Trientine Capsules

Along with their useful effects, all medicines can cause unwanted side-effects although not everyone experiences them. The table below lists some of the most common ones associated with trientine. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve over the first few days of taking a new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

Speak to your doctor if you experience stomach pain or diarrhoea that doesn't go away.

If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

• Keep all medicines out of the reach and sight of children.
• Store in the original container in a refrigerator (2-8°C). Do not allow the capsules to freeze.
• Use within three months of first opening and do not use if the capsules become sticky or wet.

Hypersensitivity to this product.

Clinical experience with Trientine Hydrochloride Capsules has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

Trientine Hydrochloride Capsules are not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of Trientine Hydrochloride Capsules is 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under.

The daily dose of Trientine Hydrochloride Capsules should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6-12 month intervals (see PRECAUTIONS, Laboratory Tests).

It is important that Trientine Hydrochloride Capsules be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.