Orfadin 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitisinone

Available from:

Swedish Orphan Biovitrum Ltd

ATC code:

A16AX04

INN (International Name):

Nitisinone

Dosage:

10mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09080100; GTIN: 7350031440133

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ORFADIN 2 MG HARD CAPSULES
ORFADIN 5 MG HARD CAPSULES
ORFADIN 10 MG HARD CAPSULES
ORFADIN 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. 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 Orfadin
is and what it is used for
2.
What you need to know before you take Orfadin
3.
How to take Orfadin
4.
Possible side effects
5.
How to store Orfadin
6.
Contents of the pack and other information
1.
WHAT ORFADIN IS AND WHAT IT IS USED FOR
The active ingredient of Orfadin is nitisinone. This medicine is used
for treatment of a rare disease
called hereditary tyrosinemia type 1 in adults, adolescents and
children (in any age range).
In this disease 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. Orfadin
blocks the breakdown of tyrosine and the harmful substances are not
formed.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORFADIN
DO NOT TAKE ORFADIN
-
if you are allergic to nitisinone or any of the other ingredients of
this medicine (listed in section
6).
Do not breast-feed while taking this medicine, see section
“Pregnancy and breast-feeding”.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Orfadin.
-
if you g

Summary of Product characteristics

OBJECT 1
ORFADIN 2MG 5MG 10MG AND 20 MG HARD CAPSULES
Summary of Product Characteristics Updated 06-Mar-2017 | Swedish
Orphan Biovitrum Ltd
1. Name of the medicinal product
Orfadin 2 mg hard capsules
Orfadin 5 mg hard capsules
Orfadin 10 mg hard capsules
Orfadin 20 mg hard capsules
2. Qualitative and quantitative composition
Each capsule contains 2 mg nitisinone.
Each capsule contains 5 mg nitisinone.
Each capsule contains 10 mg nitisinone.
Each capsule contains 20 mg nitisinone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on
the body of the capsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on
the body of the capsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on
the body of the capsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on
the body of the capsule.
The capsules contain a white to off white powder.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Nitisinone treatment should be initiated and supervised by a physician
experienced in the treatment of
HT-1 patients.
Posology
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).
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 limi