Cuprimine (Bausch Health, Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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.

CUPRIMINE is not effective in the treatment of ankylosing spondylitis (chronic arthritis which affects the spine).

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 important nonmedicinal ingredients are:

D & C Yellow 10, Gelatin, Lactose, Magnesium Stearate, and Titanium Dioxide.

What dosage forms 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.

Reduction of vitamin B6 and iron in the body may occur during treatment with CUPRIMINE.

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, so-called 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.

This is not a complete list of side effects. For any unexpected effects while taking CUPRIMINE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 15-30°C. Keep container tightly closed.

KEEP OUT OF REACH OF CHILDREN.

Reporting Side Effects

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

Last revised: December 12, 2019

CUPRIMINE^® is a registered trademark of Bausch Health Companies Inc. or its affiliates.