexual desire
  • Strange or disturbing thoughts or moods

Tell your doctor immediately or go to the emergency at the nearest hospital if you develop:

  • Severe persistent headache or vision problems
    • Some women who have taken Parlodel to prevent breast milk production have had seizures, high blood pressure, stroke, heart attack, or mental disorder. It is not known whether these problems are caused by Parlodel or are complications of giving birth.
  • Any signs of stomach bleeding such as red or black bowel movements, bloody diarrhea, bleeding from the back passage, or vomiting blood
    • Some people being treated with high doses of Parlodel for acromegaly have had serious stomach bleeding.
  • Confusions, hallucinations or sudden sleep attack
    • Some people being treated with Parlodel for Parkinson’s disease, especially in high doses, have experienced mental changes.
  • Muscle stiffness, agitation, very high fever, or heart problems
  • Wheezing, cough, or other breathing problems; chest pain; back pain; swelling of the feet; or kidney problems while taking Parlodel

When Parlodel is used for a long time to treat Parkinson’s disease, it can affect the lungs, heart, or abdomen. Your doctor may ask you to have regular chest x-rays to see if you are developing any problems.

Some people may have other side effects not yet known or mentioned.

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 Validus Pharmaceuticals LLC at 1-866-982-5438.

PEDIATRIC USE:

The safety and efficacy of bromocriptine for the treatment of prolactin-secreting pituitary adenomas has been established in patients age 16 to adult. No data are available for bromocriptine use in children under the age of 8 years.

GERIATRIC USE:

Clinical studies have not been conducted in a sufficient number of patients to determine whether the elderly respond differently from younger subjects. However, other reported clinical experiences have not identified differences in response or tolerability between elderly and younger patients.

OVERDOSAGE:

The most commonly reported symptoms associated with acute Parlodel overdose are

  • Nausea
  • Vomiting
  • Constipation
  • Diaphoresis
  • Dizziness
  • Pallor
  • Severe hypotension
  • Malaise, lethargy, drowsiness,
  • Confusion , delusions, and hallucinations
  • Repetitive yawning

Seek emergency medical attention or call the Poison Help Line at 1-800-222-1222.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

THIS PACKAGE INSERT IS FOR USE WITH PARLODEL® (BROMOCRIPTINE MESYLATE) ONLY

CONTRAINDICATIONS

You should not use Parlodel® (bromocriptine mesylate) if you are hypersensitive to bromocriptine or to any of the other ingredients in Parlodel, have uncontrolled hypertension (high blood pressure), if you are being treated for hyperprolactinemia (a condition of elevated levels of prolactin – the protein responsible for breast development during pregnancy and lactation), have sensitivity to any ergot alkaloids (chemicals produced by certain plant fungi).

Parlodel should be withdrawn when pregnancy is diagnosed.

In the event that you are pregnant and your doctor reinstitutes Parlodel therapy to control a rapidly expanding macroadenoma (pituitary tumors that are larger than ten millimeters in diameter), and you experience sudden high blood pressure, your doctor must weigh the benefit of continuing Parlodel against the possible risk of its use.

When Parlodel is being used to treat acromegaly – a disorder caused by excessive production of growth hormone that results in abnormal growth of bones including hands, feet, and face; or prolactemia, a condition charactertized by a deficiency of prolactin; or Parkinson’s disease, and you subsequently become pregnant, your doctor will make a decision as to whether the therapy continues to be medically necessary or should be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (eclampsia, preeclampsia, or pregnancy-induced hypertension) unless your doctor determines that withdrawal of Parlodel is considered to be medically unwise.

Parlodel should not be used during the postpartum period if you have a history of heart disease or other severe cardiovascular conditions unless your doctor determines that withdrawal is not medically indicated.

WARNINGS

Your doctor should conduct a complete evaluation of your pituitary gland before starting treatment with Parlodel.

The safety of Parlodel treatment during pregnancy to mother and fetus has not been established.

If you become pregnant while taking Parlodel, tell your doctor immediately. Your doctor should monitor you closely during pregnancy if you are taking Parlodel. Adenomas on the pituitary may expand and compress the optic nerve, which may require emergency pituitary surgery. In most cases, optic nerve compression resolves after delivery. Reinitiating Parlodel may improve vision if you have suffered from nerve compression during pregnancy.

Parlodel may cause extreme sleepiness, and episodes of sudden sleep onset, particularly if you have Parkinson’s disease. You should not drive or operate heavy machinery while taking Parlodel. If you experience extreme sleepiness or sudden sleep onset, your doctor may reduce your Parlodel dose or discontinue your Parlodel therapy.

