Trientine 250mg Capsules

Product Description

Trientine is used for:

Treating Wilson disease in patients for whom other treatments are ineffective or not appropriate.

Trientine is a chelating compound. It works by binding to copper to help remove it from the body.

Do not use Trientine if:

• You are allergic to any ingredient in Trientine
• Contact your doctor or health care provider right away if any of these apply to you.

Before using Trientine:

 Some medical conditions may interact with Trientine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have iron deficiency

Some MEDICINES MAY INTERACT with Trientine. Tell your health care provider if you are taking any other medicines, especially any of the following

Mineral supplements, because the effectiveness of Trientine may be decreased.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trientine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Trientine:

Use Trientine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Trientine on an empty stomach at least 1 hour before or 2 hours after eating and at least 1 hour before or after taking any other drug, food, or milk.

Swallow Trientine whole. Do not break, crush, or chew before swallowing.

Take Trientine with water.

If you miss a dose of Trientine, take it as soon as possible. If it is almost time for your next  dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2  doses at once.

Ask your health care provider any questions you may have about how to use Trientine.

Important safety information:

Patients receiving Trientine should remain under regular medical supervision throughout the period of drug administration. Patients, especially women, should be closely monitored for evidence of iron deficiency and anemia.

LAB TESTS, including serum iron, serum copper levels, urinary copper levels, and blood counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Trientine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Trientine, discuss with your doctor the benefits and risks of using Trientine during pregnancy. It is unknown if Trientine is excreted in breast milk. If you are or will be breast-feeding while you are using Trientine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Trientine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal muscle contractions or spasms; iron deficiency; lupus; muscle weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; red, swollen, or blistered skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Proper storage of Trientine:

• Store Trientine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), in a tightly closed container. Do not freeze. Keep Trientine out of the reach of children and away from pets.

General information:

. If you have any questions about Trientine, please talk with your doctor, pharmacist, or  other health care provider.

• Trientine is to be used only by the patient for whom it is prescribed. Do not share it with  other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Trientine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Trientine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trientine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Trientine.

For the Consumer

Applies to trientine: oral capsule

As well as its needed effects, trientine (the active ingredient contained in Syprine) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking trientine, check with your doctor or nurse as soon as possible:

More common – Symptoms of anemia

• Unusually pale skin
• unusual tiredness

Rare

• Fever
• general feeling of discomfort, illness, or weakness
• joint pain
• skin rash, blisters, hives, or itching
• swollen glands

Note: Signs of anemia are more likely to occur in children, menstruating women, and pregnant women, who usually need more iron than other patients. If these signs appear during trientine treatment, your doctor will need to do some tests.

For Healthcare Professionals

Applies to trientine: oral capsule

Nervous system

Central nervous system side effects have included dystonia, malaise, myasthenia gravis, and weakness.

Immunologic

Immunologic side effects have included systemic lupus erythematosus.

Hematologic

Hematologic side effects have included iron deficiency and hypochromic microytic anemia. The hypochromic microytic anemia was reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Musculoskeletal

Musculoskeletal system side effects have included muscle spasm, muscle pain, cramps, and rhabdomyolysis. The rhabdomyolysis was reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Gastrointestinal

Gastrointestinal side effects have included heartburn, epigastric pain and tenderness, acute gastritis, aphthoid ulcers, abdominal pain, melena, and anorexia. These side effects were reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Dermatologic

Dermatologic side effects have included thickening, fissuring, and flaking of the skin. These side effects were reported in 4 patients being treated with trientine (the active ingredient contained in Syprine) who had primary biliary cirrhosis.

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

Note : This product information is intended only for residents outside of the EU. Taj Accura Pharmaceuticals Limited medicines help to treat and prevent a range of conditions—from the most common to the most challengin

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management.

This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

*The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised July 2014. Copyright(c) 2014 Taj Pharma.

Selected from General Medical Drug data included with permission.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.