Patient Medication Information: uses, side effects, how to take - Bromocriptine
What is BROMOCRIPTINE used for?
BROMOCRIPTINE is used in adults for the treatment of:
galactorrhea due to high levels of the hormone prolactin. Galactorrhea is a milky discharge from the nipples in women who are not pregnant or breastfeeding. This can happen with or without changes to your menstrual cycle.
- women with menstrual cycle disorders and infertility caused by not having the right amount of the hormone prolactin.
- prolactin-secreting adenomas. These are non-cancerous tumours of the pituitary gland in the brain that produce prolactin.
- prolactin-dependent male hypogonadism. This condition happens when the testicles do not produce enough of the male sex hormone testosterone.
- acromegaly, together with surgery or radiotherapy. Acromegaly is abnormal growth caused by high levels of growth hormone.
- Parkinson’s disease, together with the medicine levodopa. Parkinson’s disease is a disease of the nervous system caused by low levels of dopamine, a substance in the brain.
How does BROMOCRIPTINE work?
BROMOCRIPTINE belongs to a group of medicines called prolactin inhibitors and dopamine agonists. It works by decreasing the release of prolactin and growth hormone in the body, which treats diseases where you need less of these substances. It also works by increasing the release of dopamine in the brain, which treats diseases where you need more of this substance.
What are the ingredients in BROMOCRIPTINE?
Medicinal ingredients: Bromocriptine mesylate
Non-medicinal ingredients:
Tablets: Croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
Capsules: Cornstarch, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40, gelatin, iron oxide black, lactose monohydrate, propylene glycol, red iron oxide, shellac glaze, stearic acid, talc, titanium dioxide, and yellow iron oxide.
BROMOCRIPTINE comes in the following dosage forms:
Tablets: 2.5 mg
Capsules: 5 mg
Do not use BROMOCRIPTINE if:
- You are allergic to bromocriptine mesylate or other ergot alkaloids or any of the non-medicinal ingredients in BROMOCRIPTINE (see What are the ingredients in BROMOCRIPTINE?);
- You have or have ever had pregnancy-induced high blood pressure (toxemia of pregnancy).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BROMOCRIPTINE. Talk about any health conditions or problems you may have, including if you:
- have high or low blood pressure,
- are taking or have recently taken medicine for high or low blood pressure,
- are taking phenothiazines for mental health problems,
- drink alcohol,
- have abnormal growths that develop in your pituitary gland,
- have, or have ever had stomach ulcers and bleeding,
- have severe kidney or liver problems,
- have Parkinson’s disease and are taking the medicine levodopa,
- have had a heart attack or other heart problems,
- have breathing problems,
- have just given birth as you may be more at risk of certain side effects. These are very rare but may include high blood pressure, vision problems, heart attack, seizures (fits), stroke or mental health problems,
- are pregnant or planning to become pregnant,
- are breastfeeding,
are lactose intolerant or have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
Because lactose is a nonmedicinal ingredient in BROMOCRIPTINE.
Other warnings you should know about:
Parkinson’s disease: If you have Parkinson’s disease and are taking BROMOCRIPTINE for a long period of time, your healthcare professional will monitor you for scar tissue formation in the abdomen. See the Serious side effects and what to do about them table, below for more information on this and other serious side effects.
Driving and using machines: BROMOCRIPTINE can cause you to feel dizzy. Give yourself time after taking BROMOCRIPTINE to see how you feel before driving a vehicle or using machinery.
Blood tests and monitoring: BROMOCRIPTINE can cause abnormal blood test results. Your healthcare professional will do blood tests to check your liver, blood, heart, and kidney function regularly while you are taking BROMOCRIPTINE. They will also monitor your blood pressure. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BROMOCRIPTINE:
- Erythromycin used to treat bacterial infections;
- Domperidone used to prevent nausea and vomiting;
- Ergot alkaloids such as ergometrine used to stop blood loss after giving birth and ergotamine tartrate used to treat migraines;
- Alcohol. You should not drink alcohol while you are taking BROMOCRIPTINE as it may increase side effects.
How to take BROMOCRIPTINE:
Follow the directions given to you by your healthcare professional.
Take BROMOCRIPTINE tablets and capsules:
- by mouth;
with food.
Usual dose:
The dose of BROMOCRIPTINE depends on the condition you are being treated for.
Galactorrhea: The usual starting dose is 1.25 - 2.5 mg (1/2 to 1 tablet) at bedtime. This can be increased after 2-3 days to 2.5 mg (1 tablet) two times daily. If required, your healthcare professional will increase the dose to 2.5 mg (1 tablet) three times daily.
Prolactin-dependent menstrual disorders and infertility: The usual starting dose is 1.25 - 2.5 mg (1/2 to 1 tablet) at bedtime. This can be increased after 2-3 days to 2.5 mg (1 tablet) two times daily. If required, your healthcare professional will increase the dose to 2.5 mg (1 tablet) three times daily.
Prolactin secreting adenomas: The usual starting dose is 1.25 mg (1/2 a tablet) 2 or 3 times daily. The usual maintenance dose is 5 - 7.5 mg daily (2 to 3 tablets). If required, your healthcare professional will increase your dose slowly over a period of several weeks to 10 - 20 mg (4 to 8 tablets or 2 to 4 capsules) daily.
Prolactin dependent male hypogonadism: The usual starting dose is 1.25 - 2.5 mg (1/2 to 1 tablet) at bedtime. This can be increased after 2 to 3 days to 2.5 mg (1 tablet) two times daily. If required, your healthcare professional will increase the dose to 2.5 mg (1 tablet) three times daily.
Acromegaly: The usual starting dose is 1.25 - 2.5 mg (1/2 to 1 tablet) at bedtime. This can be increased slowly over a period of 2 to 4 weeks to 10 -20 mg (4 to 8 tablets or 2 to 4 capsules) daily. Daily doses of 20 mg should be taken in four equally divided doses.
Parkinson’s Disease: The usual starting dose is 1.25 mg (1/2 tablet) at bedtime. This will be increased to 2.5 mg daily in two divided doses. If required, your healthcare professional will increase the dose by 2.5 mg, taken in 2 or 3 divided doses, every 2 to 4 weeks. The maximum dose is 40 mg (16 tablets or 8 capsules) daily.
Overdose:
Symptoms of overdose include nausea, vomiting, dizziness, drowsiness, low blood pressure, sweating and hallucinations.
| If you think you, or a person you are caring for, have taken too much BROMOCRIPTINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose, take it as soon as you remember. 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 dose.
What are possible side effects from using BROMOCRIPTINE?
These are not all the possible side effects you may have when taking BROMOCRIPTINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting
- diarrhea, constipation
- loss of appetite
- stomach pain
- abdominal cramps, abdominal discomfort
- headache
- dizziness, lightheadedness
- nasal congestion or stuffiness
- fatigue, drowsiness
- weakness, lack of energy
- insomnia (trouble sleeping), nightmares
- anxiety, nervousness
- skin rash
- blurred vision
- ringing in the ears
- leg cramps
- numbness or tingling of the hands and feet
- hair loss
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in appetite or weight, reduced sex drive and thoughts of death or suicide | √ | ||
| Hallucinations: seeing, hearing or sensing things that are not real | √ | ||
| Movement disorders: abnormal involuntary movements of the face, arms, legs or body, “on-off” phenomenon (switch between mobility and immobility), ataxia (impaired coordination) | √ | ||
| Shortness of breath | √ | ||
| Vertigo: sensation of spinning and loss of balance | √ | ||
| Visual disturbances | √ | ||
| UNCOMMON | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
| RARE | |||
| Abnormal sensations in the hands and feet: tingling of fingers, cold feet, numbness, muscle cramps of feet and legs, exacerbation of Raynaud’s syndrome (pale or white fingers and toes, caused by cold temperatures or stress) | √ | ||
| Blepharospasm: uncontrolled squeezing or twitching of the eyelids | √ | ||
| Dry mouth, trouble swallowing | √ | ||
| Edema: swelling of the legs, ankles or feet | √ | ||
| Erythromelalgia: burning pain, severe redness, and increased skin temperature in the hands and feet, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| that either comes and goes or is continuous | |||
| Gastrointestinal problems (ulcer, bleeding): stomach pain, blood in the vomit or stool, dark black or tarry stool | √ | ||
| Heart problems: fast, slow or irregular heartbeat | √ | ||
| Paresthesia: abnormal skin sensation, feeling like pins and needles | √ | ||
| Lung problems: cough, shortness of breath, chest pain, fatigue | √ | ||
| Retroperitoneal fibrosis (scar tissue formation in the abdomen): back pain, swelling of the extremities, decreased urination, nausea, vomiting, fatigue | √ | ||
| Seizures convulsions or fits, with or without loss of consciousness | √ | ||
| Skin changes: coloured patches, spots on skin | √ | ||
| Urinary problems: change in urinary frequency, involuntary leakage of urine (incontinence), inability to urinate | √ | ||
| VERY RARE | |||
| Feeling sleepy or drowsy during the day, suddenly falling asleep without warning | √ | ||
| Heart problems: abnormal thickening of the heart valves, inflammation or leaking of fluid in the heart - these may cause shortness of breath, chest pain, dizziness, lightheadedness, weakness, swelling in your ankles and feet | √ | ||
| Neuroleptic Malignant Syndrome: muscular stiffness, high fever, altered consciousness, high blood pressure, excessive salivation | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| May happen if you stop taking BROMOCRIPTINE suddenly. | |||
| UNKNOWN | |||
| Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | √ | ||
| Increased sexual drive or an increase in sexual thoughts or feelings | √ | ||
Low blood pressure: dizziness, fainting, lightheadedness, shock May occur when you go from lying or sitting to standing up. | √ | ||
| Mental health problems | √ | ||
| Myocardial Infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, possible irregular heartbeat | √ | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking, loss of balance | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15 and 30°C.
Protect from light. Protect tablets from moisture.
Keep out of reach and sight of children.
If you want more information about BROMOCRIPTINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://www.aapharma.ca/en/product-listing, or by calling 1-877-998-9097.