Parlodel® (bromocriptine mesylate) capsules will be available shortly

HOW SHOULD THIS MEDICINE BE USED?

Parlodel® (bromocriptine mesylate) capsules come as a capsule, which can be taken by mouth. It is recommended that Parlodel be taken with food. The specific dosage of Parlodel that your doctor prescribes for you will depend on your medical condition and your response to treatment.

Use this medicine according to you doctor’s instructions and take it at the same time each day in order to get the most benefit from it. Do not suddenly stop taking this medicine without consulting your doctor because your condition may worsen if you suddenly stop taking Parlodel.

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

Because of possible serious side effects (e.g., high blood pressure, seizure, heart attack, stroke), Parlodel is not always recommended for stopping unwanted breast milk.

WHO SHOULD NOT TAKE PARLODEL?

Those people having hypersensitivity to bromocriptine or to any of the inactive ingredients (colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide) of Parlodel, uncontrolled hypertension, and sensitivity to any ergot alkaloids should talk to their doctors before taking Parlodel.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Parlodel should be withdrawn when pregnancy is diagnosed.

Do not take Parlodel if you have any of the following medical conditions:

  • High blood pressure that is not controlled (uncontrolled hypertension)
  • Toxemia during pregnancy or immediately after giving birth, with symptoms such as high blood pressure, fluid build-up and convulsions
  • Severe heart disease
  • Mental illness now or in the past
  • A history of coronary artery disease or other severe cardiovascular conditions unless your doctor considers use of Parlodel to be medically necessary
  • You are breast feeding

If you are not sure whether any of the above conditions apply to you, your doctor can advise you.

Do not take Parlodel after the expiry date printed on the packaging or if the packaging is torn or shows signs of tampering.

Before you start to take Parlodel:

Tell your doctor if you have any of the following health problems/medical conditions:

  • Diabetes
  • Problems with your liver
  • Black stools or stomach ulcers
  • Problems with blood circulation
  • Excessive drowsiness, or if you unexpectedly fall asleep

Your doctor may want to take special precautions if you have any of the above conditions.

Tell your doctor if you are pregnant or intend to become pregnant.

Your doctor can discuss the benefits and risks of taking this medicine during pregnancy.

Tell your doctor if you are breast-feeding or intend to breast feed.

Parlodel prevents the production of breast milk due to its effects on prolactin.

Tell your doctor if you are lactose intolerant.

This medicine contains lactose.

TAKING OTHER MEDICINES:

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Parlodel may interfere with each other. These include:

  • Medicines containing ergot alkaloids, such as medicines used to treat migraine headaches
  • Medicines used to treat high blood pressure
  • Any other medicine that may either raise or lower blood pressure
  • Levodopa, a medicine for Parkinson’s disease
  • Some antibiotics used to treat infections, such as erythromycin
  • Octreotide, a medicine used to treat acromegaly and certain tumors
  • Medicines used to treat HIV/AIDS, such as ritonavir, nelfinavir, indinavir, and delavirdine
  • Medicines used to treat fungal infections such as ketoconazole, itraconazole, and voriconizole
  • Dopamine antagonists, such as phenothiazides, butyrophenones thioxanthenes, metoclopramide, and domperidone
  • Phenylpropanolamine (a medicine used to treat nasal congestion)
  • Bromocriptine, a medicine used to treat Parkinson’s disease
  • Sumatriptan, a drug used to treat migraine
  • Ergot alkaloids, medicines used to treat migraine and post-delivery bleeding

You may need to take different amounts of medicines or to take different medicines while you are taking Parlodel. Your doctor and pharmacist have more information.

Make sure you tell your doctor about any of these medicines or over the counter drugs before you start taking Parlodel.

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 which 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 that are taking Parlodel for the inhabitation 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 has 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 which 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 which 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 has 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 is limited data supporting the use of Parlodel for the treatment of prolactin-secreting adenomas in patients age 11-15.

GERIATRIC USE

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