Patient Medication Information: uses, side effects, how to take - Jamp Cabergoline
ABOUT THIS MEDICATION
What the medication is used for:
JAMP Cabergoline is used:
- in the treatment of hyperprolactinemia (abnormally high levels of prolactin in the blood);
in the prevention of the production of breast milk in women after childbirth, if it is medically advisable not to breast-feed.
What it does:
JAMP Cabergoline works by acting on a gland called the pituitary which is located at the base of the brain. By stimulating this gland, it prevents the production of the hormone prolactin.
When it should not be used:
Do not take JAMP Cabergoline if you:
- are allergic to cabergoline or ergot-like drugs or any of the ingredients in JAMP Cabergoline;
- have uncontrolled high blood pressure;
- have heart valve problems (cardiac valvulopathy);
- have or have had lung or heart problems related to fibrotic tissues (tissues are hardened due to scarring).
What the medicinal ingredient is:
Cabergoline
What the important non-medicinal ingredients are:
Citric acid anhydrous, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
What dosage forms it comes in:
JAMP Cabergoline 0.5 mg tablets are white to off-white, scored, oval-shaped, flat face, bevelled-edge tablet, debossed with letter “c” and number “05” on either side of break line and plain on other side.
Each tablet contains 0.5 mg of cabergoline.
WARNINGS AND PRECAUTIONS
BEFORE you use JAMP Cabergoline talk to your doctor or pharmacist if you:
- are pregnant or plan to get pregnant;
- are breastfeeding or plan to breastfeed;
- have kidney problems;
- have liver problems;
- have cardiovascular problems (high or low blood pressure);
- have Raynaud’s Syndrome (resulting from poor blood circulation in the extremities such as fingers and toes which may turn blue and feel cold);
- have ulcer or bleeding in the stomach or intestines;
- have had pregnancy complications with high blood pressure (preeclampsia or eclampsia);
- have a history of mental illness.
If you need long-term treatment with JAMP Cabergoline, your doctor should assess your heart, lung and kidney functions before starting JAMP Cabergoline, and continue with regular follow-up during treatment with JAMP Cabergoline to monitor for any signs and symptoms of fibrotic disorders. Your treatment with JAMP Cabergoline will be discontinued at the first sign of fibrotic disorders.
Impulse control disorders such as addictive gambling, excessive eating or spending and increased sex drive (libido, hypersexuality) have been reported in patients who are treated with dopamine agonists including cabergoline.
Aggression has been reported in patients who are treated with dopamine agonists including cabergoline.
Cabergoline may cause sleepiness. Do not drive, operate machinery, or engage in any activities that require alertness while taking JAMP Cabergoline.
The safety and effectiveness of cabergoline in children have not been established.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist about your other medicines, including the ones you buy without a prescription and natural health products. Drugs that interact with JAMP Cabergoline include:
- medicines to treat high blood pressure;
- medicines that contain ergot alkaloids (e.g., to treat migraine headache);
- macrolide antibiotics (e.g., erythromycin);
- dopamine antagonists such as medicines to treat mental illness and prevent nausea (e.g., phenothiazines, butyrophenones, metoclopramide).
While taking JAMP Cabergoline
Tell your doctor and pharmacist that you are taking JAMP Cabergoline if you are about to start taking any new medicines.
Usual dose:
Adults:
Follow your doctor’s instructions carefully about how much JAMP Cabergoline to take and when to take it.
To treat hyperprolactinemia: initial dose is 0.5 mg per week as a single dose or two divided doses. The dose may be increased monthly. The recommended dose ranges from 0.25 mg to 2 mg per week.
To prevent the production of milk, the recommended dose is two tablets taken once, on the first day after delivery of the child.
JAMP Cabergoline should be swallowed, preferably with food.
Overdose:
Do not take more tablets than your doctor has told you to.
| If you think you, or a person you are caring for, have taken too much JAMP Cabergoline, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you should forget to take your tablet at the usual time, take it as soon as you remember up to 1 day before your next scheduled dose. Do not double dose.
Like many medicines, JAMP Cabergoline may cause side effects.
Tell your doctor or pharmacist right away if you suffer from any of the following side effects while taking this medication:
- dizziness
- headache
- nausea or vomiting
- constipation
- abdominal pain, or heartburn, or pain in the stomach
- weakness or tiredness
- breast pain
- hot flashes
- depression
- shortness of breath
- swelling
The most common side effects are nausea, headache, dizziness / vertigo, decreases in blood pressure without any symptoms and abdominal pain. Less commonly reported side effects are palpitations, pain in the upper middle of the abdomen, somnolence, nose bleeding, and temporary blindness in one half of the visual field of one or both eyes.
Tell your doctor if you or your family / caregiver notices that you are developing urges or cravings to behave in ways that are unusual for you, and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or
an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
Check with your doctor or pharmacist right away if you have any problems while taking JAMP Cabergoline, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
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 | |
Low blood pressure Fainting Disorders related to fibrotic tissues (which may appear following these first signs and symptoms: dyspnoea, shortness of breath, lower limb oedema, persistent cough or chest pain) | ||
√ √ | √ | |
This is not a complete list of side effects. For any unexpected effects while taking JAMP Cabergoline, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature, 15-25°C, in tight containers. Protect from light.
You should not use your medication after the expiration date printed on the carton and label.
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Keep all medications out of reach and sight of children.
This medication could harm them.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by: Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
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. |
MORE INFORMATION
If you want more information about JAMP Cabergoline:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada