Patient Medication Information: uses, side effects, how to take - Act Cabergoline
ABOUT THIS MEDICATION
What the medication is used for:
ACT CABERGOLINE is used:
- in the treatment of hyperprolactinaemia (abnormally-high levels of prolactin in the blood);
in the prevention of the production of breast milk in women after child birth, if it is medically advisable not to breast-feed.
What is does:
ACT 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 ACT CABERGOLINE if you:
- are allergic to cabergoline or ergot-like drugs or any of the ingredients in ACT 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 nonmedicinal ingredients are:
Lactose, leucine.
What dosage forms it comes in:
ACT CABERGOLINE is available as 0.5 mg tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use ACT CABERGOLINE talk to your doctor or pharmacist if you:
- are pregnant or plan to get pregnant;
- are breast-feeding or plan to breast-feed;
- have kidney problems;
- have liver problems;
have cardiovascular problems (high or low blood pressure);
- have Raynaud’s syndromes (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 ACT CABERGOLINE, your doctor should assess your heart, lung and kidney functions before starting ACT CABERGOLINE, and continue with regular follow-up during treatment with ACT CABERGOLINE to monitor for any signs and symptoms of fibrotic disorders. Your treatment with ACT 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 ACT CABERGOLINE.
Aggression has been reported in patients who are treated with dopamine agonists including ACT CABERGOLINE.
ACT CABERGOLINE may cause sleepiness. Do not drive, operate machinery, or engage in any activities that requires alertness while taking ACT CABERGOLINE.
Safety and effectiveness of ACT CABERGOLINE in children have not been established.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor or pharmacist about your other medicines, including the one you buy without prescription and natural health products. Drugs interact with ACT CABERGOLINE include:
- medicines to treat high blood pressure;
- medicines containing 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 ACT CABERGOLINE
Tell your doctor and pharmacist that you are taking ACT CABERGOLINE if you are about to start taking any new medicines.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults:
Follow your doctor’s instructions carefully about how much ACT CABERGOLINE to take and when to take it.
To treat hyperprolactinaemia: initial dose is 0.5 mg per week as single dose or two divided doses. The dose may be increased monthly. 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.
ACT CABERGOLINE should be swallowed, preferably with food.
Overdose:
Do not take more tablets than your doctor has told you to.
| In case of drug overdose, contact a health care practitioner, 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like many medicines, 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 ACT CABERGOLINE, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| 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 ACT CABERGOLINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature 15°C to 30°C.
You should not use your medication after the expiration date printed on the carton and label.
Keep all medications out of the reach of children. This medication could harm them.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: -----------------------------------------------------------------------
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited by: Phone: 1-800-268-4127 ext. 3; Email: druginfo@tevacanada.com; or Fax: 1-416-335-4472 This leaflet was prepared by: Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com. Last revised: November 21, 2019