CUPRIOR Film-coated tablet Ref.[9243] Active ingredients: Trientine

Treatment should only be initiated by specialist physicians with experience in the management of Wilson’s disease.

Posology

The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient’s clinical response (see section 4.4).

The recommended dose is between 450 mg and 975 mg (3 to 6 1⁄2 film-coated tablets) per day in 2 to 4 divided doses.

Special populations

Elderly

No dose adjustment is required in elderly patients.

Renal impairment

There is limited information in patients with renal impairment. No specific dose adjustment is required in these patients (see section 4.4).

Paediatric population

The starting dose in paediatrics is lower than for adults and depends on age and body weight.

Children ≥5 years

The dose is usually between 225 mg and 600 mg per day (1 1⁄2 to 4 film-coated tablets) in 2 to 4 divided doses.

Children aged <5 years

The safety and efficacy of trientine in children aged <5 years have not been established. The pharmaceutical form is not suitable for administration to children <5 years.

The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).

Method of administration

Cuprior is for oral use. The film-coated tablets should be swallowed with water. The scored film-coated tablet can be divided in two equal halves, if required, to provide a more precise dose or facilitate administration.

It is important that Cuprior is 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 medicinal product, food, or milk (see section 4.5).

Occasional cases of trientine overdose have been reported. In cases up to 20 g of trientine base there were no apparent adverse effects reported. A large overdose of 40 g of trientine base resulted in self- limiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported.

There is no antidote for trientine acute overdose.

Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia. Overtreatment and excess copper removal can be monitored using values of urine copper excretion and of non-ceruloplasmin bound copper. Close monitoring is required to optimise the dose or to adapt treatment if necessary (see section 4.4).

30 months.

This medicinal product does not require any special storage conditions.

OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.

Pack size: 72 or 96 film-coated tablets.

Not all pack sizes may be marketed.

No special requirements.