THE INFORMATION FOR THE CONSUMER WARNINGS AND PRECAUTIONS
Lederle LEUCOVORIN® In very rare cases sloughing of the skin, rarely leading to death, calcium folinate tablets has been reported in patients receiving Leucovorin along with other medications known to have similar side-effects. This leaflet is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Lederle Leucovorin should only be used under the direct supervision of a Leucovorin Calcium. Contact your doctor or pharmacist if clinician experienced in the use of cancer chemotherapeutic you have any questions about the drug. agents.
BEFORE you use LEUCOVORIN talk to your doctor or pharmacist if: ABOUT THIS MEDICATION . You have symptoms of gastrointestinal disorders. . You are taking cytotoxic drugs (hydroxycarbamide What the medication is used for: cytarabine, mercaptopurine, thioguanine). . You are epileptic and are being treated with The medication is used - phenobarbital, primidone, phenytoin and succinimides. a) To diminish the toxicity and counteract the effect of impaired . If you are Pregnant or Nursing. METHOTREXATE elimination. b) To treat the megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of INTERACTIONS WITH THIS MEDICATION pregnancy and infancy. LEUCOVORIN can interfere with the breakdown or metabolism of certain drugs. In particular, you should inform your doctor if What it does: you are taking any of the following:
LEUCOVORIN is a reduced form of folic acid. LEUCOVORIN . Cytotoxic drugs - 5-fluorouracil (5FU), Methotrexate (High limits METHOTREXATE action on normal cells by competing doses of LEUCOVORIN may reduce the efficacy of with METHOTREXATE for the same transport processes into the Methotrexate. LEUCOVORIN may enhance the toxicity of cell. LEUCOVORIN rescues bone marrow and gastrointestinal fluorouracil.) cells from METHOTREXATE but has no apparent effect on pre- . Folic acid antagonists – cotrimxazole, pyrimethamine existing METHOTREXATE nephrotoxicity. . Anti-epileptic substances - phenobarbital, primidone, phenytoin and succinimides.
When it should not be used:
Do not take LEUCOVORIN PROPER USE OF THIS MEDICATION . if you are allergic (hypersensitive) to calcium folinate or any of the other ingredients of LEUCOVORIN OR Usual dose: . If you have megaloblasic anaemia due to Vitamin B12 Take your dose as prescribed by the physician. deficiency Overdose:
What the medicinal ingredient is: If you take too much LEUCOVORIN (Overdose): . Immediately call your doctor or go to the nearest hospital LEUCOVORIN Calcium (also known as calcium folinate). emergency department . Do this even if you have no signs of discomfort . Always take the labelled medicine bottle with you, even if it What the important nonmedicinal ingredients are: is empty
Non-medicinal ingredients are: Lactose, Magnesium Stearate, Missed Dose: Microcrystalline Cellulose, Sodium Starch Glycolate and Starch Not Applicable. Pregelatinized 1500.
What dosage forms it comes in:
Tablet: 5 mg LEUCOVORIN as LEUCOVORIN calcium
Lederle Leucovorin (calcium folinate) Prescribing Information Page 19 of 20
This is not a complete list of side effects. For any unexpected SIDE EFFECTS AND WHAT TO DO ABOUT THEM effects while taking LEUCOVORIN, contact your doctor or pharmacist. Undesirable effects have been rarely reported.
Allergic sensitization, including anaphylactoid/anaphylactic reactions (including shock) and urticaria, has been reported HOW TO STORE IT following administration of folinic acid. Tablets should be stored at 15-30°C. Protect from light.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with Stop taking REPORTING SUSPECTED SIDE EFFECTS your doctor or drug and pharmacist call your You can report any suspected adverse reactions associated with doctor or the use of health products to the Canada Vigilance Program by Only In all pharmacist one of the following 3 ways: if cases ------severe Report online at Very . Mucositis https://www.canada.ca/en/health-canada/services/drugs-health- Common (swelling and/or products/medeffect-canada/adverse-reaction-reporting.html ulcers of the Call toll-free at 1-866-234-2345 mouth, lip, throat and upper Complete a Canada Vigilance Reporting Form and: gastrointestinal - Fax toll-free to 1-866-678-6789, or tract) - Mail to: . Stomatitis (mouth Canada Vigilance Program ulcers) Health Canada . Chelitis (swelling Postal Locator 1908C of the lip) Ottawa, Ontario K1A 0K9 Common . Nausea,
. Vomiting, Postage paid labels, Canada Vigilance Reporting Form and the . Diarrhea adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at . Palmar-Plantar Erythrodys- https://www.canada.ca/en/health-canada/services/drugs-health- aesthesia (Hand products/medeffect-canada/adverse-reaction-reporting.html and Foot Syndrome) NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada . Allergic reactions Uncommon Vigilance Program does not provide medical advice. . Any skin disorders
MORE INFORMATION Rare . Seizures /syncope (Fainting / Dizziness) This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Very Rare . Anaphylactoid / anaphylactic Pfizer Canada Inc., at: 1-800-463-6001 or at www.pfizer.ca reactions (including shock) This leaflet was prepared by Pfizer Canada Inc. Frequency . Allergic reactions, urticaria undetermined Last revised: October 10, 2018 . Fever . Hyperammonemia (excess ammonia in the blood)
Lederle Leucovorin (calcium folinate) Prescribing Information Page 20 of 20