Wilzin
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
14-06-2019
Данни за продукта
(SPC)
14-06-2019
Доклад обществена оценка
(PAR)
12-01-2010
Активна съставка:
zinc
Предлага се от:
Recordati Rare Diseases
АТС код:
A16AX05
INN (Международно Name):
zinc
Терапевтична група:
Other alimentary tract and metabolism products,
Терапевтична област:
Hepatolenticular Degeneration
Терапевтични показания:
Treatment of Wilson's disease.
Каталог на резюме:
Revision: 11
Статус Оторизация:
Authorised
Дата Оторизация:
2004-10-12
Листовка
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
WILZIN 25 MG HARD CAPSULES
WILZIN 50 MG HARD CAPSULES
zinc
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you personally. Do not pass it
on to others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Wilzin is and what it is used for
2.
Before you take Wilzin
3.
How to take Wilzin
4.
Possible side effects
5
How to store Wilzin
6.
Further information
1.
WHAT WILZIN IS AND WHAT IT IS USED FOR
Wilzin belongs to a group of medicines called Various Alimentary Tract
and metabolism products.
Wilzin is indicated in the treatment of Wilson’s disease, which is a
rare inherited defect in copper
excretion. Dietary copper, which cannot be properly eliminated,
accumulates first in the liver, then in
other organs such as the eyes and the brain. This potentially leads to
liver damage and neurological
disorders.
Wilzin blocks the absorption of copper from the intestine thereby
preventing its transfer into the blood
and its further accumulation in the body. Unabsorbed copper is then
eliminated in the stool.
Wilson’s disease will persist during the entire lifetime of the
patient and therefore the need for this
treatment is life-long.
2.
BEFORE YOU TAKE WILZIN
DO NOT TAKE WILZIN
If you are allergic (hypersensitive) to zinc or any of the other
ingredients of Wilzin.
TAKE SPECIAL CARE WITH WILZIN
Wilzin is usually not recommended for initial therapy of patients with
signs and symptoms of
Wilson’s disease because of its slow onset of action.
If you are currently treated with another anti-copper agent, for
example, penicillamine, your doctor
may add Wilzin before stopping the initial treatment
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Wilzin 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of
zinc acetate dihydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Capsule with aqua blue opaque cap and body, imprinted "93-376”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Wilson’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 dose 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 syr
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