WILZIN Hard capsule Ref.[7402] Active ingredients: Zinc

Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson’s disease (see section 4.4). Wilzin is a life-long therapy.

There is no difference in dose between symptomatic and presymptomatic patients.

Wilzin is available in hard capsules of 25 mg or 50 mg.

Adults: The usual dose is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily.

Children and adolescents: Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible.

The recommended dosage is as follows:

• from 1 to 6 years: 25 mg twice daily.
• from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily.
• from 16 years or if bodyweight above 57 kg: 50 mg three times daily.

Pregnant women: A dose of 25 mg 3 times daily is usually effective but the dose should be adjusted to copper levels (see section 4.4 and section 4.6).

In all cases, dose should be adjusted according to therapeutic monitoring (see section 4.4.).

Wilzin must be taken on an empty stomach, at least 1 hour before or 2-3 hours after meals. In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid-morning, between breakfast and lunch. It is also possible to take Wilzin with a little protein, such as meat (see section 4.5).

In children who are unable to swallow capsules, these should be opened and their content suspended in a little water (possibly sugar or syrup flavoured water).

When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption. The administration of the chelating treatment and Wilzin should be separated by at least 1 hour.

Three cases of acute oral overdose with zinc salts (sulphate or gluconate) have been reported in the literature. Death occurred in a 35 year-old woman on the fifth day after ingestion of 6 g of zinc (40 times the proposed therapeutic dose) and was attributed to renal failure and haemorrhagic pancreatitis with hyperglycaemic coma. The same dose did not produce any symptoms except for vomiting in an adolescent who was treated by whole-bowel irrigation. Another adolescent who ingested 4 g of zinc had serum zinc level of about 50 mg/l 5 hours later and only experienced severe nausea, vomiting and dizziness.

Treatment of overdose should be with gastric lavage or induced emesis as quickly as possible to remove unabsorbed zinc. Heavy metal chelation therapy should be considered if plasma zinc levels are markedly elevated (>10 mg/l).

Shelf life: 3 years.

Do not store above 25°C.

White HDPE bottle with a polypropylene and HDPE closure and contains a filler (cotton coil). Each bottle contains 250 capsules.

No special requirements.