Details for: CUPRIMINE
Company: BAUSCH HEALTH, CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00016055 | CUPRIMINE | PENICILLAMINE | 250 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CUPRIMINE (penicillamine capsules, USP) is indicated in the treatment of:
- Wilson's disease (a disease which causes the body to retain copper);
- chronic lead poisoning,
- cystinuria (buildup of cystine stones in the kidneys and bladder), and
- severe, active rheumatoid arthritis which fails to respond to conventional treatment.
What it does
Penicillamine is a chelating agent that binds and removes copper and lead from the body. Penicillamine also reduces excess cystine excretion in cystinuria. The mechanism of action of penicillamine in rheumatoid arthritis is not known although it appears to suppress disease activity.
When it should not be used
Do not use CUPRIMINE if you:
- are allergic to penicillamine or to any ingredient in the formulation. (See: What the important nonmedicinal ingredients are);
- have severe kidney problems;
- have had blood or bone marrow problems because of treatment with penicillamine;
- are breast-feeding or intend to breast-feed;
- are pregnant. (CUPRIMINE may be used in the treatment of Wilson's disease in pregnant women. Please consult your health care professional.);
- receive gold therapy, antimalarial or anti-cancer drugs, phenylbutazone and oxyphenbutazone;
- have evidence of lead in the gastrointestinal tract.
What the medicinal ingredient is
Penicillamine
What the non-medicinal ingredients are
D & C Yellow 10, Gelatin, Lactose, Magnesium Stearate, and Titanium Dioxide.
What dosage form it comes in
Capsules. Each capsule contains 250 mg penicillamine. CUPRIMINE 250 mg are ivory opaque capsules imprinted radially with “ATON 705” on cap and “CUPRIMINE” on body. All capsules contain white to almost white powder.
Warnings and precautions
BEFORE you use CUPRIMINE talk to your doctor or pharmacist if you think any of the following applies to you:
- If you have any medical problems now or have had in the past, especially kidney problems or blood diseases;
- If you are having or planning to have any type of surgery;
- If you are allergic to penicillin as you may also be allergic to penicillamine;
- If you have a muscle disease (i.e., myasthenia gravis);
- If you are pregnant or intending to become pregnant;
- If you are breast-feeding or intending to breast-feed.
Interactions with this medication
You should tell your doctor about any medication that you
are using or plan to use, including any medicine obtained
without a prescription, vitamins or mineral supplements.
You should not take CUPRIMINE if you are receiving:
- gold therapy;
- antimalarial medication;
- cytotoxic medication (anti-cancer drugs);
- antacid, iron;
- oxyphenbutazone or phenylbutazone.
Proper use of this medication
Usual Dose
It is important to take CUPRIMINE as directed by your doctor. CUPRIMINE must be taken on an empty stomach, at least one hour before a full meal or two hours after a full meal. Avoid taking any medication, food or milk within at least one hour after taking CUPRIMINE. Take with a full glass of water and drink plenty of water while taking this medication.
Overdose
If you take more than the dose prescribed by your physician, contact your physician or pharmacist immediately.
Missed Dose
If you miss a dose, do not take a double dose. The next dose
should be taken as usual.
If you need any explanations or further information, ask your
physician or pharmacist.
Side effects and what to do about them
Any medicine may have unintended or undesirable effects, socalled side-effects.
The most common side effects are loss of appetite, stomach pain,
nausea, vomiting, diarrhea, loss of sensitivity, taste change or loss
of taste perception, mouth or tongue infections.
Some patients may also experience allergic reactions (such as
swelling, severe trouble breathing, itching, or rashes).
Some patients may also experience easy bleeding or bruising,
blood in the urine.
Other side effects include: fatigue, weight gain, joint pain; blisters,
hives, fever; yellowing of skin and eyes, ringing in the ear, foggy
vision and/or decreased vision sharpness, agitation, anxiety, hair
loss, and muscular weakness.
Tell your physician or pharmacist promptly about these or any
other unusual symptoms.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Allergic Reactions (swelling, severe trouble breathing, itching, rashes). | ✔ | ||
| Easy bleeding or bruising, blood in the urine. | ✔ | ||
| Loss of appetite, stomach pain, nausea, vomiting, diarrhea. | ✔ | ||
| Loss of sensitivity, taste change or loss of taste perception, mouth or tongue infections | ✔ | ||
| Uncommon | |||
| Fatigue, weight gain, joint pain | ✔ | ||
| Blisters, hives, fever | ✔ | ||
| Yellowing of skin and eyes | ✔ | ||
| Ringing in the ear, foggy vision and/or decreased vision sharpness, agitation, anxiety, hair loss, muscular weakness | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking CUPRIMINE, contact your doctor or pharmacist
How to store
Store at 15-30°C. Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.
Reporting 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 three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 at:
http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp or obtained by contacting
the sponsor, Bausch Health, Canada Inc. at: 1-800-361-4261
This leaflet was prepared by Bausch Health, Canada Inc.
Last revised: December 12, 2019
CUPRIMINE® is a registered trademark of Bausch Health
Companies Inc. or its affiliates.