Nitisinone Dipharma 20 mg hard capsules

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Nitisinone

Fáanlegur frá:

Dipharma Arzneimittel GmbH

ATC númer:

A16AX04

INN (Alþjóðlegt nafn):

Nitisinone

Lyfjaform:

Capsule, hard

Lækningarsvæði:

nitisinone

Leyfisdagur:

2020-05-01

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NITISINONE DIPHARMA 2 MG HARD CAPSULES
NITISINONE DIPHARMA 20 MG HARD CAPSULES
Nitisinone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nitisinone Dipharma is and what it is used for
2.
What you need to know before you take Nitisinone Dipharma
3.
How to take Nitisinone Dipharma
4.
Possible side effects
5.
How to store Nitisinone Dipharma
6.
Contents of the pack and other information
1.
WHAT NITISINONE DIPHARMA IS AND WHAT IT IS USED FOR
Nitisinone Dipharma contains the active substance nitisinone.
Nitisinone Dipharma is used to
treat
-
a rare disease called hereditary tyrosinemia type 1 in adults,
adolescents and children (in
any age range)
-
a rare disease called alkaptonuria (AKU) in adults.
In these diseases your body is unable to completely break down the
amino acid tyrosine (amino acids
are building blocks of our proteins), forming harmful substances.
These substances are accumulated in
your body. Nitisinone Dipharma blocks the breakdown of tyrosine and
the harmful substances are not
formed.
For the treatment of hereditary tyrosinemia type 1, you must follow a
special diet while you are
taking this medicine, because tyrosine will remain in your body. This
special diet is based on low
tyrosine and phenylalanine (another amino acid) content.
For the treatment of AKU, your doctor may advice you to follow a
special diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITISINONE DIPHARMA
DO NOT TAKE NITISINONE DIPHARMA
-
if you are allergic t

Vara einkenni

Health Products Regulatory Authority
02 December 2022
CRN00D83F
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitisinone Dipharma 20 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 20 mg nitisinone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
White, opaque capsules (shell size 2, length 18.0 mm) imprinted
"company logo" on the cap and "20" on the body of the
capsule in dark blue ink
The capsules contain a white to off white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hereditary tyrosinemia type 1 (HT-1)
Nitisinone Dipharma is indicated for the treatment of adult and
paediatric (in any age range) patients with confirmed diagnosis
of hereditary tyrosinemia type 1 (HT-1) in combination with dietary
restriction of tyrosine and phenylalanine.
Alkaptonuria (AKU)
Nitisinone Dipharma is indicated for the treatment of adult patients
with alkaptonuria (AKU).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HT-1:
Nitisinone treatment should be initiated and supervised by a physician
experienced in the treatment of HT-1 patients.
Treatment of all genotypes of the disease should be initiated as early
as possible to increase overall survival and avoid
complications such as liver failure, liver cancer and renal disease.
Adjunct to the nitisinone treatment, a diet deficient in
phenylalanine and tyrosine is required and should be followed by
monitoring of plasma amino acids (see sections 4.4 and 4.8).
_Starting dose HT-1_
The recommended initial daily dose in the paediatric and adult
population is 1 mg/kg body weight administered orally. The
dose of nitisinone should be adjusted individually. It is recommended
to administer the dose once daily. However, due to the
limited data in patients with body weight <20 kg, it is recommended to
divide the total daily dose into two daily
administrations in this patient population.
_Dose adjustment HT-1_
During regular monitoring, it is appropriate to follow urine