Low blood pressure may also occur with Parlodel treatment for any indication; particular care should be exercised when driving a vehicle or operating machinery. In rare cases, high blood pressure, heart attack, seizures, and stroke have occurred in women who are taking Parlodel for the inhibition of lactation. Any of these reactions may occur, even in women who have had normal pregnancies and deliveries. If you develop a constant and/or progressively severe headache or visual disturbances, seek emergency help immediately.

Use of Parlodel for the prevention of lactation or if you have uncontrolled high blood pressure is not recommended. Parlodel therapy should be discontinued if you are being treated for hyperprolactinemia and become pregnant.

When you are undergoing Parlodel treatment for a rapidly expanding macroadenoma, and you experience severe high blood pressure associated with pregnancy, the benefit of continuing with Parlodel treatment must be weighed against the possibility of developing high blood pressure. Likewise, when Parlodel is being used to treat acromegaly or Parkinson’s disease and you subsequently become pregnant, the benefit of Parlodel therapy must be weighed against the possibly of high blood pressure. If you develop high blood pressure, Parlodel should be withdrawn unless your doctor decides that withdrawal would cause more harm than good.

Use of Parlodel with other ergot alkaloids is not advised. Similarly, use of Parlodel with medicines for high blood pressure is not advised.

Your blood pressure should be monitored if you are taking Parlodel. If high blood pressure, severe or unremitting headaches or other evidence of central nervous system problems arise, Parlodel therapy should be discontinued.

Long-term and high-dose treatment with Parlodel can cause fluid build-up, scarring, development of fibrous tissue, and inflammation of heart and lung tissue. If you have these symptoms, your doctor should examine you thoroughly, and discontinuation of Parlodel treatment should be considered.

PRECAUTIONS

Safety and efficacy of Parlodel have not been established in patients with kidney or liver disease. Parlodel should be used with caution in patients with a history of psychosis or cardiovascular disease. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption should not take Parlodel.

Hyperprolactemic States: Visual impairment can occur in patients having macroprolactemia. Parlodel treatment can reduce hyperprolactermia; however, there is a chance of visual impairment even with successful treatment. In these instances, your doctor should assess whether the Parlodel dosage should be reduced, even if there is some elevation of prolactin and tumor re-expansion.

Careful assessment of the pituitary is essential to detect the presence of a prolactin-secreting adenoma, especially when you are trying to become pregnant. If you are not seeking pregnancy, you should use contraceptive measures, other than oral contraceptives, during Parlodel treatment. Pregnancy testing is recommended every 4 weeks during Parlodel treatment. Parlodel treatment should be discontinued as soon as pregnancy is detected. If you have any symptoms of enlargement or a previously undetected or existing prolactin-secreting tumor, you should be monitored closely during pregnancy.

Acromegaly: Numb fingers and toes in response to cold is a side effect seen with some acromegalic patients treated with Parlodel. This condition can be reversed by reducing the dose of Parlodel and may be prevented by keeping the fingers warm. There is no evidence that Parlodel increases the incidence of peptic ulcers in acromegalic patients treated with Parlodel; however, some cases of severe gastrointestinal bleeding, sometimes fatal, have been reported.

Tumor expansion should be monitored during Parlodel treatment.

Parkinson’s Disease: Safety during long-term use for more than 2 years at the doses required for Parkinsonism has not been established.

You should be periodically monitored for liver, kidney, and cardiovascular function and should have regular blood tests.

Patients who are taking Parlodel at the same time as levedopa may have hallucinations that usually resolve when the Parlodel dosage is decreased; however, in some instances, Parlodel therapy may need to be discontinued.

Patients treated with anti-Parkinson’s medicines can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. You should discuss any of these urges with your doctor.

If you have any history of heart problems, speak with your doctor as you may need monitoring during your Parlodel treatment.

You should be monitored for melanomas on a regular basis when using Parlodel for any indication.

DRUG INTERACTIONS

Alcohol may potentiate the side effects of Parlodel. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. Caution should be used when administering Parlodel with drugs that are strong inhibitors of CYP3A4. Concomitant use of Parlodel with other ergot alkaloids is not recommended.

PREGNANCY

There have been no significant studies that show that Parlodel causes a risk to the fetus in any trimester.

Nursing Mothers: Parlodel should not be used during lactation in postpartum women.

PEDIATRIC USE

The safety and efficacy of Parlodel for the treatment of prolactin-secreting pituitary adenomas have been established in patients age 16 to adult. Safety and efficacy of Parlodel has not been established in pediatric patients under the age of 8 years. There are limited data supporting the use of Parlodel for the treatment of prolactin-secreting adenomas in patients aged 11-15.

GERIATRIC USE

There are no studies demonstrating that patients older than 65 repond to Parlodel differently than younger patients.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch